SAJBL Vol 9, No 1 (2016)

ISSN 1999-7639

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW May 2016 Vol. 9 No. 1

Financial support for SAJBL is received from the Medical Protection Society.

SAJBL is published by the Health and Medical Publishing Group.

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW May 2016 Vol. 9 No. 1

CONTENTS

2

EDITORIAL Medical negligence: Alternative claims resolution an answer to the epidemic?

A Dhai

FORUM 4 May doctors refuse to treat rape survivors in order to avoid having to give evidence in court?

D McQuoid-Mason 7

Mediation as an alternative solution to medical malpractice court claims N Claassen

ARTICLES 11 Constitutional, legal and regulatory imperatives for the renewed care and prevention of congenital disorders in South Africa

H Malherbe, A L Christianson, C Aldous, M Christianson 18 Respect for vulnerability is a human right: Article 8 of the UNESCO Declaration on Bioethics and Human Rights, and senior citizens in South Africa

R Rheeder 22 Social media in the healthcare context: Ethical challenges and recommendations

C Grobler, A Dhai 26 Should drinking during pregnancy be criminalised to prevent fetal alcohol spectrum disorder?

J B Gardner 31 Client confidentiality: Perspectives of students in a healthcare training programme

N Nortje, J de Jongh 35 But is this really the ‘parent’ or ‘guardian’? Practical strategies for consent to child research in South Africa

C M Slack, A E Strode 39 Ethical considerations in implementing a biometric co-enrolment prevention system in clinical trials in South Africa

J Moodley, S Naidoo, N S Morar, V Govender, P Charls, G Ramjee 42 Contextualising the role of the gatekeeper in social science research

S Singh, D R Wassenaar

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BOOK REVIEW Medical Ethics Today. The BMA’s Handbook of Ethics and Law A Dhai

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CPD The SAJBL is published by the Health and Medical Publishing Group (Pty) Ltd, Co. registration 2004/0220 32/07, a subsidiary of SAMA. Suites 9 & 10, Lonsdale Building, Gardener Way, Pinelands, 7405 All letters and articles for publication must be submitted online at www.sajbl.org.za Tel. 021 532 1281 / E-mail: publishing@hmpg.co.za

EDITOR Ames Dhai CO-EDITOR David McQuoid-Mason EDITORIAL BOARD Kevin Behrens Alexandra Capron Peter Cleaton-Jones Liz Gwyther Mariana Kruger Willem Landman Leslie London Nhlanhla Mkhize Charles Ngwenya J P de V van Niekerk Daniel Wikler HMPG CEO AND PUBLISHER Hannah Kikaya Email:hannahk@hmpg.co.za EXECUTIVE EDITOR Bridget Farham MANAGING EDITORS Ingrid Nye Claudia Naidu TECHNICAL EDITORS Emma Buchanan Paula van der Bijl Diane de Kock PRODUCTION AND ADMINISTRATION MANAGER Emma Jane Couzens DTP AND DESIGN Carl Sampson CUSTOMER SERVICE AND ONLINE SUPPORT Gertrude Fani FINANCE AND ADMINISTRATION Tshepiso Mokoena HMPG BOARD OF DIRECTORS Prof. M Lukhele (Chair), Dr M R Abbas, Dr M J Grootboom, Mrs H Kikaya, Prof. E L Mazwai, Dr M Mbokota, Dr G Wolvaardt ISSN 1999-7639

EDITORIAL

Medical negligence: Alternative claims resolution an answer to the epidemic?

Ames Dhai Editor amaboo.dhai@wits.ac.za The price paid by society because of unreasonable medical neg­ ligence claims cannot be ignored. While medical malpractice systems in the country are exorbitantly costly, they are also inefficient. This impacts directly on access to healthcare, a basic human right in the country as enshrined in section 27 of the Bill of Rights of the Constitution of South Africa (SA).[1] Practising defensive medicine, irrespective of the sector in which healthcare is delivered, has now become the norm, with the focus being not just patient health and best interests, but also that of safeguarding against possible medical malpractice liability, thereby increasing unnecessary clinical and diagnostic procedures. The unequivocal situation is that currently the fear of lawsuits holds hostage practitioners’ options and preferences for delivery of ethically exercised care to their patients, leading to frustration and dissatisfaction both to practitioners and patients.[2] Moreover, a culture of blame is also now pervasive.

While the Medical Protection Society (MPS) has over the past 6 years witnessed deterioration in their overall claims environ­ ment in the country, it does not believe that the situation is owing to a decline in professional standards. Several complex factors, some of them positive, are attributed to the current state of affairs. According to the MPS, these include the fact that robust, patient-centered complaints systems are lacking, thereby leaving litigation by patients as the only viable avenue for redress. Delays are endemic because of the lack of efficient and predictable legal processes for the handling of clinical negligence claims. Claim sizes have therefore increased. The costs of settling claims also increase with protracted legal processes. Attorneys have refocused their interest areas towards personal injury and, in particular, clinical negligence claims following amendments to the Road Accident Fund Act.[3] Protections for patients in terms of their rights in the Constitution and the Consumer Protection Act,[4] coupled with increasing patient expectations with regard to greater involvement in and understanding of their healthcare, while positive, have also contributed to the upturn in the frequency of claims. The MPS further states that the clinical negligence system currently in place does not facilitate efficient and fair resolution of disputes. Rather, it is adversarial, time-consuming, expensive, lacks transparency and frequently gives rise to ‘trial by ambush’.[5] The situation in SA reflects the experience of practitioners in many parts of the world. Various approaches towards addressing

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May 2016, Vol. 9, No. 1 SAJBL

the problem have been considered and embarked upon, and alter­ native claims resolution (ACR) has been proposed by many.[2] ACR approaches include non-judicial, specialised health courts systems with specialised judges and state-appointed neutral experts to systematically adjudicate claims. Medical review and screening panels to weed out frivolous complaints and encourage swift settlement of meritorious claims have also been proposed. Peer review of expert testimony could be considered in order to curb the number of experts who are willing to make dogmatic state­ments irrespective of bias. Negotiation and mediation as a form of ACR are valuable considerations as well. Negotiation is when two or more people work together towards mutually agreeable out­comes by creating a deal or resolving a conflict. Mediation is ‘… facilitated negotiation in which the parties involved in conflict meet in the presence and with the assistance of an impartial third party called the mediator’.[2] In this issue, Judge Claassen explains the merits of embarking on a process of mediation rather than litigation for medical negligence claims.[6] Greater disclosure of medical errors has been advocated by many.[2,5] This approach is supported as it is good ethical practice and enhan­ces the patient-practitioner trust relationship. However, a major and realistic fear with the method proposed is that open and honest dis­closures could facilitate further medical negligence claims. In some countries apology laws have been enacted to protect statements of apology made by medical practitioners by excluding the use of these apologies as evidence in medical malpractice litigation. Emerging evidence does show that in such situations mal­practice claims have been dramatically reduced by up to 47% in compensation payments and settlement times have been reduced to about 6 months. It has also been shown that apology laws have helped with expediting the resolution process and decreasing the claims frequency.[2] Other forms of reform include staggered payments of damages should the award exceed a predefined threshold and the capping or limiting of claims on noneconomic and punitive damage. While medical insurance premiums have been shown to be kept down in countries where capping has been implemented, varied results have been found as regards claims and payouts for noneconomic damages.[2] In the USA, 29 states have introduced a limit on damages.

Limits range from USD250 000 in California to USD750 000 per incident in Tennessee and Wisconsin. A reported 19% decrease in the average value of noneconomic claims coupled with a decline from 4% to 1.4% in the probability that a case would be brought to court is promising with regard to limiting frivolous lawsuits and keeping down the costs of healthcare by capping claims.[5] However, limiting payouts must not erode the principle of fairness and patients have to be adequately reimbursed for damages legitimately claimed for.

Controversy in the USA over this process has led to legal challenges, and seven states have had their Supreme Courts revoke capping as unconstitutional.[5] Instead of merely capping claims, redu­cing monetary incentives for attorneys by limiting their fees should

EDITORIAL be included in legal reform. This could include a sliding scale fee schedule that reduces contingency fees or a peer review process when contingency fees are charged.[2] Early in 2015, Dr A Motsoaledi, the Minister of Health (MoH) of SA convened a Medico-Legal Summit where much of the above was highlighted. In addition, inherent systems failures in the public healthcare sector were underscored as contributing to the escalating frequency of malpractice and negligence claims against the state.[7] An outcome of the Summit was the establishment of a ministerial medico-legal task team to develop a declaration which would assist with addressing this SA crisis. The MedicoLegal Summit declaration was signed into effect on 15 March this year by the MoH. The declaration addresses three categories of concerns: patient safety, administrative and legal. Implementation of the resolutions in the de­claration will utilise a phased approach – immediate, medium term and long term. The task team has planned a process whereby provincial heads will be engaged in implementing this declaration. It is hoped that with time the culture of blame will evolve into a culture of patient safety irrespective of the sector in which healthcare is delivered.

Acknowledgements: I would like to thank Dr Terence Carter, Deputy Director General of Health and the medico-legal task team for giving me permission to report on the Declaration.

References 1. Republic of South Africa. The Constitution of the Republic of South Africa.

Pretoria: Government Gazette, 1996.

2. World Health Organization. Rapid Scoping Review of Medical Malpractice Policies in Obstetrics. Geneva: World Health Organization, 2015. www.whoreport_malpracticemodels_-12aug2015_final.pdf (accessed 1 May 2016).

3. Republic of South Africa. Road Accident Fund Amendment Act 19. Pretoria: Government Gazette, 2005.

4. Republic of South Africa. Consumer Protection Act 68. Pretoria: Government Gazette, 2008.

5. Medical Protection Society. Challenging the Cost of Medical Negligence. The Case for Reform. London: Medical Protection Society, 2015. http://www.medicalprotection. org/docs/default-source/pdfs/Booklet-PDFs/sa-booklets/challenging-the-cost-ofclinical-negligence---the-case-for-reform.pdf?sfvrsn=4 (accessed 1 May 2016) 6. Claassen N. Mediation as an alternative solution to medical malpractice court claims. S Afr J BL 2016;9(1):7-10. DOI:10.7196/SAJBL.469 7. Dhai A. Medico legal litigation: Balancing spiraling costs with fair compensation.

S Afr J BL 2015;8(1)2-3. DOI:10.7196/SAJBL.407

S Afr J BL 2016;9(1):2-3. DOI:10.7196/SAJBL.474

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FORUM

May doctors refuse to treat rape survivors in order to avoid having to give evidence in court?

D McQuoid-Mason David McQuoid-Mason is Professor of Law at the Centre for Socio-Legal Studies, University of KwaZulu-Natal, Durban, and publishes and teaches in medical law.

Corresponding author: D J McQuoid-Mason (mcquoidm@ukzn.ac.za)

It has been reported recently that private doctors often refuse to treat rape survivors because they do not want to give evidence in court.

Private doctors and hospitals must treat patients in emergency situations, but may otherwise refuse to treat patients provided such refusal is not unconstitutional. Rape survivors require emergency medical treatment and should not be refused treatment by private doctors and hospitals because practitioners do not wish to give evidence in court. Such refusal is unconstitutional. Sexual assault evidence kits may be used by both private doctors and hospitals. Given the high rate of sexual violence in South Africa it is recommended that both private and state doctors should have stocks of sexual assault kits, and the National Police Commissioner’s national instruction for providing assistance to survivors of sexual offences. District surgeons ‘on call’ must treat rape survivors as requiring emergency medical treatment. They may not defer seeing them until the next day as this violates their constitutional right to dignity and exposes them to secondary victimisation.

S Afr J BL 2016;9(1):4-6. DOI:10.7196/SAJBL.461

It has been reported recently that ‘[m]any doctors are reluctant to take on rape cases because they fear the courtroom and are horrified by the brutality of the crime’ and that this failure by them is ‘contributing to South Africa’s (SA) dismal conviction rate for sexual offences’.[1] It was also reported that ‘[o]verstretched health workers and police also fail to prioritise sexual assault’ and that there is a less than 9% conviction rate for the 62 649 sexual offences reported during 2013 - 2014.[1] If doctors refuse to treat rape survivors as victims of sexual offences and do not record the necessary medicolegal evidence correctly there is little chance of rape survivors who lay criminal charges against alleged offenders having their day in court and receiving justice.

Consider the following facts: A woman is attacked and raped by two men over a period of three and a half hours in the late afternoon and early evening. She is also stabbed, has second-degree burns inflicted on her breasts and torso with an iron, her face is bruised all over and her eardrum is burst. When she arrives at a private hospital by ambulance, the two sisters on duty inform her that a rape kit has to be taken within hours of the rape, and must be done at a provincial hospital and rape crisis centre, which are only open during office hours. A doctor at the hospital refuses to treat her injuries – without even examining her – because he says that he would be tampering with the evidence. The doctor does not offer her a painkiller. She is later told that the private hospital’s protocol is that they will only assist if the rape survivor’s life is in danger. She goes to a provincial hospital which opens its rape crisis centre and the survivor is attended to by a nursing sister who telephones the district surgeon ‘on call’. The district surgeon ‘on call’ does not respond to the sister’s calls.

Hours later the sister is given authority to give the survivor a painkiller and an intern treats her wounds. The district surgeon arrives the next morning to see her.[2]

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The above scenario begs the following questions: • Are nursing staff and doctors at private hospitals legally obliged to treat rape survivors?

• Can sexual assault evidence collection kits only be used at public hospitals?

• Can a district surgeon who is ‘on call’ refuse to examine a patient until the morning after she was raped the evening before?

Are nursing staff and doctors at private hospitals legally obliged to treat rape survivors?

As a general rule healthcare practitioners in private practice or private hospitals are not obliged to treat people unless it is a medical emergency or the refusal to treat is unconstitutional.[3] A medical emer­gency is defined as a situation where a person ‘suffers a sudden catastrophe which calls for immediate medical attention’.[4] In such in­ stan­ces a patient should not be turned away from a hospital which is able to provide the necessary treatment.[3] In emergency situations there is a duty to treat and stabilise a patient who cannot afford the services of a private practitioner or hospital before referring them to a public hospital or clinic.[5] It has been suggested that ‘there can be little doubt that a rape survivor in the South African context, given the high probability of HIV infection, qualifies for the constitutional right to emergency medical treatment as defined by the Constitutional Court’.[5] This is particularly so where the 72-hour limit for successful prevention of HIV infection is approaching.[5] Even if all rape cases were not treated as emergencies, rape survivors who can afford the services of a private practitioner or hospital cannot be refused treatment on unconstitutional grounds.

Obvious examples are if private practitioners or hospitals refuse to treat people on the grounds of their race, religion, gender or

FORUM any of the other listed grounds in the Constitution that outlaw discrimination.[6] Any other unlisted grounds of unfair discrimination are also unconstitutional.

It is submitted that a refusal by private practitioners or hospitals to treat rape survivors who can afford their services on the grounds that the doctors or hospital staff do not wish to give evidence in court is ‘unfair discrimination’. Such a refusal undermines the constitutional right of rape survivors to have their dignity respected.[7] It also violates their right not to be treated in a cruel, inhuman and degrading way,[8] by being left in a painful, degrading, unhygienic and psychologically disturbed state while waiting to be transferred to another healthcare institution, before receiving any medical attention.

The challenge with rape survivors is that healthcare practitioners have to balance ‘the sometimes competing demands of appropriate medical care and management of the survivor with the need to collect proper forensic evidence’, and it has been suggested that ‘[in] such cases the healthcare of the patient takes precedence’.[9]

Can sexual assault evidence collection kits only be used at public hospitals?

Where the rape survivor lays a criminal charge

HIV infection.[12] The police should then be requested to collect and transport the rape survivor to a public health facility for further care.

Rape survivors should not be turned away by private healthcare facilities, nor should they be kept waiting for unreasonable periods of time until the police arrive or before they are transported to a state hospital.[12] If there are likely to be unreasonable delays the private institution should arrange for the necessary transport to a state hospital.[5] Where, however, the survivor wishes to continue treatment at a private institution, and can afford it, the request cannot be refused on unconstitutional grounds,[5] for instance, because the doctors do not want to give evidence in court.

Where a rape survivor is kept waiting at a private facility, and not provided with PEP to prevent HIV infection when the 72-hour PEP deadline is about to expire, she may have an action against the facility for negligence if she contracts the virus because it is no longer possible for her to receive PEP treatment. If she can prove such negligence she may claim for pain and suffering, loss of expectation of life, loss of earnings and future medical expenses.[5]

Where the rape survivor does not wish to lay a criminal charge

The Criminal Law (Sexual Offences and Related Matters) Amendment Act[10] requires the National Commissioner of Police to issue a na­tional instruction with guidelines for the police to follow when providing assistance to survivors of sexual offences. Where a rape survivor reports the matter to the police, the latter must take the person for a medical exam­ination by a district surgeon or a person appointed by the De­part­ment of Health (DoH) to conduct such medical exami­ nations.[11] In such cases healthcare practitioners will refuse to conduct a medi­cal examination before a docket has been opened and a South African Police Service (SAPS) 308 form has been completed. The SAPS 308 form contains a request by the police for the rape survivor to be examined by a health practitioner. The results of the examination will be recorded by the health practitioner on a J88 form.[11] When a rape survivor lays a charge with the police, the investigating officer must inform the rape survivor: • of the need for HIV testing and post-exposure prophylaxis (PEP) • of the purpose of obtaining samples • of the reasons why SAPS 308 and J 88 forms must be completed • that he or she may request the return of articles seized as evidence after the conclusion of the criminal case, with a warning that the articles may be damaged during the forensic process • that he or she will be allowed to wash or have a bath once the medical examination is complete • that the healthcare professional will answer questions relating to the medical treatment or services available if further treatment is needed • that the healthcare professional may refer the survivor to a public health establishment.[11]

Where a rape survivor does not wish to lay a criminal charge, the restrictions regarding the use of the SAPS 308 and J 88 forms do not apply and she may be examined by a private or state-employed doctor.[12] However, if the victim later changes her mind and wants to report the incident, it is recommended that the medical practitioner should record the examination in accordance with annexure C of the national instruction.[12] The doctor should collect and preserve any evidence using a sexual assault evidence collection kit as if the victim had been examined at the request of the police.[12] Given the high incidence of sexual violence in SA, all public and private health establishments and private sector medical practitioners who are likely to be consulted by the victims of sexual offences (whether or not they are likely to be reported to the police) should ensure that they have a stock of sexual assault evidence collection kits[12] as well as copies of the national instruction and its annexures, which include: • a list of the public health establishments in each province providing PEP treatment • a list of the sexual offences under the Sexual Offences Amendment Act • possible samples to be taken from the victim • possible samples to be taken from the suspect • a sexual offence statement checklist • guidelines to taking a statement from a child victim.[12]

Where the time limit of 72 hours after the rape is about to expire, and a rape survivor who reports directly to a private healthcare facility wishes to lay a criminal charge, the facility should immediately contact the police.[12] At the same time the facility should provide counselling and deal with the medical examination as required in annexure C of the national instruction. The facility should also conduct HIV testing, and where necessary, provide the initial PEP treatment to prevent

District surgeons, usually general medical practitioners, are full-time or part-time paid officials of the DoH. Part-time district surgeons simultaneously run their private medical practices. Although district surgeons are required to examine complainants in cases of alleged rape who have been referred to them by the police, complainants may insist that their private medical practitioner also be present. District surgeons are bound by all the rules of the medical profession,[13]

Can a district surgeon who is ‘on call’ refuse to examine a patient until the morning after she was raped the evening before?

May 2016, Vol. 9, No. 1 SAJBL

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FORUM including the duty to assist in emergencies and not to violate the constitutional rights of patients.

District surgeons are bound by the terms of their contracts with the DoH, which may require them to be ‘on call’ on certain occasions to treat rape survivors and other victims of sexual assault. The DoH’s National Policy Guidelines for Victims of Sexual Offences[14] require public health facilities to ensure that services for victims of sexual offences are available on a 24-hour basis, and that: • rape victims are moved to the front of health queues • for forensic reasons medical evidence must be captured as quickly as possible • the victim should be allowed to wash after the examination • medical and psychological problems should be dealt with quickly • the intervention by the health professional should be sensitive to the experience of the victim • the attending health practitioner must ensure that secondary victimisation does not take place.[14] It is submitted that these policy guidelines must be observed by fulltime and part-time district surgeons who are paid a salary by the DoH to render forensic services in addition to their other health work.

In the scenario mentioned in the introduction almost every one of the DoH’s policy guidelines regarding rape survivors was violated by the district surgeon ‘on call’ who refused to examine the patient until the following day. These include the district surgeon’s: • failure to capture the medical evidence as quickly as possible • refusal to see her until the next morning, which resulted in the victim not being able to wash until then • not ensuring that the victim’s medical and psychological problems were dealt with quickly • allowing her to remain in cruel, inhuman and degrading circum­ stances until the next morning, which resulted in secondary vic­ timisation.

Conclusion Private doctors and hospitals must treat patients in emergency situations. They may refuse to treat certain patients, provided such refusal is not unconstitutional. Rape survivors require emergency medical treatment. They may not be refused treatment by private

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doctors and hospitals because practitioners do not wish to give evidence in court. Such refusal is unconstitutional as it amounts to ‘unfair discrimination’. Sexual assault evidence kits may be used by private doctors and hospitals. Given the high rate of sexual violence in SA it is recommended that both private and state doctors should have stocks of sexual assault kits on hand, and the National Police Commissioner’s national instruction for providing assistance to survivors of sexual offences. District surgeons ‘on call’ must treat rape survivors as requiring emergency medical treatment. They may not defer seeing them until the next day as this violates their constitutional right to dignity and exposes them to secondary victimisation.

References 1. Narsee AJ. Traumatised by sex crimes, SA’s doctors shun victims. Johannesburg: Times Media Group; Sunday Times, 27 December 2015:11.

2. Anonymous letter. When hospitals add to the ordeal of rape. Johannesburg: Times Media Group; Sunday Times: 27 December 2015:16.

3. McQuoid-Mason DJ. The Medical Profession and Medical Practice. In: Joubert WA, Faris JA, eds. The Law of South Africa. Vol 17(2) 2nd ed. Durban: LexisNexis, 2008: 37-38 para 44.

4. Soobramoney v. Minister of Health, KwaZulu-Natal 1998 1 SA 765 (CC).

5. McQuoid-Mason DJ, Dhai A, Moodley J. Rape survivors and the right to emergency medical treatment in order to prevent HIV infection. S Afr Med J 2003;93(1):41-44.

6. Republic of South Africa. Constitution of the Republic of South Africa, Section 9(3). Pretoria: Government Gazette, 1996.

7. Republic of South Africa. Constitution of the Republic of South Africa, Section 10.

Pretoria: Government Gazette, 1996.

8. Republic of South Africa. Constitution of the Republic of South Africa, Section 12(1)(e). Pretoria: Government Gazette, 1996.

9. Martin LJ. Sexual offences. In: Dada MA, McQuoid-Mason DJ, eds. Introduction to Medico-Legal Practice. Durban: Butterworth, 2001:248.

10. Republic of South Africa. Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32, Section 2. Pretoria: Government Gazette, 2007.

11. Republic of South Africa. National Instruction No. 3, Government Notice 865, Sections 10 and 16. Pretoria: Government Gazette No. 31330, 15 August 2008.

12. McQuoid-Mason D. Assisting victims of sexual offences: Ensuring a professional service by the SAPS – how it affects medical practitioners. S Afr Med J 2006;96(7): 509-601.

13. McQuoid-Mason DJ. The responsibility of doctors during the State of Emergency.

Acta Jurid (Cape Town) 1988:65-106.

14. Department of Health. Uniform National Health Guidelines for dealing with Survivors of Rape and other Sexual Offences. Pretoria: Department of Health, 1998. http://www. justice.gov.za/policy/guide_sexoff/sex-guide02.html (accessed 2 January 2016).

FORUM

Mediation as an alternative solution to medical malpractice court claims N Claassen, BCom, LLB, LLM Neels Claassen is retired judge in the High Court of South Africa, South Gauteng, Johannesburg and a retired member of the Alternative Dispute Resolution Association of South Africa and the South African Association of Arbitrators.

Corresponding author: N Claassen (neelsclaassen15@gmail.com)

Is there a crisis in the healthcare industry? Most certainly there is. Dr Motsoaledi, Minister of Health, publicly acknowledged the existence of such a crisis at a Medico-Legal Summit held at his initiative in Pretoria on 9 and 10 March 2015 at St Georges Hotel.[1] Currently, as recently confirmed by the MEC for Health, Ms Mahlangu, there are about 2 000 pending court cases against the Gauteng Provincial Health Department, the total quantum being claimed amounting to approximately ZAR 3.5 billion. During 2013/2014 this department spent about ZAR 256 million on legal costs payable to claimants’ attorneys. No budget for these expenses exists, resulting in payment being made from funds designated for the acquisition of medical equipment and other purposes.[1] This undermines the department’s ability to renew old equipment and upgrade to more modern equipment, resulting in even further claims. More claims are therefore to be expected.

The Medical Protection Society also confirmed an increase in medical malpractice claims against their members of nearly 550% compared to 10 years ago. The quantum of claims that exceeded ZAR 5 million per claim, also increased by 900%.[2,3] The ripple effect of these increases in medico-legal claims causes insurance premiums for healthcare professionals to become exorbitantly expensive, resulting in some practitioners leaving the medical profession. Practitioners also act more defensively in applying their trade, resulting in additional and sometimes unnecessary tests that increase the costs of medical care and often cause further grounds for the institution of claims.

S Afr J BL 2016:9(1):7-10. DOI:10.7196.SAJBL.469

•

•

•

•

•

•

What motivates patients to institute court claims against health­care professionals?

• The desire for monetary compensation: Parents claim­ing on behalf of injured children; dependents claiming for loss of support from a deceased; claims in respect of minors only prescribe after they reach 18 years of age resulting in forced settlements for lack of being able to defend the claim due to the absence of medical records and the relevant medical personnel associated with the event which occurred so long ago.

Touting and advertising by lawyers: Touting is illegal but advertising is legal. Hospitals should more readily enforce their reserved rights of admission to remove persons caught touting for work from patients.

Claiming on a contingency fee basis: No risk involved for the claimant, as the attorney is paid nothing if the claim fails but receives 25% of any amount successfully recovered.

Lack of proper doctor/patient communication undermining ‘informed consent’: Proper explanatory communications with patients are important, both pre- and post-treatment.

Deterioration of service by overburdened and understaffed medical personnel and equipment causes unnecessary adverse out­comes, giving rise to claims.

Criminal conduct: It has been reported that healthcare staff unlawfully sell the hospital records to attorneys leaving the hos­ pital defenceless. If attorneys are found to be in possession of original hospital records, it should be reported to the police for investigation.[1] Advent of constitutional protections: Section 10 (right to human dignity); section 11 (right to life); section 12(2) (right to bodily

and psychological integrity); section 27 (right to healthcare services, ability to support dependents, right not to be refused emergency medical treatment); section 28 (children rights to basic healthcare services, protection from maltreatment, neglect, abuse or degradation, entitlement to legal representation in civil proceedings); section 34 (everyone has the right to go to court or other tribunal or forum).[4] • Consumer Protection Act 68 of 2008 making patients aware of their rights and limiting the protective effect of exculpatory clauses: Section 22 (right to information in plain language); section 48 (right to fair, reasonable and just contract terms); section 49 (right to proper notice of certain terms and conditions); section 51 (prohibited terms and conditions); section 54 (right to quality service); section 58 (warning concerning nature of risks); section 61 (faultless liability for damage caused by goods and services).[5] In Afrox Healthcare Bpk v, Strydom 2002 (6) SA 21 (SCA),[6] a case de­ cided PRIOR to the promulgation of the Consumer Protection Act, the Supreme Court of Appeal in Bloemfontein enforced an exemption clause in the admission document of the hospital that absolved: ‘… the hospital and/or its employees and/or agents from all liability and indemnified them from any claim instituted by any person (including a dependant of the patient) for damages or loss of whatever nature (including consequential damages or special damages of any nature) flowing directly or indirectly from any injury (including fatal injury) suffered by or damage caused to the patient or any illness (including terminal illness) contracted by the patient whatever the cause/causes are, except only with the exclusion of intentional omission by the hospital, its employees or agents.’

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FORUM The negligence of a nurse (tying bandages too tightly which cut the blood supply to the wound) caused complications and the claimant suffered damages, but the court ruled that such negligence was excluded by the exemption clause and held the hospital not liable for the claimed damages. It is doubtful whether this conclusion would in future be upheld in light of the clauses referred to above in the Consumer Protection Act. In particular, Regulation 44(1) introduced by the Minister responsible for consumer protection matters, provides that a consumer agreement is presumed to be unfair if it has the purpose or effect of ‘excluding or limiting the liability of the supplier for death or personal injury caused to the consumer through an act or omission of that supplier’.[6] In Britain the Unfair Terms Act of 1977, prohibits the exclusion of liability for negligence, including ordinary negligence, leading to bodily injuries or death. In terms of section 2(2)(a) of our Consumer Protection Act, courts in South Africa (SA) are permitted to take cognisance of ‘appropriate foreign and international law’ when interpreting the Act and may well in future lean towards greater protection of patients’ rights as in the UK.[5,7] This provision is also in line with section 39(1) and (2) of our Constitution, which enjoins courts to develop the common law in the spirit, purport, and objects of the Bill of Rights and, in doing so, it must take cognisance of international law and may consider foreign law.[4]

12 main disadvantages of litigation • It has become too costly; however, it would seem the same holds true for arbitration. Litigants are enticed by the promise inherent in ‘contingency fee’ based cases that their attorney will not charge if the case is lost but will charge 25% of any amount successfully recovered. They tend to forget, however, that if the case is lost, the winning parties’ costs will be for their account. Also, taking 25% of any damages recovered can be substantial depending on the amount so awarded.[1] • It is too time consuming: It takes years to come to trial and then there may be interim procedures, postponements and/or further appeal processes extending the final conclusion of the matter even further. The economy of settling now for ZAR 1 000 instead of 4 years down the line is not always adequately explained.

• There is usually a winner and a loser and sometimes both are dissatisfied with the outcome!

• Lawyers prevent opposing parties from communicating with one another and so prevent any early amicable settlement between them. ‘Don’t speak to me, speak to my lawyer’!

• Adverse publicity and cross-examination can ruin a successful professional career, even in cases where the claim is completely unmeri­torious. Adverse publicity and cross-examination can also undermine a patient’s dignity even in successful claims.

• Not all adverse outcomes or mistakes or errors constitute neg­ ligence justifying the institution of a claim.[8] • Most claims are settled at the doors of court after the parties had already suffered much trauma and incurred substantial legal costs.

• Often the root of the complaint is never disclosed or dealt with in the proceedings because of the absence of evidence about the true cause of the patient’s complaint.

• Many claims are instituted long after the event that gave rise to the alleged damages, this seriously hampers the proper investigation and ventilation of all relevant facts to enable a just verdict to be reached.

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• The presiding officers in courts are judges and magistrates who are not necessarily au fait with complex medical procedures and complications, sometimes resulting in unjust decisions.

• Litigation seldom, if ever, results in reconciliation of the opposing parties.

• Court decisions are sometimes based on legal technicalities (exceptions, prescription, lack of compliance with notice periods, etc.) that are far removed from the parties’ needs, leaving the matter unresolved and both parties dissatisfied.

Mediation During December 2014 the court-annexed mediation in certain Magistrates Courts in Gauteng and North West, was inaugurated.[9] Rule 73 of the Magistrates’ Court Rules defines mediation as the ‘process by which a mediator assists the parties in actual or potential litigation to resolve the dispute between them by facilitating discussions between the parties, assisting them in identifying issues, clarifying priorities, exploring areas of compromise and generating options in an attempt to resolve the dispute’. Rule 71(b), (c), (d) and (f) declares that the main purpose of mediation is to ‘promote restorative justice … preserve relationships between litigants or potential litigants which may be­ come strained or destroyed by the adversarial nature of litigation; facilitate an expeditious and cost-effective resolution of a dispute … provide litigants … with solutions … which are beyond the scope and powers of judicial officers’.

The success rate of mediations is estimated at between 80% and 90%.

In the year 2000, Singapore boasted a success rate of 93% out of 3 943 cases.[10] Mediation is suitable for the resolution of multiple disputes between multiple parties, such as between individuals on the one hand and companies, municipalities and even government departments on the other.[11] It equalises power imbalances in the process.

In Hong Kong legal practitioners are liable to be disbarred if they fail to first advise their clients on the benefits of mediation before resorting to court litigation. In Britain it was decided in Halsey v.

Milton Keynes NHS Trust [2004] EWCA Civ 576 that ‘all members of the legal profession who conduct litigation should now routinely consider with their clients whether their disputes are suitable for ADR.’ (Alternative Dispute Resolution, such as refereeing, mediation or arbitration.)[12] Before any mediation commences, the mediator and the parties normally sign a mediation agreement wherein all the attributes of mediation are contractually secured.[13] The Minister of Justice has been quoted as saying that he intends to submit to cabinet a policy framework to facilitate the diversion of all claims against the state, first to mediation.[14] The Ministry of Justice retains a list of qualified mediators.

The attributes and benefits of mediation • Mediation is far less costly than litigation or arbitration. According to the Government Gazette mediation tariffs have been set, inter alia determining that a level 1 mediator may charge ZAR 4 500 and a level 2 mediator ZAR 6 000 as a maximum fee per day shared equally by both parties.[15] • Mediation is far less time consuming than litigation or arbitration.

It has been estimated that the largest portion of mediations are completed in less than a day. Mediating parties are also not

FORUM

•

•

•

•

•

•

•

subject to waiting time for trial dates, as in the courts. It is only the mediator and the parties who have to coordinate their diaries for a suitable date.

Mediation is a voluntary and not a compulsory process and under no circumstances does it deny a party’s right to withdraw and enforce his right to litigate in court. If any party feels aggrieved by the mediation process, withdrawal at any stage is permissible. In such event, the mediator would usually ask for a private session with the aggrieved party to enquire the reason for his or her dissatisfaction in order to have an opportunity to remove any misunderstanding and hopefully convince that party to continue with the process. Where the mediator is of the view that the aggrieved party is unreasonable in his refusal to continue with the mediation, he will record such fact and a subsequent court hearing the dispute may issue a punitive costs order against such party. Although it is generally not a compulsory process, certain legislation obliges disputing parties to submit their disputes to mediation first before instituting litigation.

Mediation is an informal process. The formal laws of evidence and the rules of court do not bind the parties. Knowledge of court procedures is, therefore, not a prerequisite for parties to engage in mediation successfully.

Mediation is without prejudice to either party’s rights. This allows parties to speak freely without fear of their rights being adversely affected. Such freedom often leads to the parties getting to grips with the real problem. If, however, the mediation fails, then neither party is allowed to refer to anything said or admitted during the mediation during any later court proceedings.

Mediation is a private and confidential affair where no adverse publi­ city will influence the parties to withhold the truth. It is a safe place to speak the unadulterated truth! It is also permissible to have your own attorney present throughout the mediation process. Experience has shown that it is sometimes beneficial to have the parties’ attorneys present. It makes their clients feel safe and comfortable and undermines any fear they may have that they will be prejudiced.

Mediation is client based, i.e. the interests or needs and not the rights of each party are paramount. It is not rights based, as is the case in litigation or arbitration. The skilled mediator guides the parties to a mutual solution satisfactory to them irrespective of their legal rights. Thus, they arrive at a solution designed by their own needs leaving two winners instead of a loser and a winner.

In arriving at a solution, the parties are not limited to their legal remedies. Often, a mere apology suffices to bring healing to broken relationships. It would be wise to remember, ‘having your day in court’ does not always result in ‘having your say in court’.

Mediation called for at the earliest moment possible allows the parties to face one another after the event sooner than in litigation.

At such early stage, attitudes have not yet hardened and the relevant documentation and personnel that can shed light on the causes of the problem are usually still available. No waiting time for trial dates is required and the problem can be resolved while everything is still fresh in the memory of the respective parties.

The mediator facilitates any lack of understanding or any miscommunication existing between the parties in language devoid of legal formalism or scientific technicalities. Where the problem is, however, technical or scientific in nature, the mediator will be in a position to guide the parties to appoint a single independent expert to look at the problem and give a neutral view

or explanation. Both parties are encouraged to agree in advance to accept the independent expert’s conclusion and to share equally his or her fees. Usually this procedure will resolve the problem, resulting in a far more cost-effective resolution of the dispute than a procedure where each party employs his or her own expert.

• Another benefit of mediation is that it engenders equality between the parties and removes any imbalance in power between the ‘stronger’ professional and the ‘weaker’ lay patient. This balance occurs during private sessions that the mediator conducts with each party in the absence of the other, where the weaker party is free to speak without reservation. This freedom usually discloses the real nature of the dispute and the real needs of the party.

• Mediation allows the parties greater control over the process in comparison to litigation where their legal representatives are in control. The process of mediation removes the disadvantages of the adversarial nature of litigation. The adversarial process produces surprises that are often devastating to the parties. Cases are often decided on legal principles far removed from the parties’ interests, e.g. a case may be decided on depending on whom the onus of proof rests, a concept far removed from the parties’ interests and real needs.

• A mediator does not supply the parties with a verdict. Nor does the mediator judge the credibility of the parties and/or their witnesses.

A mediator does not cross-examine anyone as is done in court or arbitration proceedings. The bona fides of each party or person are accepted without question, and this removes the threatening atmosphere that is so often prevalent in court proceedings. It is a safer place to protect one’s dignity and reputation.

How is mediation initiated and implemented?

Once the parties have agreed to submit their dispute to mediation, a mediator is appointed suitable to both parties. Parties may approach any person known to be a qualified mediator or they may approach the Clerk of the Magistrates’ Courts where court annexed mediation is practised or they may approach the Ministry of Justice for referral to a mediator if none is known by the parties.

A mediation agreement is signed which also reflects the mediator’s fees as well as all the attributes of the process referred to above. The mediation can then take place at any convenient place agreed upon by the parties, usually at no cost to either party.

The process of mediation usually commences with a joint session where each party is given an opportunity to state his or her case to the mediator. In so doing, the mediator obtains, in advance, undertakings from the parties to avoid all derogatory language in stating their case. If they disobey, the mediator reminds them of their undertaking and so maintains peace and a comfortable atmosphere.

After this session, the mediator explains that each party is now afforded an opportunity to discuss in private with the mediator his or her grievances. During this session the mediator undertakes not to disclose anything said in confidence to him to the other party unless the party in session authorises the mediator to do so. If either party in private session authorises the mediator to disclose to the other party certain confidential information, the mediator normally writes it down and checks with the party whether the information to be disclosed has been correctly recorded. It is then within the discretion of the mediator to decide when he or she regards it as profitable or

May 2016, Vol. 9, No. 1 SAJBL

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FORUM wise to make such disclosure to the other party. The mediator then meets privately with the other party under the same conditions.

After the private sessions, the mediator calls both parties into open session if it is deemed advisable to do so within his discretion, alternatively he can commence with another round of private sessions to test and see whether the parties have closed the gap in their differences. This process is repeated until the parties reach a solution satisfactory to both.

Once the parties arrive at an agreement, the mediator assists them in recording the settlement in writing whereafter each party signs the agreement. The agreement can be made an order of court.

This has the benefit that if either party breaches the terms of the agreement, the other party can enforce the agreement by execution through the sheriff of the court. If it was not made an order of court, the agreement can be enforced through litigation. It is always easier to enforce an agreement arrived at by way of settling a dispute than having to prove your rights without such a settlement.

Conclusion It would be to the benefit of all state hospitals against which malpractice claims have been instituted, to attempt agreeing with the claimants and/or their legal representatives to refer such court cases for resolution by mediation. Such requests for mediation must preferably be in writing. In case the claimants or their legal representatives refuse unreasonably to agree to mediation, such refusal could be used to obtain an adverse costs order against them

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at the end of the court case, thus saving the state having to pay the inordinate amount of legal costs, as in the past.

References 1. Dhai A. Medico-legal litigation: Balancing spiralling costs with fair compensation.

S Afr J BL 2015;8(1):2-3. DOI:10.7196/SAJBL.407 2. Botes M. Mediation: A perfect solution to healthcare disputes. De Rebus 2015;28(4):67.

3. Pepper MS, Slabbert MN. Is South Africa on the verge of a medical malpractice litigation storm? S Afr J BL 2011;4(1):29-35.

4. Republic of South Africa. Constitution of the Republic of South Africa No. 108. Bill of Rights:7-39. Government Gazette, 1996.

5. Republic of South Africa. Consumer Protection Act 68. Government Gazette 2008.

6. Afrox Healthcare Bpk v. Strydom 2002 (6) SA 21 (SCA) the Supreme Court of Appeal in Bloemfontein.

7. United Kingdom Legislation. Unfair Terms Act. London: United Kingdom Legislation, 1977. http://www.legislation.gov.uk/ukpga/1977/50?view=plain (accessed 20 September 2015).

8. Buthelezi v. Ndaba 2013 SA 437 (SCA).

9. Republic of South Africa. Rules Board for Courts of Law Act (107/1985): Districts and subdistricts for implementation of Rules of Medication (GN 855 GG 38164/3110-2014). Pretoria: Government Gazette, 2014 10. Van der Merwe BC. Court annexed mediation: Should it be embraced by the legal profession. De Rebus 2015;24(4):66.

11. Republic of South Africa. Rules Board for Court of Law (83/1985). Pretoria: Government Gazette, 2014.

12. Halsey v. Milton Keynes NHS Trust [2004] EWCA Civ 576.

13. Republic of South Africa. Rules Board for Courts of Law Act. Form MED-6 of Annexure 3. Pretoria: Government Gazette, 2014.

14. Manyathi-Jele N. Court annexed mediation officially launched. De Rebus 2015;11(4): 57.

15. Republic of South Africa. Rules Board for Courts of Law Act (107.1985): Fees payable to mediators, qualification standards and levels of mediators (GN 854 GG 38163/31-10-2014). Pretoria: Government Gazette, 2014.

ARTICLE

Constitutional, legal and regulatory imperatives for the renewed care and prevention of congenital disorders in South Africa H Malherbe,1 MSc, BSc (Hons); A L Christianson,2 FRCP, MA; C Aldous,1 PhD, MSc, BSc (Hons); M Christianson,3 LLM, LLB, BA School of Clinical Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa Wits Centre for Ethics (WiCE), University of the Witwatersrand, Johannesburg, South Africa 3 School of Law, University of the Witwatersrand, Johannesburg, South Africa 1 2

Corresponding author: H Malherbe (helen@hmconsult.co.za)

Medical genetic services for the care and prevention of congenital disorders have declined significantly in recent years due to competing health priorities, with previously developed services becoming compromised. With an infant mortality rate of 28/1 000 live births, South Africa (SA) has passed the threshold of 40/1 000 when such services should be implemented. This article outlines the international background and SA legislative framework for medical genetic services and their implementation. International, regional and national conventions, legislation, and policy were studied for relevance to genetic services and their implementation was evaluated, including a comparison of sector capacity between 2001 and 2015. A comprehensive legislative and regulatory framework exists in SA for the provision of medical genetic services, but implementation has been fragmented and unsustained. Congenital disorders and genetic services are not prominent in national strategies and excluded from interventions aimed at combating child mortality and non-communicable diseases. Capacity today is at a lower level than in 2001. The failure to recognise the burden of disease represented by congenital disorders is the underlying reason for the implementation and service shortfall.

Child mortality rates have stagnated since 2011 and can be significantly further reduced by prioritising healthcare issues other than HIV/AIDS, including congenital disorders. It is now an imperative that SA responds to World Health Assembly Resolution 63.17 and prioritises congenital disorders as a healthcare issue, providing services to uphold the dignity and human rights of the most vulnerable members of society.

S Afr J BL 2016;9(1):11-17.DOI:7196/SAJBL.429

teratogens.[2,3] CDs are often undiagnosed, or misdiagnosed due to a lack of awareness of attending clinicians to make appropriate diagnoses.[2,4,5] Mortalities as a result of CDs are often incorrectly attributed, burying CDs as an issue.[2,4,5] However, up to 70% of CDs can be prevented, cured or the resulting disability ameliorated through appropriate,

timely treatment.[2,6] Lack of data resulting from poor diagnoses results in the CD burden being under-reported in many MLIC countries, where CDs are substantially under-reported.[3,4,5,7] In SA, only 2 174 CD cases were documented in 2012 via the Birth Defect Collection Tool administered by the Department of Health,[8] compared with the

28

30 Percentage of under 5 deaths due to congenital anomalies

Congenital disorders (CDs) are an underestimated cri­ tical health issue. Competing health priorities have re­ sul­ ted in the neglect of medi­cal genetic services for the care and prevention of CDs. While a comprehensive national legislative and regulatory frame­ work exists for these services, providing for the fundamental and socio-economic rights enshrined in the constitution, poor implementation has resulted in shortfalls in service for those affected by CDs, many of whom are living with disability.

The internationally agreed definition of CDs are abnormalities of structure or function present from birth, which may be evident at birth or manifest later in life.[1] Although CDs are a global problem, over 90% occur in middle- and low-income countries (MLIC), where 95% of those affec­ ted consequently die.[2] In South Africa (SA), one in every 15 live births is affected by a CD.[3] Modelled data indicate a minimum of 6.8% of SA births, of which 80.5% are caused by genetic factors and 19.5% by

26 25 20 14

15 9

10 5 0

3

5

Low income

5

6

Low middle income 2010

Upper middle income

High income

2013

Fig. 1. Comparison of the percentage of under-five deaths resulting from congenital anomalies for World Bank Country Classifications. [9]

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80 70 % of infant deaths due to CDs

83 118 (6.8%) expected, indicating underreporting of 97%.[3,9] As SA develops, the proportion of child­hood deaths from CDs is increasing, as morta­lity from com­municable diseases decrea­ses.[3,9] This fol­ lows the epidemiological trend in industrialised countries where CDs emerged and remain as the leading cause of child death and disability.

[2,3] Fig. 1 compares the percentage of under-five deaths resulting from congenital anomalies (a subset of CDs) between the World Bank Country Classifications according to Gross National Income (GNI) per capita.[9] The proportion of deaths from congenital anomalies in all GNI groups increased between 2010 and 2013, and in high-income countries they are the leading cause of deaths, accounting for 28% in children under five.

Significant reductions in the infant mortality rate (IMR) and the under-five mortality rate (U5MR) were seen between 2008 and 2011 from comprehensive HIV/AIDS interventions and the childhood Expanded Programme of Immunisation.[10,11] However, both the IMR and the U5MR have stagnated since 2011 and the neonatal mortality rate since 2009.[12] This indicates that health issues other than those being addressed, such as CDs, require prioritisation.[3,9,10,12] In 2013, congenital abnormalities (obvious structural abnormalities) overtook infection as the third leading cause of death in early neonates, accounting for 11.24% of early neonatal deaths in infants weighing >1 000 g compared with 8.84% from infection.[13] When the IMR falls below 20/1 000 live births in a country, CDs emerge as the leading cause of infant death.[14] Fig. 2 illustrates the IMR decreasing as countries develop and transition epi­ de­ ­ miologically, and the increasing propor­ tion of CD-related infant deaths.[9] The need for medical genetic services is usually recognised by nations when their IMR falls below 40/1 000 live births, as infant and child mortality can be signifi­ cantly further reduced through such measures. [4,5,14,15] Up to 40% of serious congenital malformations which may be fatal if untreated, can be cured by surgical intervention, and in 30% of cases the degree of resulting disability can be reduced through relevant treatment. [4,6] With an IMR of 28 live births in 2014[12] SA is beyond the point when appropriate services should be implemented to further reduce child mortality and to better care for those who are disabled by CDs.[3,4,9,14,15,]

60 50 40 30 20 10 0 0

10

20

30

40

50

60

70

80

90

100

110

120

130

Infants deaths/1 000 live births (IMR)

Fig. 2. Relationship between infant mortality and percentage of infants dying from CDs, based on global country figures.[9]

Medical genetic services for the care and prevention of CDs ensure that people with CDs, or at reproductive risk of having children with CDs, can live and reproduce as normally as possible.[5,16] They are key in reducing the contribution of CDs to the disease burden and should provide the ‘best possible patient care’ in the prevailing circumstances for those affected or at risk of CDs.[9,15,16] Medical genetic ser­ vices established at human genetics de­partments and medical schools have been the mainstay in SA since the 1970s.[9] Access to these services has been limited to urban areas with some rural outreach.[9] Services began to improve in the late 1990s and early 2000s, when CDs first emer­ged as a health issue and the Policy Guidelines for the Management and Preven­tion of Genetic Disorders, Birth Defects and Disabilities were published.[17] However, service implementation continued through the established framework of academic centres, rather than integrating services into primary healthcare and extending clinical genetic services beyond urban areas, as was recommended in the 2001 Policy Guidelines.[9,17]

Constitutional, legal and regulatory framework in SA Several international treaties and reso­ lutions indicating global political com­ mit­ ment towards CDs are applicable to SA and summarised in Table 1. Notable is World Health Assembly (WHA) Resolution 63.17 of 2010.[18] This recognises the importance

of CDs as a cause of stillbirths and neonatal deaths, and their contribution to the U5MR and attaining Millennium Development Goal (MDG) 4 to reduce child mortality by two-thirds.[19] Achieving MDG4 required ‘ac­ ce­ lerated progress in reducing neonatal mor­tality including the prevention and ma­ n­agement of birth defects.[9,18] Although pro­ gress was made towards an U5MR of 20/1 000 live births, MDG4 was not achieved.[9] SA is a signatory to international pro­ tocols and conventions that have resulted in na­ tional legislation (Table 1).[9] Most rele­vant to medical genetic services is the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD).[20] Signed and ratified in 2007, the UNCRPD promotes, protects and ensures full and equal enjoyment of all human rights and fundamental freedoms by all persons with disabilities and promotes respect for their inherent dignity.[20] The United Nations Convention on the Rights of the Child (UNCRC), ratified by SA in 1995, concerns the rights of the disabled child without discrimination, while ensuring dignity, promoting self-reliance and community participation.[21]

The Constitution and National Legislation A comprehensive, national legislative framework exists in SA for the provision of medical genetic services (Table 2).[9] The constitution of SA underpins all other

ARTICLE legislation and provides for fundamental rights to equality, dignity, freedom and security of the person, education and life.[22] Section 27 provides for the socio-economic right of everyone to access healthcare services, including reproductive healthcare, and social security: women, children and people with disabilities are entitled to these s27 rights with the qualification that:

‘[t]he State must take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of each of these rights’.[22] Children’s rights not subject to the concept of progressive realisation are listed in s28(1)(c), which states that every child has the right:[9] ‘to basic nutrition, shelter, basic health care services and social services’.[22]

Table 1. International treaties, conventions, declarations, protocols of relevance to medical genetic services[9] Document

Article/rule/overview

World Programme of Action Concerning the Disabled (1982)[35]

Prevention, rehabilitation and equalisation of opportunities

Standard Rules on the Equalisation of Opportunities for Persons with Disabilities (1993)[36]

Rules: 1. Awareness raising; 2. Medical care; 3. Rehabilitation; 4. Support service; 5. Accessibility

United Nations Convention on the Rights of the Child (signed 1993 and ratified 1995)[21]

Articles: 2. No discrimination; 6. Right to life; 23. Disabled child; 24. Healthcare; 26. Social Security

International Covenant on Economic, Social and Cultural Rights (1966) (signed 1994 and ratified 2015)[37]

Article: 12. Physical and mental health

United Nations Millennium Declaration (signed 2000)[19]

Goal 4: Reducing under-five mortality by two-thirds by 2015

United Nations Convention on the Rights of Persons with Disabilities (signed and ratified 2007)[20]

Articles: 5. Equality/non-discrimination; 6. Women with disabilities; 7. Children with disabilities; 8. Awareness raising; 9. Accessibility; 10. Right to life; 19. Living independently; 20. Personal mobility; 23. Respect for home and family; 25. Health; 26. Habilitation and Rehabilitation

African Charter on the Rights and Welfare of the Child (‘Children’s Charter’) (signed 1997 and ratified 2000)[38]

Articles: 5: Right to life;13. Protection of physically/mentally disabled to ensure dignity; 14. Physical/mental health and healthcare

The New Partnership for Africa’s Development (2001)[39]

Healthcare provision and delivery Articles: 16. Health; 23. Girls and young women; 24. Mentally/physically challenged youth

African Youth Charter (signed and ratified 2009)[40] World Health Assembly Resolution 63.17 (signed and ratified 2010)

[18]

Urges member states to address CDs as a healthcare issue through specific actions

Table 2. Key national legislation of relevance to medical genetic services[9] Title

Overview and sections relevant to CDs

Constitution of the Republic of South Africa (108 of 1996)[22]

Chapter 2: Bill of Rights. Sections: 9. Equality; 10. Human dignity; 11. Life; 27(1)(a). Access to healthcare services, including reproductive healthcare; 27(1)(c). Access to social security including appropriate social assistance; 28(1)(c). Every child has the right to basic healthcare services

Health Professions Act (56 of 1974)[28]

Regulates the health professions through the Health Professions Council of South Africa

National Health Act (61 of 2003)

Sections: 4(3)(a). Free healthcare to pregnant/breastfeeding women, children under six not members/beneficiaries of medical aid schemes (c) free termination of pregnancy; 21(2)(b)(vii). Genetic services; 21(2)(k) & 25(2)(w). Management, prevention and control of communicable and NCDs; 23 (1)(a)(ix) & 27(1)(a)(ix). Epidemiological surveillance/ monitoring of national and provincial trends; 21, 23, 25 & 27. Implementation of national/provincial policy and compliance; 39(2)(a)&(d) and 70(2)(d) Health needs of vulnerable groups including children and people with disabilities; 48. Development and provision of human resources in national health system; 52. Regulations relating to human resources; 70. Identification of health research priorities

[23]

Choice on Termination of Pregnancy Act (92 of 1996)[24]

Sections: 2(b)(ii) and minors 5(5)(a)(ii) Termination of pregnancy (TOP) between 13 - 20 weeks inclusive if substantial risk that the fetus would suffer from a severe physical/ mental abnormality Sections: 2(c)(ii) and minors 5(5)(b)(ii) TOP after the 20th week if the continued pregnancy would result in a severe malformation of the fetus

The National Health Laboratories Service Act (37 of 2000)[26]

Laboratory services for the public health sector Sections 4 & 5: Cost-effective and efficient health laboratory services including training

Mental Health Care Act (17 of 2002)[25]

A legal framework for mental health in SA with an emphasis on human rights

The Nursing Act (33 of 2005)

Regulates the nursing profession through the South African Nursing Council

[27]

Sections: 11. Children with disability or chronic illness; 156(1)(g). Care and protection

Children’s Act (38 of 2005)[30] Social Assistance Act (13 of 2004)

[29]

Sections: 7. Care dependency grants; 9. Disability grants

May 2016, Vol. 9, No. 1 SAJBL

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ARTICLE This includes children with CDs, and those living with disability caused by CDs.

National Health Act The National Health Act (NHA) 61 of 2003 provides a framework for a single healthcare system for the country, rectifying the socioeconomic imbalances and inequities of the health services of the past and provides for many of the rights outlined in the Bill of Rights.[23] The NHA is the only piece of national legislation in which genetic ser­vices feature prominently. A clear directive is included in Chapter 3, under Main functions of the National Department in s21(2)(b)(vii):[9] ‘the Director-General must, in accordance with national health policy, issue and promote adherence to, norms and standards on health matters including genetic services.’[23] Genetic services are listed among other vital services, including sterilisation and termination of pregnancy, and the provision of health services/ healthcare services for convicted persons and persons awaiting trial, highlighting the considered importance of these services.

The NHA stipulates that the national policy is executed via the provincial departments of health in a top-down approach. National and provincial health councils ensure national policy is implemented provincially and that provincial health plans comply with national policy (NHA s21, 23, 25, 27).[23] To date, no provincial policies or health plans for genetic services have been developed, with the exception of the Western Cape (Prof. Raj Ramesar and Dr Mike Urban, personal communication), and most provinces refer to the 2001 national policy[17] Other sections of the NHA relevant to medical genetic services include: • management, prevention and control of non-communicable disea­ ses (NCDs) through healthcare services (s21(2)(k) and s25(2)(w)) • epidemiological surveillance and monitoring of disease trends (s23(1)(a)(ix) and s27(1)(a)(ix)) • identification of priority health problems and research priorities relevant to the burden of disease (s70) • health needs of vulnerable groups, including children and people with disabilities (s39(2)(a)&(d), s70(2)(d))

Table 3. National policies, strategies, guidelines, charters and initiatives relevant to medical genetic services Document

Year

Overview

1997

The right of people with disabilities to play a full, participatory role in society

Policy Guidelines for the Management and Prevention of Genetic Disorders, Birth Defects and Disabilities[17]

2001

Goals, objectives, strategies and delivery of clinical and laboratory services for the care and prevention of CDs, including human capacity recommendations

Guidelines on Ethics for Medical Research. Book 2.

Reproductive Biology and Genetic Research[42]

2002

Section 3.3: Genetic screening and testing

Department of Health. Strategic Framework for the Modernisation of Tertiary Hospital Services[43]

2003

Human genetics throughout document in proposed models. Appendix 4: Revised human capacity recommendations

National Guidelines for the Care and Prevention of the Most Common Genetic Disorders, Birth Defects and Disabilities[31]

2005

Targeting primary health care providers, describing common CDs and strategies for their care/prevention

National Perinatal and Neonatal Morbidity and Mortality Committee[45]

2008

Audit perinatal and neonatal deaths and produce annual reports and final report in 2011

National Patients’ Rights Charter[46]

2008

Common standard to realise, uphold, promote and protect the constitutional right of access to healthcare services Section 2: Access to healthcare; 2(3)(c) Provision for special needs (newborn, children, pregnant women, disabled); (d) Counselling; (e) Palliative care; (g) Health information

Negotiated Service Delivery Agreement. Outcome 2: A long and healthy life for all South Africans[47]

2010

Strategic outputs: 1. Increasing life expectancy, NCDs and burden of disease; 2. De­­ crea­­sing maternal and child mortality; 4. Strengthening health system effectiveness

National Health Insurance in South Africa Policy Paper[48]

2011

To transform existing institutions/organisation in the healthcare system to make the system more equitable, offering universal coverage to a defined comprehensive package of services

South Africa’s National Strategic Plan for a Campaign on Accelerated Reduction of Maternal and Child Mortality in Africa[49]

2012

To rapidly reduce maternal and child mortality

Strategic Plan for Maternal, Newborn, Child and Women’s Health and Nutrition in South Africa 2012-2016[33]

2012

Reducing maternal and child mortality. Long-term health conditions in children (p24)

Committee on Morbidity and Mortality in Children Under 5 Years[50]

2012

Reviews and monitors maternal, perinatal and childhood mortality and morbidity data in SA

National Department of Health: Strategic Plan 2014/152018/19[32]

2014

Programme 3: Maternal and child health. NCDs

Guidelines for Maternity Care in South Africa[44]

2015

Chapters: 4. Antenatal care; 9. Pregnancy problems; 10. Intrauterine, neonatal deaths and stillbirths; 15. Screening for congenital anomalies

Integrated National Disability Strategy White Paper

14

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[41]

ARTICLE • human resources including adequate resources for education and training of healthcare personnel (Chapter 7).[23]

Other national legislation Other key national legislation provides for different aspects of genetic services and are summarised in Table 2.[9] Notable are: • The Choice on Termination of Pregnancy Act (1996), used as part of a preventive strategy when severe abnormalities are detected in utero (s2(b)(ii), 2(c)(ii), s5(5)(a)(ii), s5(5)(b)(ii).[24] • The Mental Health Act (2002) provides a legal framework for mental health, emphasising the human rights of the mentally ill.[25] • The National Health Laboratories Service (NHLS) Act (2000) provides for laboratory services as an essential component of genetic services.[26] • The Nursing Act and the Health Professions Act provide for statutory bodies regulating these professions.[27,28] In SA, genetic counsellors require registration under the Health Professional Council of South Africa.[28] • Social Assistance Act (2004) provides for care dependency and disability grants.[29] • Matters concerning the disabled child are specified in the Children’s Act (2005).[30]

National policy Two key policy documents focus solely on CDs: National Policy Guidelines for the Management and Prevention of Genetic Disorders, Birth Defects and Disabilities[17] and National Guidelines for the Care and Prevention of the Most Common Genetic Disorders, Birth Defects and Disabilities.[31] The National Policy Guidelines outline goals, objec­ tives, strategies, personnel requirements and delivery of clinical and laboratory services appropriate for the care and prevention of CDs. Despite these policies, CDs are not regarded as a healthcare issue in SA strategic plans (Table 3), despite the emphasis on reducing child mortality in response to MDG4. The Department of Health (DoH) Strategic Plan 2014/15-2018/19 recognises mental health disorders as a NCD, aiming to improve access to services through screening and treatment, but does not acknowledge the significant genetic component of many of these disorders.[32] In the DoH Strategic Plan for Maternal, Newborn, Child and Women’s Health and Nutrition in South Africa 2012 - 2016, CDs are mentioned as a cause of neonatal death, contributing to 15 - 20%

of children affected by a long-term/chronic health conditions who are ‘not receiving the care they require’. [9,33] No responding interventions are outlined.[9] NCDs are a key strategic focus in these policies, but there is no cognisance that CDs are an NCD, the first experienced in life, contributing to the 43% of NCD related deaths annually in SA.[14,34] A draft Disability Rights Policy, a first step to implementing the UNCRPD[20] was published for public comment in early 2015. A review of several health and disability policy documents is underway, including the 2001 Policy Guidelines [17] and accompanying clinical guidelines proposed.

Implementation Despite the existence of a comprehensive legislative framework for the development of medical genetic services, implementation has fallen short and medical genetic services are in decline.

In Table 4, personnel capacity is compared between 2001 and 2015, demonstrating that these services are at a lower base today than in 2001.[3,9] Of over 1 000 healthcare providers, mainly labour ward nurses, trained through the Medical Genetics Education Programme (MGEP), less than 100 remain in services for care and prevention of CDs.[9] The lack of continued support forced trainees to discontinue their genetic nursing role and move to non-related fields. This has resulted in reduced clinical capacity to identify and diagnose CDs and has influenced the surveillance of CDs.[9] SA is the only country (of eight emerging economies) where positive development in improving medical genetic service structures has ceased and indeed regressed.[3,7] Reasons for this decline since 2001 include competing health priorities that have redirected political commitment and funding.[3,9] The lack of investment in medical genetic services has resulted in insufficiently trained personnel, inadequate capacity at all levels, and severely com­ promised laboratory services.[3,9] These shortfalls make it impossible to uphold the constitutional rights of those affected by CDs, including children and those living with disability, through the practical provision of the services they require.

Conclusion While the SA constitution is admired globally for its protection of hu­ man rights, there has been a failure to translate these consti­tu­tional imperatives into effective, accessible services for the care and preven­ tion of CDs. Failure to recognise the burden of disease represented

Table 4. A comparison of medical genetic services capacity in 2001 and 2015[9] 2001‡

Recommended* Category

Number/ratio (Pop = 46 13 m)†

Medical geneticists

20/1 per 2 m

Number 4

‡

2015

Ratio (Pop = 44 82 m)†

Number

Ratio (Pop = 54 96 m)§

1 per 11.2 m

12¶

1 per 4.6 m

∏

1 per 6.1 m

Genetic counsellors

80/1 per 580 000

<20

1 per 2.2 m

Medical scientists/ technologists

100/1 per 450 000

50

1 per 900 000

9

26**

1 per 2.1 m

* Department of Health. Strategic Framework for the Modernisation of Tertiary Hospital Services. Discussion Document. Pretoria, South Africa: Department of Health, 2003;86. ‡ Department of Health. Policy Guidelines for the management and prevention of genetic disorders, birth defects and disabilities. Pretoria, South Africa: Department of Health, 2001. † Statistics South Africa. South African Statistics 2014. Pretoria, South Africa: Statistics South Africa, 2014. § Statistics South Africa. Mid-Year Population Estimates 2015. Pretoria, South Africa: Statistics South Africa, 2015. ¶ No medical geneticists are employed by the State in Gauteng. Personal communication: A. Krause, 11 February 2016. ∏ Figure increased to 9 in April 2016 plus 6 in private practice. Personal communication: T. Wessels, 25 February 2016. ** NHLS academic medical scientists only. Personal communication: H. Soodyall, 27 July 2015.

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by CDs is the underlying cause of this unethical shortfall in services.[9] Despite the comprehensive legal framework remaining unchanged, the implementation of this legislation has declined. ‘We have the con­ stitution, the law, the guidelines and policy – but good laws are being lost in translation’ (Prof. Marylyn Christianson, Special Olympics Disability Summit, Shanghai, 2007). In the words of the 2013 GenTee Report,[7] ‘the continuing lack of commitment to the country’s constitutional, legal and regulatory framework [has resulted in] an implosion of genetic services in the public domain due to very limited public will, commitment and funding [resulting in] inequitable genetic services [impacting] the ability of the poorer population to utilize services according to their needs’.

It is an imperative that SA responds to WHA 63.17[18] and prioritises CDs as a healthcare issue by providing the required medical genetic services to uphold the dignity and human rights of people with CDs, the most vulnerable of our society.

Acknowledgement. This research was undertaken with the assistance of a bursary from the College of Health Sciences, University of KwaZulu-Natal.

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2. Christianson A, Howson CP, Modell B. March of Dimes: Global Report on Birth Defects, the Hidden Toll of Dying and Disabled Children. New York: March of Dimes Birth Defects Foundation, 2006. http://www.marchofdimes.org/materials/ global-report-on-birth-defects-the-hidden-toll-of-dying-and-disabled-childrenfull-report.pdf (accessed 22 July 2015).

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9. Malherbe H, Aldous C, Woods D, Christianson A. The contribution of congenital disorders to child mortality in South Africa. In: Padarath A, King J, Mackie E, Casciola J, eds. South African Health Review 2016. Edition: ISSN 1025-1715. Cape Town: Health Systems Trust, 2016:137-152.

10. Kerber KJ, Lawn JE, Johnson LF, et al. South African child deaths 1990 - 2011: Have HIV services reversed the trend enough to meet Millennium Development Goal 4? AIDS 2013;27(16):2637-2648. DOI:10.1097/01.aids.0000432987.53271.40 11. Madhi SA, Bamford L, Ngcobo N. Effectiveness of pneumococcal conjugate vaccine and rotavirus vaccine introduction into the South African public immunisation programme. S Afr Med J 2014;104(3 Suppl 1):228-234. DOI:10.7196/SAMJ.7597 12. Dorrington R, Bradshaw D, Laubscher, R, Nannan N. Rapid Mortality Surveillance Report 2014. Cape Town: South African Medical Research Council, 2015. http://www.mrc.ac.za/ bod/RapidMortalitySurveillanceReport2014.pdf (accessed 3 September 2015).

13. Pattison R, Rhoda, N. Saving Babies 2012-2013: Ninth Report on perinatal care in South Africa. Pretoria: Tshepesa Press, 2014;35. http://www.ppip.co.za/wpcontent/uploads/Saving-Babies-2012-2013.pdf (accessed 1 October 2014).

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15. Modell B. Kuliev A. The history of community genetics: The contribution of the haemoglobin disorders. Community Genet 1998;1(1):3-11. [PMID: 15178981] 16. World Health Organization, Human Genetics, Chronic Diseases and Health Promotion. Community Approaches to the Control of Hereditary Diseases. Report of a WHO Advisory Group, 3-5 October 1985. Geneva: World Health Organization, 2005;34. http://www.who.int/genomics/publications/WHOHGNWG85.10.pdf?ua=1 (accessed 10 August 2015).

17. Republic of South Africa. Policy Guidelines for the Management and Prevention of Genetic Disorders, Birth Defects and Disabilities. Pretoria: Department of Health, 2001. http://www.gov.za/sites/www.gov.za/files/humangenetics_0.pdf (accessed 4 June 2015).

18. World Health Assembly. Resolution 63.17. Birth Defects. Geneva: World Health Assembly,2010. http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R17-en. pdf (accessed 2 September 2014).

19. United Nations General Assembly. Resolution 55/2. United Nations Millennium Declaration, A/RES/55/2. Geneva: United Nations General Assembly, 2000. http:// www.un.org/millennium/declaration/ares552e.html (accessed 2 September 2015).

20. United Nations General Assembly. Resolution 61/106. Convention on the Rights of Persons with Disabilities, A/RES/61/106. Geneva: United Nations General Assembly, 2007. http://www.un.org/disabilities/convention/conventionfull. shtml (accessed 2 September 2015).

21. United Nations General Assembly. Convention on the Rights of the Child, Treaty Series. Geneva: United Nations General Assembly, 1989. https://treaties.un.org/ doc/Publication/UNTS/Volume%201577/v1577.pdf (accessed 12 March 2015).

22. Republic of South Africa. Constitution of the Republic of South Africa Act No. 108. Pretoria: Government Gazette, 1996;17678. http://www.gov.za/documents/ constitution-republic-south-africa-1996 (accessed 2 September 2015).

23. Republic of South Africa. National Health Act No. 61. Pretoria: Government Gazette, 2004;26595. http://www.gov.za/sites/www.gov.za/files/a61-03.pdf (accessed 25 February 2015).

24. Republic of South Africa. Choice on Termination of Pregnancy Act No. 92.

Pretoria: Government Gazette, 1996;17602. http://www.gov.za/sites/www.gov. za/files/Act92of1996.pdf (accessed 4 February 2015).

25. Republic of South Africa. Mental Health Care Act No. 17. Pretoria: Government Gazette, 2002;24024. http://www.gov.za/sites/www.gov.za/files/a17-02.pdf (accessed 6 March 2015).

26. Republic of South Africa. National Health Laboratory Service Act No. 37. Pretoria: Government Gazette, 2000;21879. http://www.gov.za/sites/www.gov.za/files/ a37-00_0.pdf (accessed 16 March 2015).

27. Republic of South Africa. Nursing Act No. 33. Pretoria: Government Gazette, 2005;28883. http://www.gov.za/sites/www.gov.za/files/a33-05_0.pdf (accessed 16 March 2015).

28. Republic of South Africa. Health Professions Act No. 56. Pretoria: Government Gazette, 1974;4445. http://www.gov.za/sites/www.gov.za/files/Act%2056%20 of%201974.pdf (accessed 16 March 2015).

29. Republic of South Africa. Social Assistance Act No. 13. Pretoria: Government Gazette, 2004;26446. http://www.gov.za/sites/www.gov.za/files/a13-04_0.pdf (accessed 19 March 2015).

30. Republic of South Africa. Children’s Act No. 38. Pretoria: Government Gazette, 2005;28944. http://www.gov.za/sites/www.gov.za/files/a38-05_3.pdf (accessed 15 March 2015).

31. Republic of South Africa. National Guidelines for the Care and Prevention of the Most Common Genetic Disorders, Birth Defects and Disabilities. Pretoria: Department of Health, 2004.

32. Republic of South Africa. Strategic Plan 2014/15-2018/9. Pretoria: Department of Health, 2014. http://www.health-e.org.za/wp-content/uploads/2014/08/SADoH-Strategic-Plan-2014-to-2019.pdf (accessed 1 December 2015).

33. Republic of South Africa. Strategic Plan for Maternal, Newborn, Child and Women’s Health (MNCWH) and Nutrition in South Africa 2012 – 2016. Pretoria: Department of Health, 2012. http://www.health.gov.za/index.php/2014-08-15-12-54-26/ category/95-2012s?download=173:strategic-plan-for-maternal-newborn-child-andwomen-s-health-and-nutrition-in-south-africa-2012-2016 (accessed 4 July 2015).

34. World Health Organization. Noncommunicable Diseases Country Profiles.

Geneva: World Health Organization, 2014. http://apps.who.int/iris/ bitstream/10665/128038/1/9789241507509_eng.pdf?ua=1 (accessed 3 July 2014).

35. United Nations General Assembly. Resolution 37/52. World Programme of Action Concerning the Disabled, A/RES/37/52 (3 December 1982). Geneva: United Nations General Assembly, 1982. htttp://www.un.org/documents/ga/res/37/ a37r052.html (accessed 3 September 2015).

36. United Nations General Assembly. Resolution 48/96. Standard Rules on the Equalization of Opportunities for Persons with Disabilities, A/RES/48/96 (20 December 1993). Geneva: United Nations General Assembly, 1993. http://www. un.og/documents/ga/res/48/a48r096.html (accessed 22 March 2015).

ARTICLE 37. United Nations General Assembly. International Covenant on Economic, Social and Cultural Rights, Treaty Series, vol. 993. Geneva: United Nations General Assembly, 1966. http://www.ohchr.org/Documents/ProfessionalInterest/cescr. pdf (accessed 15 March 2015).

38. Organisation of African Unity. African Charter on the Rights and Welfare of the Child, 11 July 1990, CAB/LEG/24.9/49. Addis Ababa: Organisation of African Unity, 1990. http://www.unicef.org/esaro/African_Charter_articles_in_full.pdf (accessed 15 March 2015).

39. Organisation of African Unity. The New Partnership for Africa’s Development.

Addis Ababa: Organisation of African Unity, 2001. http://www.nepad.org/system/ files/NEPAD%20Framework%20(English).pdf (accessed 3 September 2015).

40. African Union. African Youth Charter. Addis Ababa: African Union, 2006. http://www. thepresidency.gov.za/docs/african_youth_charter.pdf (accessed 15 March 2015).

41. Republic of South Africa. Integrated National Disability Strategy White Paper.

Pretoria: Office of the Deputy President, 1997. http://www.gov.za/sites/www. gov.za/files/disability_2.pdf (accessed 2 September 2015).

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Reproductive Biology and Genetic Research. Cape Town: Medical Research Council, 2002. http://www.mrc.ac.za/ethics/ethicsbook2.pdf (accessed 5 June 2015).

43. Republic of South Africa. Strategic Framework for the Modernisation of Tertiary Services. Pretoria: Department of Health, 2003. http://www.kznhealth.gov.za/ hospmodernisation.pdf (accessed 22 July 2015).

44. Republic of South Africa. Guidelines for Maternity Care in South Africa.

Pretoria: Department of Health, 2015. http://www.rmchsa.org/wp-content/ uploads/2013/05/Maternal-Care-Guidelines-2015_FINAL-15.6.15.pdf (accessed 3 September 2015).

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Pretoria: National Perinatal Morbidity and Mortality Committee, 2011.

46. Health Professions Council of South Africa. National Patients’ Rights Charter, Guidelines for Good Practice in the Health Care Professions. Pretoria: Health Professions Council of South Africa, 2008. http://www.hpcsa.co.za/downloads/ conduct_ethics/rules/generic_ethical_rules/booklet_3_patients_rights_charter. pdf (accessed 15 March 2015).

47. Republic of South Africa. Negotiated Service Delivery Agreement for Outcome 2: A Long and Healthy Life for all South Africans. Pretoria: Office of the President, 2010. http://www.thepresidency.gov.za/MediaLib/Downloads/Home/Ministries/ DepartmentofPerformanceMonitoringandEvaluation3/TheOutcomesApproach/ Health%20Sector%20NSDA.pdf (accessed 20 March 2015).

48. Republic of South Africa. National Health Insurance in South Africa Policy Paper.

Pretoria: Department of Health, 2011. http://www.gov.za/sites/www.gov.za/files/ nationalhealthinsurance_2.pdf (accessed 3 September 2015).

49. Republic of South Africa. South Africa’s National Strategic Plan for a Campaign on Accelerated Reduction of Maternal and Child Mortality in Africa. Pretoria: Department of Health, 2012. http://www.health.gov.za/index.php/201408-15-12-54-26/category/95-2012s?download=169:south-africa-s-nationalstrategic-plan-for-a-campaign-on-accelerated-reduction-of-maternal-and-childmortality-in-africa-carmma (accessed 19 March 2015).

50. Republic of South Africa. Committee on Morbidity and Mortality in Children under 5 years. 2nd Triennial Report of the Committee on Morbidity and Mortality in Children under 5 Years (CoMMiC). Pretoria: Department of Health, 2014. http://www.kznhealth. gov.za/mcwh/2nd-CoMMiC-Triennial-Report-2014.pdf (accessed 3 September 2015).

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Respect for vulnerability is a human right: Article 8 of the UNESCO Declaration on Bioethics and Human Rights, and senior citizens in South Africa R Rheeder, BA THM THD Unit for the Development of Reformed Theology, North-West University, Potchefstroom, South Africa Corresponding author: R Rheeder (Riaan.rheeder@nwu.ac.za)

It is untrue that the elderly in South Africa (SA) are probably discriminated against in healthcare as the result of inadequate legislation that does not conform to international standards. The National Health Act recognises vulnerability and gives expression to it. Respect for vulnerability has not yet been introduced to fundamental political and bioethical frames of reference in SA and that is probably the reason why the concept and right have not become part of the ethical awareness in healthcare. The appeal of this article is that respect for vulnerability must be brought to conform to the Universal Declaration on Bioethics and Human Rights by declaring the ethical principle as an independent human right.

S Afr J BL 2016;9:18-21. DOI:10.7196/SAJBL.456

An increasing awareness of the problems and suffering posed by the human condition of vulnerability calls for reflection on an ethos of vulnerability. The topicality of the theme of vulnerability is confirmed by Ten Have, who indicates that the number of scientific articles using ‘vulnerability’ as a key word have increased exponentially from 10 in 1967 to 3 277 in 2014 (search conducted on Pub Med), the majority of the articles having been published since the year 2000.[1] According to Ten Have, the ethical concept has gained momentum because of factors like globalisation (which brings about asymmetric power through medical research), failed states (which bring about poverty and hunger), natural disasters, the AIDS epidemic and market driven economies that do not consider the wellbeing of citizens.[1] In a recent scientific study, it has been pointed out that vulnerable elderly citizens are discriminated against in the health environment in South Africa (SA).[2] Wareham, who is on the academic staff of the Steve Biko Centre for Bioethics, has shown (based on a study project by the Community Law Centre of the University of the Western Cape)[3] that at the micro level, individual physicians refer elderly patients less frequently than other patients for more specialised (hospitalisation) and tertiary (speciality diagnosis and treatment) treatment. At the meso level of hospital care and practitioner policy, it also frequently occurs that training for geriatric care is not prioritised. At the meso level, it has been found that national or provincial policy and decisions focus mainly on the treatment of HIV/ AIDS patients, sometimes to the disadvantage of geriatric treatment programmes, as the former group consists mainly of young people.[2] In this study, article 8 of the Universal Declaration on Bioethics and Human Rights (UDBHR) of the United Nations Educational, Scientific and Cultural Organization (UNESCO) will be investigated to identify principles that relate to the human condition of vulnerability. Article 8 has the specific heading ‘Respect for human vulnerability and personal integrity’, and it reads as follows: ‘In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken

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into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.’[3] The UDBHR is to my mind one of the most important instruments in the development of human rights and bioethics, as the international community (191 member states) accepted it unanimously in 2005.

This means the declaration was the first global political and bioethical text to which all the governments in the world, also SA, committed themselves. It is still the only document with such a widespread acceptance.[5-7] The primary aim of this article is to promote awareness of the UDBHR in SA (and Africa). Article 23 of the UDBHR makes an appeal to states that have signed the Declaration to promote the principles of the article through education in all areas. Mathooko and Kipkemboi, two UDBHR researchers from Africa, are convinced that bioethical teaching is necessary in Africa.[4] The problem statement arises from UNESCO research results showing the UDBHR has had little or no impact in SA.[5] This conclusion is, among others, confirmed by the fact that the two excellent academic books published in the field of bioethics and human rights, namely Bioethics, Human Rights and Health Law: Principles and Practice (2011)[10] and Medical Ethics, Law and Human Rights: A South-African Perspective (2011)[11] have no discussion of or reference to the UDBHR. To bring into effect the primary aim of creating an awareness of the UDBHR in SA, UNESCO’s understanding of the principle of respect for vulnerability will be explained briefly. It is also important to consider that the establishment of an ethos of human rights in (South) Africa will depend on all citizens’ understanding of and concurrence in the fundamental content of the UDBHR. With regard to the latter, it can be mentioned that in contrast to all other bioethical instruments, the UDBHR is definitely aimed at developing countries.

From the primary aim, two related aims flow forth. In the Handbook of Global Bio-Ethics,[8] which uses the UDBHR as a frame of reference, it is stated that legislation in Africa, and by implication in SA, does

ARTICLE not conform to international bioethical standards. This statement implies that inadequate legislation is probably the reason for the above-mentioned discrimination against the elderly. The second aim, the first of the two related aims, is therefore to ascertain whether the National Health Act[12] of SA conforms to international political, bioethical and legal guidelines as found in article 8 of the UDBHR. Awareness of article 8 will be created by testing SA legislation according to the international guidelines that will be identified in UNESCO’s understanding of the principle of respect for vulnerability (the first aim). The third aim, the second of the two related aims, is to suggest a possible reason for the discrimination against the vulnerable elderly in healthcare.

To bring the first aim into effect (directed at the second aim), a brief discussion of UNESCO’s understanding of article 8 follows below.

Respect for vulnerability in global perspective Respect for vulnerability embodies the following seven matters according to UNESCO literature that explains article 8: ‘Respect for vulnerability’ as an ethical concept, in the first place, is a relatively new concept in contemporary bioethics. It was used in the Belmont Report in 1979 for the first time. Since 1982, it has also been used in the guidelines of the Council for International Organizations of Medical Sciences (CIOMS), and since 2000, in the Declaration of Helsinki. The concept has never evolved into a completely independent principle. Although the CIOMS has referred to the protection of vulnerable people as a ‘principle’ since 1991, its guidelines are ambiguous. On the one hand, it describes vulnerability as a ‘principle’, but on the other hand, it incorporates the protection of vulnerable people as a secondary concept within the principles of respect for persons and justice.[1,6] Furthermore, vulnerability is restricted to research in the above-mentioned documents. There is no denying that the UDBHR in 2005 was the first international document that gave the concept of respect for vulnerability the status of a fundamental independent ethical principle and human right, not only in research, but also in the field of medical intervention and technology. Its status as a fundamental and independent principle implies that the principle now has a position equal to other principles, e.g. autonomy, and that it has to be considered and balanced in the same way as those principles.[13] Human dignity, in the second place, serves as motivation for special protection of vulnerable people. It is the basic point of departure of the UDBHR as found in article 3. The above argument is confirmed by article 2 of the UDBHR, which states that the aim of the declaration is, among others, ‘to provide a universal framework of principles’, with the specific aim ‘to promote respect for human dignity’. Article 8 is a powerful universal acceptance of the dignity of the human being and of his or her right to be treated with dignity.[6,14] It must be noted, in the third place, that the UDBHR does not provide a definition of vulnerability; therefore, conclusions can only be made from the limited information in the UDBHR itself and from commentaries. As an introduction, UNESCO accepts that vulnerability is a permanent condition of all humanity. This expresses the fragility and finiteness of human existence and therefore vulnerability is a characteristic that is shared by all people. According to Neves and Ten Have, [1,6,13,15,20] this fact is acknowledged in article 8 by the appeal that ‘human vulnerability’ should be taken into account and respected.

Neves and the International Bioethics Committee (IBC) point out that the words ‘special vulnerability’ in article 8 indicates that some people in certain circumstances are more vulnerable than others. They are more vulnerable because of an inability, which could be caused by internal and external factors, to make autonomous decisions. Children and disabled persons are examples of vulnerability because of internal factors; poor women are examples because of external factors; and elderly persons move between internal and external factors.[13,15] The term vulnerability is derived from the Latin word vulnus, which means ‘wound’. A wounded human being is a weakened human being on whom further harm can easily be inflicted. The concept of vulnerability relates to human fragility or debility, which implies that a human being that exists in certain circumstances (e.g. a new-born baby) does not have the ability or means to protect him- or herself against harm or to promote his or her personal advantage.[6,13,16,18] When the question is asked, in the fourth place, who could be more vulnerable, the UDBHR offers three answers: • Both articles 8 and 24 refer to individual vulnerability • In article 8, there is an unspecified reference to ‘groups of special vulnerability’ • Article 24 singles out two groups, namely ill and disabled people, but it also mentions other conditions or circumstances that can render people more vulnerable. Examples are personal, societal and environmental conditions, as well as limited resources.

According to McLean,[17] individuals and groups with special vulner­ ability may include the following: embryos and fetuses, children, women, pregnant women, the disabled, the poor, terminally ill per­ sons, illiterate persons, the elderly, minority groups and isolated populations. The IBC points out that vulnerability is not a ‘one-off concept’, but that it must be identified or ascertained. Further, the identification of vulnerability is a delicate process that has to be conducted very carefully and judiciously. The IBC is also of the opinion that vulnerability is mostly determined at an individual level (as part of the group or community), as the UDBHR associates vulnerability with the personal integrity of the individual.[6,15,18,19] In which areas or domains of bioethics, in the fifth place, can special vulnerability be expected? Although the meaning of the term ‘bioethics’ is not spelled out in the UDBHR, it is understood in a broader sense than its meaning in (medical) research. According to article 8, vulnerability is discussed in the areas of research, medical practice and technology.

The principle of vulnerability acknowledges the fact that exercising autonomy (and giving informed permission) does not necessarily eliminate vulnerability, which implies that autonomy can be reduced in a subtle and unperceivable way. Today, it is generally accepted that even patients whose physical and cognitive abilities are intact, are uniquely vulnerable in the bioethical environment because of the bigger expertise and social authority of the treating doctor. Here, mention is made of an unequal power relationship that can increase vulnerability. The patients vulnerability can further be aggravated by disease, pain, discomfort and the desire for healing, which can influence good reasoning and common sense. The latter is a fortiori true of those patients whose physical and mental abilities are seriously afflicted so that their capacity of selfdetermination is limited or absent. In the context of healthcare, the patient is to a greater or lesser extent dependent on the skills, expertise, judgement and goodwill of the caring professional. Individually and collectively, it means patients can be uniquely vulnerable.[6,13]

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ARTICLE From the discussion above, in the sixth place, it has become clear that respect for vulnerability as a principle must have definite ethical impli­cations. ‘Vulnerability without the perspective of resisting it results in misery and fatalism,’ Ten Have states.[1] The first implication of acknowledging vulnerability as a global principle is the fact that vulnerable human life demands or puts one under the obligation to protect the vulnerable. What is meant by protection? First, article 8 puts an obligation on states to support and create the necessary international and national laws, bargains and/or arrangements, ethical frameworks (like the UDBHR), infrastructure and protocols in which patient rights are outlined and which can be used as instruments to protect vulnerable people. Second, a strong functioning infrastructure that includes independent multidisciplinary and pluralistic ethical committees must be created with the purpose of evaluating all research that involves people and testing the research according to the principle of vulnerability (UDBHR art. 19).[4,6,15] The second ethical implication emerges when the UDBHR describes vulnerability in a positive sense as help to vulnerable people. Vulnerable people must not only be protected, but their wellbeing must be promoted (‘human vulnerability should be taken into account’).[4] Vulnerability can also be understood as a form of affirmative action. The idea is to ‘empower’ vulnerable people. Ten Have verbalises the positive approach as follows: ‘It expresses the normative requirement that these vulnerable fellow human beings need special care. More is needed than non-interference; they should receive assistance that will enable them to realize their potential as human beings.’[1,15, 20,21] Respect for human vulnerability in the UDBHR is formulated as a normative prescription with the purpose not only to protect vulnerable people against abuse, but also to seek them out positively and then help them to reach their full potential, which is known as ‘ethics of care’.[16] Priority must be given to vulnerable people. In the light of the above discussion of the first domain, positive help to vulnerable people could mean the following according to the IBC: ‘States to intervene directly by providing adequate health education and access to available therapies. International solidarity to be encouraged to facilitate such provision’.[14-18] Who is responsible, in the seventh place, for the protection against harm and for the promotion of the wellbeing of the vulnerable human being? Because vulnerable people cannot protect their personal interests effectively themselves, other people are responsible for protecting their interests and promoting their wellbeing. The other can be ‘... States ... individuals, groups, communities, institutions and corporations, public and private’ (UDBHR art. 1). ‘Being ill, receiving treatment and care, participating in research are first of all individual affairs; involving others requires consent and individual decisionmaking. Precisely such discourse was questioned in the philosophical perspective on vulnerability,’ Ten Have states.[1, 4, 14, 15, 20, 21] In order to reach the second aim, a brief evaluation of the National Health Act will now be given in light of the guidelines for respect for vulnerability that have emerged from the study of article 8 of the UDBHR.

Respect for vulnerability in SA It is clear that the international community recognises respect for vulnerability as an ethical principle and human right. In the National Health Act, the concept of vulnerability is referred to in four instances.

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The purpose of the law is stated as follows: ‘The objects of this Act are to regulate national health and to provide uniformity in respect of health services across the nation by... (c) protecting, respecting, promoting and fulfilling the rights of ... (iv) vulnerable groups such as women, children, older persons and persons with disabilities.’[12] To give expression to this aim the Act determines that the following actions could be considered for vulnerable groups: • Free healthcare issuing certificates of need with the purpose to realise and promote the following in society: equitable distribution and rationalisation of health and promotion of access to health services and the optimal utilisation of healthcare resources • Identifying health research priorities regarding health needs.[21] From this reference, it can be concluded that the National Health Act conforms to the international guidelines of UNESCO regarding the following matters: • Vulnerability is recognised as a reality of being a human being.

• Recognition is given to vulnerable groups. (Different from the UDBHR, the act specifies vulnerable groups such as women, children, elderly persons and the disabled).

• Disabled persons are specifically mentioned as being vulnerable.

• Vulnerable people must be protected.

• Vulnerable people must be positively helped where possible.

• Legislation gives attention to the concept of vulnerability.

From the above discussion, it is clear that the SA health legislation does indeed give expression to the concept of vulnerability; there­ fore, the reason for the above-mentioned discrimination cannot be solely ascribed to a lack of conformity to universal principles and guidelines. At the most, one could to my mind reason that the Act does not elaborate on the principle of respect for vulnerability within the context of medical practice (as well as in scientific knowledge and associated technologies); this incompleteness could lead to the above-mentioned discrimination.

What could be put forward as the reason for the above-mentioned discrimination against the elderly despite the fact that the National Health Act does indeed want to promote respect for vulnerability?

One of the most important reasons according to Wareham is the following:[3] ‘The strongest basis for discriminating against the elderly is the principle that we should do the most good and provide the most benefit with the resources at our disposal. This common sense idea is related to the bioethical principle of beneficence and has a theoretical foundation in utilitarian ethical theory. On the face of it, it seems likely that more benefit will accrue by treating the young rather than the elderly. A person who receives a heart transplant at the age of 40 is likely to gain many more healthy life years than a person who receives a transplant at the age of 85. The older person is likely to have poorer health and die from other causes before he or she can enjoy the full benefit of the intervention.’

The larger problem is that although the phenomenon of vulnerability is recognised in SA, respect for vulnerability as an independent value in its own right, as found in the UDBHR, has not yet been accepted as a human right in SA; therefore, it has not yet become part of the ethical

ARTICLE awareness of the health and political community of SA. Despite the fact that the UDBHR was accepted by SA, respect for vulnerability as an independent human right and ethical principle is nowhere to be found in political documents. Therefore, there is no reference to respect for vulnerability in the South African Constitution and The Patients’ Rights Charter, for example in the case of the right to privacy.[22] Because vulnerability has, as yet, not been established as an independent right and principle, no principle and right exist against which the utilitarian bioethical principle of beneficence can be weighed. Consequently, beneficence in the medical practice is considered as the only principle, whether consciously or unconsciously.

Conclusion From the above discussion, it is clear that the statement that the elderly are probably discriminated against in healthcare as a result of inadequate legislation that does not conform to international standards is un­true. The National Health Act recognises vulnerability and gives ex­pression to it. Respect for vulnerability has not yet been introduced to fundamental political and bioethical frames of reference in SA and that is probably the reason why the concept and right have not become part of ethical awareness in healthcare.

A first step on the way to attain respect for vulnerability in SA is by declaring the universal ethical principle of vulnerability as an independent human right.

References 1. Ten Have H. Respect for human vulnerability: The emergence of a new principle in bioethics. J Bioeth Inq 2015;(12):395-408. DOI:10.1007/s11673-015-9641-9 2. Chenwi L, ed. Economic and social rights in South Africa: Special edition on the rights of older persons. ESR Review 2011;12(1):1-36 3. Wareham C. Youngest First? Why it is wrong to discriminate against the elderly in healthcare. S Afr J BL 2015;8(1):37-39. DOI:10.7196/SAJBL.374 4. UNESCO. Universal Declaration on Bioethics and Human Rights. Paris: UNESCO Publishing, 2006. http://unesdoc.unesco.org/images/0014/001461/146180e.pdf (accessed 18 November 2013).

5. UNESCO, International Bioethics Committee (IBC). Report of the International Bioethics Committee of UNESCO. On Consent. Paris: UNESCO Publishing, 2008. http://unesdoc. unesco.org/images/0017/001781/178124e.pdf (accessed 18 November 2013).

6. Solbakk J. Vulnerability: A futile or useful principle in healthcare ethics? In: Chadwick R, Ten Have H, Meslin EM, eds. The Sage Handbook of Health Care Ethics. London: Sage, 2011: 228-238.

7. UNESCO. Explanatory Memorandum on the Elaboration of the Preliminary Draft Declaration on Universal Norms on Bioethics. Paris: UNESCO Publishing, 2008. http://unesdoc.unesco.org/images/0013/001390/139024e.pdf (accessed 7-October 2014).

8. Mathooko J, Kipkemboi J. African perspectives. In: Ten Have H, Gordijn B, eds. Handbook of Global Bioethics. Dordrecht: Springer Science and Business Media, 2014:253-268.

9. Langlois A. Negotiating Bioethics: The Governance of UNESCO’s Bioethics Programme. New York: Routledge, 2013:1-192.

10. Dhai A, McQuoid-Mason D. Bioethics, Human Rights and Health Law: Principles and Practice. Claremont: Juta, 2011:1-194.

11. Moodley K. Medical Ethics, Law and Human Rights. Pretoria: Van Schaik, 2011:1-377.

12. Republic of South Africa. National Health Act No. 61. Pretoria: Government Gazette, 2003.

13. Neves MP. Article 8: Respect for human vulnerability and personal integrity. In: Ten Have H, Jean M, eds. UNESCO. Universal Declaration on Bioethics and Human Rights: Background, Principles and Application. Ethics Series. Paris: UNESCO Publishing, 2009:155-171.

14. Martin JF. Article 7: Persons without the capacity to consent. In: Ten Have H, Jean M, eds. UNESCO. Universal Declaration on Bioethics and Human Rights: Background, Principles and Application. Ethics Series. Paris: UNESCO Publishing, 2009:139-155.

15. UNESCO, International Bioethics Committee (IBC). The Principle of Respect for Human Vulnerability and Personal Integrity: Report. Paris: UNESCO Publishing, 2009:1-54.

16. Tzitzis S. The ethical and the legal aspects of vulnerability in the christian perspective. In: Tham J, Garcia A, Miranda G, eds. Religious Perspectives on Human Vulnerability in Bioethics. Dordrecht: Springer, 2014:53-61.

17. Sheila A, McLean M. Respect for human vulnerability and personal integrity. In: Ten Have H, Gordijn B, eds. Handbook of Global Bioethics. Dordrecht: Springer Science + Business Media, 2014:105-117.

18. Miranda G. Vulnerability: How did the principle come about? In: Tham J, Garcia A, Miranda G, eds. Religious Perspectives on Human Vulnerability in Bioethics.

Dordrecht: Springer, 2014:11-15.

19. Ucko H. Christian Perspective on vulnerable groups: The elderly and the disabled. In: Tham J, Garcia A, Miranda G, eds. Religious Perspectives on Human Vulnerability in Bioethics. Dordrecht: Springer, 2014:143-153.

20. Ten Have H. The principle of vulnerability in the UNESCO Declaration on Bioethics and Human Rights. In: Tham J, Garcia A, Miranda G, eds. Religious Perspectives on Human Vulnerability in Bioethics. Dordrecht: Springer, 2014:15-29.

21. Republic of South Africa. National Health Act No. 61. Pretoria: Government Gazette 2003:4(1)(2)(d); 39(1)(a)(2)(a)(d); 70(1)(2)(d).

22. Republic of South Africa. Constitution of the Republic of South Africa. National Patients’ Rights Charter. Pretoria: Government Gazette, 1996. http://www. dohttp://www.doh.gov.za/docs/legislation/patientsright/chartere.html h.gov. za/docs/legislation/patientsright/chartere.html (accessed 5 January 2016).

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ARTICLE

Social media in the healthcare context: Ethical challenges and recommendations C Grobler,1 MB ChB, DOH, FC Psych, MMed Psych, MD Psych; A Dhai,2 MB ChB (UND), FCOG (CMSA), LLM (UND), PG Dip Int Res Ethics 1 2

Department of Psychology, Faculty of Health Sciences, Nelson Mandela Metropolitan University , Port Elizabeth, South Africa Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Corresponding author: C Grobler (dr.stof@mweb.co.za)

The popularity of social media has grown rapidly and healthcare practitioners and students commonly use sites such as Facebook. The ethical and professional implications and their benefits and hazards must be considered. Concerns include blurring of boundaries between an individual’s public and professional lives, maintaining privacy and confidentiality of patient information, damaging the public image of the profession and inter-professional relationships. The same laws that apply to conduct in the real world also apply in cyberspace. Harmful or derogatory posts may result in a defamation lawsuit. The internet may also provide opportunities for patient education through peerreviewed websites and to build professional networks. Institutions should have policies on the uses of social media. Emerging technology will continue to change the landscape of social media and social networking and the way patients and practitioners use websites will continue to evolve. Practitioners should proactively manage digital identity by reviewing publicly available material and maintaining strict privacy settings about their information.

S Afr J BL 2016;9(1):22-25. DOI:7196/SAJBL.464

The popularity of social media has grown rapidly and sites such as Facebook and Twitter are commonly used among healthcare practitioners and students.[1] As new technologies and practices, such as social networking, are embraced, the ethical and professional implications and their benefits and hazards must be considered.

‘Social media’ describes the online and mobile tools that people use to share opinions and experiences, information, images and video and audio clips, and includes websites and applications used for social networking.[2] Examples of popular media tools include: • Facebook – a networking site with over 1 billion users • Twitter – a micro-blogging service that enables its users to send and read text-based posts of up to 140 characters, known as ‘tweets’ • LinkedIn – a site with over 200 million users that offers features aimed at establishing professional networks • YouTube – a free video-sharing website, a subsidiary of Google, on which users can upload, view and share videos • Instagram – an online mobile photo-sharing, video-sharing and social networking service that enables its users to take pictures and videos, and share them on a variety of social networking platforms • Tumblr – a micro-blogging platform and social networking website which allows users to post multimedia and other content to a short-form blog • Flickr – an image- and video-hosting website where users share personal photographs • Blogs – derived from the term web log, a blog is a regularly updated website, usually maintained by an identified individual or organisation, with regular entries of commentary, descriptions of events or other material.

(SA) Social Media Landscape reported in 2014 that Facebook had 9.4 million users and Twitter had 5.5 million users in SA.[4] While many healthcare professionals use social media without encountering any difficulties, media interest and research into examples of unprofessional behaviour online have raised concerns that some practitioners and students may unknowingly expose themselves to risk because of the way they use these applications and upload personal material onto the internet.[5] In a national survey on how doctors view and use social media in Australia in 2013, the following trends emerged:[6] • There was a clear linear relationship between increasing age and decrea­sing social media use. All interns, junior medical officers and doctors un­der­taking specialty training used some form of social media, compared with 72% of specialist physicians and 69% of general practitioners.

• Facebook with 59% was the most commonly used platform (women 74%, men 52%).

• Most participants used social media at least once a week; 25% did not use social media websites.

• Doctors frequently informed their patients about online resources, with 70% discussing available online information sources for their particular illness. Rural doctors were more likely to discuss internet resources with their patients than their urban colleagues.

• The older the participants were, the less likely they were to know how to remove photos of themselves which they would not want patients to see; no participant over 65 years knew how to do this, compared with 7% aged 46 - 55 and 50% aged under 25 years.

Females (48%) were more likely than males (26%) to control and curate their online profile including adjusting privacy settings.

In the USA, Facebook is the most commonly used social media platform by physicians up to the age of 60 years.[3] The South African

The same professional ethics that are expected from healthcare professionals, are expected of health sciences students, yet in a

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ARTICLE study in 2009 in the US, 60% of responding deans of medical schools reported that medical students had posted unprofessional content online including violations of patient confidentiality, discriminatory language, use of profanity in reference to specific persons or faculties and depictions of intoxication.[7] Although healthcare practitioners and students should be free to take advantage of the many personal and professional benefits that social media can offer, they must be aware of the potential risks involved. Concerns include blurring of boundaries between an individual’s public and professional lives, maintaining privacy and confidentiality of patient information, the public image of the profession and inter-professional relationships.

Risks associated with the use of social media Blurring of boundaries

Social media can blur the boundary between a practitioner’s private and professional life. Practitioners may choose to disclose personal infor­ma­ tion about themselves during face-to-face consultations with patients, but are able to control the extent and type of such self-disclosure.

Maintaining appropriate online boundaries may prove difficult if a practitioner performs a non-medical role in his or her community, e.g. member of a local religious group using social media to organise its activities. This may result in them getting friend requests from current patients. Doctors’ surveys show that some accept selected requests on this basis, depending on the circumstances.[8] Given the greater accessibility of personal information, entering into informal relationships with patients on sites like Facebook can increase the likelihood of inappropriate boundary transgressions.

The initial decision about whether to extend the patient-practitioner relationship to the online setting must consider the following: • the intended purpose of the exchange and the content of conversation • the immediacy of electronic media and expectations • how communication will take place while maintaining confidentiality • the ease of use and immediacy of social media tools can lead to unintended outcomes.

While most practitioners would not consider entering into an informal relationship with a patient online, research suggests that some practitioners have accepted friend requests from patients and decide on an individual basis whether to accept the request or not.[9] Online relationships between practitioners of varying levels of training also need consideration. Consultants may receive ‘friend’ requests from students, and vice versa. These digital ‘relationships’ can blur professional and personal boundaries, especially when the practitioner is in the role of evaluator. Therefore, the purpose of ini­ tiating online relationships must be considered as to whether this would be for mentorship, research work, or career advice. Regardless of intent, the traditional boundaries encouraged in trainee-teacher relationships should apply when these parties interact through social media. These boundaries should also apply to staff and other healthcare practitioners.[10] Most social media sites have privacy settings that allow users to control and restrict access to their personal information. However, the default settings for both sites permit various types of content to be

shared beyond an individual’s network of friends. Research suggests that medical professionals may not be using these settings to limit access to their profile.[11] Patients may misinterpret the professional concern of their practitioner for concern of a more personal nature and make their feelings known. The Medical Defence Union (MDU) reports on their website that, in the last 5 years, those cases notified to the MDU by members who have received romantic advances have increased.

The MDU is notified of between 10 and 30 cases a year. Medi­ cal professionals most commonly approached by patients with romantic intentions are general practitioners (GPs), psychiatrists and gynaecologists. Of the 100 cases from the MDU’s files, 72 were GPs and 28 hospital doctors, while 72 were men and 28 were women.[12]

Confidentiality Confidentiality is a recurring issue featuring on the Medical Protection Society’s (MPS) advice line.[13] Confidentiality respects patient privacy and rights, encouraging patients to seek medical care and openly discuss issues. Confidentiality may be hard to maintain given electronic health records, electronic data processing, email, the faxing of patient information, third-party payment for medical services, and the sharing of patient care and information among health pro­ fessionals and institutions.

The National Health Act 2003[14] makes it an offence to disclose a patient’s information without their consent. The Health Professions Council of South Africa (HPCSA)’s Guidelines For Good Practice In The Health Care Professions aimed at ‘Confidentiality: protecting and providing information’ states on ‘Retaining confidentiality’: ‘Patients have a right to expect that information about them will be held in confidence by healthcare practitioners. Confidentiality is central to trust between practitioners and patients. Without assurances about confidentiality, patients may be reluctant to give practitioners the information they need in order to provide good care’. [15] Numerous online breaches were found of patient confidentiality on social networking sites by medical students, including identifiable information about patients being discussed on Facebook.[7] Social media also crosses individual and organisational boundaries, enabling outsiders to piece together many bits of information from multiple sources (e.g. postings from several different team members) that, when put together, can result in a breach of patient confidentiality.[16]

Public image of the profession Professionalism is the foundation of the social contract between practitioners and society. In exchange for the privilege of caring for patients and the accompanying status and respect, society expects physicians to practise professionally and empathetically.[17] The inti­ mate nature of the relationship between physicians and patients results in the expectation of high ethical behaviour by physicians.[18] Societal expectations often extend beyond professional practice and into the daily activities of the physician. Poor judgment reflects on the individual doctor and on the profession.[19] The HPCSA’s General Ethical Guidelines For The Health Care Professions stresses the importance of practitioners honouring their patients’ trust and are reminded that they must avoid abusing their position of power.[20] Practitioners should realise that the media might routinely monitor online activity to research stories or look for potential stories.

Information posted on a social networking site may be disseminated,

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ARTICLE whether intended or not, to a larger audience, be taken out of context, and remain publicly available or permanently retrievable online.[13] Online behaviour of an individual may also harm employability and recruitment and limit professional development and advancement.

Globally, institutions have harnessed the power of digital media to attract patients, new faculty, or trainees, especially in allied health pro­fessional education.[21] Employers have turned away job applicants because of questionable digital behaviour, including inappropriate photographs or information and content that displays drinking or drug use.[22] Documented public missteps include physicians taking digital photographs during surgery,[23] posing with weapons and alcohol,[24] and unprofessional posts[25] that may ultimately harm the individual and the profession.

Inter-professional relationships The internet is becoming the forum for debates on medical matters and medical practitioners should be able to engage in them fully.

However, the individual freedom to voice opinions on internet forums is not absolute and can be restricted by the need to prevent harm to the rights and reputations of others. Sound judgement must be exercised when posting online, and unsubstantiated or negative comments about individuals or organisations must be avoided.[26]

The SA legal landscape There is a general misconception that ‘cyberspace’ is a separate, imaginary jurisdiction with its own laws and rules. Cyberspace refers to the realm of electronic communication within the online world of computer networks and the internet. There is, however, no separate set of ‘social media laws’ or ‘cyber laws’ that only applies to the online world. The same laws that apply to conduct in the real world apply to conduct in cyberspace.[27] SA’s law of defamation protects a person’s right to an unimpaired reputation. This also applies to everything said and done online and is therefore available to vindicate damages suffered as a result of harmful or derogatory posts. Defamation is the act of making an unjustified statement about a person or organisation through the publication of content that refers to that person and is considered to harm their reputation. An alleged defamatory statement could result in legal action against the individual and their organisation.

Something may be considered defamatory if it damages their reputation or good name, lowers the esteem in which they are held in the minds of others or negatively affects what people think of them.

Such content attacks a person’s moral character, or exposes him or her to derision or ridicule.[27]

Benefits of social media for practitioners and the profession The internet is a powerful tool for education; eight in ten internet users go online for health information.[28] Online decision aids are increasingly popular among patients seeking health information, and warrant familiarity by practitioners.[29] Patients should be guided to peer-reviewed media and websites with quality control of information.

Practitioners and medical students use social media tools in many innovative and creative ways, e.g. building social and professional networks, sharing health-related information and engaging with the public, patients and colleagues in shaping health policies and priorities.[30] In addition to the social media tools aimed at the general public,

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some online providers offer closed online communities, forums and networks developed specifically for doctors. Many practitioners also publish their own blogs and websites.[6]

Recommendations for conduct of medical practitioners and students in the social media Be aware of personal and professional boundaries and the potential of their blurring when using social media platforms: • Maintain an appropriate balance between life as a private individual and responsibilities as a professional.

• Preferably do not accept current or former patients as friends or followers.

• Professional profiles should be constructed with an explicit purpose, e.g. networking or community outreach.

• Use the most secure privacy settings on social networking sites.

• If a patient persists in contacting the practitioner, keep a log of all contacts and seek advice from a medical defence organisation.

• Traditional boundaries apply regarding interaction between ‘teacher and student’ and should also apply to staff and allied health professionals.

Respect the privacy of patients: • The health professional’s duty of confidentiality applies online and offline.

• Patients or their medical conditions must not be discussed on public forums, except with their explicit and informed consent.

• Rarely, information may be encountered on social media sites re­sul­ting in a professional obligation to make a disclosure, e.g. information relating to child abuse and criminal acts. In these situations, appropriate professional guidance should be followed and advice sought.

• Informal or derogatory comments about patients must not be posted on public internet forums.

Manage proactively personal and professional online image and behaviour: • Practitioners represent themselves but also the profession and must always act professionally and not bring the profession into disrepute.

• Regularly review the privacy settings for each social media profile and ‘audit’ personal profile pages and information retrieved by search engines and compare this with the desired professional image to portray to others. Take time to think about what to show the world.

• Be careful of personal photographs that are posted and adapt security settings to permit the posting of any photographs in which one is ‘tagged’.

• Learn how to promptly delete posts but understand that even deleted material may be recovered or remain publicly available in some circumstances.

• Identify openly with one’s professional name if posting in a professional capacity.

• The use of a pseudonym does not provide reliable anonymity and will not protect one from disciplinary action in the event of a complaint.

• Do not respond on the network if a patient makes defamatory comments on a social network about a practitioner, but rather request in a separate communication that the post and/or com­ ment be removed.

ARTICLE • Express views openly but not in a way that will cause offence. Avoid comments that could be perceived as racist, sexist, homophobic or otherwise prejudiced, even if meant in jest or as satire.

• If posting, check that everything is up-to-date, evidence-based and factually accurate.

• If a colleague is seen to behave inappropriately online, bring this to their attention discreetly to enable them to reflect and take action.

Healthcare professionals can also be patients and inappro­pri­ate online behaviour may be a symptom of an underlying stress-related problem.

• Consider the quality of online resources recommended and guide patients to peer-reviewed media and websites.

• The permission of the employer or educational supervisor should be obtained before setting up a blog.

• Avoid posting online or using social media sites when under the influence of alcohol or when stressed, tired or upset.

• Be aware that journalists looking for potential stories may monitor medical practitioners and students’ online behaviour on social media sites.

Conclusion Social media presents opportunities and challenges to healthcare professionals and students. Innovative ways for practitioners to inter­ act with patients are presented which may improve the health of com­ munities. The tenets of professionalism and the doctor-patient relationship should govern these interactions. Institutions should have policies on the uses of digital media. Education about the ethical and professional use of these tools is critical to maintaining a respectful and safe environment for patients, the public, and practitioners. As patients continue to turn to the web for healthcare advice, practitioners should maintain a professional presence and direct patients to reputable sources of information.[26] Emerging technology and societal trends will continue to change the landscape of social media and social networking and how patients and practitioners use websites will continue to evolve.

Practitioners should be proactive in managing digital identity by reviewing publicly available material and maintaining strict privacy settings about their information. Practitioners must be familiar with these technologies to guide themselves, and their patients, as they navigate the online terrain.[10] Acknowledgement. The authors are members of the Human Rights, Law and Ethics Committee of the South African Medical Association. They wish to thank Drs Mawunyo CE Ati, Akthar Hussain, Jacobus J van Niekerk and Ntsakisi J Masinga (committee members) and Ms Marli Smit (Senior Legal Advisor) for their valuable insights during the conception of the paper.

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14. Republic of South Africa. National Health Act. Pretoria: Government Gazette, 2004. http://www.gov.za/documents/national-health-act (accessed 31 January 2015).

15. Health Professions Council of South Africa. Confidentiality: Protecting and Providing Information. Pretoria: Health Professions Council of South Africa, 2008. http://www. hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/rules/generic_ ethical_rules/booklet_10_confidentiality_protecting_and_providing_information. pdf (accessed 31 January 2015).

16. Fenton CH. A few fears felt using Facebook. Brit Med J 2011;343:d5619–d5619.

DOI:10.1136/bmj.d5619 17. Cruess SR, Cruess RL. Professionalism must be taught. Brit Med J 1997;315(7123):1674-1677. DOI:10.1136/bmj.315.7123.1647 18. Lu E. The ‘Exceptional’ Social Contract of being a Physician. [city]: Medicine for Change, 2010. http://www.medicineforchange.com/physician-social-contract (accessed 1 February 2015).

19. Farnan JM, Higa JT, Paro JAM, Reddy ST, Humphrey HJ, Arora VM. Training physicians in the digital age: Use of digital media among medical trainees and views on professional responsibility and regulation. AJOB Primary Research, 2010;1(1):3-10. DOI:10.1080/21507711003697527 20. Health Professions Council of South Africa. General Ethical Guidelines For The Health Care Professions. Pretoria: Health Professions Council of South Africa, 2008. http:// www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/rules/ generic_ethical_rules/booklet_1_guidelines_good_prac.pdf (accessed 31 January 2015).

21. Cain J, Scott DR, Smith K. Use of social media by residency program directors for resident selection. Am J Health Syst Pharm 2010;67(19):1635-1639. DOI:10.10.2146/ajhp090658 22. Farnan JM. Online medical professionalism: Patient and public relationships: Policy statement from the American College of Physicians and the Federation of State Medical Boards. Ann Intern Med 2013;158(8):620. DOI:10.7326/0003-4819158-8-201304160-00100 23. The Associated Press. YouTube surgery video spells trouble for docs. New York: Health care on NBC News, 2008. http://www.nbcnews.com/id/24157772/ns/ health-health_care/t/youtube-surgery-video-spells-trouble-docs/#.VM5yycazjFJ (accessed 31 January 2015).

24. Cable News Network (CNN). Photos of drinking, grinning aid mission doctors cause uproar. Atlanta: CNN, 2010. http://edition.cnn.com/2010/WORLD/ americas/01/29/haiti.puerto.rico.doctors/ (accessed 31 January 2015).

25. Vartabedian B. Unprofessional Physician Behavior on Twitter. Texas: 33 Charts, 2011. http://33charts.com/2011/05/unprofessional-physician-behavior-twitter. html (accessed 31 January 2015).

26. Mansfield SJ, Morrison SG, Stephens HO, BonningMA, Wang S, Withers AHJ, et al. Social media and the medical profession. Med J Aust 2011;194(12):642-644.

27. Sadleir E, De Beer T. Don’t Film Yourself Having Sex and Other Legal Advice for The Age of Social Media. Johannesburg: Penguin Books (South Africa), 2014.

28. Fox S. Health Information is a Popular Pursuit Online. Washington: Pew Research Center, 2011. http://www.pewinternet.org/2011/02/01/health-information-is-apopular-pursuit-online/ (accessed 31 January 2015).

29. Hawn C. Take two aspirin and tweet me in the morning: How Twitter, Facebook, and other social media are reshaping health care. Health Aff 2009;28(2):361-368.

DOI:10.1377/hlthaff.28.2.361 30. Kind T, Genrich G, Sodhi A, Chretien KC. Social media policies at US medical schools. Med Educ Online 2010;15:5324. DOI:10.3402/meo.v15i0.5324

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ARTICLE

Should drinking during pregnancy be criminalised to prevent fetal alcohol spectrum disorder?

J B Gardner, PhD, MSc Med Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: J B Gardner (Jillian.Gardner@wits.ac.za)

The harmful effects of alcohol use during pregnancy have been well documented. Fetal alcohol spectrum disorder (FASD) is the collective term encompassing the various clinical diagnoses that can occur in a child who was exposed to alcohol prenatally. The affected child suffers a range of lifelong primary and secondary disabilities. There is no cure for FASD, but it is preventable if women do not drink during pregnancy.

Should women be banned from, and/or punished for drinking during pregnancy for the sake of preventing fetal harm? This article considers the appropriateness of criminalising drinking during pregnancy as a means of preventing fetal harm and consequently FASD in children, and concludes that criminal approaches are unjustified, potentially discriminatory and likely to be ineffective.

S Afr J BL 2016:9(1):26-30. DOI:10.7196.SAJBL.468

The harmful effects of alcohol use during pregnancy have been well documented.[1-6] Drinking during pregnancy has been correlated with negative pregnancy outcomes including an increase in spontaneous abortion, fetal growth retardation, premature delivery, abruptio placentae and breech presentations.[7] During the first trimester, alcohol can change the way in which cells grow and organise them­selves and result in abnormalities of the face, heart, brain, limbs and urogenital system.[3] In the second trimester, it can lead to miscarriage, and in the third trimester, it can impair overall fetal growth.[3] Because the brain continues to grow throughout pregnancy and postpartum, it is most sensitive to alcohol’s damaging effects.

Fetal alcohol spectrum disorder (FASD) is a collective term encom­ passing the various clinical diagnoses that can occur in a child who was exposed to alcohol prenatally.[1-8] Fetal alcohol syndrome (FAS) is the most severe condition on the spectrum of disorders.[1-8] Less severe conditions are partial FAS, alcohol-related neurological defects/neurodevelopment disorder (ARND) and alcohol-related birth defects (ARBD).[1,6,8,9] Children with FAS are distinguished by a characteristic pattern of features. They display central nervous system (CNS) damage, have distinct dysmorphic facial features and are significantly below average height and weight, or both.[8] Several very specific facial abnormalities, that may be absent or mild in other FASD conditions, are visible in children with FAS. Therefore, the presence of the highly specific FAS facial features confirms a FAS diagnosis (even in the absence of confirmed maternal drinking during pregnancy) and distinguishes it from the other less severe conditions on the FASD spectrum.[3] For example, children diagnosed with partial FAS display all of the key FAS features, but their facial features are less defined than those of children with FAS. Children with ARND display few or none of the FAS facial features and their growth and height may range from normal to minimally deficient, but they display significant CNS damage whereas those diagnosed with ARBD present with a

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range of congenital abnormalities that are associated with prenatal alcohol exposure but have none of the other key features of FAS.[3] Consequently, a diagnosis of ARBD or ARND can only be made if there is confirmed heavy maternal drinking during pregnancy.[3] The affected child suffers a range of lifelong primary and secondary disabilities.[8] Primary disabilities are ‘the direct cause of organic brain damage due to prenatal alcohol exposure’[10] and create ‘problems with communication skills, memory, learning ability, visual and spa­ tial skills, intelligence and motor skills.’[11] Secondary disabilities are those that arise as a consequence of primary disabilities and include ‘mental health problems, disrupted schooling experience, trouble with the law, inappropriate sexual behaviour, alcohol and drug abuse, difficulty with independent living, difficulty with employment and problems with parenting.’[3] There is no cure for FASD. Alcohol’s damaging effects on the fetus and consequently the born child are permanent and cause problems that persist throughout an affected individual’s life. Surgery can repair some of the physical problems and services can be made available to improve mental and physical development so that affected individuals may lead relatively normal lives, but they remain below average in physical and mental development throughout their lives.[8]

Prevalence of FASD in South Africa FASD is a major public health issue in both well- and poorly re­ sourced countries where alcohol is widely used.[1,3] Worldwide, it is a lead­ing common preventable cause of mental disability and birth defects.[1,3-5] Although there has been no single national study conducted to determine the prevalence of FASD in South Africa (SA),[4] the Central Drug Authority (CDA) estimates the incidence of FAS in the country to be between 8% and 12%.[12] Several localised studies conducted in three of the country’s provinces found the prevalence of FASD to be among the highest in the world.[2,4-6,13-15] The most widely used international summary prevalence estimate for FAS in the developed world is 1 - 1.5 cases per 1 000 live births.[16,17] However, surveys involving school children

ARTICLE in Gauteng, the Western Cape and Northern Cape found the preva­ lence of FASD to be considerably higher. As Table 1 indicates, FASD is prevalent in many areas throughout SA. It is not restricted to rural and agricultural areas nor to a specific ethnic group.[4,5]

The financial cost of FASD The exact fiscal impact of FASD for the country has not been calculated.

Where the issue is discussed it seems to be under the general costs of alcohol abuse and birth defects to society. Recent cost calculations estimate the tangible cost of harmful alcohol use to the SA economy to be ‘R37.9 billion, or 1.6% of the 2009 GDP.’[18] Together with genetic disorders and other birth defects, the Department of Health (DoH) estimates the costs of FASD to the state to be several billion rand annually.[19] It must, however, be borne in mind that these costs may not include the costs associated with secondary disabilities such as depression, crime, violence and substance abuse.

Prevention through criminalisation FASD is not a hereditary condition so it cannot be passed onto one’s child. It is entirely preventable if women do not drink during pregnancy. The idea that women should be banned from, and/or punished for, drinking during pregnancy as a means to prevent FASD and its associated costs, is controversial, but not entirely uncommon.

For example, in the USA, several states have considered or imple­ mented laws aimed at preventing alcohol and drug use during pregnancy, which effectively infringe a woman’s rights for the sake of the fetus.[20-22] Some states have approached the problem by focusing on the pregnancy period, whereas others have chosen to intervene only after a child is born.[20] Among the policies proposed or adopted have been ones that allow for: • the removal of a child into (usually) state custody if a mother tests positive for drug or alcohol use[21] • mandatory reporting by health professionals and social workers of suspected maternal drug or alcohol use[23] • others to seek a court order to compel a pregnant woman to undergo treatment[22] • the inclusion of prenatal drug or alcohol exposure in their definitions of child abuse and neglect[24] or child endangerment.[20] In the UK, the Court of Appeal recently had to deal with the contentious question of whether drinking excessively during preg­nancy should be regarded as a criminal offence. After considering the appeal, which was brought by a local authority who sought to recover compensation from the government-funded Criminal Injuries Compensation Scheme, in order to fund the care of a child with FAS, the court ruled that excessive drinking during pregnancy is not a criminal offence under UK law. Lawyers for the city argued that the mother had committed the crime of grievous bodily harm, but one of the judges explained that the essential ingredient for the crime to be committed is that the harm is inflicted on a person.[25] Under UK law, the fetus cannot have any rights of its own at least until it is born and has a separate existence from the mother.[26,27] Consequently, the Court of Appeal ruled that compensation should not be awarded for the damage done to the child during pregnancy because she was not a legal ‘person’ while in the womb. So a crime of grievous bodily harm could not have been committed against her, as a fetus is not a ‘person’.[25] Alcohol is not a banned or illegal substance in SA, although its sale, advertising and use are subject to regulation. Anyone aged 18 years

and older can purchase alcohol in terms of the Liquor Act 59 of 2003.

There are currently no binding regulations on alcohol advertising, sponsorships, sales promotion and product placement;[28] however, the DoH is considering passing legislation in the form of the Control of Marketing of Alcoholic Beverages Bill (2013), which will totally prohibit the advertising and promotion of alcoholic products in the country.[29] In terms of the Regulations to the Foodstuffs, Cosmetics and Disinfectants Act (54 of 1972), container labels for alcoholic beverages must contain at least one of seven health messages or warnings that includes one that reads ‘Drinking during pregnancy can be harmful to your unborn baby’.[30] Driving a vehicle with a blood alcohol concentration of 0.05% and higher is criminal,[28] but drinking during pregnancy is not, although there has been a contentious pro­ posal from the Gauteng Provincial Government, in the form of the Gauteng Liquor Bill[31] that sought to prevent pregnant women from acquiring alcohol as a way of addressing concerns about the high rate of alcohol misuse and FASD in the country.[31] In terms of section 53(1) of the bill, a licensee (defined in the bill as person to whom a licence has been issued and who is thereby authorised to conduct a business in terms of the bill), may not sell, supply, or give alcohol to pregnant women. Any person who is guilty of an offence in terms of the bill is liable to a fine not exceeding R100 000 or to imprisonment for a period not exceeding 10 years or to both such fine and imprisonment.

Although the provisions are not directly aimed at pregnant women, they do ultimately operate to restrict women’s access to an otherwise legal substance for the sake of reducing the harm associated with drinking during pregnancy.

Why drinking during pregnancy should not be criminalised To use the law as a blunt instrument to get pregnant women to comply with healthy behaviours may initially appear tempting. The benefits of women not drinking during pregnancy are obvious, but there are serious problems with criminalisation, particularly with regard to its underlying view of the status of the fetus and its consequences.

Criminalising pregnant women’s behaviour is troubling because it involves intrusions and restrictions of varying duration, degree and risk in a woman’s freedom and rights. Proponents of criminalisation typically argue that the rights of pregnant women should be curtailed in some circumstances, either because they believe that the fetus has rights or because of the consequences of permitting women to do entirely as they wish. They may further point out that the harm to the woman is minor compared with the benefits to the child and society.

However, there are several reasons that warrant concern about criminalising women’s behaviour in an attempt to prevent FASD.

Implication for the maternal-fetal relationship A particular concern about criminalisation relates to its underlying view of the status of the fetus. Criminalising drinking during preg­­nancy implies that the fetus has rights which are paramount and superior to those of the woman in whose body it resides and depends on for its existence. This is tantamount to treating women as merely fetal containers because it considers the interests of the fetus to be separate to those of the mother, even though this is not factually the case.

Essentially criminalisation conceives the relationship between mother and fetus to be one of adversaries, where their rights are in conflict. If

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ARTICLE

Table 1. Prevalence of FASD in communities in SA Province

Site

Participants

Findings

Western Cape

Aurora (West Coast)

Grade 0 – 7 schoolchildren at one school

Of 160 children screened, 78 (49%) were screen-positive, of whom 63 (81%) were clinically assessed for FAS. The overall FAS/PFAS rate among screened learners was 17.5%, with 16 (10%) children having FAS and 12 (7.5%) PFAS.[2]

Four small towns and their surrounding rural areas

Grade 1 schoolchildren

1 354 children were enrolled into the study. FAS was found to occur in 93 - 128 per 1 000 children, PFAS in 58 - 86, and ARND in 32 - 46 per 1 000 children. In total FASD affects 182 - 259 per 1 000 children or 18 - 26%.[9]

Wellington

Grade 1 schoolchildren in 13 primary schools

Of 1 147 children, 747 (65.1%) were enrolled in the study. The overall rate of FASD was 135.1 - 207.5/1 000 (or 13.6 - 20.9%).

For FAS: 59.3 - 91/1 000 For PFAS: 45.3 - 69.6/1 000 For ARND: 30.5 - 46.8/1 000[1]

818 Grade 1 schoolchildren

Combined FAS and PFAS prevalence of 68.0 - 89.2/1 000[13]

857 Grade 1 schoolchildren

FAS prevalence of 65.2 - 74.2/1 000[6]

Grade 1 schoolchildren

FAS rate of 40.5 - 46.4/1 000[14]

Roodepan

435 Grade 1 schoolchildren

Galeshewe

1 152 Grade 1 schoolchildren

Complete ascertainment of FAS was made in 1 503 (94.7%) of 1 587 eligible children. Overall, FAS was diagnosed in 83 (5.5%) and FASD in 96 (6.4%). Levels of FAS were high in both areas: 26 (6.3%) from Roodepan compared with 57 (5.2%) from Galeshewe.[4]

De Aar

Grade 1 schoolchildren at eight primary schools

Combined FAS and PFAS prevalence of 119/1 000[5]

Upington

Grade 1 schoolchildren at 15 schools

Combined FAS and PFAS prevalence of 74.4/1 000[5]

Gauteng

Northern Cape

fetuses are granted rights, they would have separate claims to life, and abortion (save perhaps to save the woman’s life) would be tanta­mount to murder. Conceiving the relationship in these terms is, however, not an accurate depiction and is counterproductive. In general, most women act in ways that promote fetal health and well-being and they do so, not because they necessarily believe that the fetus has rights, but rather because they have duties towards their children.

Currently, under SA law, the fetus is not a legal person[32,33] and it is up to the pregnant woman to decide whether she wishes to consent to treatment that may affect her fetus or if she wishes to voluntarily engage in harmful behaviour. Any tension between a pregnant woman’s rights, e.g. with respect to abortion and consent to medical treatment, will generally have been settled in favour of prioritising the rights of the mother, no matter how unpleasant the results may be for the fetus. The Choice on Termination of Pregnancy Act[34] permits abortion on request by a woman during the first 12 weeks of her pregnancy, for medical reasons or social reasons in the 13th to 20th week of pregnancy and, after the 20th week, to save the life of the woman or to prevent the fetus being born malformed or injured. In the landmark case of the Christian Lawyers’ Association of SA v. Minister of Health,[35] the Act was challenged on the basis that it permitted the termination of human life, effectively violating a fetus’s right to life. The High Court, however, rejected the challenge on the basis that the word ‘everyone’, used in section 11 of the Constitution [36] to describe the bearers of the right to life, does not include a fetus. Even the provisions pertaining to child abuse contained in the Children’s Act[37] do not seem to extend to the fetus. In terms of the Act, abuse is defined as ‘any form of harm or ill-treatment deliberately inflicted on a child’, which includes assaulting or deliberately injuring a child, sexually abusing a child

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or allowing a child to be sexually abused, bullying by another child, a labour practice that exploits a child, or exposing or subjecting a child to behaviour that may harm him or her psychologically or emotionally. The Act defines a child as a person under the age of 18 years of age. This implies that women can currently not be held liable for fetal harm.

Not evidence based Women most at risk of giving birth to a child with FASD are those who drink heavily or use alcohol in harmful ways during preg­ nancy.[1,2,4-6] Underlying criminalisation of drinking during pregnancy is the idea that women will weigh the benefits of drinking against the costs of doing so (punishment) and choose abstinence. But this is an unreasonable expectation if the woman is addicted to alcohol, because it assumes two things: • that it is entirely within her control to choose not to drink • that she will choose abstinence if she judges the costs to be too high.

Criminal approaches treat what is nowadays widely understood to be a medical condition or disease – addiction – as primarily a moral weakness and/or failing. Furthermore, in the case of women who are addicted to alcohol, there is a strong likelihood that heavy drinking took place before they realised they were pregnant.[4] In which case, criminalisation would do little to prevent harm to the fetus and it would be unreasonable to punish women if they did not know that they were pregnant at the time of their drinking.

Treatment has been found to be a more effective method than criminalisation to reduce and prevent abuse and provide a healthier perinatal environment for children.[38] However, there are reportedly few

ARTICLE public sector alcohol and other drug abuse treatment facilities available in SA.[39] Punishing women for failing to seek treatment that may actu­ally not be available would therefore be unjust. Moreover, prisons are often inadequately equipped to provide for the specialised needs of pregnant women and children,[38] and there are concerns about the mental and emotional effects of children growing up in prisons.

A further concern about criminalisation is that it neglects to acknowledge the limitations of current medical knowledge and pre­ dictions of pregnancy outcomes. The relationship between maternal alcohol use and the development of FASD is not fully understood.

The relationship is one of correlation rather than one of proven causality. Although FASD is preventable if a pregnant woman does not drink alcohol, much of the data are rendered problematic by several confounding factors,[5,6,13] and there is uncertainty about the precise dose, timing and conditions of exposure to alcohol that result in FASD. While heavy drinking is an established risk factor,[4-6] less clear is the effect of moderate drinking. Although a body of literature suggests that moderate drinking during pregnancy is not linked to detrimental impacts on mental or behavioural development during early childhood,[40] a systematic review of the effects of low to moderate alcohol use during pregnancy from six studies in five countries did, however, find that it may have an impact on children’s cognitive and socio-emotional development.[41] A myriad personal, social, economic and environmental factors influence a woman’s decision to drink and consequently contribute to poor pregnancy outcomes. These include factors such as older age at pregnancy, polydrug use, low socio-economic status, poor nutritional status and genetics.[4-6,10] Given the incomplete understanding of fac­ tors underlying pregnancy outcomes in general and the contribution of individual maternal behavioural and socioeconomic factors in particular, it seems unjust to criminalise drinking during pregnancy in the face of such scientific and medical uncertainty.[20]

Consequences for women’s access to healthcare and relationships with health professionals The threat of criminal prosecution can negatively impact on efforts to prevent FASD, in that it can have the effect of undermining efforts to encourage women to seek treatment for alcohol abuse or addiction[38] and prenatal care, which greatly reduces the adverse effects of abuse during pregnancy.[42] Additionally, they may feel compelled to terminate their pregnancy (which is lawful in SA) rather than continue and face criminal prosecution.

If health professionals are required to report to authorities their pregnant patients who drink, this would place them in a policing role, which may have detrimental effects on their relationships with patients. They could lose their treatment function and instead degenerate into a social monitoring function, which will not only compromise a woman’s privacy, but also implies that the doctrine of informed, voluntary consent can be encroached in the case of women who drink/drank during pregnancy, thus undermining women’s rights and their ability to make their own choices while pregnant.

Potentially unfair and discriminatory Finally, if drinking during pregnancy is crimina­ lised, what other behaviours can the state forbid and punish for the sake of preventing

harm to a fetus? Making one particular form of behaviour during pregnancy into a criminal offence would lay the ground for crimi­ nalising a wide range of other behaviours – e.g. improper nutrition,[43] folic acid deficiency[44] or being stressed[45] – that pose risk to the fetus.

In this respect, women who drink any alcohol during pregnancy and give birth to a child with FASD could become the subject of criminal sanction. Even if a woman limits her use, but does not completely abstain, she could still be held criminally liable.

But it is not only women whose behaviours impact fetal health and wellbeing, because a man’s drinking, smoking and exposure to workplace chemicals has been found to affect his sperm, which can lead to childbirth issues and birth defects.[46,47] It would, therefore, be unfair and discriminatory, hence contrary to the dictates of justice, to single out pregnant women who drink for punishment and not the behaviour of others that pose a risk to the fetus. To avoid charges of unfair discrimination criminal sanctions would have to extend to any person whose behaviour is harmful to the fetus. As such, criminalisation threatens the autonomy and privacy of not only pregnant women, but anyone else whose behaviour is potentially harmful to the fetus.

Components of an ethical state response to prevent FASD For many people, criminalising pregnant women for behaviours that may result in harm to their fetuses may be satisfying from a moral point of view, but moral outrage and emotion should not be the basis of law, at least in liberal democratic societies. Criminalising pregnant women who abuse and are dependent on alcohol is contrary to the dictates of science and modern medicine that tends to view addiction as a disease over which people have little control. Efforts that create criminal penalties as a mechanism for addressing health problems that pregnant women may face should therefore be rejected.

Criminalisation seems neither justified nor likely to be effective at preventing FASD. There is a strong public interest in promoting the health and welfare of pregnant women and children but these interests are unlikely to be served by criminalising women’s behaviour.

An ethically appropriate and effective response to FASD prevention requires a coordinated multifaceted approach that does not penalise, but instead aims to assist women and children. This approach should include the following interventions: • education, early identification and referral of women at risk of having a child with FASD • provision of appropriate treatment and rehabilitation facilities that cater for the needs of pregnant women • early diagnosis and therapy for children with FASD • access to contraception and abortion services.

As with a criminal response, all of the above interventions require resources – human and financial – but the costs of these interventions are likely to be less and be more effective at reducing and preventing FASD. Criminalisation of pregnant women who drink will do little good for mother and child, and is not respectful to women because it treats them merely as a means to an end. Consideration of the mutual interests of the mother and fetus is likely to result in better pregnancy outcomes and is arguably more cost effective than criminalisation. By integrating efforts within existing programmes, limited resources can be used more efficiently, thereby providing additional public health benefits.

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ARTICLE Acknowledgement. Prof. AA van Niekerk, Department of Philosophy at Stellenbosch University, who supervised the doctoral research on which this article is based.

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27. Nixon DJ. Should UK law reconsider the initial threshold of legal personality? A critical analysis. Hum Reprod Genet Ethics 2010;16(2):182-217. DOI:10.1558/hrge.v16i2.182 28. World Health Organization. Global Status Report on Alcohol and Health. Gene­ va: World Health Organization, 2014. http://apps.who.int/iris/bitstream/10665/ 112736/1/9789240692763_eng.pdf?ua=1 (accessed 15 October 2015).

29. Department of Trade and Industry. National Liquor Policy Review. Pretoria: Department of Trade and Industry, 2015. http://www.gov.za/sites/www.gov.za/ files/38808_gen446.pdf (accessed 15 October 2015).

30. Republic of South Africa. Regulations relating to the labelling of alcoholic beverages. Pretoria: Government Gazette No. R. 109, 11 February 2005. No. 27236. http://www.gov.za/sites/www.gov.za/files/27236c.pdf (accessed 15 October 2015).

31. Gauteng Provincial Legislature. Gauteng Liquor Bill of 2011. Gauteng: Gauteng Provincial Gazette, 2011. http://www.restaurant.org.za/pdf/gauteng_liquor_ bill%202013.pdf (accessed 13 June 2013).

32. McQuoid-Mason D. Terminating the pregnancy of a brain-dead mother: Does a fetus have a right to life? The law in South Africa. S Afr J BL 2014;7(2):44-46. DOI: 10.7196/SAJBL.317 33. Pickles C. Approaches to pregnancy under the law: A relational response to the current South African position and recent academic trends. De Jure Law J 2014;47(1):20. http://www.saflii.org.za/journals/DEJURE/2014/2 (accessed 13 June 2015).

34. Republic of South Africa. The Choice on Termination of Pregnancy Act 92. Pretoria: Government Gazette, 1996. http://www.acts.co.za/choice-on-termination-ofpregnancy-act-1996/ 35. Christian Lawyers’ Association of South Africa v. Minister of Health (2004 (10) BCLR 1086 (T). http://www.dgrujudgements.co.za/sites/default/files/Mojapelo4. pdf (accessed 2 February 2015).

36. Republic of South Africa. Constitution of the Republic of South Africa, Act No. 108.. Pretoria: Government Gazette, 1996. http://www.acts.co.za/constitution-ofthe-republic-of-south-africa-act-1996/ (accessed 2 February 2015).

37. Republic of South Africa. Children’s Act 38. Pretoria: Government Gazette, 2005. http://www.justice.gov.za/legislation/acts/2005-038%20childrensact.pdf (accessed 2 February 2015).

38. d’Ariach L, Curtis CE, Ferrari JR, Olson BD, Jason LA. Substance abusing women and their children: A cost-effective treatment option to incarceration. J Soc Work Prac Addict 2006;6(4):71-90. DOI:10.1300/J160v06n04_05 39. Lopez Gonzalez L, Maseko C, Mvlisi M. Government switches strategy on drugs.

Johannesburg: Health-e News, 16 October 2013. http://www.health-e.org. za/2013/10/16/government-switches-strategy-drugs/ (accessed 2 February 2015).

40. Kelly Y, Iacovou M, Quigley MA, Wolke D, Kelly J, Sacker A. Light drinking versus abstinence in pregnancy – behavioural and cognitive outcomes in 7-year-old children: A longitudinal cohort study. BJOG 2013;20(11):1340-1347.

DOI:10.1111/1471-0528.12246 41. Swedish National Institute of Public Health. Low dose alcohol exposure during pregnancy – does it harm? Stockholm: Swedish National Institute of Public Health, 2009. https://www.folkhalsomyndigheten.se/pagefiles/12314/R2009-14low-dose-alcohol-exposure-pregnancy.pdf (accessed 3 June 2013).

42. El-Mohandes A, Herman AA, Nabil El-Khorazaty M, Katta PS, White D, Grylack L. Prenatal care reduces the impact of illicit drug use on perinatal outcomes. J Perinatol 2003;23(5):354-360. DOI:10.1038/sj.jp.7210933 43. King JC. The risk of maternal nutritional depletion and poor outcomes increases in early or closely spaced pregnancies. J Nutri 2003;133(5):1732S-1736S 44. Bray GA, Bellanger T. Epidemiology, trends, and morbidities of obesity and the metabolic syndrome. Endocrine 2006;29(1):109-117. DOI:10.1385/ENDO:29:1:109 45. Glover V. Prenatal stress and its effects on the fetus and the child: Possible underlying biological mechanisms. Adv Neurobiol 2015;10:269-83.

DOI:10.1007/978-1-4939-1372-5_13 46. Boston University. Sperm Damage from Toxins Can Affect Children, Grand­ children. Rockville: ScienceDaily, 21 February 2008. https://www.sciencedaily.com/ releases/2008/02/080217133251.html (accessed 18 April 2016).

47. Little RE, Sing CF. Association of father’s drinking and infant’s birth weight. New Engl J Med 1986;314(25):1644-1645. DOI:10.1056/NEJM198606193142516

ARTICLE

Client confidentiality: Perspectives of students in a healthcare training programme N Nortjé,1 DPhil; J de Jongh,2 PhD 1 2

Department of Psychology, University of the Free State, Bloemfontein, South Africa Department of Occupational Therapy, University of the Western Cape, Cape Town, South Africa

Corresponding author: Nico Nortjé (nortjenico@gmail.com)

Background. Confidentiality is an important ethical principle for all health professionals and also has a legal bearing on duty. One of the most difficult issues health professionals face in their daily fieldwork practice is a conflict between their professional duties, as illustrated in keeping a patient’s medical information confidential, and having empathy with a family member’s need to know. This moral dilemma is difficult for students to circumvent and therefore this paper presents healthcare students’ perspectives of confidentiality.

Methods. We aimed to explore healthcare students’ views and experiences of confidentiality as an ethical principle by adopting a qualitative explorative approach. Purposeful sampling was under­taken where specific individuals with specific experiences were identified. Data were collected by means of written responses from two open-ended questions and analysed thematically. Two themes emerged.

Conclusion. Confidentiality, as with other ethical principles, is an important obligation of a good client-therapist relationship as identified by students. However, the students’ responses illustrate that it cannot be absolute, and cognisance must be taken as to when it is acceptable, and even desirable, to override confidentiality because of conflicting, greater duties.

S Afr J BL 2016;8(1):31-34. DOI:7196/SAJBL.460

Confidentiality is an important and shared human value in Western bioethics and is included in inter­ national bioethical guidelines including the Helsinki declaration, Belmont report, guidelines of the Council for the International Organization of Medical Sciences (CIOMS), and many others.[1] The obligation of the physician to pre­ serve as confidential any information regarding his patient was first mentioned in the Hippocratic Oath: ‘What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken about’.[2] How­ever, the Hippocratic Oath has been criticised for enabling doctors to be selective in keeping medical confidentiality. The Geneva Declaration (1948) clearly stated that the physician shall preserve confidentiality on all he knows about the patient even after his death.[2] Confidentiality is an ethical and a legal matter. In South Africa (SA), the origin of this legal position reflects a liberal individualistic dialogue as encapsulated in the Bill of Rights of the Constitution of the Republic of South Africa[3] and the National Health Bill.[4] The legal approach to confidentiality is based on an individualistic perception of patient autonomy in that patients are viewed as separate from others and free from social constraints when making informed choices, as long as they do not harm others.[5] Benchmark judicial decisions have influenced medical confidentiality at large, such as the British example of the trial of the Duchess of Kingston in 1776. This trial reveals that the case that became the foundation of modern interpretations of medical confidentiality arose from little more than an attempt by a private surgeon, Caesar Hawkins, to secure his personal interests and status as a gentleman in eighteenth century high society.[6] One of the most difficult issues medical health professionals face in their practice is a conflict between professional duties. Such a conflict

may arise when they know that a patient’s medical information has implications for family members but their professional duty to keep the information in confidence prevents them from disclosing it.[5] However, research conducted in several countries, including England, Australia, Canada, and the USA demonstrates the importance of medical confidentiality to patients. Findings suggest that patients who believe that their confidentiality will be respected are more likely to seek treatment, discuss problems openly, and return for follow-up care.[7] Absolute privacy, that is to say complete confidentiality of all in­for­mation that the patient reveals to the healthcare provider, is neither possible nor desirable in the practice of medicine.[8] Effective, responsible medical treatment requires that we achieve a balance between disseminating patient information and keeping it private.

Breaching confidentiality can be acceptable or required by medical authorities when failure to act could lead to physical harm either to the patient or to people in contact with that patient.[1] This is illustrated by the Tarasoff case[9] (where bodily harm was inflicted on Tatiana Tarasoff by a fellow student, who told a psychiatrist about it, which resulted in her death) and the case for progressive, infectious diseases, where the healthcare provider or researcher has a duty to protect the health of those who may be at risk. The ethics of public health has become more critical in an era of viral and multidrug-resistant bacterial epidemics[10] such as the recent outbreak of Ebola. Although students understand what respecting confidentiality means, as laid down by the SA legal system, they often face ethical dilemmas as to when and to whom they may disclose information.

Confidentiality, in the healthcare system of a developing country such as SA, can often not be given the same precepts as in Western countries. The investigation of the ethical principle of confidentiality is especially relevant to students in SA:

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ARTICLE • Firstly, within the primary healthcare (PHC) approach, most students work in diverse and predominantly poorer community settings. Subgroups within dominant cultures may respond differently to similar situations.[11] Therefore, students working in community settings have access to a client’s family and personal life, as in a hospital setting.

• Secondly, the holistic and client-centred approach, used by students in their interventions, tends to involve not only the client as an individual but also the broader community which gives them access to sensitive information regarding the client as a holistic human being.[12] This is particularly, but not solely, within the field of mental health.[13] Therefore, we aimed to ascertain how healthcare students define confidentiality and in which cases, they argue, it may be breached.

Sample and methodology A qualitative research approach was adopted as the aim was to explore healthcare students’ views and experiences of confidentiality as an ethical principle. A non-probability sampling technique was used by inviting a cohort of 33 final-year healthcare students from a university in SA to participate in the study. Since this study is exploratory in nature, purposive sampling was employed where specific individuals with specific experiences were identified.[14] The inclusion criteria included registration of the students in the Faculty of Community and Health Sciences and with the Health Professions Council of South Africa (HPCSA).

Data were collected by means of two open-ended questions to explore their views and experiences of confidentiality. The questions asked were: • What is your understanding of the concept of confidentiality?

• When (if at all) is one allowed to breach confidentiality?

Participation was voluntary and all participants were assured that they could leave the study at any time without any adverse effect. The study protocol received ethics approval.

The reliability or consistency of the data analysis in qualitative research is an evolving process and can differ vastly from interpre­ tation to interpretation.[14] Of paramount importance to any quali­ tative study is the authenticity of the data which refers to the concept that a fair, honest, and balanced account of social life from the viewpoint of someone who lives it every day,[15] has been given.

Thematic analysis is a method for identifying, analysing and reporting patterns (themes) within the data. ‘It organises and describes data in detail.’[16] Thematic analysis involves searching for themes that emerge as being important to the description of the phenomenon.[17] In this study data analysis was done as suggested

by Terre Blanche, Durkheim and Kelly.[18] The steps involved included: • Familiarisation and immersion, i.e. a reading and re-reading of the text to get to know it • Identifying codes that come directly from the data by breaking up the content into phrases, words or labels • Collapsing the codes together into categories of the broader themes that were emerging through this process • Comparing categories that belonged together or differed from one another so that data were no longer presented as linear columns but a collapse of various pieces of each into separate meaningful bundles or themes

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• Interpreting themes and checking that interpretation with the participants.

Results From the thematic analysis the following two most salient themes emerged: • that students have a varied understanding of confidentiality but that most saw it as a relationship between healthcare provider and client • that confidentiality may not be breached unless one is forced to by an organ of the state.

Confidentiality as a relationship This theme highlights the participants’ perceptions and understanding of confidentiality as an ethical principle. They described their under­ standing of confidentiality by using concepts like accountability, trust, safeguard, therapeutic relationship, agreement, respect, protect, being loyal, not sharing or revealing information and being faithful to your client. The participants tended to compare confidentiality closely with protecting the privacy of the individual or group to whom they provided a service. Most of the participants perceived confidentiality as an agreement between the health professional and the client. As participants quoted: ‘It is an agreement to withhold any information regarding the client identity or any information they share with you.’

‘In my opinion confidentiality is kept through the therapeutic relationship with my client and me.’

Some participants perceived confidentiality as a health professional’s ethical and legal obligation to not disclose any information regarding their clients, without their consent. They experienced confidentiality in practice in order to build trust and strong interpersonal relationships.

One participant highlighted: ‘The aim is to create an environment of trust where the client is free to discuss anything knowing that his or her privacy, personal integrity and safety will be maintained within the process.’

Most participants experienced confidentiality as a sign of the respect that the health professional has for the client. According to the participants, they have a responsibility to respect, secure and protect the privacy of the client and the information. One participant quoted: ‘Confidentiality is the act of sacredly protecting your client.’

Most of the participants believed that confidentiality could never be compromised and that it was necessary to promote a trusting and secure relationship with their clients within a safe environment. Even in situations where sharing of the client’s information with those who have the appropriate authority to receive it, the quantity and content of the information provided should reflect a principle of ‘need to know’ basis only, as highlighted in the following quote: ‘To me it all comes down to respecting as well as protecting my client’s human right to privacy.’

ARTICLE All the participants experienced confidentiality as being loyal to their clients. For the participants to be loyal towards their clients did not only mean being faithful and trustworthy towards them, but maintaining a good relationship that is professional and therapeutic.

Breaching confidentiality This theme captured the students’ perceptions and views regarding the disclosure of client information and the reasons for breaching their confidentiality. All the students agreed that if any information about their clients had to be disclosed, they should be informed before commencing any interventions and that the client should give consent. From the findings it was evident that the only time that client confidentiality could be breached was when there was a threat to selfharm, harm to others or being a danger to society, and when the law requests information about a client. One participant said: ‘Confidentiality is allowed to be broken when the client is a danger to him or herself or to others, when he or she is psychotic, when under the age of 16, when information is needed for the court and when the client gives permission that information may be released.’

Some participants experience confidentiality as an oath that is taken by the health professional whereby it cannot be broken. Another quoted: ‘As a professional we cannot divulge a client’s information to other sources without their consent or knowledge.’

Most of the participants were of the opinion that when they are forced to disclose information, they will follow reasonable personal action when informing responsible authorities. All were in agreement that before disclosing client information the client should be informed so that trustworthiness present in the therapeutic relationship between the health professional and the client could be maintained. All these needs should be seen against the section of the National Health Act (61 of 2003) which explicitly emphasises that confidentiality may be broken: • when patient’s consent is ordered by a court of law or obligated by law (i.e. Children’s Act 38 of 2005) • when public health and/or safety is at risk.

Discussion Confidentiality, as with other ethical principles, is an important obli­ gation of a good patient-physician relationship. The philosophical foundation of this obligation is the acknowledgement of the dignity of patients as individuals and their universal right to control their own affairs. However, as with other ethical principles underlying that relationship, it cannot be absolute. Healthcare professionals should understand when it is acceptable, and even desirable, to override them because of conflicting, greater duties.[19] The results suggest that students see confidentiality as a very im­portant, almost non-negotiable, agreement between themselves and their patients/clients and that it must be ‘sacredly’ protected. A plausible explanation of why students would see it as an absolute rule could be that they see ethics as legalistic and rule-based to instruct rather than guide. Although the knowledge that confidentiality is important for the client-healthcare provider relationship and is a

good point of departure, students should receive instruction that this is a principle and with experience the concept definition will develop into a non-absolute. The healthcare setting in SA necessitates this as many clients are being cared for by caregivers who are also an integral part of the team and need to be privy to some information. However, what to disclose is of the utmost importance and must be identified at the hand of the greater duty.

The literature is clear on when confidentiality may need to be breached[1,2,5,8] – all efforts to do so must be with the client’s consent. But if that cannot be achieved, the healthcare professional cannot escape their responsibilities to the public welfare,[20] as is the present argument in the Ebola pandemic. Both legal precedents and quasi-legal standards such as codes of practice and professional guidance are usually justified, explicitly or implicitly, in terms of a utilitarian calculus; that disclosure in certain circumstances is justified because overall greater benefit will result than there would be from maintaining confidentiality.[21] From the results it was interesting that some students held the opinion that confidentiality only becomes applicable if the client reaches a specific age (16 years) or is mentally stable (not psychotic). These misconceptions are a clear sign of seeing the duty of confidentiality as a legal requirement rather than one bestowed upon the deontological principle of autonomy of an individual, regardless of age or mental ability but rather as a right bestowed upon a person.

Enabling students to understand the impact of social norms on cultural diversity is important for healthcare educators and different cultural views of confidentiality should be included in training. SA is a pluralistic society and has an Anglo-Saxon cultural and philosophical tradition that excludes family from decision-making around the health (physical or mental) of an individual family member, as is illustrated by legal dictum such as the right to privacy as enshrined in section 12(2) of the Bill of Rights (Constitution of the Republic of South Africa, 1996).

Implications for practice The undergraduate curriculum for training health professionals should not focus on ethical principles alone but should also introduce the concept of jurisprudence where students are taught the philosophy of law. This, together with developing critical reflection (Socratic dia­ logue), should encourage students to apply their knowledge and understanding of confidentiality and how this can change according to their duties to inform and protect. Furthermore, it is recommended that there should be increased efforts for students to engage in interdisciplinary education and practice. They should engage in joint reflections and dialogue around various practice issues, specifically related to confidentiality, as different members of an interdisciplinary team could hold different definitions.

Students should be exposed to SA common law and traditions where the elders of a clan often hold the decision-making power of those ‘under their guidance’. This important contribution to the SA legal framework will encourage students not to become ethnocentric in their approach to healthcare but to be sensitive to broader cultural beliefs and traditions.

References 1. Alahmad G, Dierickx, K. What do Islamic Institutional Fatwas say about medical and research confidentiality and breach of confidentiality? Dev World Bioeth 2012;12(2):104-112. DOI:10.1111/j.1471-8847.2012.00329.x

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ARTICLE 2. Papadodima SA, Spiliopoulou CA, Sakelliadis EI. Medical confidentiality: Legal and ethical aspects in Greece. Bioethics 2008;22(7):397-405. DOI:10.1111/j.14678519.2008.00654.x 3. Republic of South Africa. The Constitution of the Republic of South Africa (108).

Pretoria: Government Gazette, 1996. www.gov.za/documents/constitution/1996/ a108-96.pdf (accessed 20 August 2014).

4. Republic of South Africa. National Health Act (61). Pretoria: Government Gazette, 2003. www.gov.za/documents/download.php?f=68039 (accessed 20 August 2014).

5. Gilbar R. Medical confidentiality within the family: The doctor’s duty reconsidered.

Int J Law Policy Family 2004;18 (2):195-213. DOI:10.1093/lawfam/18.2.195 6. Ferguson AH. The lasting legacy of a bigamous duchess: The benchmark precedent for medical confidentiality. Soc Hist Med 2006;19(1):37-53. PMID: 17153159 7. Jenkins G, Merz JF, Sankar P. A qualitative study of women’s views on medical Confidentiality. J Med Ethics 2005;31(9):499-504. DOI:10.1136/jme.2004.010280 8. Brown B. Protecting the confidentiality of medical records in an interconnected environment. J Health Care Compli 2010;12(6):35-38.

9. Kyler-Hutchison P. Ethical reasoning and informed consent in occupational therapy. Am J Occup Ther 1988;42(5):283-287.

10. Balint J. Should confidentiality in medicine be absolute? Am J Bioeth 2006;6(2):19-20. PMID: 16500838 11. Lapine A,Wang-Cheng R, Goldstein M, Nooney A, Lamb G, Derse AR. When cultures clash: Physician, patient, and family wishes in truth disclosure for dying patients. J Pallitat Med 2001;4(4):474-480. PMID: 11798479

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12. Sim J, Waterfield J. Validity, reliability and responsiveness in the assessment of pain.

Physiother Theory Pract 1997;13(1):23-37. DOI:10.3109/09593989709036446 13. Sim J. Client confidentiality: Ethical issues in occupational therapy. Bri J Occupat Ther 1996;2:56-61. DOI:10.1177/030802269605900204 14. Nortjé N. Ethical tensions faced by dietetic students during fieldwork. S A J Clinical Nutri 20134;27(3):128-131.

15. Neuman WL. Basics of Social Research – Qualitative and Quantitative Approaches.

2nd ed. Boston: Pearson, 2007:108-139.

16. Braun V, Clarke V. Using thematic analysis in psychology. Qualitat Research Psychol 2006;3(2):77-101. DOI:10.1191/1478088706qp063oa 17. Fereday J, Muir-Cochrane E. Demonstrating rigor using thematic analysis: A hybrid approach of inductive and deductive coding and theme development.

Inter J Qualitat Methods 2008;5(1):80-92.

18. Terreblanche M, Durrheim K, Kelly K. Firsts Steps in Qualitative Data Analysis.

In: Terre Blanche M, Durrheim K, Painter D, eds. Research in Practice: Applied Methods in Social Sciences. 2nd ed. Cape Town: University of Cape Town Press, 2006:320-344.

19. Geiderman JM, Moskop JC, Derse AR. Privacy and confidentiality in emergency medicine: Obligations and challenges. Emerg Med Clin North Am 2006;24(3):633656. DOI:10.1016/j.emc.2006.05.005 20. Balint J. Should confidentiality in medicine be absolute? Am J Bioeth 2006;6(2):1920. DOI:10.1080/15265160500506464 21. Jones C. The utilitarian argument for medical confidentiality: A pilot study of patients’ views. J Med Ethics 2003;29(6):348-352. DOI:10.1136/jme.29.6.348

ARTICLE

But is this really the ‘parent’ or ‘guardian’? Practical strategies for consent to child research in South Africa C M Slack,1 MA Clin Psych, PhD; A E Strode,2 LLM, PhD 1 2

HIV/AIDS Vaccines Ethics Group, School of Applied Human Sciences, University of KwaZulu-Natal, Pietermaritzburg, South Africa School of Law, University of KwaZulu-Natal; HIV/AIDS Vaccines Ethics Group, University of KwaZulu-Natal, Pietermaritzburg, South Africa

Corresponding author: C M Slack (slackca@ukzn.ac.za)

Research ethics committees (RECs) in South Africa may require consent from a parent or legal guardian for child research. In instances where an REC determines that parental or guardianship consent is required, how far should researchers go to establish if the accompanying adult is in fact the parent or guardian? Should researchers accept disclosures at face value, probe assertions that are made, or even call for supporting documentation?

In this article we set out the facts research staff should possess, propose key questions they could ask, and recommend practical steps for uncertain cases. We recognise that a parental/guardianship consent strategy may not be appropriate in all instances, but do not debate that issue in this article. This article is confined to practical advice for researchers wishing to implement a parental or guardianship consent approach.

S Afr J BL 2016:9(1):35-38. DOI:10.7196/SAJBL.457

Research ethics committee (REC)s in South Africa (SA) are likely to require consent from a parent or legal guardian for child enrolment into clinical trials according to ethical norms in clinical trial guide­ lines.[1] RECs may stipulate parental or guardianship consent for other child studies that are more than minimal risk, according to ethical norms in national guidelines.[2,3] Of course, some RECs may stipulate mandatory parental consent for other child studies in compliance with recent legal norms,[4] even though many commentators have argued against mandatory parental consent without the possibility of a waiver.[5,6] This article does not debate the circumstances under which resear­ chers should seek proxy consent from parents or guardians v. other adults such as caregivers; nor does it debate the conditions under which researchers should seek independent consent from child participants themselves in accordance with their evolving capacity to make reasoned choices and independent judgements.[7] This article simply assumes that in some instances RECs will have determined that consent from a parent or legal guardian is required for child enrolment into a particular study, as per the ethical norms of the REC[1-3] and as part of a comprehensive review of whether the protocol meets norms for ethical research as set out in the most recent ethical guidelines.[3] See Table 1.

In instances where an REC has made a proper determination that parental or guardianship consent is required, how far should researchers go to establish if the accompanying adult is in fact the parent or guardian? Should researchers accept disclosures at face value, probe assertions that are made, or even call for suppor­ ting documentation? In this article we set out the facts research staff should possess, propose key questions they could ask, and recommend practical steps for uncertain cases. This operational detail is not contained in current ethical guidelines[3] nor recent regulations issued by the Minister of Health.[8]

Table 1. Norms for child research set out in national ethical guidelines (Department of Health (DoH) 2015) The participation of children is indispensable for the research The research problem is of relevance to children Taking part would not be contrary to the best interests of the child [new] The research presents acceptable standards of risk for child participants The research will take into account children’s privacy interests [new] The research will ensure abuse and neglect are reported [new] The research will ensure thoughtful reporting of underage sex [new] The research will seek appropriate permission for the research (consent from parent or legal guardian (LG), or from a substitute, or from children themselves are possible approaches depending on various factors) The research will be reviewed by an REC with appropriate child expertise

Implementing a parent and/or guardian consent approach In our view, taking reasonable steps to implement a parental or guar­ dianship consent strategy means the following: • Researchers should be aware of the current definition of ‘parent’, ‘guardian’ and ‘caregiver’ in SA because the accompanying adult may be of the view that they fall into these categories, when they do not meet the strict legal definition. As set out in a previous article, in law, a ‘parent’ is the biological or adoptive mother or father of a child, and is also generally the child’s legal guardian with some specific exclusions, for example, a gamete donor.[7] A parent is the child’s ‘guardian’ in most instances, firstly, if she is the biological

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ARTICLE mother of a child if she is over 18 (her mother will be the child’s guardian if she is under 18).[7,9] Secondly, if he is the biological father of a child in certain circumstances: these circumstances include he must have been or is over 18, married to the biological mother or was in a permanent life partnership at any time-point during her pregnancy or after the child’s birth, or he has agreed to be identified as the child’s father; or he has paid damages in terms of customary law; or he has paid for, or tried to pay for, the costs of raising the child.[7,9] Another person may be the guardian if s/he has been nominated for this position in a will written by the existing guardian or if they have been appointed as guardian by the High Court.[7,9] Finally, a caregiver is a person who cares for a child with the implied or express consent of a parent or guardian and can include, for example, a foster parent, an aunt or a grandparent.[7,9] • Research staff should ask questions to establish the nature of the relationship between the child and the accompanying adult, in a thorough yet non-interrogatory fashion. Research staff should present the rationale for asking questions. They could use words to this effect: ‘Many adults may genuinely believe they are the parent or guardian because they take care of the child on a day-to-day basis, but they might not fall within the legal definition of a parent or guardian.

We need to be able to tell the difference for this particular study’.

• Research staff should document answers to questions. Consent staff should document key aspects of the consent conversation, for future reference or for advice from senior research staff.

• Research staff should call for documentation, where doubt exists.

In cases where there is doubt that the presenting adult meets the legal definition of a parent or guardian, research staff should call for documentation but in a way that maintains a respectful, trusting and transparent relationship with this important research stakeholder.[10-12] They should explain that such requests are needed to meet REC requirements that permission is received from a strict subset of adults. Researchers should ensure that re­quests are not taken as a comment on the honesty or goodwill of the accompanying adult. (‘As before, we recognise that many adults provide children with as much care as the actual parent, and sometimes more, but for this research we have to find adults who fit into a narrow legal definition of ‘parent’ or ‘guardian’, and documents would shed more light’).

In the Tables below, we set out certain scenarios, as well as the know­­ledge that consent staff should have, probes they can use, and requests they can make for documentation in uncertain cases.

Conclusion Where researchers need to obtain parental or guardianship consent, they should act reasonably by being aware of which adults legally fall into these two categories, by trying to assess whether accompanying adults factually fall into these two categories and by having some procedure for addressing uncertainty. The recommendations set out

Table 1. Accompanying female adult reports she is the parent Scenario

Know

Ask

If in doubt, ask for:

A child is accompanied to the research site by an adult female who says she is the parent

That a female over 18, who is the biological mother of the child, is both the parent and legal guardian[7]

‘Are you over 18?’ and ‘are you the biological mother’ or ‘did you give birth to this child?’

An ID book

If questions are answered easily, do not call for documents

A signed affidavit from a respected community leader or An unabridged birth certificate (from Department of Home Affairs)

Table 2. Accompanying male adult reports he is the parent Scenario

Know

Ask

If in doubt, ask for:

A child is accompanied to the research site by an adult male who says he is the parent

That a male over 18 who is the biological father of a child is the parent but is not automatically the legal guardian[7]

‘Are you the biological father?’

A signed affidavit from a respected community leader to attest to one of the conditions or Ask for an unabridged birth certificate (from Department of Home Affairs)

To also be a guardian: - he must be married to the child’s mother, or have been married to her during the pregnancy, or any time after the baby’s birth or - he was living with her in a committed partnership at the time of the birth or - he consented to being identified as the child’s father or - he paid damages in terms of customary law or - he contributes or has contributed to the child’s upbringing and expenses.[7]

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‘Are you now, or were you ever married to the mother when she was pregnant or after the birth?’ (civil or customary marriage) or ‘Were you living with the child’s mother when the child was born?’ or ‘Have you admitted to others that s/he is your child?’ or ‘Does the child use your surname?’ or ‘Do you help with caring for her/him?’ or ‘Do you help with paying for her/his needs?’

If one of these questions can be answered easily, then do not seek documentation

ARTICLE

Table 3. Accompanying adult reports s/he is the adoptive parent Scenario

Know

Ask

If in doubt, ask for:

A child is accompanied to the research site by an adult who says s/he is the adoptive parent

That if a woman or a man is the adoptive parent of a child, they are the parent and legal guardian[7]

‘How did you come to be the adoptive parent?’

‘Was this done through the courts or a social worker?’

‘When was the adoption done?’

‘If there was a social worker, who were they?’

A copy of the court order

If these questions can be answered easily, then do not seek documentation.

Table 4. Accompanying adult reports s/he is the legal guardian Scenario

Know

Ask

If in doubt, ask for:

A child is accompanied to the research site by an adult who says s/he is the guardian

That a legal guardian is a parent or other person responsible for administering and safeguarding the child’s property, helping the child with administrative, contractual and legal matters and providing consent when required by law. Such persons (when they are not the parent) are generally nominated in the parent’s will or appointed by a court[7]

‘Who was the guardian before you?’

A copy of the court order or even the will if not deemed to be too sensitive a document

‘Did a court appoint you as the guardian?’

‘Did the parents appoint you to act as the child’s guardian?’

‘Was the appointment made in a will?’

Table 5. Accompanying adult is likely to be a caregiver Scenario

Know

Ask

Take steps

A child is accompanied to the research site by an adult who is most likely the caregiver

That caregivers include persons providing day-to-day care with the parent’s permission, such as foster parents, relatives (including grandparents), and persons receiving a childcare grant for a child[7]

‘Do you care for the child with the parent’s permission?’

Where necessary (e.g. if there is no parent/guardian) ask if the caregiver is prepared to be appointed as the guardian by a court, and refer them to local legal services, such as a campus law clinic

here were implemented successfully in a study funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) that enrolled adolescents in an HPV vaccine trial at numerous sites in SA. We do not submit that parental/guardianship consent is always the appropriate strategy and agree with the latest national ethical guidelines that in some instances a different consent approach will be acceptable.[3] This article provides some advice to researchers who wish to meet their responsibilities when implementing a parental/ guardianship consent approach.

We acknowledge that asking for documentation in uncertain cases might exacerbate mistrust between the researcher and a key research stakeholder, inadvertently becoming a barrier to otherwise ethical child research.[13,14] It is also possible that certain community members might perceive the law as side-lining important cultural norms.[15] Therefore, researchers should share their experiences with various approaches, and stakeholder experiences of these approaches should be actively researched, including negative impacts, to allow adjustment and refinement.

Acknowledgements. Initial support for this research was made possible by funds from the EDCTP. The work described here was also supported

‘Do you receive a grant to care for this child?’

by the National Institutes of Health (NIH) award number 1RO1 A1094586 (CHAMPS: Choices for Adolescent Methods of Prevention in SA). The content is solely the responsibility of the authors and does not necessarily represent the official views of the EDCTP or the NIH. It does not necessarily represent the views of any council or committee with which the authors are affiliated.

Thanks also to Glenda Gray and Fatima Laher for discussion on this issue.

References 1. National Department of Health, South Africa. South African Good Clinical Practice guidelines. 2nd ed. Pretoria: NDoH, 2006. http://www.kznhealth.gov.za/research/ guideline2.pdf (accessed 15 May 2009).

2. National Department of Health, South Africa. Ethics in Health Research: Structures, Principles and Processes. Pretoria: NDoH, 2004. http://www.mrc.ac.za/ ethics/DOHEthics.pdf (accessed 15 May 2009). National Department of Health, South Africa. Ethics in Health Research: Structures, Principles and Processes, 2nd ed. Pretoria: NDoH, 2015. http://www.mrc.ac.za/ethics/ethics.html (accessed 15 May 2015).

3. Republic of South Africa. National Health Act No. 61, Section 71. Pretoria: Government Printer, 2003.

4. Strode A, Richter M, Wallace M, Toohey J, Technau K. Failing the vulnerable: Three new consent norms which will undermine health research with children. S Afr J HIV Med 2014;15(2):46-49. DOI:10.4102/hivmed.v15i2.18 5. Zuch M, Mason-Jones AJ, Mathews C, Henley L. Changes to the law on consent in South Africa: Implications for school-based adolescent sexual and reproductive health research. BMC 2012;12(3):1-5. DOI:10.1186/1472-698X-12-3

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ARTICLE 6. Strode A, Slack C. Using the concept of ‘parental responsibilities and rights’ to identify adults able to provide proxy consent to child research in South Africa. S Afr J BL 2011;3(2):55-58.

7. Republic of South Africa, Department of Health. R378 Regulations Relating to Research with Human Subjects (published for public comment). Pretoria: Government Gazette No. 36508, 2013.

8. Republic of South Africa. Children’s Act, No. 38. Pretoria: Government Gazette No. 28944, 2005.

9. Santelli JS, Smith Rogers A, Rosenfeld WD, et al. Guidelines for Adolescent Health Research: A Position Paper of the Society for Adolescent Medicine. J Adolesc Health 2003;33(5):396-409. DOI.1016/j.jadohealth.2003.06.009 10. UNAIDS/AVAC. Good participatory practice: Guidelines for biomedical HIV prevention trials. Geneva: UNAIDS, 2011. http://www.unaids.org/en/media/ unaids/contentassets/documents/unaidspublication/2011/JC1853_GPP_ Guidelines_2011_en.pdf (accessed 21 April 2012).

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11. West SK, Ukpong M, Heise L. Community engagement in HIV prevention trials: Evolution of the field and opportunities for growth. Aids2031 background paper. Seattle: PATH publications, 2008. http://www.path.org/ publications/files/aids2031_comm_engage.pdf (accessed 21 November 2014).

12. DiClemente RJ, Ruiz MS, McDermott J. Barriers to adolescents’ participation in HIV biomedical prevention research. J Acquir Immune Defic Syndr 2010;54(Suppl 1):S12-S17. DOI10.1097/QAI.0b013e3181e1e2c0 13. Nelson RM, Lewis LL, Struble K, Wood SF. Ethical and regulatory considerations for the inclusion of adolescents in HIV biomedical prevention research. J Acquir Immune Defic Syndr 2010;54(1):S18-S24.

DOI:10.1097/QAI.0b013e3181e2012e 14. Jaspan H, Soka N, Strode A, et al. Community perspectives on the ethical issues surrounding adolescent HIV vaccine trials in South Africa. Vaccine 2008;26(45):5679-5683. DOI.org/10.1016%2Fj.vaccine.2008.08.033

ARTICLE

Ethical considerations in implementing a biometric co-enrol­ ment prevention system in clinical trials in South Africa J Moodley,1 BPharm; S Naidoo,1 PhD; N S Morar,1 M MedSci; V Govender,1 MB BCh; P Charls,2 G Ramjee,1,3,4 PhD, FRCP HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa Information Technology Services Division, South African Medical Research Council, Cape Town, South Africa 3 Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK 4 Department of Global Health, School of Medicine, University of Washington, USA 1 2

Corresponding author: J Moodley (Jothi.Moodley@mrc.ac.za)

Preventing co-enrolment in clinical trials ensures participant safety and data integrity. To facilitate co-enrolment checks, a novel biometric coenrolment prevention system (BCEPS) was developed and implemented in 2010 by the HIV Prevention Research Unit (HPRU) in collaboration with the South African Medical Research Council’s (SAMRC) Information Technology Services Division. The use of this web-based system to capture participant’s identification details in real time was approved by the SAMRC Ethics Committee. BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA). Participants who screened at the clinical research sites (CRSs) had their names, SA identity or passport number and fingerprints captured onto BCEPS after comprehensive education and discussion. This information was verified at all study visits. If a participant attempted to screen or co-enrol at multiple CRSs, the system flagged this as a potential coenrolment. By addressing the ethical concerns around participant consent and rights, participant confidentiality and privacy, data security and access, and data management and storage, we were able to successfully implement BCEPS within the clinical trials conducted at HPRU, while adhering to the principles of good clinical practice (GCP), including respect for persons, beneficence and justice.

S Afr J BL 2016;9:39-41. DOI:10.7196/SAJBL.405

South Africa (SA) has become one of the leading locations for the conduct of clinical trials due to its high-burden of disease, limited access to healthcare, well established research infrastructure and access to suitably qualified investigators.[1] Co-enrolment or concurrent enrolment of participants into multiple clinical trials testing therapeutic or prevention agents, is a potential risk in this setting.[2] Co-enrolment has the potential to affect the power of a study that determines the effect of an intervention, bias the study due to possible interactions between the interventions, increase the burden of clinic attendance and study procedures on participants and impact on the safety of the participant due to the possible unexpected interactions between interventions.[3] Reported reasons for coenrolment in this region include access to high quality healthcare at the clinical research site (CRS), study re-imbursements, altruism, access to investigational products such as study gels to enhance sexual pleasure, perceived low risk of being identified by researchers as being co-enrolled, and peer pressure by fellow co-enrollees.[3] In 2008, the HIV Prevention Research Unit (HPRU) of the South African Medical Research Council (SAMRC) identified several participants who co-enrolled in two HIV prevention clinical trials being conducted in close proximity.[2] These co-enrolments fortunately did not impact on participant safety and study outcomes.[4] This incident did, however, raise concerns among sponsors and researchers that co-enrolment in HIV prevention clinical trials is a reality that must be identified and prevented from occurring.[4] When designing any research protocol, it is imperative that investigators consider the potential impact of co-enrolment on study outcomes, safety and burden of study procedures on participants. If co-enrolment has the

potential to either augment or negate the therapeutic effect of the interventions or alter the adverse event profile of the intervention being studied, then the possibility of co-enrolment should be avoided.

This consideration is especially important when implementing trials in resource-poor settings where trial participants are more likely to attempt to co-enrol.[2]

Biometrics co-enrolment prevention system The biometrics co-enrolment prevention system (BCEPS) is a novel approach used to prevent co-enrolment of research parti­cipants in multiple clinical trials in SA.[2] This system was developed and implemented by the HPRU in collaboration with the SAMRC Infor­mation Technology (IT) Services Division and an external deve­loper in 2010.[2] This is a webbased system, which uses biometric technology to capture participant’s personal identification details in real time.[2] In brief, this system is used to capture the participant’s full name, SA identity number or passport number (if not South African) and fingerprints. This information is used to determine if a participant has screened and/or enrolled at any other research site that is listed in the co-enrolment database. The system can also link studies which are pre-determined by the investigators, to allow co-enrolment.

BCEPS is currently utilised by 26 CRSs within 13 research orga­ nisa­tions in SA, and to date has more than 26 500 participants registered on the system. All participating research organisations sign a memorandum of agreement (MOA) which is a legal agreement between the research organisation and SAMRC. On signing the MOA, the participating research organisations agree to abide by the terms and conditions applicable to the use of the

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ARTICLE system. Prior to its implementation in 2010, BCEPS was externally evaluated by an independent company to ensure its functionality.

More recently the system was audited by a study sponsor to verify compliance with applicable regulations and guidelines for the use of computerised systems in clinical trials and for compliance with the MOA.

Regulatory oversight Research involving humans must be scientifically sound and conducted in accordance with basic ethical principles as outlined in the Declaration of Helsinki and by the Council for International Organisations of Medical Sciences (CIOMS): respect for persons, beneficence, and justice.[5,6] Furthermore, SA has stringent ethical guidelines stipulated by the National Health Act (2003) and the SA Good Clinical Practice (GCP) guidelines which ensure that the rights, wellbeing and safety of individuals participating in clinical trials are protected.[7,8] In addition, clinical research trials must be approved by the local ethics committee Medicines Control Council (MCC) and be registered with the South African National Health Research Ethic Committee (NHREC) trial registry. Registration of clinical trials on NHREC ensures that all SA researchers are aware of the current clinical trials being conducted.

BCEPS was initially approved by the SAMRC ethics committee in 2010 for use in trials conducted within the HPRU and reviewed again in 2014. During the 2014 review process, the ethics committee commented that ‘the fingerprint system is good to have, but it should be balanced with ethics principles’. The following considerations were raised by the committee: • If the fingerprint database will be kept indefinitely, please pro­vide more and detailed information on the safety and security mea­ sures that will be taken to preserve confidentiality. Who will be accountable for this sensitive information? The committee asked for guidelines and standard operating procedures (SOPs) for the use of fingerprints to give them assurance.

• Separate consent should be added to the informed consent where the participant agrees to give their fingerprints to other researchers.

• If a participant refuses to give their fingerprints, will they be exclu­ded from the study? Can a participant ask to withdraw their fingerprint data from the database?

Based on the above mentioned findings, the following ethical considerations have been implemented:

Participant consent and rights To achieve understanding of BCEPS, participants are required to read and sign a co-enrolment participant information sheet (PIS), approved by the SAMRC ethics committee. This PIS includes comprehensive in­ for­mation on the purpose and use of BCEPS. Participants also receive detailed counselling regarding the risks of co-enrolment at their screening, enrolment and at follow up clinic visits. The CRS staff must ensure that while consent is required to add the participant’s data to BCEPS, the participant does have a right to refuse, or to withdraw from BCEPS at any time. Investigator discretion is used to decide if it is safe for the participant to enrol in the study; or continue with study product use without co-enrolment checks if the participant refuses.

To date, at HPRU, no participant has refused consent or withdrawn from BCEPS.

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Participant confidentiality and privacy When implementing BCEPS, care is taken to ensure the participants right to privacy and confidentiality is maintained as the system is used by many CRSs. The system is managed externally by the SAMRC IT Services Division, in order to preserve the confidentiality and security of participant data. This process is ex­plained to partici­ pants in the waiting room. All SAMRC IT staff sign a confidentiality agreement. All correspondence regarding BCEPS queries is done via email between the participating CRSs and the SAMRC IT Services Division. It is therefore crucial that this communication does not compromise the confidentiality of the participants. Delegated CRS staff, trained to send queries to a dedicated email address, ensure that only essential participant information such as the name and SA identity number are shared. There is no link to the unique study identity number and any participant-specific study data. A copy of this correspondence is filed at the CRS and the email is deleted to ensure the protection of participant confidentiality.

Data security and access To ensure that the system is secure and to prevent unauthorised access to the data, BCEPS is password protected and has two levels of authentication as a security measure. To gain access to the system authorised and trained study staff are required to login to a Secure Socket Layer Virtual Private Network (SSL VPN) portal using a username and password and thereafter login again using their fingerprint in order to access the application. The SSL VPN creates an encrypted connection between the user’s computer and the server.

The BCEPS server hosting BCEPS is protected by a CISCO Systems Inc. firewall located in a demilitarised zone (DMZ). Fingerprints are stored as an encoded text string and not as an image and therefore cannot be copied or reverse engineered. No data, such as study identifiers or participant clinical data are stored locally, or on computers.

When a participant is in attendance for a study visit at the CRS, their fingerprint is scanned to check if they are currently enrolled on the system. The system alerts the user if a co-enrolment is detected in another study or at another site. The researcher then has the option to contact the investigator from the other site and/or study to discuss the participant’s current status in the study in order to assess if it is safe to proceed with study participation. This process contributes to participant safety and data integrity.

Data management and storage Trained SAMRC IT staff members install BCEPS at each participating research site. They ensure that the delegated CRS staff are trained on the system and provided with a data entry guide that contains instructions on the use of BCEPS. Research staff then follow the site-specific standard operating procedures (SOPs) on the prevention of participant co-enrolment.

Staff members who experience technical problems with BCEPS are encouraged to contact the SAMRC IT Ser­vices Division that subsequently resolves all system related issues in a timeous manner. Data for each participant are maintained on the system for up to 15 years but can be removed by the SAMRC IT if requested by the participant. The data are backed up daily on the server and are also duplicated on the SAMRC disaster recovery site every night. Should internet connectivity be lost at site, there is an option to connect to the server using a dedicated laptop via 3G.

ARTICLE Quality assurance Quality checks at the CRSs include verifying that the participant’s correct name and identity number, as per the SA identity document, has been captured. Daily checks are performed to ensure that no participant has inadvertently been omitted from BCEPS. If a parti­ cipant presenting at a research site is not captured on the system due to human error, this could have a huge impact on participant safety and data integrity.

Conclusions and recommendations Ethically, researchers must protect the rights, safety and wellbeing of participants. It is therefore important for each research organisation to develop a co-enrolment prevention plan or SOP which identifies all potential sources of co-enrolment and implements measures to prevent co-enrolment from occurring. To identify potential sources of co-enrolment, research organisations must engage with each other regularly as well as with all stakeholders and community structures to ensure that there is awareness of all investigational products undergoing clinical trials in the country. More importantly, CRSs within close geographical proximity must maintain open dialogue on their respective research agendas.

Real-time verification of the enrolment status of participants using BCEPS is valuable to prevent co-enrolment. However, its utility is limited if all clinical research organisations conducting clini­cal trials in SA do not subscribe to one co-enrolment prevention system. By addressing the ethical concerns around participant consent and rights, participant confidentiality and privacy, data security and access, and data management and storage, we were able to successfully implement BCEPS at HPRU. There have been no concerns raised by participants or communities regarding its use in our setting.

Since SA will continue to conduct many large-scale trials, especially in the area of HIV prevention and treatment, it is essential that research organisations engage in robust dialogue on the potential ethical and safety concerns of co-enrolment and implement the use of a single shared database in the country to prevent co-enrolment in multiple studies.

References 1. Wemos Foundation. The Clinical Trials Industry in South Africa: Ethics, Rules and Realities. Amsterdam: Wemos Foundation, 2013. http://www.wemos.nl/files/ Documenten%20Informatief/Bestanden%20voor%20’Medicijnen’/Clinical_ Trials_Industry_South_Africa_2013_v3.pdf (accessed 20 June 2014).

2. Harichund C, Haripersad K, Ramjee G. Participant verification: Prevention of co-enrolment in clinical trials in South Africa. S Afr Med J 2013;103(7):491-493.

DOI:10.7196/SAMJ.6674 3. Karim QA, Kharsany A, Naidoo K, et al. Co-enrollment in multiple HIV prevention trials: Experiences from the CAPRISA 004 Tenofovir gel trial. J Contem Clin Trials 2011;32(3):333-338. DOI:10.1016/j.ccc.2011.01.005 4. Ramjee G, Coumi N, Dladla-Qwabe N, et al. Experiences in conducting multiple community-based HIV prevention trials among women in KwaZulu-Natal, South Africa. AIDS Res Ther 2010;7:10. DOI:10.1186/1742-6405-7-10 5. World Medical Association. World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Paris: World Medical Association, 2013. http://www.wma.net/en/30publications/10policies/ b3/ (accessed 20 June 2014).

6. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: Council for International Organizations of Medical Sciences, 2002. http://www.cioms.ch/ publications/guidelines/guidelines_nov_2002_blurb.html. (accessed 20 June 2014).

7. Republic of South Africa. National Health Act. Pretoria: Government Gazette, 2003. http://www.saflii.org/za/legis/consol_act/nha2003147/ (accessed 20 June 2014).

8. Republic of South Africa, Department of Health. Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa. Pretoria: Department of Health, 2006. http://www.google.co.za/url?sa=t&rct=j&q=&esrc= s&source=web&cd=1&ved=0CBwQFjAA&url=http%3A%2F%2Fwww.kznhealth. gov.za%2Fresearch%2Fguideline2.pdf&ei=FMO4VMiGCIeBPdWygcAK&usg=AF QjCNFPS2z5fpitrvxT2v5_b4D-5k-BKg (accessed 20 June 2014).

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ARTICLE

Contextualising the role of the gatekeeper in social science research S Singh,1 PhD; D R Wassenaar,2 PhD Department of Dentistry, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa South African Research Ethics Training Initiative (SARETI). Discipline of Psychology, School of Applied Human Sciences, University of KwaZulu-Natal, Pietermaritzburg, South Africa

1 2

Corresponding author: S Singh (singhshen@ukzn.ac.za)

Accessing research participants within some social institutions for research purposes may involve a simple single administrative event. However, accessing some institutions to conduct research on their data, personnel, clients or service users can be quite complex. Research ethics committee chairpersons frequently field questions from researchers wanting to know when and why gatekeeper permission should be sought.

This article examines the role and influence of gatekeepers in formal and organisational settings and explores pragmatic methods to improve understanding and facilitation of this process. Conscientious and well-informed negotiations with gatekeepers are required in order to honour the ethical obligations to conduct appropriate stakeholder engagement before and during research, along with respect for the autonomy of institutions and their employees/clients/service recipients. Provision must be made to identify explicit and implicit gatekeepers to initiate and build collaborative networks that could best support the research process. Careful mutually respectful access agreements which consider the needs and vulnerabilities of both the gatekeeper and the researcher can improve the quality of the scientific data collected. Strategic planning in the research process must take these sometimes complex processes of gatekeeper permission into careful account.

S Afr J BL 2016;9(1):42-46. DOI:7196/SAJBL.465

Ethics review of all research, including social and behavioural research, has been mandatory in South Africa (SA) since the introduction of the current National Health Act.[1] In the course of ethics review, research ethics committees (RECs) need to establish that the proposal adheres to applicable ethics guidance.[2] One dimension of such guidance requires that RECs are satisfied that adequate prior community consultation has taken place with research stakeholders. Furthermore, RECs are required to ensure that respect for the autonomy of individuals is assured, usually operationalised through the informed consent process and documents.[3] If the research is to be conducted in an institutional setting and not in the public domain, permission needs to be obtained from the legitimate authorities in charge of such institutions to conduct research in such settings – based on the principle of respect for autonomy.

Data suggest that RECs often withhold final ethics approval until the principal investigator (PI) obtains written permission from the authorised signatories of the institution that hosts the intended research participants.[4] This permission is often referred to as gatekeepers’ permission which is the focus of this paper.

The role and influence of gatekeepers in social science research has been the subject of some debate and remains a challenge for many researchers.[5,6] Despite most research ethics guidance emphasising the necessity of prior community engagement, including identification and engagement with gatekeepers, published[7] and anecdotal evidence from our own experience as REC chairpersons suggests that many social science researchers view this process as tedious, time-consuming and obstructionist. Reluctance to engage in this process is probably multi-determined and could include the

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need to meet tight timelines and funding obligations. There are legitimate grounds for debate when research is not being conducted on the physical premises of a specified organisation, for example, employees of organisation X might be recruited outside the legal entrance of the premises of an organisation, without any physical or electronic violation of the physical boundaries of that organisation.

At the same time, entry into an organisation based on deception, disguise, manipulation or false pretences undermines the moral and ethical responsibilities of the researcher.[8] This would be a breach of ‘professional propriety and ethics’.[8] Researchers are morally and ethically obliged to engage in an open and transparent manner when seeking access to an institution for research purposes.

A gatekeeper is described as someone who controls access to an institution or an organisation such as a school principal, managing director or administrator.[5,9-11] Research conducted in spaces such as shopping malls would also require gatekeeper permission because such spaces are usually privately owned or managed. Research in legitimate public spaces, e.g. streets, sidewalks, parks, public beaches, public markets, neighborhoods, taxi ranks, bus shelters, etc., are usually exempt from gatekeeper permissions, although in SA research in designated traditional areas would require gatekeeper permission from a designated traditional leader.[12,13] All institutions and organisations have an autonomous right to permit or deny access to their information, space, personnel and clients and/or service users for research purposes, unless such information is already published in the public domain.

This article will focus primarily on the role and influence of gatekeepers in formal and organisational settings and explore pragmatic methods to improve understanding and facilitation of this

ARTICLE process. An understanding of the communication processes and the identification of key stakeholders at various levels of the organisation with the potential to influence the support base for the study are all critical factors to consider.[9,14,15] REC chairs frequently field questions from researchers wanting to know when and why gatekeeper permission should be sought.

SA RECs generally agree that a study can only be provisionally approved until the researcher can produce and lodge formal proof of gatekeeper permission, while other RECs might issue full approval with a stipulation that the researcher obtain written proof of gatekeeper permission before recruitment and data collection. Before an REC can approve a study, RECs are required to evaluate whether the intended research site has the resources to host the proposed study, and to consider the possible effects of the study on the site itself.[2,3,6] These are usually covered in a letter of permission from the site gatekeeper.

The process of obtaining gatekeeper permission and support for a study may be a dynamic process and researchers need to be aware of multiple influences on this process.

Access and cooperation Access to an organisation to conduct research on its data, personnel, clients or service users can be complex, involving either a formal process of gaining entry into an organisation, followed by an informal process where the researcher becomes known to the relevant gatekeepers. It may involve a negotiated transaction between the researcher and the organisation.[8,9] These different points of entry have implications for the research process. A formal process of access would require an understanding of the organisation’s operational hierarchy and rules regarding professional etiquette and strategic planning for recruitment and data collection. The informal process involves the researcher’s ability to respect the boundaries of the access granted, adopt an objective and formal stance to the research process even if he or she is known to the gatekeepers and research participants.[9] Ethical dilemmas can occur if the gatekeeper is coercive in influencing participant involvement in the research. Conversely, denial of access, by virtue of the researcher’s relationship with the gatekeepers, is also a critical issue to consider when planning a project.

Although the terms access and cooperation are used inter­ changeably, these are different processes.[10] Obtaining gate­keeper permission from the higher levels of the organisation does not, and probably should not, guarantee cooperation from multiple layers of organisational membership, and should never overrule individual autonomy to refuse research participation.[10] It is important that researchers respect and understand the attitudes and contextspecific influences of intermediate gatekeepers within the institution.

Both levels of gatekeepers are influenced, driven and shaped by different priorities, which in turn could impact on the project.

Factors to consider In order to maximise the possibility of being granted access to an institution for research purposes, it is important that the researcher persuade the gatekeeper (and the REC) of the social value of the study. This is a standard ethics review requirement in biomedical and social science research.[3,16] In addition, the gatekeeper has a right to know the proposed research processes and their potential consequent impact on the normal operational functioning of the

institution or organisation, for example, a school principal will want to know how research on learners will impact on class learning time, and possibly even how results might reflect badly on the reputation of her school. The researcher must also articulate the potential risks and/or costs and benefits of the study, with particular reference to the value that this study can bring to the organisation, and similar organisations in question. A clear recruitment process that outlines the nature, process and considerations for participant recruitment is likely to attract a positive decision from the gatekeeper. In some cases, a direct benefit may not be possible and the researcher needs to be explicit about this issue.[10,17] At the very least, the researcher should offer the organisation feedback on the results of the study, as a way of operationalising the ethical obligation of respect for study participants.[3] The recruitment process of potential research participants has an ethical dimension that RECs, gatekeepers and researchers themselves must consider carefully, especially when the researcher is part of the organisation or staffing structure being researched. It might be more difficult for colleagues, clients or service recipients to decline research participation when being recruited by a colleague. This could compromise the voluntariness of research participation and thus undermine the voluntary informed consent requirement.[18] Another example of this could be a scenario where the researcher is an educator/teacher and the study is a classroom-based activity involving learners. Although learners (as research participants) would have been assured of their right to decline or withdraw at any stage of the study, this can be difficult in practice, especially considering the power relations between the educator and the learner and when the research is conducted in classroom activity time.[19,20] Therefore a clear distinction needs to be drawn between the goals of research versus the goals of service delivery to ensure that the host institution’s functioning and core services are not disrupted by the research.

All researchers have an ethical obligation to minimise foreseeable risks. These risks could include physical, emotional or informational risks, including pain, discomfort, embarrassment, emotional distress, breach of confidentiality, stigmatisation and ostracism. For example, a researcher investigating sexual violence among school children would need to assure both the gatekeeper (and the REC) that a strategy is in place to ensure confidentiality, privacy and anonymity in addition to outlining the selection and recruitment strategy, as well as providing information about pre-negotiated referral and care facilities for those expressing a need for psychosocial or other relevant support. These strategies must be planned for and clearly articulated in the formal application process for gatekeeper permission. Where the researcher is known to the potential participants, a clear indication should be given on how the researcher will minimise potential bias in sample selection and recruitment and maximise participant voluntariness.

Use of non-institutional recruiters might be a sound ethical strategy to overcome these threats to the ethical and scientific quality of the proposed study. Qualitative studies, while utilising seemingly innocuous ‘conversations’[21,22] can mobilise much stronger emotional distress in participants than impersonal questionnaires or even transient pain caused by minimal risk routine biomedical procedures, and these must be anticipated and planned for.[3] Similarly, focus groups hold threats of disclosure of sensitive information that can harm individuals (and cause organisational instability) which the investigator cannot control, despite appeals to all members

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ARTICLE to observe confidentiality.[18] Researchers should anticipate such issues and assure gatekeepers and RECs that all reasonable precautions to prevent or minimise harm will be taken and monitored.

Broadhead and Rist also outline the potential influence of gatekeepers in determining the conditions of entry into the organisation, access to data and respondents, restricting and wanting control over the scope of data analysis and publication.[8] There may be circumstances where the nature of the research investigation may bring the research into conflict with the organisation, with the real possibility of access being denied. Here again, the researcher needs to engage with the gatekeeper to outline the potential benefits of having to investigate these negative events and to commit to constructive recommendations that will help to improve the organisation. Therefore, there is a need for social skills and professional integrity in such negotiations with gatekeepers.

Other dilemmas could also potentially threaten the integrity of the research process.

This is reflected in the scenario where a host institution may wish to influence or manipulate the data, or request access to the raw data.

This could be particularly challenging if the researcher is employed in the same company or institution. Another scenario could be when a gatekeeper grants permission for a study and later withdraws support. This could create challenges for the researcher in terms of what happens to the data already collected. In a similar situation, a gatekeeper who granted permission to a student, who was an employee at the institution, resigned. This situation was resolved by allowing all data collected during the period when the gatekeeper permission was valid, to be used for research purposes.

All data collected at and after the date of withdrawal was not considered usable. Ideally, the departed gatekeeper’s successor should honour the prior permission, but may not always do so. This highlights the importance of anticipating such issues and specifying them in the draft gatekeeper’s letter of agreement.

Researchers (and RECs) are advised to provide a draft pro-forma of such a letter which specifies the purpose, nature and duration of the study, the sample and recruitment strategy, confidentiality and curation of the raw data, roles of sub-gatekeepers in the organisation (e.g. unit managers), publication, anonymity of the participants and possibly

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of the host organisation itself.[23] Such a letter could also include agreement on how premature withdrawal by either party will be managed and the fate of the incomplete data set. If unresolved the researcher should seek the advice of the REC that approved the study.

RECs should also increase their competence to review such gatekeeper letters, much as Materials Transfer Agreements have become routine for oversight of biological samples over the past few years.[24,25] Researchers should carefully consider any conditions placed by gatekeepers when providing access to staff or information.

These conditions, e.g., access to the raw data or restriction on the publication of results, must be carefully considered before being agreed to by the researcher.

Further dilemmas could occur when resear­ chers generate sensitive data that could cast a negative image of the institution. There is a risk of publishing negative results and facing possible alienation or denial of access into the institution for future research. In general, researchers should assure anonymity of the host institution wherever possible,[23] espe­ cially if the findings are in the general public good. There may be circumstances where anonymity does not prevent deductive disclosure[26] because the host institution may be one-of-a-kind in the region.[27]

A practical guide Buchanan et al[28] postulate a four-stage access model involving ‘getting in, get­ ting on, getting out and getting back’ com­

Entrance into an organisation

Formal access

Pre entry

During fieldwork

After fieldwork

Getting back

Formal communication (onlinedirectory, formal telephone calls, email, cover letter with official letterhead) Fix appointments based on interviewees’ availability Need to emphasise benefits of research; issues of anonymity and confidentiality assured

Informal access

Informal ways of communication (informal emails, telephone calls to familiar people) Formal appointments are usually not necessary Benefits of research often taken for granted by the organisation Issues of anonymity and confidentiality assured

Adapt to the cultural norms of the research site (e.g. dress formally might need to address interviewees formally using surnames) Take into account the differences in languages and accent Need to obtain permission to taperecord interviews, take photographs or video record the interviews, observations, etc

Adapt to the languages comfortable and familiar to the interviewees Need to obtain permission to tape record interviews

Send a formal thank you note immediately Send a copy of the result (report) to the respective organisation

Express informal thank you

Exit research site by retaining good rapport with the research site for future needs (less obstacles when getting back)

Familiar with the research site, easy to gain access again

Fig. 1. Process of gaining entrance into an organisation[9]

ARTICLE ponents. This pragmatic guide could assist researchers in planning for the research process. The ‘getting on’ component of the model involves communication, personal appearance, tact, respect for persons, and recognition of diversity in culture and social norms and practices.[9,28] The ‘getting out’ component deals with adherence to agreed timelines to ensure minimal disruption to the host organisation or institutions’ operational functioning. The ‘getting back’ component is perhaps the most critical aspect of the research process. There is increasing concern that researchers are not giving organisations an opportunity to consider and utilise the findings, especially when the findings are negative and could harm the reputation of the host institution or organisation. The ethical obligation of respect requires that researchers provide participants and host institutions with appropriately tailored feedback, to maximise the benefits of the study[3] which, for example, allows the organisation to plan remedial measures if indicated by the data.

Johl and Renganathan also provide a useful phased framework for responsible engagement with organisations and their gatekeepers.

They refer to the various components as ‘pre-entry’, ‘during fieldwork’, ‘after fieldwork’ and ‘getting back’.[9] The pre-entry phase identifies both the formal and informal process of initiating communication with the gatekeepers (Figure 1). This process should be seen as a layered approach, fostering communications at multiple levels of gatekeeping. Issues such as recruitment of participants, impact on the organisation’s operational functions, confidentiality and anonymity must be explicitly outlined. There is therefore a need for strategic planning to build gatekeeper trust and support for the project. The researcher should also ensure that ethics review and approval from a registered REC are in place before data collection commences.

In the fieldwork phase, the researcher must ensure that all activities captured in the gatekeeper agreement letter are adhered to. Informed consent must be obtained from the individual participants for all aspects of the data collection process. Participants should be given the right to accept or reject the use of audio or video recorders or the use of photographs. In addition, the researcher should respect cultural diversity and the social dynamics that prevail in that work environment. The researcher should also adhere to the agreed timelines for data collection and ensure minimal disruption of the operational functioning of the institution. It is also good practice to send a note of appreciation to the gatekeeper at the end of the study.

Feedback sessions, where agreed to, should be done in a constructive manner, even when the study results are negative.

There is an ethical obligation to present feedback in a form that is tailored to the audience so as to maximise understanding, utility and implementation, with acknowledgement of the limitations of the data, as required by scientific integrity guidance.[29,30] Feedback sessions could be conducted in different ways, for example, a presentation, workshop, event, or a summary electronic or hard copy report, tailored for each specific audience.

Conclusion Gatekeepers play an essential and undervalued role in the generation of good research data. Conscientious and well-informed negotiations with gatekeepers are required in order to honour the ethical obligations to conduct appropriate stakeholder engagement before and during research, along with respect for the autonomy of institutions and their employees/clients/service recipients. Careful

mutually respectful access agreements, which consider the needs and vulnerabilities of both the gatekeeper and the researcher, can improve the quality of the scientific data collected. Strategic planning in the research process must take these sometimes complex processes of gatekeeper permission into careful account. Although gatekeeping permissions are often a simple single administrative event, this is not always the case. It can be a complex, layered process approach involving layers of gatekeepers with the potential to influence the data collection process. Researchers should be respectful of this and well prepared to consider and understand gatekeepers’ concerns.

Provision must be made to identify explicit and implicit gatekeepers to initiate and build collaborative networks that could best support the research process, bearing in mind that these collaborations could be biased by vested interests. Respectful work with gatekeepers will ensure that good quality social science research is conducted with consideration and respect for all parties concerned.

We hope that this article stimulates more critical reflection and practice by RECs and researchers of the role of gatekeepers in research.

Future research could examine gatekeepers’ own perspectives on the issues arising when hosting researchers in institutional research settings.

References 1. Cleaton-Jones P, Wassenaar, D. Protection of human participants in health research: A comparison of some US Federal Regulations and South African Research Ethics guidelines. S Afr Med J 2010;100(11):710-716.

2. Department of Health, South Africa. Ethics in research: principles, processes, structures. Pretoria: National Health Research Ethics Council, 2015: 9-17.

3. Wassenaar DR, Mamotte N. Ethical issues and ethics reviews in social science research. In: Leach M, Stevens M, Lindsay G, Ferrero A, Korkut Y, eds. The Oxford Handbook of International Psychological Ethics. New York: Oxford, 2012:268-282.

4. Denny SG, Silaigwana B, Wassenaar D, Bull S, Parker M. Developing ethical practices for public health research data sharing in South Africa: The views and experiences from a diverse sample of research stakeholders. J Empir Res Hum Res Ethics 2015:10(3):290-301. DOI:10.1177/1556264615592386 5. Clark T. Gaining and maintaining access: Exploring the mechanisms that support and challenge the relationship between gatekeepers and researchers. Qual Soc Work 2011;10(4):485-502. DOI:10.1177/1473325009358228 6. Das C, McAreavey R. A delicate balancing act: Negotiating with gatekeepers for ethical research when researching minority communities. Int J Qualit Methods 2013;12(1):113-131. DOI:10.1177/160940691301200102 7. Seahloli MS. Challenges encountered when applying for ethics and permission to conduct the non-clinical trial study in the hospitals and clinic. S Am J Clinic Res 2015:2(1):1-14.

8. Broadhead RS, Rist RC. Gatekeepers and the social control of social research. Soc Probs 1976;23(3):325-336. DOI:10.1525/sp.1976.23.3.03a00080 9. Johl SK, Renganathan S. Strategies for gaining access in doing fieldwork: Reflection of two researchers. EJBRM 2010;8(1):42-50.

10. Wanat CL. Getting past the gatekeepers: Differences between access and cooperation in public school research. Field Meth 2008:20(2):191-208. DOI: 10.1177/1525822X07313811 11. Wiles R, Heath S, Crow G, Charles V. Informed consent in social research: A literature review. Southhampton: ESRC National Centre for Research Methods.

NCRM Methods Review Papers. NCRM/001. University of Southampton, 2005. http://eprints.ncrm.ac.uk/85/1/MethodsReviewPaperNCRM-001.pdf (accessed 10 January 2016).

12. Mandel J. Negotiating expectations in the field: Gatekeepers, research fatigue and cultural biases. Singapore J Trop Geog 2003;24(2):198-210. DOI:10.1111/14679493.00152 13. Matshidze PE. The role of Makhadzi in traditional leadership among the Venda.

A thesis submitted in fulfilment of the degree of Doctor in Philosophy. KwaZuluNatal: University of Zululand, 2013. http://uzspace.uzulu.ac.za/bitstream/ handle/10530/1327/THE+ROLE+OF+MAKHADZI+IN+TRADITIONAL+LEADERSHI P+AMONG+THE+VENDA.pdf (accessed 20 March 2016).

14. Herd B. The wizard and the gatekeeper: Of castles and contracts. BMJ 1995;310(6986):1042-1044.

15. Willems DL. Balancing rationalities: Gatekeeping in health care. J Med Ethics 2001;27(1):25-29.

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ARTICLE 16. Emanuel EJ, Wendler D, Grady C. An ethi­cal framework for biomedical research.

In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, eds. The Oxford textbook of clinical research ethics. New York: Oxford University Press, 2008:123-133.

17. Campbell J. Ethical Considerations with Gatekeepers. Mark Bound Nova Southeastern DCAR 7120NSU PhD. Program. 10, April 2012. https://www. academia.edu/1526314/Ethics_in_Qualitative_Research_Gatekeepers (accessed 20 March 2016) 18. Mamotte N, Wassenaar DR. Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study. J Health Psychology 2016; 1-18. DOI: 10.1177/1359105316628737 19. Heath S, Charles V, Crow G, Wiles R. Informed consent, gatekeepers and gobetweens. Amsterdam: International Association Sixth International Conference on Social Science Methodology, 2004. http://www. sociologyandsocialpolicy.soton.ac.uk/Proj/Informed_Consent/Resources.html (accessed 10 December 2015).

20. Homan R. The principle of assumed consent: The ethics of gatekeeping. J Philos Educ 2001;35(3):329-43. DOI:10.1111/1467-9752.00230 21. Redwood S, Todres L. Exploring the ethical imagination: Conversation as practice versus committee as gatekeeper. Forum: Qualitat Soc Res 2006:7(2):26.

22. Schrag ZM. How talking became human subjects research: The federal regulation of the social sciences 1965-1991. J Policy History 2009:21(1):3-37. DOI:10.1017/ s0898030609090010

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23. Uys LR. Should researchers protect the good name and reputation of institutions in which research is done? S Afr J Higher Educ 2008:22(2):457-465.

24. Barchi F, Matshlagela K, Jones N, Kebaabetswe PM, Merz JM. The keeping is the problem: A qualitative study of IRB-member perspectives in Botswana on the collection, use and storage of human biological samples for research. BMC Med Eth 2015;16(3):54. DOI:10.1186/s12910-015-0047-3 25. Staunton C, Moodley K. Data mining and biological sample exportation from South Africa: A new wave of bioexploitation under the guise of clinical care? S Afr Med J 2016;106(2):136-138. DOI:10.7196/SAMJ.2016.v106i2.10248 26. ACH Media. Avoid ‘deductive’ disclosures by revamping informed consent. Atlanta: ACH Media, 2010. http://www.ahcmedia.com/articles/115236-avoid-deductivedisclosures-by-revamping-informed-consent (accessed 10 January 2016).

27. Kaiser K. Protecting respondent confidentiality in qualitative research. Qual Health Res 2009;19(11):1632-1641. DOI:10.1177/1049732309350879 28. Buchanan D, Boddy D, Mc Calman J. Getting In, Getting On, Getting Out and Getting Back. In: Bryman A, ed. Doing Research in Organisations. London: Routledge, 1988: 53-67.

29. Fernandez CV, Kodish E, Weijer C. Informing study participants of research results: An ethical imperative. IRB 2003;25(3):12-19. DOI:10.2307/3564300 30. Thorogood A, Joly Y, Knoppers BM, et al. An implementation framework for the feedback of individual research results and incidental findings in research. BMC Med Ethics 2014;15(1):88. DOI:10.1186/1472-6939-15-88

BOOK REVIEW

Medical Ethics Today. The BMA’s Handbook of Ethics and Law By the British Medical Association, Ethics Department.

Pp Xiii + 925. Wiley-Blackwell & Sons, Ltd, Publication. 3rd ed, 2012.

ISBN 978-1-4443-3708-2 With rapid advances in science and technology modern healthcare gives rise to complex multidimensional dilemmas that the physician is not fully equipped to handle. Furthermore, in many countries, phy­ si­cian autonomy has been restrained by governments and other authorities enforcing controls on medical practitioners, adding to the many issues they are confronted with. Physicians are challenged with questions on behavior and decision-making as frequently as scientific and technical ones on an almost daily basis in current medical practice. It is therefore not surprising that the BMA’s Handbook of Ethics and Law goes beyond a simple guidebook or manual and is a voluminous comprehensive sourcebook of around 1 000 pages covering almost every eventuality that physicians could face in the practice of healthcare.

This book, which sets out to bridge the gap between theory and practice, comprises 21 chapters and 3 appendices. The latter are the Hippocratic Oath, the Declaration of Geneva and the Declaration of a New Doctor, as devised by Imperial College School of Medicine graduating year of 2001. It is interesting to note the Declaration from Imperial College introduces a positive duty on physicians to assist patients with developing agency. It also establishes the advocacy role of physicians in the context of human rights violations, the need to strive to change laws that are contrary to professional ethics and work towards a fairer distribution of health resources.

The book starts off with a section that describes what medical ethics is and leads into a framework of good ethical practice in healthcare. This section also briefly explains the theories and principles pertinent to the practice of healthcare and assists the reader with developing skills in critical analysis. A stepped approach on how to handle an ethical dilemma is detailed.

Chapter 1 deals with the doctor-patient relationship. General prin­ciples are discussed to start off with. This is then followed by topics including the changing expectations of the doctorpatient re­la­tionship, types of relationships in modern medicine, the importance of good communication, trust and reciprocity and recognising responsibilities and boundaries. Chapter 2 deals with consent and chapter 3 with adults who lack capacity. In chapter 4, which looks at children and young people, subjects like combining respect for autonomy with best interests, cultural

practices and child protection are detailed. Confidentiality, health records and contraception, abortion and birth are the subject matter for chapters 5, 6 and 7, respectively. Chapter 8 details issues in the context of assisted reproduction and considers the new dilemmas that could arise with new reproductive technologies, how assisted reproduction is regulated, access to treatment and pre-implantation genetic testing, among others.

Ethical and legal issues in the context of genetics are covered in chapter 9. Topics in this chapter range from consent for genetic testing and confidentiality within families to consumer testing and controversial uses of genetic material. Caring for patients at the end of life, euthanasia and physician assisted suicide and responsibilities after a patient’s death are detailed in the 3 chapters that follow. Prescribing and administering medicine is detailed in chapter 13. The challenges and dilemmas, pressures from patients and employers’ conflicts of interests and pharmacogenetics are just some of the topics included in this chapter, which is followed by research and innovative treatment (chapter 14), emergency situations (chapter 15) and doctors with dual obligations (chapter 16). The following 5 chapters consider issues around providing treatment and care in detention settings, education and training, teamwork, shared care referral and obligation, public health dimensions of medical practice and reducing risk, clinical error and poor performance.

Throughout the book, ethical, legal and human rights issues are given due consideration. Practical and relevant case studies in the form of vignettes and case law together with best practice in realworld situations are included in each chapter. Although this book is voluminous (most chapters are 40 - 50 pages), it is justifiably so, as almost all ethical and legal issues that could arise in medical practice are covered. Practical guidance points are offered for the various dilemmas. While the laws are specific to the UK, their principles could be applied in any country and the legal guidance is particularly helpful in regions where such laws are nascent or do not exist at all.

The handbook is an excellent resource for students and healthcare practitioners in all disciplines in health science, academics, lawyers and policy makers. It will be an invaluable investment for university libraries, and health sciences and medico-legal practices globally.

Ames Dhai (amaboo.dhai@wits.ac.za) S Afr J BL 2016;10(1):47 DOI:10.7196/SAJBL.475

May 2016, Vol. 9, No. 1 SAJBL

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CPD QUESTIONNAIRE

May 2016 True (A) or false (B): Medical negligence: Alternative claims resolution an answer to the epidemic?

1. The clinical negligence system currently in place in South Africa does not facilitate efficient and fair resolution of disputes.

2. A decline in professional practice standards is directly responsible for the deterioration in the overall claims environment in the country.

Mediation as an alternative solution to medical malpractice court claims 3. Claims in respect of minors only prescribe after they reach 18 years.

4. Touting by lawyers is legal but advertising is illegal.

Should drinking during pregnancy be criminalised to prevent fetal alcohol spectrum disorder?

5. Anyone aged 12 years and older can purchase alcohol in terms of the Liquor Act 59 of 2003.

6. Driving a vehicle with a blood-alcohol concentration of 0.05% and higher is a criminal offence in South Africa.

Constitutional, legal and regulatory imperatives for the renewed care and prevention of congenital disorders in South Africa 7. The United Nations Convention on the Rights of the Child concerns the rights of the disabled child without discrimination.

8. A national legislative framework does not exist in SA for the pro­ vision of medical genetic services.

May doctors refuse to treat rape survivors in order to avoid having to give evidence in court?

9. A medical emergency is defined as a situation where a person ‘suffers a sudden catastrophe which calls for immediate medical attention’.

10. The South African Department of Health does not have a national policy guideline for victims of sexual offences.

Ethical considerations in implementing a biometric co-enrolment prevention system in clinical trials in South Africa 11. South Africa has become one of the leading locations for the con­ duct of clinical trials.

Client confidentiality: Perspectives of students in a healthcare trai­ning programme 12. The legal approach to confidentiality is based on an individualistic perception of patient autonomy.

13. Breaching confidentiality can never be acceptable in the practice of healthcare by medical practitioners.

Respect for vulnerability is a human right 14. Respect for vulnerability was used for the first time in the Belmont Report in 1979.

15. South African health legislation does not give expression to the concept of vulnerability.

But is this really the ‘parent’ or ‘guardian’? Practical strategies for consent to child research in South Africa 16. A ‘parent’ is the biological or adoptive mother or father of a child.

17. A caregiver is a person who cares for a child but does not include a foster parent.

Ethical challenges in the social media in the healthcare context 18. Most social media sites have privacy settings that allow users to control and restrict access to their personal information.

Contextualising the role of the gatekeeper in social science research 19. A gatekeeper is described as someone who controls access to an institution or an organisation.

20. Researchers are in a position to control absolute confidentiality of focus group discussions involving their research participants.

A maximum of 6 CEUs will be awarded per correctly completed test.

Effective in 2014, the CPD programme for SAJBL will be administered by The CPD programme for SAJBL will be administered by Medical Practice Consulting: Medical Practice Consulting: CPD questionnaires must be completed online at www.mpconsulting.co.za CPD questionnaires must be completed online at www.mpconsulting.co.za After submission you can check the answers and print your certificate.

After submission you can check the answers and print your certificate.

Questions may be answered up to 6 months after publication of each issue.

Questions may be answered up to 6 months after publication of each issue.

Accreditation number: MDB015/176/02/2016 (Ethics) Accreditation number: MDB015/176/02/2016 (Ethics)

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