SAJBL Vol 7, No 2 (2014)

ISSN 1999-7639

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW November 2014 Vol. 7 No. 2

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 november

2014 Vol. 7 No. 2

CONTENTS

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EDITORIAL The Ebola crisis: Ethical challenges in the African context A Dhai

ARTICLES 44 Terminating the pregnancy of a brain-dead mother: Does a fetus have a right to life? The law in South Africa

D McQuoid-Mason 47 Pregnant, dead, and on a ventilator: A few thoughts in response to Prof.

McQuoid-Mason

A Nienaber 51 Article 6 of the UNESCO Universal Declaration of Bioethics and Human Rights: A moral force in South Africa

R Rheeder 55

Moral perspectives on covert research A A van Niekerk

59 Enhancing capacity of research ethics review committees in developing countries: The Kenyan example G Omosa-Manyonyi, W Jaoko, K M Bhatt, S K Langat, G Mutua, B Farah, J Nyange, J Olenja, J Oyugi, S Wakasiaka, M Khaniri, K Fowke, R Kaul, O Anzala 64 An analysis of the validity of medical legal documentation in cases where the patient refuses treatment and/or transport

R Spicer, S Sobuwa 69

Can private obstetric care be saved in South Africa?

G Howarth, P Carstens

OPINION 74 The battle against stem cell hype: Are we doing enough? Can the medical and scientific community do more to support regulatory boards in advocating ethical evidence-based medicine?

R J Burman 76

The war in Gaza: A humanitarian crisis M A Sathar

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LETTERS TO THE EDITOR The ethics of claiming a 60% reduction in HIV acquisition from voluntary medical male circumcision P S Millard

79

Health promotion is ethical S Nieuwoudt, S Goldstein, A Myers, N Christofides, K Hofman

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FORUM Quality healthcare: An attainable goal for all South Africans?

N P Moyakhe

84

BOOK REVIEW Global Health Law A Dhai

85

CPD

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 EDITOR Janet Seggie EDITOR EMERITUS Daniel J Ncayiyana CONSULTING EDITOR J P de V van Niekerk DEPUTY EDITOR Bridget Farham EDITORIAL SYSTEMS MANAGER Melissa Raemaekers SCIENTIFIC EDITOR Ingrid Nye TECHNICAL EDITORS Emma Buchanan Paula van der Bijl Diane de Kock HEAD OF PUBLISHING Robert Arendse PRODUCTION ASSISTANT Bronlyne Granger ART DIRECTOR Brent Meder DTP & DESIGN Carl Sampson HMPG BOARD OF DIRECTORS M Veller M Lukhele M Mbokota A A Stulting M R Abbas V Memela G Wolvaardt ISSN 1999-7639 Plagiarism is defined as the use of another’s work, words or ideas without attribution or permission, and representation of them as one’s own original work. Manuscripts containing plagiarism will not be considered for publication in the SAJBL. For more information on our plagiarism policy, please visit http://www.sajbl.org.za/ index.php/sajbl/about/editorialPolicies

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

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SAJBL is published by the Health and Medical Publishing Group.

EDITORIAL

The Ebola crisis: Ethical challenges in the African context The six building blocks for an effective national health system are: • Health workforce • Health service delivery • Health information systems • Medical products, vaccines and technologies • Health financing • Leadership, governance and management.

Ames Dhai Editor amaboo.dhai@wits.ac.za The current outbreak of Ebola virus disease (EVD) in West Africa is proving particularly challenging to contain. At the time of preparing this editorial, over 2 500 lives have already been lost since the index case, which involved a 2-year-old child who died in December 2013. This outbreak was officially reported by the World Health Organization (WHO) towards the end of March this year. The Ebola virus is a filovirus that is believed to be harboured by specific bat species in the affected regions. Transmission is from bat to bat and spill-over occurs into other animal species, in particular antelope and primates. Spill-over to humans is through contact with infected animals or direct contact with infected bats. Once a person is infected, mortality is reported to be between 60% and 90%, and the disease spreads quickly through contact with infected tissues and body fluids of affected persons. It is therefore not surprising that EVD is now one of the most feared diseases of the globalised world.[1] EVD has given rise to several ethical challenges, ranging from concerns regarding measures to contain the disease, to how decisions are made in terms of who to treat in the face of limited treatments, to the planning and conducting of clinical trials in this context.[2,3] Moreover, the age-old concerns regarding lack of access to healthcare in Africa have resurfaced. It is this lack of access that clearly interferes with the achievement of the Millennium Development Goals (MDGs) on the continent, and while progress has been achieved globally in making people healthier since 1990, this progress is not equally distributed. Dr Margaret Mungherera, President of the World Medical Association (WMA), recently stated that in Africa there has been very little progress – the disease burden continues to be disproportionate to the population. Africa has 11% of the world’s population but 49% of the maternal deaths, 50% of the under-5 deaths and 62% of the burden of HIV/AIDS globally. She pointed out that three countries have achieved only one MDG so far, e.g. Ethiopia has achieved MDG 4, and by 2015, no African country will have attained all the MDGs. The reality is that with the current status quo, most African countries will attain the MDGs 35 years or more after 2015. This is because of problems of natural disasters, political instability, wars, poor political governance, inadequate health financing, inattention to the social determinants of health, and weak health systems.

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All six need strengthening in African countries.[4] It is therefore not surprising that the regions affected with EVD, with their fragmented and under-resourced health infrastructure where strict infection control and quarantine are difficult to achieve, are struggling to contain the disease. Infection control as a preventive measure ought to be routine practice in health facilities throughout the globe, including Africa.

EVD was first described in 1976 and has been recorded in several central African countries including the Democratic Republic of Congo, Sudan, Gabon and Uganda, with cases having been imported into South Africa. In the past, cases have also been imported into the Netherlands, Italy and the USA.[1] However, EVD has been seen as mainly an African disease, and it is perhaps because of this that market-driven drug development has not found it necessary to invest in research and development in this arena. This is not unexpected, given Big Pharma’s slow response to other infectious diseases in the developing world. This is also a stark reminder of the 90/10 disequilibrium that was frequently raised in ethical discourse on global distributive justice in research during the past decade, where 90% of research conducted globally was aimed at 10% of the world’s privileged populations. It has been stated that treatments and a vaccine would probably have been available today if the prevalence of EVD was, in the main, a problem of high-income countries.[5] In this context, research and development would no doubt be financially attractive to drug companies.

The reality of the current outbreak is that health workers now confront several problems – problems they did not face when dealing with EVD in Africa in the past. Health systems in the three affected countries are extremely weak. This, coupled with insufficient staff, equipment and facilities, makes disease surveillance, isolation and supportive care almost impossible without assistance from wellresourced regions. In addition, fear of the disease and mistrust of health professionals have resulted in patients being removed from hospitals and being concealed, together with others that are sick in the communities. Moreover, cross-border movement between the three affected countries in West Africa has facilitated spread across a vast stretch. Effective contact tracing, which is critical for containment of the disease, has therefore become increasingly challenging, especially in remote rural areas.[2] Because no cure or vaccine exists for the disease, the WHO convened a special consultation on 11 August to assess the ethical implications of the use of unregistered interventions which existed in the laboratory in small quantities at that time. A day later a statement was released that in the face of the EVD threat, it was ethical to offer unproven interventions with as yet unknown efficacy

EDITORIAL and adverse effects as potential treatment or prevention. The ethical criteria to guide the provision of such interventions should include transparency regarding all aspects of care, ensuring freedom of choice and informed consent, respecting confidentiality, human dignity and involving the community.[6] The WHO decision is in line with the WMA’s Declaration of Helsinki (section 37) on ‘Unproven Interventions in Clinical Practice’, which states: ‘In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.’[7] The WHO followed with a statement on 5 September which highlighted four critical elements that are required for treatment and research in this context: • Appropriate protocols for informed consent and safe use must be rapidly developed.

• Mechanisms for evaluating pre-clinical data need to be established in order to recommend which interventions are to be evaluated as a first priority.

• A platform needs to be set up for transparent and real-time collection and sharing of data.

• A safety monitoring board must be established so that data from all interventions can be evaluated.[8]

The incidence of EVD continues to spiral, and external sources have now come forward to assist the affected countries. However, for as long as governments in these countries do not commit to strengthen their healthcare systems and improve the underlying social deter­minants of health attempts at combating the Ebola crisis and other crises following in the future could end up being ineffective.

References 1. Weyer J, Blumberg LH, Paweska JT. Ebola virus disease in West Africa – an unprecedented outbreak. S Afr Med J 2014;104(8):555-556. [http:/dx.doi. org/10.7196/SAJBL.8672] 2. Rid A, Emanuel E. Ethical considerations of experimental interventions in the Ebola outbreak. Lancet August 21, 2014. [http://dx.doi.org/10.1016/S01406736(14)61315-5] 3. Kass N. Ebola, ethics and public health: What next? Ann Intern Med August 19, 2014. http://annals.org/ (accessed 21 September 2014).

4. Dhai A. Congratulations SAMA on another highly successful conference. SAMA Insider October 2014:5-6.

5. Kerridge I, Gilbert L. Epidemic ethics: Four lessons from the current Ebola outbreak. http://theconversation.com/epidemic-ethics-four-lessons-from-thecurrent-ebola-outbreak-30534 (accessed 22 August 2014).

6. World Health Organization. Ethical Considerations for Use of Unregistered Interventions for Ebola Virus Disease (EVD). Geneva: World Health Organization, 2014. http://www.who.int/mediacentre/news/statements/2014/ebola-ethicalreview-summary/en/ (accessed 22 August 2014).

7. World Medical Association. Declaration of Helsinki. Helsinki, Finland, June 1964.

Amended October 2013. http://www.wma.net/en/30publications/10policies/ b3/ (accessed22 August 2014).

8. World Health Organization. Statement on the WHO Consultation on Potential Ebola Therapies and Vaccines. Geneva: World Health Organization, 2014. http://www.who.int/mediacentre/news/statements/2014/ebola-therapiesconsultation/en/ (accessed 15 September 2014).

S Afr J BL 2014:7(2)42-43. DOI:10.7196/SAJBL.359

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ARTICLE

Terminating the pregnancy of a brain-dead mother: Does a fetus have a right to life? The law in South Africa D McQuoid-Mason, BComm LLB, LLM, PhD Professor of Law, Centre for Socio-Legal Studies, University of KwaZulu-Natal, Durban, South Africa Corresponding author: D McQuoid-Mason (mcquoidm@ukzn.ac.za)

In the recent Texas case of Munoz v. John Peter Smith Hospital, the court granted a husband an order for the removal of life support from his brain-dead pregnant wife whose body was decaying, after a hospital had tried to keep her on ‘life support’ until the fetus was born. In South Africa the court would have issued a similar order but for different reasons, viz. because in this country: (i) a fetus has no legal rights until it is born; and (ii) unlawfully subjecting a dead pregnant women to ‘life-support’ measures to keep a fetus alive, where the deceased has not made a will to that effect, and against the wishes of the family, could result in a criminal charge of violating a corpse.

S Afr J BL 2014:7(2)44-46. DOI:10.7196/SAJBL.317

Recently, in the Texas case of Munoz v. John Peter Smith Hospital,[1] a husband obtained a court order for the removal of ‘life support’ from his brain-dead pregnant wife. The question the court had to consider was whether a pregnant woman who is carrying a viable fetus, and is clinically and legally dead, should be kept on ‘life support’ until the fetus is born. The court ordered that ‘life support’ should be withdrawn and Mrs Munoz’s body released to her husband and family. It found that Mrs Munoz could not be regarded as a ‘patient’ because she was dead. Therefore, the Texas Health and Safety Code stating that’ life support’ must be given to ‘pregnant patients’[2] did not apply.[3] The question arises whether a South African (SA) court would have issued a similar order but for different reasons, because there is no such code here.

The facts in the Munoz case Mrs Marlise Munoz, a 33-year-old paramedic who was 14 weeks pregnant, suffered a suspected pulmonary embolism which left her brain dead. Nine weeks later, when the fetus was 23 weeks old, her husband sued the John Peter Smith Hospital after the doctors told him that a Texas law forbade the hospital from withdrawing ‘life support’ from his dead wife until the fetus’s birth or a miscarriage occurred.[4] Mr Munoz approached the court to order the hospital to remove his wife from ‘any respirators, ventilators or other “life support”, and to release the body to her family for proper preservation and burial’.[5] He argued that: • The Texas Health and Safety Code[2] that disallows the withdrawal of life-sustaining treatment from pregnant patients does not apply to dead people or their fetuses.

• The hospital was treating the body in a criminal manner.

• The deceased’s constitutional rights to privacy and equal protection were being violated because she had made advance directives to her husband and parents stating that she did not want to be kept on ‘any type of artificial “life sustaining treatment”, ventilators or the like’.[5]

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The application did not mention that the fetus was badly deformed.[4] When ordering the withdrawal of treatment and release of the body, the court only considered the first argument and held that the Texas Health and Safety Code[2] did not apply to Mrs Munoz because she was dead. It did not rule on any of the other grounds in the application.[3] Such a ruling could not have been given in SA had Mrs Munoz died in this country, because there is no statute similar to the Texas Code[2] here. However, in the unlikely event that such a case arises in SA, a similar result could have been achieved on other grounds. In order to determine the grounds on which an SA court will have issued a similar order, but for different reasons, it is necessary to consider: • The provisions of the Choice on Termination of Pregnancy Act[6] • The legal rights of deceased persons • The criminal law protection afforded to deceased persons • The legal status of a fetus in SA.

Choice on Termination of Pregnancy Act (Choice Act) In SA it appears that the Choice Act[4] does not apply to similar situations to that of Mrs Munoz because there was no expulsion of the fetus as required by the definition of ‘termination of pregnancy’.

The Choice Act defines a termination of pregnancy as ‘the separation and expulsion, by medical or surgical means, of the contents of the uterus of a pregnant woman’.[7] In the Munoz case there was no question of separating or expelling ‘the contents or the uterus’ of Mrs Munoz. The request was to discontinue ‘life support’ which would have meant that the fetus would have died while in her uterus. Therefore the Choice Act would not have applied.

If Mrs Munoz had been alive and living in SA at the time, and 24 weeks pregnant, the termination could have been performed in terms of the Choice Act because the fetus was ‘distinctly abnormal’.[4] Under the Act, after 20 weeks of gestation, the pregnancy may be terminated if its continuation ‘would result in a severe malformation of the fetus’.[8]

ARTICLE Do deceased persons have legal rights under the constitution and common law?

Civil-law rights of the dead to bring civil actions under the Constitution

Although deceased persons lose their constitutional and common law rights to bring civil actions, there may be some protection for their bodily integrity under criminal law and certain statutes.

The Constitution[9] only applies to people who are alive, and as in common law, a person’s legal personality terminates on their death.[10] Therefore, a deceased person no longer has a constitutional right to equality, human dignity, freedom, security and privacy.[11] On this basis the constitutional arguments raised in the Munoz case regarding the deceased’s right to privacy and equality being violated by subjecting her body to ‘life sustaining treatment’ against her will[4] would not have succeeded had the case been brought in SA. However, the values in the Constitution enshrined in the rights listed in the Bill of Rights,[12] particularly the rights to dignity and privacy, give a good indication of how common law should be developed when the court considers whether an act of omission is contra bonos mores (contrary to good morals) and unlawful.[13]

The rights of the dead to bring civil actions under common law According to common law, the ‘legal personality of a person is terminated by death: a dead person can have neither rights nor obligations’.[10] Therefore, when a person dies before the matter has gone to court and the pleadings joined (litis contestatio), the person loses all their legally enforceable rights in respect of their personality, including their bodily integrity.[10] However, the law protects their body and regulates its disposal: ‘not in the interests of the deceased but partly in the interests of public health and partly because of respect for the dead’.[10] Although a person loses their common law rights to bring a civil action on death, they may preserve their wishes in a valid will in terms of the Wills Act,[14] or ask their next of kin to do certain things for them – even if the latter requests are not legally enforceable.

For instance, a person could record in a will her wishes regarding what should happen if she dies while pregnant – even though this would be a most unlikely occurrence. Such a will would have to comply with the Act,[4] and not be a so-called ‘living will’ or advance directive, because such documents only subsist while a person is alive.[5] If there is no will recording the wishes of the deceased pregnant person, her next of kin (e.g. spouse, partner, parents, etc.) could request a hospital to maintain the body with ‘life support’ until the child is born – even though there may be no legal obligation on the hospital to do so. However, this will only apply if such treatment will not be medically futile, as was the situation in the Munoz case – otherwise it would be unethical and probably illegal for the hospital to do so. The World Medical Association defines ‘futile medical treatment’ as treatment that ‘offers no reasonable hope of recovery or improvement’ or from which ‘the patient is permanently unable to experience any benefit’.[15] Recently, in Canada, a Mrs Robyn Benson who had been declared brain-dead when she was 22 weeks pregnant was treated with ‘life support’ for 6 weeks to enable the child to be born – at the request

of her husband. Although the doctors had hoped to maintain the ‘life support’ until 34 weeks of gestation, a healthy premature baby boy was delivered after 28 weeks.[16] This case differs from the Munoz case in three respects: • Mrs Benson died when the fetus was 22 weeks old, unlike Mrs Munoz who died when the fetus was only 14 weeks old ­– although the application for withdrawal of treatment was made at 24 weeks.

• Mr Benson had requested that his dead wife be subjected to ‘lifesupport’ treatment.

• The fetus in the Benson case was healthy – unlike in the Munoz case, where it was ‘distinctly abnormal’.[4]

Criminal law protection of the dead under common law Although a deceased person is unable to take civil action against interference with their personality rights such as their body, it is a crime to violate a corpse.[17] Violating a dead body consists of the unlawful and intentional violation of a dead human body.[17] However, it will be a good defence if the alleged perpetrators genuinely believed that they had obtained the necessary consent to interfere with the body.[17] It may be legally justifiable to subject a dead person to shortterm ‘life support’ to preserve certain tissue and organs for lawful transplantation under the National Health Act,[18] but – apart from any statutory offence committed in terms of the Act – unlawfully subjecting a corpse to intrusions by ‘life support’ mechanisms could well be interpreted as violating a corpse and a crime under SA law.[17] According to the attorney in the Munoz case, the fetus was ‘gestating within a dead and deteriorating body, as a horrified family looks on in absolute anguish, distress and sadness’.[4] The lawyer argued that by not withdrawing treatment from Mrs Munoz’s body, the hospital was ‘disturbing and damaging the body, treating it in an offensive manner, and [committing] an act that is both a tortious wrong and a criminal violation’.[5] There is little doubt that had the Munoz case arisen in SA, such conduct by the doctors would be regarded as contra bonos mores (contrary to good morals) and unlawful. The legal convictions of society would be outraged[19] by the fact that a pregnant dead woman carrying a grossly defective fetus was being subjected to ‘life support’ mechanisms, while her body was decaying and traumatising the deceased’s family. It is clear that the doctors acted intentionally – and in SA there would be no basis for a claim that they mistakenly believed that they were bound to preserve the fetus by a statute like the Texas Code.[2] Therefore, they could be found guilty of the common law crime of unlawfully violating a corpse by subjecting her body to ‘life support’.[17]

Legal status of the fetus The fetus is not regarded as a person in SA law and is not protected by the Constitution or common law unless it is born alive.[20] This is similar to the approach in England.[21] In SA the courts have held that there are no legal grounds for the appointment of a curator to represent a fetus in cases where its mother wishes to terminate a pregnancy.[22] Similarly, in England the court has refused to make a fetus a ward of the court to protect it from a mentally disturbed mother.[23] The courts in the USA

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ARTICLE have held that ‘the State may not override a pregnant woman’s competent treatment decision, including refusal of recommended invasive medical procedures, to potentially save the life of the viable fetus’.[24] In SA, if a viable fetus is destroyed it is not murder but abortion, because the fetus is not regarded as a human being.[25] If the Munoz case had occurred in SA, nothing could have been done on behalf of the fetus – leaving aside the fact that it would not have been medically justifiable to try to preserve the life of a ‘distinctly abnormal’ fetus. The courts are likely to have ordered the hospital to withdraw the ‘life support’ treatment and to release Mrs Munoz’s body to her husband. The basis of the decision could be that to apply ‘life support’ to a deceased ‘decaying’ pregnant corpse, against the wishes of her husband and family, was unlawfully interfering with her body and constituted the crime of violation of a corpse. The death of the fetus is a natural consequence of its mother’s death and should not be interfered with unless there are good medical and legal grounds for doing so.

Conclusion In light of the above, the situation in SA regarding the termination of pregnancy of dead pregnant mothers is as follows: • The Choice Act and the Constitution do not apply to dead pregnant women.

• If the pregnant woman has made an advance directive or appointed a surrogate decision-maker in terms of the National Health Act, such directives and appointments fall away on her death.

• A pregnant deceased woman’s body may be subjected to ‘life support’ until the baby is born at the request of the next of kin (e.g. a spouse or partner) and if it is medically justifiable.

• A person who intentionally and unlawfully subjects a pregnant deceased woman’s body to ‘life support’ may be guilty of the common-law crime of violation of a corpse.

• Persons accused of violating the corpse of a pregnant mother by subjecting it to ‘life support’ to keep a fetus alive, can raise the defence that they genuinely believed that they had the necessary consent for their conduct – provided this can be established.

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References 1. Munoz v. John Peter Smith Hospital, Tarrant County District Court, Texas, 24 January 2014 (unreported). Sapa-AP-AFP. Switch of my dead wife, plea. The Mercury, 28 January 2014:5.

2. Texas Health and Safety Code. Texas, USA. 1989:166.049 3. Munoz v. John Peter Smith Hospital Case No. 096270080-14 Tarrant County District Court 96th Judicial District Texas. 24 January 2014 (unreported). http:// www.thaddeuspope.com/images/Munoz_202053415-Judge-Order-on-Munoz.

Matter.pdf (accessed 12 February 2012).

4. Lupkin S. Why Texas foetus might have had ‘abnormalities’ before mother was brain dead. World News. http://www.abcnews.go.com/Health/texas-fetus-abn (accessed 12 February 2014).

5. Janicek JH, Plaintiff’s Attorney. Plaintiff’s motion to compel defendants to remove Marlise Munoz from ‘life sustaining’ measures and application for unopposed expedited rule. Tarrant County District Court, Texas. 14 January 2014. http://www://scribd. com/199665794/munoz-versus-John-Peter-Smith-Hospital (accessed 12 February 2012).

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

Government Gazette 1996.

7. Republic of South Africa. Choice on Termination of Pregnancy Act No. 92, Section 1. Government Gazette 1996.

8. Republic of South Africa. Choice on Termination of Pregnancy Act No. 92, Section 2(1)(b). Government Gazette 1996.

9. Republic of South Africa. Constitution of the Republic of South Africa.

Government Gazette 1996.

10. Neethling J, Potgieter JM, Knobel JC. Law of Delict. 6th ed. Durban: LexisNexis Butterworth, 2010: 253.

11. Republic of South Africa. Constitution of the Republic of South Africa, Sections 10-12 and 14. Government Gazette 1996.

12. Republic of South Africa. Constitution of the Republic of South African, Chapter 2. Government Gazette 1996.

13. Christison A, Hoctor S. Criminalisation of the violation of a grave and of a dead body’. Obiter 2008;28(1):23-43.

14. Republic of South Africa. Wills Act No. 7, Section 2. Government Gazette 1953.

15. World Medical Association. Handbook of Medical Ethics. 2nd ed. 2009. http://www. wma.net/en/30publications/30ethicsmanual/pdf/etl (accessed 30 April 2014).

16. SAPA-AFP. Brain-dead woman gives birth to a healthy son, life support removed.

The Mercury 12 February 2014:6. http://www.all4women.co.za/brain-deadwoman-gives-birth-to-a-healthy-son-life-(sic) (accessed 12 February 2014) 17. S v. Coetzee 1993 2 SACR 191 (T).

18. Republic of South Africa. National Health Act No. 63. Government Gazette 2003.

19. Clarke v. Hurst NO 1992 (4) 636 (D).

20. Christian Lawyers Association of South Africa v. Minister of Health 1998 (4) SA 1113 (T).

21. Paton v. British Pregnancy Advisory Service Trustees [1978] All ER 987 (QB).

22. Christian League of Southern Africa v. Rall 1981 2 SA 821 (O).

23. Re F (in utero) [1988] 2 All ER 193 (CA).

24. In re Fetus Brown 294 Ill. App. 159 (1997).

25. Cf. S v. Mshumpa 2008 1 SACR 126 (E).

ARTICLE

Pregnant, dead, and on a ventilator: A few thoughts in response to Prof. McQuoid-Mason A Nienaber, BA Hons, LLB, LLM, LLD Department of Public Law, University of Pretoria, South Africa Corresponding author: A Nienaber (annelize.nienaber@up.ac.za)

Advances made by medical science are able to extend human life, sometimes by highly technical means such as life-support systems. Often these procedures prove life-saving, and the patient recovers fully; at other times, however, life-extending treatment is futile, such as when the patient is declared brain dead. Advances in reproductive technologies, similarly, have been able bring hope by treating and curing infertility.

This article responds to an article by Professor McQuoid-Mason entitled ‘Terminating the pregnancy of a brain-dead mother: Does a fetus have a right to life?’ He examines the law in South Africa and the legal implications of the Munoz case, which concerned an application for a court order to have a brain-dead pregnant woman removed from a ventilator. Departing from Prof. McQuoid-Mason’s discussion, this article highlights a few of the ethical and legal implications of new technologies that enable pregnancy to be extended beyond the pregnant woman’s life. This article questions the ethical and legal appropriateness of the use of new technologies, especially in situations where such use is contrary to the pregnant woman’s express wishes. In this context, the article deliberates on whether the dead may be considered to be the bearers of rights that must be respected.

S Afr J BL 2014:7(2)47-50. DOI:10.7196/SAJBL.330

Does one have to be alive to be pregnant? The answer to this question would have been a very definite ‘yes’ – and would have elicited scant controversy – in the earlier parts of the previous century. In the year 2014, however, answers to this question are less straightforward. Advances in reproductive technologies have made it possible not only to treat infertility, but to make imaginable what before had belonged to the realm of science fiction (for example, Aldous Huxley’s Brave New World (1932) anticipated the possible consequences of the development of new reproductive technologies, while the idea of a ‘womb for hire’ was fictionalised in Margaret Attwood’s The Handmaid’s Tale (1985)). New reproductive technologies, now standard practice, are artificial insemination and reproduction, the cryopreservation of sperm, oocytes and embryos, embryo transfer, and preimplantation genetic diagnosis and manipulation, to name but a few. Yet more new technologies, previously inconceivable, such as same-sex procreation, which will make it possible for gay and lesbian couples to have biological children without the help of a donor sperm or ovum, are currently being developed.[1] Better healthcare, including drug development and advances in technology, such as cardiopulmonary resuscitation and life-support systems, have made it possible to treat previously fatal conditions and so extend human life. It has become possible to drastically extend the fertility of women a long time after menopause. Similarly, in the past, when a pregnant woman died or was declared brain dead, that would have been that, and no thought would have been given to keeping the fetus she was carrying alive. Before, upon the death of a pregnant woman doctors had two choices: either to deliver the fetus by caesarean section if it was viable, or to let the fetus die with the pregnant woman. This situation has changed dramatically with the development of new technologies able to artificially ventilate and sustain brain-dead human beings.

I read Prof. McQuoid-Mason’s article entitled ‘Terminating the preg­ nancy of a brain-dead mother: Does a fetus have a right to life?’[2] with great interest, and started pondering some of the ethical implications of the court case he discusses. The Munoz[3] case, in my view, highlights some of the very important ethical and legal implications of new technologies that enable pregnancy to be extended beyond the pregnant woman’s life. While not wishing to detract from Prof.

McQuoid-Mason’s insightful analysis of the law in South Africa (SA) relating to the legal status of the fetus, I would like to shift the focus to an analysis of the ‘rights’ of the pregnant cadaver and the ethical and legal appropriateness of artificially ventilating the cadaver in an attempt to save the fetus.

I begin with a short summary of the facts of the Munoz case,[3] after which I differentiate between pregnant women who are brain dead and those who are in a persistent vegetative state (PVS), as this distinction is germane to my argument. My discussion of brain death brings me to a discussion in the next section of some of the ethical concerns raised by the Munoz case. This is followed by an analysis of whether the rights to equality, dignity, privacy and bodily integrity may find application in the situation of artificially ventilating a brain-dead pregnant woman so that she may give birth to a live fetus. I conclude the article with a few words of caution regarding the ethical desirability of new technologies that enable pregnancy to be extended beyond the pregnant woman’s life.

The Munoz case Although the facts of the case are summarised in Prof. McQuoidMason’s article, I provide a brief summary here for ease of reference.

Marlise Munoz, a 33-year-old paramedic, was declared brain dead in November 2013 by the physicians at John Peter Smith Hospital in Fort Worth, Texas, USA.[4] Marlise Munoz was 14 weeks pregnant with her

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ARTICLE second child when she got out of bed one night to prepare a bottle for her young son.[5] She was found unconscious and not breathing on the kitchen floor an hour later by her husband. It is suspected that she had suffered a pulmonary embolism.[6] Her husband (also a paramedic) immediately started cardiopulmonary resuscitation, after which Marlise was rushed to the hospital. Tests revealed that her brain had been without oxygen for an hour, and the consequences had been fatal, prompting a diagnosis of brain death.[7] The court case, in essence, concerned an application by Marlise Munoz’s husband, Erick, for a court order compelling the hospital to take Marlise off a ventilator so that she could ‘die’ and her body be delivered to him and her parents to be buried.[8] Marlise Munoz had indicated earlier to her husband and parents that she did not want to be kept alive by artificial means.[9] The hospital refused to take her off ventilation, citing the Texas Health and Safety Code, proscribing the removal of ‘life-sustaining treatment’ from a ‘pregnant patient’.

The statute in question, however, only proscribed the withdrawal of life-sustaining treatment from patients in a PVS, and not from patients who were brain dead. The accepted legal position in the USA is that a patient is dead when ‘according to ordinary standards of medical practice, there is irreversible cessation of all spontaneous brain function. Death occurs when the relevant functions cease.’[10] I will refer to this definition later in the article. Erick Munoz also wanted the Texas Health and Safety Code declared unconstitutional as it violated his deceased wife’s right to make decisions regarding her treatment, and because it violated her right to equality as the statute treated pregnant women differently from other (non-pregnant and male) patients.[11] When the case was eventually heard 2 months later (by which time the cadaver that had been Marlise was 22 weeks pregnant),[6] the Tarrant County District Court held that the Texas Health and Safety Code did not apply to Marlise Munoz as she was dead, and ordered that she be removed from life support.[3] It did not consider the constitutional issues raised in the application.

Brain death v. a PVS: Ethically relevant in this case?[14,15] ‘Brain death’ is defined in the USA by the Uniform Determination of Death Act[14,15] which determines that a person who ‘has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made in accordance with accepted medical standards.’[14,15] The precise methods and criteria for determining brain death vary from state to state and hospital to hospital, but the American Academy of Neurology states that three criteria must be fulfilled to confirm the diagnosis: ‘coma (with a known cause), absence of brainstem reflexes, and apnoea (the cessation of breathing without artificial support)’.[16] In practice, clinicians will also look for an absence of motor responses and will rule out any other possible explanations for loss of brain function, such as drugs or hypothermia.[16] This assessment is repeated after several hours.[17] In the UK, the National Health Service describes brain death as occurring when a person ‘no longer has any activity in their brain stem and no potential for consciousness, even though a ventilator is keeping their heart beating and oxygen circulating through their blood’.[18] When brainstem function is permanently lost, the person will be confirmed dead.[18]

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Similarly, in SA the National Health Act 61 of 2003 defines death as ‘brain death’.[19] Here, brain death is defined as ‘an irreversible and irreparable cessation of all the brainstem functions inclusive of complete cessation of the heartbeat, respiration, blood circulation and digestive functions’.[20] There exists a clinical and legal difference between brain death and a PVS. PVS is a disorder of consciousness in which patients with severe brain damage are in a state of partial arousal rather than true awareness.[21] Patients lose consciousness because of a variety of reasons, most often through some serious injury or damage to a part of the brain. In this state, patients show some measure of digestive ability and some reflex activity of muscles and nerves in response to stimuli, and in some cases are able to independently maintain respiration and circulation. Nevertheless, there is no real awareness of the person’s surroundings or any other higher cognitive functions.

After some time of being in a vegetative state, the patient is classified as being in a PVS.[22,23] In SA, one of the most well-known definitions of PVS is as follows: ‘a neurological condition where the subject retains the capacity to maintain the vegetative part of neurological function but has no cognitive function. In such a state the body is functioning entirely in terms of its internal controls.

It maintains digestive activity, the reflex activity of muscles and nerves for low level and primitive conditioned responses to stimuli, blood circulation, respiration and certain other biological functions but there is no behavioural evidence of either self-awareness or awareness of the surroundings in a learned manner.’[24] Someone in a PVS can show signs of wakefulness (they may open their eyes, for example), but have no response to their surroundings.[24] The vital difference between PVS and brain death is that a patient with PVS still has a functioning brainstem and therefore may have retained some form of consciousness.[21] Also, a person in a PVS can still breathe unaided and is sometimes thought to have a chance of recovering because the core or ‘vegetative’ functions of the brainstem are unaffected, whereas a person with brain death has no chance of recovery as the body cannot survive without artificial support. Where the brain-dead person is in a PVS, the removal of the ventilator will be legally justified if the prognosis is hopeless. When a person is kept alive artificially by means of a respirator, its eventual disconnection cannot, in law, be considered the act which causes death – it merely constitutes the termination of a fruitless attempt to avert the consequences of the fatal injury.[24] This brings me to the question of whether the difference between the two definitions is ethically and legally relevant in the case of Marlise Munoz. I think it is: the Texas Health and Safety Code did not apply to Marlise Munoz, as she was legally dead. This is evidently the correct decision, as the alternative would be the illogical situation that physicians are compelled to administer treatment to dead people. But what if Marlise Munoz were instead in a PVS? If Marlise Munoz had not been brain dead, but in a PVS, ethically the case would have been more problematic, as there would have been arguments that she might recover in time (however slim the chance of recovery may be). In addition, the court would not have been able to decide the case without considering the constitutional challenges brought by Munoz’s husband (as she would have been a ‘patient’ and within the scope of the Texas Health and Safety Code). It is unlikely that Munoz’s situation would have withstood such constitutional scrutiny. I return to this point below.

ARTICLE In the USA, as in the case of SA, patients’ rights to make autonomous decisions and to refuse treatment are, on the whole, respected.[26] Marlise Munoz had clearly indicated that she did not wish to be kept alive by artificial means, and her surrogate (her husband) had insisted on her autonomous wishes being carried out. Why, then, were the hospital personnel hesitant to carry out her wishes as expressed through her surrogate? This brings me to the next section of the article, where I consider a few of the ethical issues raised by the Munoz case.

Brief outline of some of the ethical concerns highlighted by Munoz I suspect that John Peter Smith Hospital was hesitant to carry out Marlise Munoz’s wishes as expressed through her surrogate because of a misplaced concern regarding their legal responsibilities towards the fetus she was carrying. Such a concern is not unusual, as the relationship between a pregnant woman and her unborn fetus is one of the most ethically and legally challenging in the 21st century, and not only because of the technological advances described above.

The renewed interest in the abortion debate in the USA and other countries bears witness to this complexity.[26-28] Central to the Munoz’s case is the ethical and legal question: Is human consciousness necessary for pregnancy? Put differently, does one have to be ‘alive’ and conscious to be pregnant? Must the pregnant woman be a person with an identity, capable of making autonomous decisions? Or can she merely be an unconscious body, existing to gestate the fetus and be discarded after ‘giving birth’?

Can the pregnant body be medically managed separate from a consciousness that wills the pregnancy to continue?[29] I would like the answer to these questions to be that human consciousness is indeed necessary for a pregnancy. The choice to be pregnant is one of women’s most treasured human rights, hard won in the USA in Roe v Wade,[30] and legislated in SA in the Choice on Termination of Pregnancy Act[31] and confirmed in the case of Christian Lawyers Association v Minister of Health.[32] A woman may not deliberately choose to become pregnant (the pregnancy may be the consequence of rape, or be the result of some failure in a contraceptive device or the oral contraceptive pill), but her continued pregnancy, certainly, is a conscious decision for women in societies where their right to have an abortion is acknowledged in law.

In the case of Marlise Munoz, certainly, she indicated that she did not want to be kept alive artificially. The circumstances of the Munoz case indicate that this choice or advanced directive was less valued in the eyes of the law because she was pregnant. If that indeed is the case, and it does seem so, can we deduce that women in pregnancy lose their ability to make autonomous, informed decisions regarding reproduction? Such an outcome, at the very least, would be considered absurd: women’s rights to equality, human dignity, bodily integrity and privacy do not alter when they become pregnant. This is supported by the fact that, in many jurisdictions pregnancy is a prohibited ground for discrimination. For example, in SA: ‘The state may not unfairly discriminate directly or indirectly against anyone on one or more grounds, including race, gender, sex, pregnancy [my italics], marital status, ethnic or social origin, colour, sexual orientation, age, disability, religion, conscience, belief, culture, language and birth.’[33] In Marlise Munoz’s case, the refusal of the hospital to turn off the machines that were ventilating her

cadaver not only denied her (through her surrogate) the right to make decisions regarding her medical treatment, but reminds one of the worst of consequentialist philosophies (such as some forms of utilitarianism which would regard the violation of the dead woman’s wishes acceptable if the outcome is the birth of a live baby).

However, it should be remembered that, at the time the court action was brought, Marlise Munoz was brain dead. Even if it is true that women’s constitutional rights do not alter when they become pregnant, Marlise Munoz was not only pregnant, she was also dead.

This, then, brings me to the next section of the article where I briefly examine whether the rights to privacy, equality, dignity and bodily integrity may find application in the case of a pregnant, brain-dead cadaver.

Equality, dignity, privacy and bodily integrity: Also applicable in death?

It is clear from the statute that gave rise to the Marlise Munoz case that exceptions are made for pregnant women – their advance directions are taken less seriously by the law than those of men, and those of women who are not pregnant. On the face of it, this clearly treats pregnant women unequally, potentially violating their right to equality. But do dead pregnant women have a right to equality?

I agree fully with Prof. McQuoid-Mason that cadavers are not the bearers or holders of either civil law rights or human rights.[2] In addition, there is no doubt that he is correct when he argues that the fetus, equally, has no rights in terms of the SA Bill of Rights until it is born alive.[2] Consequently, I do not want to argue that cadavers are indeed bearers of human rights, or, in the case of Marlise Munoz, that her cadaver indeed had a ‘right’ to equality and so forth.

The fact that cadavers are not protected under the Constitution and possess no rights[32] apart from those highlighted by Prof.

McQuoid-Mason regarding the desecration of a corpse and so forth, does not necessarily imply that the living can make no provisions that will be honoured upon death, or that society may do whatever it pleases with the body of the deceased, as is done by the hospital in the case under discussion. There are countless situations where the living make decisions on how their future dead bodies will be treated and where those decisions are indeed being honoured and respected. Society respects a dead person’s wish regarding how and when they wish to be buried, or whether, instead, they prefer to be cremated. The law respects the living’s wishes regarding whether they want to donate their organs upon their death or whether or not they want to donate their cadavers for medical research. In addition, an entire field of law has developed around giving effect to the will of the deceased regarding the disposal of their property after their death.

Over many centuries philosophers have grappled with questions as to whose interests are being respected in the examples mentioned above, and whose wishes are being carried out. Some argue that it is the living person’s wishes or interests, in events that occur after their deaths that are being respected. Others argue that the dead, themselves, have a limited range of ongoing interests.[35] Ronald Dworkin[36] maintains the latter, which he calls ‘critical interests’ – the interests of the living in what will become of their cadavers.

Wilkinson[37] stresses the importance of these critical interests to the human personality: what happens ‘after death can (depending on the particular person’s own idea of self-development) complete the

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ARTICLE development of the self’. Based on these views it is indeed possible to say, at the very least, that some interests of the cadaver are being protected by the law; even if these are not ‘rights’ in the classic sense of the term.[38] Marlise Munoz indicated to her relatives that she did not want to be kept alive by artificial means. The hospital was made fully aware of her wishes by her proxy, her husband. Whether we can call these wishes regarding what happens after her death merely ‘interests’ or whether they are ‘rights’, it is clear that they were not given effect to, until a court order was obtained compelling the hospital to do this. In addition, it is evident that the hospital would have acted differently had Marlise Munoz not been 14 weeks pregnant. She lost her ‘interest’ in what happens after her death to her cadaver because she was pregnant. Her pregnant dead body, therefore, had been disowned by the hospital, and her interests in it had been disclaimed.

Conclusion A woman’s autonomous choice regarding her end-of-life care should be inviolable, unaffected by whether or not she may be pregnant.

This is supported by the Ethics Committee of the American College of Obstetricians and Gynecologists: ‘pregnant women’s autonomous (end-of-life) decisions should be respected, and concerns about the impact of those decisions on fetal well-being should be … understood within the context of the women’s values’.[39] The SA legal system has not yet had to consider the complex ethical and legal questions that beset new technologies that enable the artificial ventilation and support of brain-dead pregnant cadavers such as Marlise Munoz. It is in the best interests of our society that these questions be addressed carefully and thoughtfully. And when they are, perhaps the wisest answer might simply be to accept the course of nature: a woman’s capacity to nurture a life, any life, ceases with her death.

References 1. Douglas T, Harding C, Bourne H, Savulescu, J. Stem cell research and same sex reproduction. In: Quigley M, Chan S, Harris J, eds. Stem Cells: New Frontiers in Science and Ethics. Singapore: World Scientific Publishing, 2012:207-228.

2. McQuoid-Mason D. Terminating the pregnancy of a brain-dead mother: Does a fetus have a right to life? (in press). S Afr J BL 2014;7(2)44-46.

3. Munoz v John Peter Smith Hospital Cause No 096270080-14. Tarrant County District Court 96th Judicial District Texas 24 January 2014 (unreported): http:// www.thaddeuspope.com/images/Munoz_202053415-Judge-Order-on-Munoz.

Matter.pdf. (accessed 10 May 2014).

4. Magnus DC, Wilfond BS, Caplan, AL. Accepting brain death. N Engl J Med 2014;370:891-894. [http://dx.doi: 10.1056/NEJMp1400930] 5. Grimes A. Texas law forces hospital, family to keep pregnant woman on life support against her will. http://rhrealitycheck.org/article/2013/12/23/texas-law-forces-hospital-family-tokeep-pregnant-woman-on-life-support-against-her-will/ (accessed 10 May 2014).

6. Fernandez M, Eckholm E. Pregnant and forced to stay on life support. New York Times, 2014. http://www.nytimes.com/2014/01/08/us/pregnant-and-forced-tostay-on-life-support.html?_r=0 (accessed 10 May 2014).

7. Gostin LO. Legal and ethical responsibilities following brain death: The McMath and Muñoz cases. JAMA 2014;311(9):903-904. [http://dx.doi:10.1001/ jama.2014.660] 8. Goodwyn W. The strange case of Marlise Munoz and John Peter Smith Hospital. Shots.

Health news from NPR. http://www.npr.org/blogs/health/2014/01/28/267759687/thestrange-case-of-marlise-munoz-and-john-peter-smith-hospital (accessed 10 May 2014).

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9. Dwyer S. Muñoz lesson: How the law fails us at beginning and end of life. Al Jazeera. http://america.aljazeera.com/opinions/2014/1/the-munoz-lessonhowt helawfailsusatthebeginningandendoflife.html (accessed 10 May 2014).

10. Texas Health and Safety Code Chapter 671, Section 671.001. http://www.statutes. legis.state.tx.us/Docs/HS/htm/HS.671.htm (accessed 10 May 2014).

11. Fernandez M. Suing to end life support for woman and fetus. New York Times, 2014:A14. http://www.nytimes.com/2014/01/15/us/suing-to-end-life-supportfor-woman-and-fetus.html (accessed 10 May 2014).

12. Jones DA. Metaphysical misgivings about ‘brain death’. In: Potts M, Bryne PA, Nilges RG, eds. Beyond Brain Death: The Case Against Brain Based Criteria for Human Death. Dordrecht: Kluwer Academic Publishers, 2000:108.

13. Tomlinson T. The conservative use of the brain-death criterion: A critique. J Med Philos 1984;9:383. [http://dx.doi.org/10.1093/jmp/9.4.377] 14. Uniform Determination of Death Act, Uniform Laws Annotated 589 (West 1993 and West Supp. 1997), 706 U.S.C. 1981.

15. Youngner SJ, Arnold RM. Philosophical debates about the definitions of death: Who cares? J Med Philos 2001;26(5):527-37 [http://dx.doi.org/10.1076/ jmep.26.5.527.3002] 16. Jarret C. What is brain death? http://www.wired.com/2014/02/brain-death/ (accessed 11 May 2014).

17. Wijdicks EFM. The diagnosis of brain death. N Engl J Med 2001;344:1216. [http:// doi.dx.org/10.1056/NEJM200104193441606] 18. NHS Choices. Brain stem death. United Kingdom. http://www.nhs.uk/conditions/ brain-death/Pages/Introduction.aspx (accessed 11 May 2014).

19. Republic of South Africa. Sec 1 National Health Act 61. Pretoria: Government Gazette 2003.

20. Carstens PA, Pearmain D. Foundational principles of South African medical law.

Durban: Butterworths LexisNexis, 2007:204 n433.

21. Jennet B. The vegetative state: Medical facts, ethical and legal dilemmas. J Neurol Neurosurg Psychiatry 2002;73:355-357. [http://doi.dx.org/10.1136/jnnp.73.4.355] 22. The Multi-Society Task Force on PVS. Medical aspects of the PVS – First of two parts. N Engl J Med 1994;330(21):1499–1508. [http://doi.dx.org/10.1056/ NEJM199405263302107].

23. The Multi-Society Task Force on PVS. Medical Aspects of the PVS – Second of two parts. N Engl J Med 1994;330(22):1572–9. [http://doi.dx.org/10.1056/ NEJM199406023302206] 24. Clarke v Hurst 1992 4 SA 630 (D) 640D-F. 25. Republic of South Africa. National Health Act 61, secs 7 – 8. Pretoria: Government Gazette 2003.

26. Joffe C. Roe v. Wade and beyond: Forty years of legal abortion in the United States. Dissent 2013;60(1): 54-59. [http://doi.dx.org/10.1353/dss.2013.00].

27. Fried MG. Reproductive rights activism in the post-Roe era. Am J Public Health 2013;103(1):10-14. [http://dx.doi.org/10.2105/AJPH.2012.301125].

28. Siegel NS. The new textualism, progressive constitutionalism, and abortion rights. Yale J Law Humanit 2013;25(1) Article 5. http://digitalcommons.law.yale. edu/yjlh/vol25/iss1/5 (accessed 12 May 2014).

29. Wolf SM. Feminism & Bioethics: Beyond Reproduction. Oxford: Oxford University Press, 1996.

30. Jane Roe v Henry Wade, District Attorney of Dallas County 410 U.S. 113.

31. Republic of South Africa. Choice on Termination of Pregnancy Act 92. Government Gazette 1996.

32. Christian Lawyers Association v Minister of Health 2005 1 SA 509 (T).

33. Republic of South Africa. Constitution of the Republic of South Africa.

Government Gazette 1996;17678.

34. Jordan JM. Incubating for the state: The precarious autonomy of persistently vegetative and brain-dead pregnant women. Georgia Law Review 1988;22:1165.

35. Feinberg J. The moral limits of the criminal law. Vol 1: Harm to others. Oxford: Oxford University Press, 1987. http://www.oxfordscholarship.com/view/10.1093/ 0195046641.001.0001/acprof-9780195046649 (accessed 14 May 2014).

36. Dworkin R. Life’s dominion: An argument about abortion, euthanasia, and individual freedom. New York: Knopf, 1993:201-202.

37. Wilkinson TM. Individual and family decisions about organ donation. J Appl Philos 2007;24(1):31. [http://doi.dx.org/10.1111/j.1468-5930.2007.00339.x] 38. Sperling D. Posthumous interests: Legal and ethical perspectives. Cambridge: Cambridge University Press, 2008: ‘Introduction’.

39. Committee on Ethics. ACOG committee opinion number 403 April 2008: Endof-life decision making. Obstet Gynecol 2008;111:1021-1027. [http://dx.doi. org/10.1097/AOG.0b013e3181713d92]

ARTICLE

Article 6 of the UNESCO Universal Declaration of Bioethics and Human Rights: A moral force in South Africa R Rheeder, BA, ThB, ThM, ThD Unit for the Development of Reformed Theology, North-West University, Potchefstroom, South Africa Corresponding author: R Rheeder (riaan.rheeder@nwu.ac.za)

The United Nations Educational, Scientific and Cultural Organization (UNESCO)’s Universal Declaration on Bioethics and Human Rights (UDBHR) was accepted unanimously in 2005 by the world community, consisting of 191 member nations. This means that the declaration is currently the first and only bioethical text to which the entire world, including South Africa (SA), has committed itself. Despite this, little or no attention is paid to this declaration in SA. According to UNESCO, the declaration should be brought to the attention of the community because knowledge will promote more effective application of its principles. In an attempt to answer the call of UNESCO, article 6 of the declaration is discussed briefly in this article. It is clear that the principle outlined in article 6, as a human right, comprises two important components, namely giving information and giving consent. These two ethical values must always be applied during medical intervention and research. Where these principles are applied, human autonomy is confirmed and human dignity is expressed. Although the UDBHR is not judicially enforceable in SA, its universal nature offers a clear moral force in the bioethical debate in SA. S Afr J BL 2014:7(2)51-54. DOI:10.7196/SAJBL.310

Existing research aims to investigate and give an outline of article 6 of the Universal Declaration on Bioethics and Human Rights (UDBHR),[1] as drawn up by the United Nations Educational, Scientific and Cultural Organization (UNESCO). In article 6, the UDBHR explicates informed consent as a universal ethical principle as well as a fundamental human right.[2,3,10] The problem statement of this investigation is as follows.

Firstly, the UDBHR was accepted unanimously in 2005 by the world community, consisting of 191 member nations, which means that the declaration is currently the first and only bioethical text to which the entire world, including South Africa (SA), has committed itself.[2,4,5,10] Stanton-Jean et al.[6] emphasise the fact that the world community views upholding the dogma of informed consent, in solidarity with each other, as the duty of all communities. The principle of informed consent occupies an essential position in the following international codes: Nuremberg Code (1947) and Declaration of Helsinki (1964).[3] The added value of the UDBHR could be demonstrated in the words of Veatch[14] when he says: ‘the International Bioethics Com­ mittee (IBC) heard from representatives from religious/spiritual perspectives including Confucianism, Judaism, Hinduism, Islam, Buddhism, and Catholicism. The result is the first truly international, representative codification of norms for bioethics that the world has ever seen. Rather than reflecting the norms of the professional groups or national, religious, or ideological bodies, the universal declaration can legitimately claim to speak for virtually all citizens of the world (at least through the representatives working on their behalf)’. Ethicist and human rights expert J M Vorster’s[7] statement concerning the universal declaration also holds true for the UDBHR, as he postulates that: ‘[i]t can be said that without doubt this Declaration has become an important document in … history’. Despite this, little or no attention is paid to this declaration in SA. Recently, a very important book was

published by two prominent SA academics, titled Bioethics, Human Rights and Health without paying any attention to the declaration.[8] Secondly, a recent study by the American Institute on medicine as a profession indicated that gross human rights offences took place quite recently in the American army, where medical personnel infringed on the right to autonomy and informed consent by force-feeding military prisoners.[9] The International Bioethics Committee of UNESCO (IBC) made the following statement: ‘Medical education in general and bioethics education in particular should pay particular attention to the principle of consent and to its applications … all persons should know that this principle is to be respected. Individuals, groups, communities, institutions and corporations, public and private, should therefore be made aware of the importance and relevance of this principle for research and healthcare … Moreover, since experience in many domains has shown that laws or regulations are only effectively enforced if they are backed by action in education, training and information …’[2,10] The purpose of this research is to join in UNESCO’s mission and to form part of the social responsibility initiative of teaching this universal right and the ethical principle so as to promote the way this basic right and the ethical principle is applied in SA.[2,6,10] To do so, this article focuses on the concept of informed consent as it is explicated

by UNESCO, and attention is therefore given mostly to official UNESCO literature. In this study, attention is paid to the basis of informed consent as well as the notions of information and permission.

The foundation Kollek,[3] one of the authors and official UNESCO declarer of the UDBHR, emphasises the fact that the principle of consent has an anthropological foundation within the EDBHR, and explains it as follows: ‘Therefore, article 6 on informed consent is directly related to article 3 (Human

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ARTICLE dignity and Human rights) and article 5 (Autonomy and Individual responsibility) of the Declaration. None of these articles stand alone, they need to be seen in conjunction with one another, expressing different dimensions and aspects of central normative demands.’

One of the official syllabi used by UNESCO in teaching the UDBHR worldwide (Bioethics Core Curriculum, section 1) confirms the statement above.[10] From this, it is clear that the right and principle of individual consent arises from the right and ethical value of auto­ nomy (freedom), while giving information and consent expresses human dignity.[2] UNESCO’s Casebook on Bioethics and the Holocaust confirms this truth.[11] This point of departure by UNESCO is strongly supported by the SA Constitution, as well as the SA Patients’ Rights Charter, which emphasise dignity and freedom from which informed consent ensues.[8,15,16] Attention is subsequently paid to the meaning of informed consent according to the UDBHR.

The meaning According to Kollek,[3] in the UDBHR, informed consent is viewed as a complex communication process that comprises information and consent respectively.[2,6,10] The order is as follows: firstly information, secondly consent and then intervention or research (‘prior to’ according to article 6.1,2).[1] Information is a definite prerequisite for consent.[2]

What is understood by information, according to the UDBHR? Article 6 of the UDBHR declares that informed consent comprises adequate information (‘adequate information’, according to article 6.1,2).[1] Adequate information is important because thorough information maximises good decision-making and minimises the possibility of harm.[1-3,10] What is adequate information according to the UDBHR? Here, only the core elements are highlighted and a distinction is drawn between the subject of information and the object of information.

Firstly, the focus is on the subject of information (doctor and resear­ cher). It is the duty of the person responsible for the medical inter­ vention or the research to initiate the process and provide information.

Providing information is compulsory, and the doctor must therefore make a comprehensive attempt to inform the patient.[2] Therapeutic privilege does not enjoy the same support as it did previously in the global bioethical context, owing to its misuse in the past and the fact that it stands in contrast to the autonomy of the individual. It is therefore only allowed in exceptional instances.[2,11] UNESCO is of the opinion that the doctor should also consider his or her professional experience and abilities as important information. This information could contribute to a relationship of shared trust and respect for confidentiality.[2,10] Secondly, the object of information (patient, research subject) is explored. To give valid permission or consent, the person must have the rational capacity to comprehend the information (as opposed to ‘persons without the capacity’).[1-3,10] UNESCO points out that it is difficult to determine with certainty whether the person understands all the information.[3] Stanton-Jean et al.[6] make the following very important statement: ‘The level of difficulty in which the informed consent is situated posits that it is difficult, if not impossible, for large proportions of the world population to understand what they are agreeing to by giving their ‘informed

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consent’. Beauchamp and Childress,[12] however, state the following in this regard: ‘From the fact that actions are never fully informed, voluntary, or autonomous, it does not follow that they are never adequately informed, voluntary, or autonomous.’, Stanton-Jean et al.[6] support this in principle and suggest (which is important in the SA context) that the comprehension of information can be promoted by in-depth conversations as well as by making use of aids such as graphs, sketches, cartoons, pictographs and/or videos.

It may happen that a patient or a participant in research may doubt whether he or she completely understands the information (possible goals, risks, advantages, expected results, or even their own rights). In such a case, a mediator can be used to analyse the information, and in doing so support the patient or participant in his or her decision.[2] The UDBHR distinguishes between medical intervention and scientific (medical) research in article 6.[1,2,10] With regard to the content of information, a patient in the face of a possible medical intervention should be given information on the following matters: diagnosis and prognosis, qualities and process of intervention, expected advantages of intervention (prevention, cure, palliative), possible unwanted side-effects of the intervention, possible advantages and risks of alternative interventions, or no intervention.[2,11] Persons who donate their bodies or organs after their death also need to receive as much information as possible on all the relevant aspects.[2] Living donors of organs must receive comprehensive information about the possible short- and long-term consequences of such a donation.[2] Before medical scientific research can take place, the following information requires attention: the goal of the research, the methodology of the research, the duration of the research, the expected benefits of the research for the participant (if any), the expected benefits of the research for others, the potential risks related to the research, and possible discomfort or inconvenience.

Furthermore, information related to potential risks must receive special attention.[2,10,12] • It is advisable to determine participants’ opinions on whether they would want to receive the incidental discovery of negative information before the research commences.[6] • Before an individual makes any tissue (blood, urine, saliva, etc.) or data (written, electronic questionnaires, interviews, genetics) available for research, the person must receive comprehensive information on the usage of the tissue and/or data. This includes the goal for which it will be used, when and where it will be used, whether it will be coded (made anonymous) and whether he or she has the right to withdraw tissue/data at any time.[2] • When previously collected tissue or data is to be used at a later stage in another study, information on the new situation must be provided. If this is not possible, an ethical committee must determine whether it is justified to do away with the right.[2,6] Some patients choose not to exercise their right and they do not receive information prior to intervention or research; therefore, they entrust themselves to the doctor or researcher entirely.[2] StantonJean et al.[6] point out that using one’s right to ask not to receive information has become part of the global bioethical discourse and is justified on the grounds of the individual’s autonomy. It is desirable that official ethical bodies help to decide whether not exercising the right to information is advisable in a specific case.[1]

ARTICLE Information must have the qualities indicated below: it needs to be qualitatively sound. In other words, it needs to be as clear and as complete as possible (‘provided in a comprehensible form’, UDBHR, article 6.2).[1,2,10] Too much complex information (e.g. complex terms) must be avoided on the one hand, and too little and oversimpli­ fied informationon the other.[2,3,6] It is strongly advised, especially in places such as SA, that the information be conveyed in the national or local language and structured as logically as possible.[2] Information must be individual and sensitive when directed at the audience. Hence, the information needs to be adjusted according to the circumstances and the condition of the patient; when a serious diagnosis is conveyed, tact and choice of words are exceptionally important.[2] The time and place when conveying information is equally important.[3] UNESCO asserts that the person must be informed that he or she has the right to withdraw permission or consent at any time during the process of intervention or research without having to provide reasons for doing so (‘be withdrawn … at any time and for any reason’, UNESCO, 2006, article 6.1, 6.2).[1,2,10]

What is understood by permission and consent according to the UDBHR? It is the duty of the person who will perform the medical intervention or do the research to obtain the necessary consent,[2,10] which comprises several components.

UNESCO emphasises the principle that the person who gives consent (before giving said consent) may not be under any form of external pressure (‘free’ according to UDBHR, article 6.1,2).[1,2,10] The person must give consent freely either to be treated or to participate in research, and he or she must also be able to refuse freely.[2,3] It must be ensured, as far as possible, that no person is coerced into participation in research.[2,10] UNESCO lists various inadmissible forms of coercion, namely: • Social status or asymmetrical relations can result in situations where some people do not have the frankness to ask questions or the freedom to refuse treatment or participation in research, or the freedom to express their uncertainty.[2,6,10] The same holds true for people who are incarcerated. Concerning medical research, the IBC has a general rule that persons in compulsory confinement may not be involved in research.[2] • Impoverished people may consider participating in medical research in order to receive medication or financial support. In this regard, the IBC points out that (healthy) participants from various countries come to Europe to participate in research. For this reason, numerous countries have registers in place to monitor people’s frequency of participation in medical research, and in this way these people are protected against possible side-effects and non-voluntary participation in medical research.[2] According to UNESCO, extraordinary rewards should not be offered.[2] • The IBC points out that in poor economic circumstances where there are bad medical services (shortage of doctors, lack of infrastructure, insufficient medication, and poor training), the right to informed consent might not always be implemented (according to the Mail & Guardian, only one of 394 hospitals audited between May 2011 and May 2012 in South Africa met all the acceptable standards, while under a third of staff were deemed to treat patients reasonably, with a quarter described as being caring).[13]

For this reason, many people have no choice. The IBC highlights the fact that this may not serve as an argument for neglecting the right and the ethical principle – ways of implementing the principle need to be devised.[2] • UNESCO warns against the possibility that the social expectations of a family or a community could pressure a person into making a decision they deem acceptable or good according to others. Under these circumstances, a family in distress can emotionally pressure a person into donating an important organ or into refusing a lifesaving blood transfusion.[2,10] • Tension reigns within global bioethics between individualism and community values. In some communities, the leaders of the communities make the (coerced at times) decisions on behalf of the individual and these decisions are not questioned due to respect for their leaders’ age and wisdom, and the belief that the leaders want the best for the community.[2] Kollek[3] points out that: ‘different cultural understandings of informed consent have been appreciated by the Declaration’. The point of departure is stated in article 6.3 of the UDBHR: ‘In no case should a collective community … substitute for an individual’s informed consent’. In other words, although social or collective community decision-making is a right, it may never replace the right of an individual to make a decision. The IBC and Kollek[3] summarise it as follows: ‘the order of precedence must be clear: the interests of medicine and society must never prevail over the interests of the patient … it should always remain possible for individuals to refuse to collaborate and any exertion of pressure should be avoided if they refuse to join such a programme or wish to withdraw from it.’[2,3,10] This is in line with article 12 of the UDBHR, which states that cultural diversity and pluralism may not be used to infringe on the fundamental rights and freedom of the individual.[1] According to UNESCO, freedom and voluntariness can be promoted through in-depth discussions between the healthcare worker and the patient. Probing dialogue brings about clarity and improves the relationship between the parties involved.[2,6] The IBC[2] of UNESCO points out that considering a decision (or consent) and requesting and obtaining permission is not a ‘one-time affair’.With regard to invasive medical interventions, the IBC[2] comments as follows: ‘It is advisable in such cases to give the patient time to think the question over.’[2,10] The abovementioned process (providing information, comprehension and coercion) first needs to be completed before a formal decision can be made. When an individual decides to proceed, consent must precede any medical intervention or research according to article 6 of the UDBHR.[1] It is of great importance that permission be granted, since it confirms the autonomy and the definitive will of the person involved.[2,3,10] It is necessary, however, to note here that the UDBHR declares in article 6 that consent is only required in relevant circumstances during a medical intervention (‘where appropriate’, UDBHR article 6.1), while definite consent is always required before medical research (‘express … consent’, UDBHR article 6.2).[1,2] Hence, one can distinguish between implicit and explicit consent.[2] Implicit consent, ‘where appropriate’, has two possible explanations: • In the first place, with various routine, simple non-invasive medical interventions in the doctor’s consulting room, information and the patient’s consent can be considered to be self-explanatory, for example when taking the patient’s blood pressure.[2,10] The

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ARTICLE International Bioethics Committee of UNESCO points out that the more invasive the medical intervention and the greater the physical, mental and socioeconomic consequences, the more definite and formalised the consent needs to be.[2] • In the second place, the reality that obtaining consent (as discussed above) in a crisis situation is not always a possibility is acknow­ ledged. A patient may be confused or unconscious. In these circum­ stances, consent for medical treatment is considered less critical or problematic as any reasonable person would give consent.[2] Explicit consent during research may be either written or oral consent.[2,3,10] It can be in the form of a consent form or an oral agreement in the presence of witnesses.[3] In some cases or cultures, only a gesture is sufficient.[2] Before human tissue or personal data are collected, definite consent must be obtained. Tissue and data for which consent has already been obtained and which needs to be used in later, dissimilar research, requires consent once again.[6] According to UNESCO, something like ‘overall prior consent’, where the future use of tissue and data is left to the discretion of the researcher, does not exist.[6] It is advised that, where applicable, information and consent be managed by an ethics committee.[2,3,10] Consent may be withdrawn at any time without having to pro­ vide reasons for doing so (‘may be withdrawn … at any time and for any reason’, UNESCO, 2006, article 6.1,2).[2,3] After having withdrawn consent, the person may not, by any means, be done an injustice or be treated with bias (‘without disadvantage or prejudice’, article 6.1,2).[2] In various countries, it happens that individuals give consent in advance (advanced directives) with regard to specific medical interventions or no intervention in the future. This is done in case such an individual is no longer capable of making decisions, is very weak or can no longer function in any way.[2] According to UNESCO, this expresses the individual’s autonomy and forms part of the principle of informed consent.[6] Persons who wish to donate their bodies or organs after their death must give the necessary consent prior to their death.[2,10] An important theme that surfaces in the application of article 6 of the UDBHR is the temporary suspension of an individual’s autonomy and self-determination. UNESCO notes that this derogation of rights does not happen frequently and needs to be applied very strictly according to the guidelines in article 27 of the UDBHR (‘Exceptions to and provisions set out in this declaration, in particular in article 27’, UDBHR article 2;27).[1,2] In this regard, UNESCO posits the example of individuals who need to be put in quarantine by the government due to the possible spread of an epidemic.[2]

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Conclusion The UDBHR confirms the fact that the principle of informed consent is a universal human right and not simply the opinion of the medical profession (e.g. World Medical Association) or a certain continent (e.g. the European Convention on Human rights and Biomedicine).

Although the UDBHR is not judicially enforceable in SA, its universal nature offers a clear moral force in the bioethical debate in SA. References 1. UNESCO. Universal Declaration on Bioethics and Human Rights. 2006. http:// unesdoc.unesco.org/images/0014/001461/146180E.pdf (accessed 14 June 2012).

2. IBC. Report of the International Bioethics Committee (IBC) of UNESCO on Consent. Social and Human Sciences Sector, Division of Ethics of Science and Technology, Bioethics Section. 2008. http://unesdoc.unesco.org/images/ 0017/001781/178124e.pdf (accessed 14 June 2012).

3. Kollek R. Article 6: Consent. In: Ten Have H, Jean MS, eds. The UNESCO Universal Declaration on Bioethics and Human Rights. Background, Principles and Application. Paris: United Nations Educational, Scientific and Cultural Organization, 2009:123-138.

4. UNESCO. Records of the General Conference 33rd session Paris, 3-21 October 2005, Volume 1. Resolutions, United Nations Educational, Scientific and Cultural Organization. http://portal.unesco.org/en/ev.php-URL_ID=28354&URL_DO=DO_ TOPIC&URLSECTION=201.html. (accessed 14 June 2012).

5. Ten Have H. Bioethiek zonder grenzen. Mondialisering van gezondheid, ethiek en wetenschap. Antwerpen: Valkhof Pers, Maklu-Distributie, 2011.

6. Stanton-Jean M, Doucet H, Leroux, T. Informed consent. In: H.A.M.J. Ten Have H, Gordijn B, eds. Handbook of Global Bioethics. Dordrecht: Springer Science and Business Media, 2014:737-753.

7. Vorster JM. Ethical Perspectives on Human Rights. Potchefstroom: Potchefstroom Theological Publications, 2004.

8. Dhai A, Mcquoid-Mason D. Bioethics, Human Rights and Health Law. Principles and Practice. Claremont: Juta and Company, Ltd, 2011.

9. Institute on Medicine as a Profession. Ethics abandoned: Medical professionalism and detainee abuse in the ‘war on terror’. A task force report funded by IMAP/ OSF. New York: Columbia University, College of Physicians and surgeons, 2013.

10. UNESCO, Bioethics Core Curriculum. Section 1: Syllabus Ethics Education Programme, Sector for Social and Human Sciences, Division of Ethics of Science and Technology. http://unesdoc.unesco.org/images/0016/001636/163613e.pdf 2008 (accessed 14 June 2012).

11. UNESCO, Casebook on Bioethics and the Holocaust. The UNESCO chair in bioethics. Chair holder: Prof. Amnon Carmi. The International Center for Health, Law and Ethics, Faculty of Law, University of Haifa, Israel. http://www.unescochair-bioethics.org/NTUDOC/F/pub_doc/ F8D02FF3F880A4FE/ Holocaust.pdf 2013 (accessed 29 Jul 2013).

12. Beachamp TL, Childress JF. Principles of Biomedical Ethics. 7th ed. Oxford: Oxford University Press, 2013.

13. Mail and Guardian. http://mg.co.za/article/2014-02-02-government-hospitalsfail-healthcare-standards-audit-report. 2014. (accessed 3 February 2014).

14. Veatch RM. Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict. Washington: Georgetown University Press. Kindle ed., 2012:30.

15. Republic of South Africa. Constitution of the Republic of South Africa. Section 12(2). Pretoria: Government Gazette, 1996.

16. Health Professions Council of South Africa. Guidelines for Good Practice in the Health Care Professions. In: National Patients’ Rights Charter, Booklet 3. South Africa: Health Professions Council, 2008.

ARTICLE

Moral perspectives on covert research A A van Niekerk, MA, BTh, DPhil Centre for Applied Ethics, Department of Philosophy, Stellenbosch University, Western Cape, South Africa Corresponding author: A A Van Niekerk (aavn@sun.ac.za)

The term ‘covert research’ refers to research on human subjects for which informed consent is not, and allegedly cannot, be solicited – not because of wilful negligence or the deliberate transgression of research ethics guidelines on the part of the researcher(s), but because the revelation of the nature of the research to the involved research participants would necessarily invalidate the research results. While covert research is deemed necessary in a number of sciences, such as ethnography, such research nevertheless elicits major ethical concern due to the fact that it seemingly violates the values of respect for autonomy and the protection of research subjects – values that have, since the first formulations of the Nuremberg Code, the Belmont Declaration and the series of Helsinki accords, become almost axiomatic in our understanding of the basic tenets of responsible and ethical research on human subjects. In this article, I contend that while subject autonomy is a pivotal value in morally legitimate research generally, there is more to morally legitimate research than informed consent. I conclude by formulating a few guidelines for the identification of circumstances under which covert research might and might not be morally in order.

S Afr J BL 2014:7(2)51-58, DOI:10.7196/SAJBL.320

The term ‘covert research’ refers to research on human subjects for which informed consent is not, and, allegedly, cannot, be solicited – not because of wilful negligence or the deliberate transgression of research ethics guidelines on the part of the researcher(s), but because the revelation of the nature of the research to the involved research participants would necessarily invalidate the research results.

Herrera[1] provides the following example of such research: ‘… a researcher might feign alcoholism and join a recovery group, using the meeting time to record the interaction of the members. Her carefully tailored behaviour would include the fostering of false beliefs in her cohorts.’ To reveal to the research subjects what she is actually busy with, would necessarily result in their adjusting their behaviour and thus undermining the credibility of the information that she hopes to recover. Herrera writes: ‘This is research that exploits naïve trust, and where data collection relies on a “cover story”. Far from being open in any meaningful sense, studies like this are predicated on the omission of informed consent … Arguments defending covert research usually follow vaguely utilitarian lines. The idea is that whatever risks covert methods might involve are offset, or balanced, by the benefits that follow from the research. The promise is one of net gain.’[1] The ethics of covert research is an important issue, mainly for two reasons. Firstly, it is often claimed that this kind of research is essential for the business of many sciences, such as ethnography. Secondly, in spite of this alleged importance, covert research is a kind of research that seemingly violates the values of respect for autonomy and the protection of research subjects – values that have, since the first formulations of the Nuremberg Code, the Belmont Declaration and the series of Helsinki accords, become almost axiomatic in our understanding of the basic tenets of responsible and ethical research on human subjects.

It is sometimes claimed that the acquisition of informed consent from all research subjects is the best guarantee for the protection of the legitimate interests of those subjects. That is often the case, but

not always or necessarily the case. It is, for example, quite conceivable that a research subject might unknowingly or unwittingly participate in a drug trial that might yield a therapy from which that person might as a consequence – immediately or later in life – benefit directly.

Furthermore, there exists a danger that researchers might be under the impression that the fact that a research subject has provided informed consent exempts the researchers from any further moral responsibility towards the subject in the course of the research process. The latter is also ethically untenable. The researcher’s basic moral duties of beneficence and non-maleficence towards research subjects continue in the course of the research process, irrespective of whether consent has been solicited or not.

I make these preliminary points to emphasise that, although subject autonomy is a pivotal value in morally legitimate research generally, we would do well to avoid the often mistaken assumption that informed consent is an absolute or final criterion for ethical research procedures. There is, in other words, more to morally legitimate research than informed consent. This claim, in turn, raises the more pertinent question as to whether there might then not also be a kind of ethical research on human subjects that could (and should) proceed without informed consent.

The first distinction to be made in this regard is that between covert research and deceptive research. What is common to both of these is the claim that the research cannot methodologically proceed or yield valu­able results if the subjects of research are aware of the fact that they are being researched. The reason for this is that the knowledge of being researched will almost inevitably lead to a change of behaviour among the subjects that would defeat the enterprise. This phenomenon is related to what is sometimes called the ‘Hawthorne effect’,[2] which refers to the fact that ‘the behaviour of subjects can be changed by the mere presence of the researcher’.[3] Giddens ascribes this phenomenon to what he calls the ‘double hermeneutic’ of social science research as a symptom of the ‘reflexivity of Modernity’, i.e. the phenomenon that social reality is easily transformed by the fact/process of making

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ARTICLE it a subject of research, since social actors respond and change their behaviour and therefore the fabric of social reality itself as a result of being studied or conceptualised.[4] Therefore, for example, Winlow et al.[5] report on a study of the behaviour of doormen where valuable results could only be attained by the researcher(s) themselves going undercover and becoming doormen.

This kind of covert, in the sense of undercover, research is the result of the withholding of information. It must be distinguished from deceptive research, where not only the real identity of the researcher(s) is withheld from the research subjects, but also the nature of what is being researched. The example that I gave at the beginning (Herrera’s example of a researcher feigning alcoholism) is, in fact, an example of covert research (the real identity of the researcher is not revealed) which is, at the same time, also deceptive research (what is being researched is withheld from the research subjects). Research can, in other words, be both covert and deceptive.

In deceptive research, the research subjects are deliberately deceived, not only about the real identity of (if not all, then at least some of ) the researchers, but also about what is actually being researched, in order to attain the required results. Stanley Milgram’s famous experiment in the early 1960s remains the most spectacular and notorious example of such research.[6] Milgram wished to study the extent to which submission to authority was not only a characteristic of Germans under the spell of Hitler and Nazism, but a universal human trait. He therefore set up an experiment involving ordinary US citizens who were made to believe that they were participating in a study to establish how rapidly persons under the duress of pain are able to learn complica­ ted sequences of numbers. The ‘learners’, who were in fact Milgram’s co-investigators, were separated from the ‘investigators’, who in fact were the research subjects and were made to believe that they were assisting Milgram with the experiment – the ‘subjects’ on whom the research was done were in fact Milgram’s research assistants.

These ‘investigators’ were instructed to inflict an electric shock of persistently increasing voltage on a ‘subject’ who gives a wrong answer. No shocks were in fact administered, although the ‘subjects’ feigned pain as a result of the ‘shocks’ they wanted the investigators to believe they were administering.

The remarkable finding was that, in spite of being under the sincere impression that they were inflicting severe pain, the ‘investigators’ continued to administer ever more severe shocks – in some instan­ ces up to the maximum allowed voltage. Although Milgram always claimed that his results – the insight that ordinary, seemingly non-violent US citizens are as capable as anyone else of inflicting pain and therefore of irrational obedience – could not have been attained in any other way, his research has been widely condemned, not only because of the lack of consent, but also because of the deliberate deception and the way in which he, according to his critics, abused his position of authority to instigate the deviant behaviour (the ‘investigators’ and ‘subjects’ were handsomely paid for their participation).[7] It is fairly self-evident what the main objections to covert and deceptive research are. I have already pointed out the clear-cut deception and possible abuse of personal power in the case of the Milgram experiment. Covert research is sometimes very intrusive and clearly violates the privacy of research subjects. An example in point was Humphrey’s study of the behaviour of men engaging in

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homosexual acts in public restrooms.[8] Van Amstel[3] writes in this regard: ‘Such violation [of privacy] occurred not only as a result of the actual observation of the homosexual act by Humphreys in the covert social role of “watchqueen”, but also when he secured the addresses of the men involved by tracing the licence plate numbers of their cars, and then used this information to track them down and question them.’

‘Privacy’ in this context can then be defined as ‘the claim of individuals, groups or institutions to determine for themselves when, how and to what extent information about them is communicated to others’.[9] We will note later that privacy, as defined, cannot be a right that is always and everywhere inviolable. Covert research is also often morally condemned because it allegedly violates the interests of subjects, and is therefore at loggerheads with the oldest and arguably most pervasive and compelling of all moral principles: Primum non nocere: ‘first do no harm’.[10] Available space does not allow me to deal with all the objections systematically or comprehensively. I will conclude by formulating a few guidelines to identify the circumstances under which covert research might, and might not, be morally in order. I’ll limit myself to four points: • The first guideline is: Establish a relationship of trust and integrity with research participants in as far as that is possible. If confiden­ tiality is promised to the research subject, that confidentiality must be kept under all circumstances, and if it cannot be kept, it should not be promised. A research subject ought to always have the opportunity to withdraw from participation in a study (Declaration of Helsinki, article 26).[11] It is clear that one of the main problems with covert research is that it forfeits that seemingly inalienable right of the participant. In other words, when we judge the moral legitimacy of covert research, it seems inevitable to draw on a strong (individual) human rights-orientated argument that has priority over the utilitarian concerns in terms of which covert research is normally justified.

• The second guideline is: Avoid harm as far as possible, yet not necessarily beyond the consequences of the actions of a research subject. The participants in Milgram’s experiment might have contributed to our knowledge of human behaviour, but that outcome does not weigh up to the harm that was done to them in terms of the abuse of authority to which they were submitted, the deception they suffered and the distress they consequently experienced. On this score, utilitarian concerns again do not seem to trump the claim of human rights and human dignity.

However, utilitarian concerns can also not be dismissed entirely.

It cannot be consistently argued that harm could and should never come to research participants. In this respect it seems to me better to argue, as stated in the guideline, that harm should be avoided beyond the consequences of one’s own action. By this I mean that if an agent A deliberately does things that harm others, A has no moral case to expect research done on his/her (harmful) actions to be done in such a way that that research will not yield results that will be harmful to A in turn. Take as an example undercover research into the behaviour and strategies of football hooligans in Britain. If this research clearly exposes criminal activities and tactics on the part of the hooligans that in themselves generate significant harm to other people, does the researcher have no moral duty to expose

ARTICLE such behaviour? I tend to agree with Spicker’s conclusion that ‘There is nothing intrinsic in the rights of the research subject that implies that the researcher must become complicit in the crime.’ [12] Another example that is relevant in this respect relates to an incident that occurred as a result of a research project into the integrity of processed meat in certain butcheries and supermarkets in South Africa (SA) – a project done by researchers in the Depart­ ment of Animal Studies in the Faculty of Agricultural Sciences at Stellenbosch University. In this research, meat products (such as mincemeat and hamburger patties) were simply purchased over the counter by researchers and tested.[13,14] It was found that some labels on these products were misleading, and that meat from species such horses, donkeys and camels were mixed into the meat indicated on the labels.

With reference to this incident, which was covert in the sense that research was done on food products without informing the commercial interests selling those products (although it is hard to see why there was any moral or legal obligation on the researchers to divulge such information), it can indeed be argued that if there is proof that the integrity of meat products offered commercially to the public of SA is compromised, and if such compromise is against the law, there is no compulsion on researchers establishing the integrity of such products to protect those responsible for violating the law.

The above argument, of course, presupposes that the law is legitimate and just. That is a reasonable expectation in a democratic context. Laws, however, can also sometimes be unjust.

SA, as a country, has a notorious history of unjust laws that prevailed in the time before democratisation, which only arrived in 1994. What, then, do we do when the law is itself immoral?

What about the hypothetical researcher spying under false pretences on consenting adults who have sex across the ‘colour bar’ in the old SA – something which, at that time, was ‘illegal’ – in terms of article 16 of SA’s then ‘Immorality Act’, as that law was oxymoronically called – but certainly not immoral? Is this researcher consequently ‘doing the right thing’ when he turns the participants in to the police? The answer must be negative.

The argument developed above can only be valid in a democratic context where the law has moral legitimacy.

• The third guideline is: Respect research subjects’ human rights, including their right to privacy, as far as possible, but not necessarily when they knowingly act in public. The right to privacy and the obligation to avoid harm are important but not absolute moral demands. Not all human action is of a nature that justifies the right of the actor to not divulge information about it. That is because many of our actions occur in public and are therefore open to public revelation and/or scrutiny, including the scrutiny of the researcher. Shils[15] writes in this regard: ‘Observation which takes place in public or in settings in which participants conventionally or knowingly accept the responsibility for the public character of their actions and expressions ... is different from observation which seeks to enter the private sphere unknown to the actor ... The open sphere – the sphere in which the individual has committed himself to publicity – is a legitimate object of observation, as it is of interviewing.’

To return to the last example under the previous point, this guideline has a direct bearing on the case of research into the

integrity of labels on meat products sold commercially to the public. To sell a product – any product – in a shop or butchery is a public act which is at all times open to public scrutiny. If the public is misled by such commercial transactions, researchers have both the right and arguably the moral duty to expose any misinforma­ tion or deception. It is ludicrous to, in such circumstances, demand the right to consent when investigated. Spicker[12] rightfully notes in this regard that: ‘consent becomes morally irrelevant, because the information is beyond the right of the individual to control. This is the main answer to the allegation that covert research denies research subjects the opportunity to be informed, to consent, or to withdraw from research. If they are in the public domain, they have no such rights.’

What can be conceded in terms of this argument is that the decision as to whether the researched or observed actions are indeed in the public sphere is not always that easy. Take the example of domestic violence: is wife battering an action that warrants a claim to privacy, or is it an act in the public sphere that cancels the man’s right to claim privacy? To me, it seems to be the latter, but it is conceivable that there are a number of borderline cases that might not be that easy to decide.

• The fourth guideline is: When in doubt – and even when not in much doubt – submit the proposed research to ethical review.

It is always better to consult the accrued wisdom of colleagues in a research ethics committee (REC), even if the researcher is relatively sure that consent need not be solicited for a research project. Often this ethical review will not necessarily result in placing any impediments on the protocol, but it could also be very useful in order to establish risk – if not risk to the researcher, then risk to the institution of which he or she is part. In the case of the meat research project mentioned above, it turned out that the main risk which this research provoked was not any moral misconduct on the part of the researchers, but the possible loss of financial support for the university as a result of the exposure of the possible complicity of powerful business interests in compromising the integrity of product labels.[16] Such a risk might well be one that an institution such as Stellenbosch University might under certain circumstances be willing to run for the sake of scientific credibility. It would, however, always be better for the researchers to be cautious of making that decision on their own, and to rather defer the decision until a process of proper ethical scrutiny has occurred in the ranks of a legitimate REC. Acknowledgement. I would like to thank an anonymous referee for valu­ able comments on the original manuscript, as well as my research assistant, Andrea Palk, for her help in tracing sources and editing the references.

References 1. Herrera CD. Two arguments for covert methods in social research. Br J Sociol 1999;50(2): 331-343. [http://dx.doi.org/10.1111/j.1468-4446.1999.00331.x] 2. Van Deventer JP. Ethical considerations during human centred overt and covert research. Qual Quant 2009;43(1):45-57. [http://dx.doi.org/10.1007/s11135-006-9069-8] 3. Van Amstel H. The ethics and arguments surrounding covert research. Social Cosmos 2013;4(1):21-26.

4. Giddens A. The Consequences of Modernity. Cambridge: Polity Press, 199:38-45.

5. Winlow S, Hobbs D, Lister S, Hadfield P. Get ready to duck: Bouncers and the realities of ethnographic research on violent groups. Br J Criminol 2001;41(3):536548. [http://dx.doi.org/10.1093/bjc/41.3.536]

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ARTICLE 6. Milgram S. Obedience to Authority. London: Tavistock, 1974.

7. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 3rd ed. Oxford: Oxford University Press, 1989:97-98.

8. Humphreys L. Tearoom trade: Impersonal sex in public places. London: Duckworth, 1970.

9. Western cited in Kimmel A. Ethics and Values in Social Research. London: Sage, 1988.

10. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 5th ed. Oxford: Oxford University Press, 2001:113-164.

11. World Medical Association. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 2014. http://www.wma.net/ en/30publications/10policies/b3/ (accessed 31 March 2014).

12. Spicker P. Ethical covert research. Sociology 2011;45(1):118-133. [http://dx.doi. org/10.1177/0038038510387195]

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13. Cawthorn DM, Steinman HA, Hoffman LC. A high incidence of species substitution and mislabelling detected in meat products sold in South Africa. Food Control 2013;32(2):440-449. [http://dx.doi.org/10.1016/j. foodcont.2013.09.001] 14. Cawthorn DM, Steinman HA, Hoffman LC. Letters to editor: Comments on published article: A high incidence of species substitution and mislabelling detected in meat products sold in South Africa. Food Control 2014;37(1):415-416. [http://dx.doi.org/10.1016/j.foodcont.2013.01.008] 15. Shils E. Social enquiry and the autonomy of the individual. In: Bulmer, M, ed.

Social Research Ethics. London: Macmillan, 1982:132.

16. City Press. We expose the meat label scandal. 2013. http://www.citypress.co.za/ news/meat-scandal-we-expose-the-meat-label-scandal (accessed 29 March 2014).

ARTICLE

Enhancing capacity of research ethics review committees in developing countries: The Kenyan example G Omosa-Manyonyi,1,2 MB ChB, MSc ID, DLSHTM, PgDip (STI); W Jaoko,1,2 MB ChB, MTropMed, PhD; K M Bhatt,1,3 MB ChB, MMed, MPH; S K Langat,4 MSc, PGD (International Research Ethics); G Mutua,1 MB ChB, MPH, PgDip (Epid); B Farah,1 MSc; J Nyange,1 KRN, BA PSY, MSc; J Olenja,1,5 BEd, MPhil, PhD; J Oyugi,1,2 MSc, PhD; S Wakasiaka,1,6 BSN, MPH, PhD; M Khaniri,1 LLB; K Fowke,2,7 PhD; R Kaul,2,8 MD, PhD; O Anzala,1,2 MB ChB, PhD KAVI Institute of Clinical Research, University of Nairobi, Kenya Department of Medical Microbiology, University of Nairobi, Kenya 3 Department of Internal Medicine and Clinical Therapeutics, University of Nairobi, Kenya 4 National Commission for Science, Technology and Innovation (NACOSTI)), Kenya 5 School of Public Health, University of Nairobi, Kenya 6 School of Nursing Sciences, University of Nairobi, Kenya 7 Department of Medical Microbiology, University of Manitoba, Canada 8 Department of Medicine, University of Toronto, Canada 1 2

Corresponding author: G Omosa-Manyonyi (gomosa@kaviuon.org)

Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees (ERCs) reviewing them have the capacity to ensure that they are conducted to the highest ethical standards.

Methods. The Kenya AIDS Vaccine Initiative (KAVI) Institute of Clinical Research (ICR) (KAVI-ICR) and the Kenyan National Council for Science and Technology (NCST) embarked on an exercise to enhance the capacity of ERCs in Kenya to review such protocols. This process involved conducting an audit of all ERCs in the country, and performing training needs assessments to identify knowledge and capacity gaps.

Information obtained was used to develop training materials for ERC members at workshops conducted in different parts of the country.

Results. Five accredited and 13 non-accredited ERCs were identified. Four of the accredited ERCs were located in the capital city of Kenya, Nairobi. The most common challenges cited by participants during the needs assessments were excess workload, and a lack of co-ordination and/or communication between the ERCs. Subsequently, 140 ERC members from 17 institutions across the country were trained as follows: 36 from institutions in the western part of Kenya, 38 from institutions in the south-eastern coastal region, 38 from the eastern region and 44 from Nairobi.

Conclusion. The KAVI-ICR and the NCST have developed training modules for training ERC members in Kenya and are in the process of developing a manual to train members. The Kenyan experience may be used to enhance the capacity of ERCs in the East African region.

S Afr J BL 2014;7(2):59-63. DOI:10.7196/SAJBL.308

Scientific research, including clinical trials, has evolved from being an amateur activity in the 18th century and university practice in the 19th century to an indus­ trial activity in the 20th century.[1] However, research involving human subjects is relatively new in deve­loping countries compared with the technologically advanced nations of the West.

In particular, most randomised double-blind controlled clinical trials – which provide the best evidence for clinical practice and are the ‘gateway’ between research and the use of products in public health – have in the past mainly been conducted in developed countries.[2] This has in part been attributed to a lack of adequate ethical and regulatory oversight in developing countries.

However, in the past decade, the number of clinical trials conducted in developing countries has increased tremendously[3] for several reasons. These include the high cost of conducting such trials in developed countries, access to genetically diverse populations and treatment of naive patients, and the increasing difficulty of finding sufficient numbers of qualified study participants in the sponsor’s home countries.[2,4]

In particular, pharmaceutical companies have been shifting trials from developed to developing countries. This is a result of the increased prevalence in developing countries of some clinical conditions under investigation, allowing for faster recruitment rates – the so-called ‘off-shoring’ of clinical trials.[5,6] The increase in the conduct of clinical trials in developing countries has raised ethical concerns, particularly related to the involvement of populations of poor low-income countries in clinical research originating from affluent countries.[7] To this end, there have even been calls for developing countries to strengthen their ethical research conduct if they are to continue to be an attractive place to conduct clinical research.[8] These concerns are based on the perception that these populations can easily be exploited as a result of their poverty and illiteracy, thereby allowing themselves to participate in trials without fully understanding the risks involved.

To address this concern, research ethics review committees (ERCs) in developing countries need to be well trained in order to ensure protection and minimisation of risk to study participants. These ERCs should ensure appropriate selection of research participants, without

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ARTICLE coercion, and appropriate clinical monitoring of the participants, among others. In order to achieve this, ERC members must be trained in ethics to be able to review clinical trial proposals critically to ensure that they are conducted to the highest ethical standards.

Here, we present the experience of Kenya, a developing country that is endeavouring to ensure that ERCs are equipped with the necessary expertise to ensure that studies involving human participants, and in particular clinical trials, are conducted to the highest ethical standards.

In 1957, biomedical research in Kenya was conducted with the support of the East African Medical Research Council, which had oversight for research in the three countries constituting the East African community, namely Kenya, Uganda and Tanzania. After the break-up of the East African community in 1977, Kenya established the National Council for Science and Technology (NCST) to provide this oversight, with the objectives of overseeing all science, technology and innovation in Kenya, advising the government on national research and technology, and co-ordinating all research activities in the country. With respect to co-ordination of research activities in Kenya, the NCST is responsible for ethical approval of all studies involving human subjects prior to the initiation of the studies.

In order to perform this role more efficiently and avoid unnecessary delays, the NCST, through its sub-committee, the National Bioethics Committee (NBC), accredits institutional ERCs to review and approve clinical research on its behalf. The NCST facilitates these ERCs to carry out their delegated responsibility by providing them with research guidelines.

The KAVI-ICR, a research institute at the University of Nairobi, has been conducting clinical research, including HIV vaccine clinical trials, since 2001. To date, it has conducted seven HIV vaccine clinical trials (six in adults and one in infants) and one ARV drug trial (a pre-exposure prophylaxis in men who have sex with men). In 2010, the KAVI-ICR obtained a grant from the Global Health Research Initiative (GHRI) of Canada, with the broad objective of establishing the KAVI-ICR as a centre of excellence for HIV vaccine/prevention trials in the East Africa region. This grant has expanded the KAVIICR research and training mandate and resulted in the KAVI-ICR becoming a centre of excellence for the training and conduct of clinical trials in the East Africa region. One of the specific objectives of this grant was to enhance the capacity of local institutional ERCs to handle vaccine research and development. In order to do this, the KAVI-ICR aimed to develop a training manual for ethics review boards, conduct regional training workshops for institutional ERC members and institutional administrators, obtain evaluation of the training by participants at the end of each workshop, and utilise the feedback from the evaluation obtained in the course of the year to review and revise the training manual. This article will be confined to the process we followed to enhance the capacity of institutional ERCs in Kenya.

Methods Upon being awarded the grant, we sought partnership with the NCST to conduct a needs assessment of the existing institutional ERCs. The objectives of the needs assessment were to find out how many ethics committees there were in Kenya, their capacity to review research proposals, and the number duly recognised by the NCST. At that time, the NCST was in the process of accrediting new

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institutional ERCs and re-accrediting the existing ones. In this regard, they had developed requirements and guidelines for institutional ERCs seeking accreditation. We agreed with the NCST that before rolling out an ethics training programme, it was necessary to conduct a needs assessment of the institutional ERCs in order to inform the design of the ethics training required. We then obtained from the NCST a list of currently accredited institutional ERCs and the contact details of the chairs and secretaries. Using this information, we made an inventory of all the accredited institutional ERCs in the country.

We also contacted other local universities, research institutions and hospitals that we suspected were conducting research on human subjects but were not on the list provided by the NCST, and enquired if they had ERCs. We then reached out to the chairs and secretaries of the ERCs, where this information was available, informed them about the needs assessment that was due to be conducted, and proposed to host ethics sensitisation seminars for their members. Several needs assessment and sensitisation seminars were planned in different parts of the country. Each of the accredited and non-accredited ethics committees was requested to send two representatives (preferably the chairperson and secretary) to the seminar in their nearest geographical location.

Training needs assessment and ethics sensitisation seminars Six training needs assessment and ethics sensitisation seminars were held in different regions of the country between July and September 2011. During the needs assessment, questions asked included when the ERCs were established, their membership (including gender and professional training), ethics training of each member, the ERC procedures for ethical review of protocols, and sources of funding.

Each training needs assessment exercise was followed by an ethics sensitisation seminar lasting 1 day and consisting of didactic lectures, and question-and-answer sessions. Topics covered were: • General introduction to ethics – history perspective • The role of ethics committees • Clinical trials • NCST requirements and guidelines for accreditation of ERCs • NCST guidelines for ethical review of proposals.

Feedback from participants was obtained at the end of each ethics sensitisation seminar. Information obtained was used to improve the quality of subsequent seminars.

Training modules The information obtained from the needs assessment seminars was used to develop a training module for ERCs in Kenya. The course materials for the training module were developed with input from experienced members of the Kenyatta National Hospital/University of Nairobi Ethics and Research Committee, which is one of the oldest and most experienced ERCs in the country, and the NCST (the body that is legally mandated to accredit ERCs in Kenya).

The objectives of the course were to: • Train members of ERCs on principles of bioethics • Train members on bioethics guidelines and regulations • Provide the trainees with the skills for proposal review • Provide the trainees with the skills for standard operating procedures development

ARTICLE • Form a mentorship programme • Create a network system of ERCs in Kenya • Introduce a common database to reduce potential ‘ERC shopping’ by researchers • Obtain feedback from trainees.

Participants were asked to evaluate the training at the end of each workshop. Feedback was obtained from participants using a seminar evaluation form, and the information was utilised to review and revise the training manual.

The training module developed was used to train ethics committee members during scheduled training workshops, each lasting 2.5 days. The inaugural training was dedicated to training of the chairs and secretaries of all the identified ERCs who had participated in the needs assessment. The training was conducted in collaboration with the NBC of the NCST. The training of chairs and secretaries provided an opportunity to test newly developed course material and get feedback from participants on how to enrich the materials before a national roll-out to train the ERCs.

Ethics training workshops The first of these workshops took place in April 2012. This was followed by more training workshops in different parts of the country. Invited participants were members of the ERCs from universities and from public and private hospitals, potential ERC members and trained ERC members who were expected to become potential facilitators for future training. Topics covered in the training included: • Basis for ethics • Principles of ethics • Protection of vulnerable groups • Informed consent process • Components of the clinical trials proposal • Study designs • Legal basis for ethics • Role of ethics research committees • Ethical review process of research proposals, and active monitoring of the approved studies.

Although the focus of the grant that supported this exercise was geared towards capacity building of ethics committees for review of clinical trials, the scope of the training went beyond this and addressed ethical review of other studies, including social science studies. Risk assessment of studies and expedited review of studies with no more than minimal risk were also discussed.

Ethical approval for the programme, from which this information is derived, was obtained from the Kenyatta National Hospital and University of Nairobi ethics and research committee.

Results Five institutional research ERCs had been accredited by the NCST at the time of the training needs assessment. The majority (four) of these ethics committees were located in Nairobi, the capital city of Kenya, while one was in Eldoret, a town in the north-western part of the country, about 300 km away. Thirteen institutions had functional but unaccredited ERCs. Ten (77%) of these ERCs were based outside Nairobi.

Training needs assessment and sensitisation seminars Sixteen (89%) of the ERCs identified sent representatives to the needs assessment and sensitisation seminars. The institutions included universities (10), research organisations (2) and hospitals (4). A total of 111 (72 male and 39 female) ERC members took part in the needs assessment and sensitisation seminars.

The needs assessment identified lack of knowledge in ethics and a need for training of ERC members in the following areas: role of ERCs; accreditation process and establishment of an ERC; HIV biomedical research; general introduction to ethics and historical ethics perspective; preclinical and clinical trials; in-depth ERC review process of a proposal; skills necessary for ERC members to be effective in executing their mandate; handling proposals involving vulnerable and special groups, e.g. children and pregnant women; and biosafety.

The most common challenge and/or need cited by participants was excessive workload. This was particularly more so for the accredited ERC members, who felt overwhelmed by the amount of work. Second was lack of co-ordination and/or communication between the ERCs. As a result, ERC members felt that it was possible for one ERC to reject a research proposal only for it to be approved by another. Although this may not be common, during the training a case was cited where this had happened.

Ethics training workshops A total of 58 members attended the inaugural ethics training workshop, where the chairs and secretaries of institutional ERCs were invited. By December 2013, a total of 140 (87 male and 53 female) ERC members from 17 institutional ERCs had been trained as follows: 36 (25 males and 11 females) from institutions in the western part of Kenya, 22 (14 males and 8 females) from institutions in the coastal region, 38 (28 males and 10 females) from the eastern region of the country, and 44 (20 males and 24 females) from Nairobi. The training workshops are still on course.

Discussion The NCST requires that before any ERC is accredited, its members or at least its chair must show evidence of having been trained in ethics.

This is the first time that an audit of ERCs in Kenya has been conducted with the objective of finding out how many unaccredited ERCs exist.

The purpose of the audit was to provide them with guidelines on how to seek accreditation, with the objective of streamlining the ethical review process for research involving human subjects in the country.

Many countries are investing significant resources in strengthening ERCs to review proposed research involving human participants, yet comprehensive auditing and accreditation programmes require an investment of human and financial resources that is unfeasible for many developing countries.[9] At the 2004 ministerial summit on health research in Mexico City, health officials from 58 countries called for national governments to adopt regulations providing for the ’ethical oversight‘ of research.[10] National accreditation of ERCs is one way of ensuring that they meet a certain minimum threshold of competence for the protection of research participants in the country. In many developed countries, national governments have responsibility for ERC oversight. In some developed countries, such as the UK, ERCs are required to go through a formal process of governmental accreditation, which

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ARTICLE involves a combination of self-assessment and external reviews, focusing on issues such as committee membership, operating procedures, and the documentation of meetings. The step that the NCST has taken to accredit ERCs in Kenya is therefore laudable and should be emulated by other developing countries. Accreditation programmes encourage ERCs to develop standardised policies and procedures, which help promote the consistent application of ethical principles and provide a means for checking whether they actually adhere to the policies and procedures they claim to be following.[9] This will go a long way towards ensuring that standards for ethical conduct of clinical research are maintained throughout the country. At the moment, it is possible that when one ERC does not approve a research proposal, the researcher can submit the same proposal to another ERC, which may go ahead and approve it, although only one case of this was cited. It is possible that having only a few ERCs accredited in the country, as is the case at the moment, may be a deterrent. If this is the case, the anticipated increase in accredited ERCs may be associated with an increase in such cases, and therefore mechanisms need to be put in place to prevent this from happening.

The next step would be for the NCST to develop a database of the proposals that have been submitted to the various institutional ERCs in the country, with an indication as to what decision the ERCs have made.

The fact that most of the accredited ERCs were in Nairobi, the capital city, poses a problem. This implies that protocols have to be sent long distances for review if they are to be submitted to an accredited ERC. There is, therefore, a need to encourage ERCs outside the capital city to seek accreditation. The additional accreditation of ERCs outside the capital city will not only resolve the need for transporting protocols long distances for review, but will also relieve the existing accredited ERCs from carrying excess workload, leading to an overwhelming amount of work as claimed by members.

The present audit revealed a large proportion of ERCs that were reviewing studies but which were not accredited by the national authority. This seemed to be out of ignorance. During the training-needs assessment and ethics sensitisation workshops, a number of ERC members indicated the need to know the process for accreditation and establishment of ERCs. It is apparent that measures to deter operations of ERCs that are unaccredited need to be enforced. In New Zealand, if a study proceeds without the approval of an accredited ethics committee, participants who suffer injuries may not be eligible for compensation.[12] Besides, approval by an accredited ERC is necessary for researchers to obtain access to data held by the New Zealand health information service database.[13] Many ERC members expressed the need for capacity building in the ERC review process of proposals and skills necessary for ERC members to be effective in executing their mandate and handling research proposals involving vulnerable and special groups. Training and certification programmes for ERC members can complement the accreditation process by promoting a common base of knowledge about applicable ethical and regulatory principles.[9] Lack of training of ERC members is not unique to Kenya. A study on health research ethics review and needs of institutional ERCs in Tanzania showed that 49% of 45 respondents had not had any training in health research ethics review.[14] Similarly, a case study

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of 12 African ERCs identified inadequate training of members as a major challenge faced by the committees.[15] In a study of ERCs in Africa, Nyika et al.[16] found that the majority of committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits, and monitoring of research. This study also found that 38% of the ERC members had not received any form of training.

The authors concluded that in light of increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention.

There was a large gender disparity in attendance at the ethics sensitisation seminars and training workshops. The total number of males who attended these seminars and training workshops was almost twice that of females. The low number of female ERC members in developing countries has been observed previously. A study of several ERCs in Africa conducted by Nyika et al.[16] observed that overall, females constituted only 33% of ERC members.

Crucial in ensuring ethical conduct of studies beyond ethical review of the proposal is the issue of monitoring and/or auditing the approved studies. This can be achieved by visiting selected clinical research sites to get first-hand information on how these studies are proceeding. However, this requires both time and financial resources, which remain a challenge in most resource-constrained countries.

Conclusions This study identified a lack of standardisation across ERCs in Kenya.

Almost all the accredited ERCs are in Nairobi, making it difficult for researchers in other parts of the country to access the services of these accredited ERCs. There were several unaccredited ERCs in Kenya. The NCST is in the process of ensuring that they all become accredited once the guidelines are developed for accreditation of ERCs in the country. For ERCs to be strengthened, their members need to undergo ethics training. It is also important that accredited ERCs network to ensure that a proposal rejected by one ERC is not presented to another ERC for review, thereby preventing the concept of ‘ethics committee shopping’.

The way forward The KAVI-ICR and the NCST are in the process of developing a manual for the training of ethics review boards in Kenya. In the meantime, the developed training modules are being used to train ERC members.

The Kenyan experience may be used to conduct needs assessment sessions in other countries in the region (Uganda, Tanzania, Rwanda and Burundi) and to train ERC members in these countries. At the time of writing this report, the NCST had accredited a total of 14 institutional ERCs. The fast-changing landscape is partly a result of the establishment of new universities around the country and an improved legal framework for science and technology.

Acknowledgments. This study was funded by the Global Health Research Initiative, Canada. Prof. Anastasia Guantai, Prof. Christine Kigondu and Dr Micah Ongeri organised the inaugural ethics training workshop funded by the European and Developing Countries Clinical Trials Partnership (EDCTP). Members of the Kenyatta National Hospital and the University of Nairobi ethics and research committee participated in developing materials used in the ethics training workshops.

ARTICLE References 1. Garrafa V, Lorenzo C. Moral imperialism and multicentric clinical trials in peripheral countries. Cad Saude Publica 2008;24(10):2219-2226. [http://dx.doi. org/10.1590/S0102-311X2008001000003] 2. Devasenapathy N, Singh K, Prabhakaran D. Conduct of clinical trials in developing countries: A perspective. Curr Opin Cardiol 2009;24(4):295-300. [http://dx.doi. org/10.1097/HCO.0b013e32832af21b] 3. Matsotso PM, Auron S, Banoo S, Fomundam H, Leng H, Noazin S. How does the regulatory framework affect incentives for research and development? Study commissioned for the Commission on Intellectual Property Rights, Innovation and Public Health (CIPH); Geneva: World Health Organization, 2005. http://www. who.int/intellectualproperty/studies/regulatory_framework/en/index.html (accessed 12 February, 2013).

4. Washington: American Health Line, 2006. Research notes – Clinical trials: Efforts to increase participation examined.

5. Petryna A. Clinical trials offshored: On private sector science and public health.

Biosocieties 2007;2:21-40. [http://dx.doi.org/10.1017/S1745855207005030] 6. Ballantyne AJ. How to do research fairly in an unjust world. Am J Bioeth 2010;10(6):26-35. [http://dx.doi.org/10.1080/15265161.2010.482629] 7. Lorenzo C, Garrafa V, Helge J, Vidal S. Hidden risks associated with clinical trials in developing countries. J Med Ethics 2010;36(2):111-115. [http://dx.doi. org/10.1136/jme.2009.031708] 8. Elsevier Ltd. Strengthening clinical research in India. Lancet 2007;369(9569):1233. [http://dx.doi.org/10.1016/S0140-6736(07)60568-6] 9. Coleman CH, Bouësseau MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics 2008;9:6. [http://dx.doi.org/10.1186/1472-6939-9-6]

10. Ministerial Summit on Health Research. The Mexico Statement on Health Research, 2004. http://www.google.co.ke/uri?sa=t&rct=j&q=&esrc= s&frm=1& source=web&cd=1&sqi=2&ved=0CC8QFjAA&url=http%3A%2F%2Fwww.who. int%2Frpc%2Fsummit%2Fagenda%2Fen%2Fmexico_statement_on_health_ research.pdf&ei=QdknUayBH5S10QXtwoDYDw&usg=AFQjCNGnDZaNZ4PZ Qg_Nouk3nb7nXjWHsA&bvm=bv.42768644,d.d2k (accessed 22 February 2013).

11. National Patient Safety Agency. (United Kingdom): Quality Assurance–Accreditation scheme for the National Research Ethics Service. http://www.google.co. ke/url?sa=t& rct=j&q=&esrc=s&frm=1&source=web&cd=2& ved=0CDkQFjAB&url=http%3A%2F% 2Fwww.nhmrc.gov.au%2F_files_nhmrc%2 Ffile%2Fhealth_ethics%2Fhrecs%2FUK_ NHS_Accreditation_Process_vers_3_22_05_20082.pdf (accessed 22 February 2013).

12. New Zealand Government. New Zealand Injury Prevention, Rehabilitation, and Compensation Act, Section 32(6). http://www.legislation.govt.mz/regulation/ public/2003/0388/latest/DLM235778.html (accessed 22 February 2013).

13. Health Research Council of New Zealand. Accredited Ethics Committees. http:// www.hrc.govt.nz/root/Ethics/Ethics%20Overview/Accredited_ Ethics Committees. html (accessed 22 February 2013).

14. Ikingura JK, Kruger M, Zeleke W. Health research ethics review and needs of institutional ethics committees in Tanzania. Tanzan Health Res Bull 2007;9(3):154-158.

15. Kass NE, Hyder AA, Ajuwon A, et al. The structure and function of research ethics committees in Africa: A case study. PLoS Med 2007;4(1):e3. [http://dx.doi. org/10.1371/journal.pmed.0040003.sd001] 16. Nyika A, Kilama W, Chilengi R, et al. Composition, training needs and independence of ethics review committees across Africa: Are the gate-keepers rising to the emerging challenges? J Med Ethics 2009;35(3):189-193. [http:// dx.doi.org/10.1136/jme.2008.025189]

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ARTICLE

An analysis of the validity of medical legal documentation in cases where the patient refuses treatment and/or transport R Spicer, BTech, EMC; S Sobuwa, BTech, EMC, MSc, EM Department of Emergency Medical Sciences, Faculty of Health and Wellness Sciences, Cape Peninsula University of Technology, Cape Town, South Africa Corresponding author: R Spicer (richard.spicer@westerncape.gov.za)

Objectives. We investigated whether patient record forms (PRFs), as currently completed, meet minimum legal standards and provide medicolegal protection to prehospital healthcare providers, and if their qualification levels influence the level of detail recorded in the patient records.

Methods. We retrospectively reviewed consecutive case reports at a single centre over a 1-month period for cases in which ambulance crews attended a patient and the patient later refused to accept transportation to a medical facility. Scores were calculated for each case report, based on the number of data fields completed. The scores were compared for variation between qualifications.

Results. A total of 5 873 ambulance cases were dispatched during this period. Case reports for refusal of transport (n=229) were reviewed. No case report achieved 100% compliance with legal requirements. There was no statistically significant variation between levels of qualification with regard to improved detail being recorded. Young adults were the most likely to refuse transport. Most of the refusals occurred in the late evening.

Conclusion. Refusal of transport and its documentation are poorly understood and practised by prehospital healthcare providers. The implication is that some patients’ rights could potentially be infringed. This could lead to possible grounds for litigation, for which the defence would also hinge on the adequacy of the documentation.

S Afr J BL 2014:7(2)64-68. DOI:10.7196/SAJBL.311

Refusal of transport has many ethical and legal considerations. The refusal of the transport process comprises several steps which must all be pro­ perly completed to comply with ethical and legal standards. Such documentation provides the only lasting proof of which components have been conducted correctly. Correct and detailed documentation of the refusal process can afford protection to ambulance practitioners and service providers against litigation.

It can also support valid patients’ claims should their rights have been violated.[1] Many services have formalised documents and protocols to aid the navigation of this ethical and legal minefield.[2] Their guidance could help healthcare providers (HCPs) adhere to the correct process and thus limit their exposure to legal liability, and also possibly limit infractions of the patient’s rights. Patients are afforded the right to be informed of their condition, participate in decision-making, have access to health services, and refuse treatment or transportation if they wish to do so.[3] These rights are involved when an ambulance is on-scene with a patient and the patient decides to forego any or all treatment and/ or transportation (hereafter inclusively referred to as refusal or refusal of transport).

Objectives We investigated whether the current manner in which patient record forms (PRFs) are completed meets minimum legal standards and provides medicolegal protection to prehospital HCPs. We also aimed to determine whether the HCPs level of qualification influences the level of detail recorded in the patient records.

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Methods This was a retrospective, observational review of consecutive patient care report forms completed by a single urban emergency medical services (EMS) provider for all cases involving refusal of transport by patients over a period of 1 month. Documentation was required to be completed to represent current best practice by the HCPs. Had the HCPs involved in the study been informed that an audit of the PRFs was going to take place, this could have affected the detail with which they completed their documentation, a phenomenon known as the Hawthorne effect. Informed consent for participation was therefore only sought from the EMS service provider, and not the individual practitioners. Research ethics was approved by the Cape Peninsula University of Technology Department of Emergency Medical Sciences Research Ethics Committee (BTech 08/2013).

The research was conducted at an urban ambulance station in the Western Cape Province, South Africa (SA), that serves a population of approximately 1.4 million. The station’s efficiency reports indicate an average call rate of approximately 5 000 cases per month.

PRFs in which the patient had refused transport were retrieved daily when possible. At the end of the data-collection period, we compared the station’s case statistics to determine if all the case reports for refusal had been accounted for during the continuous retrieval process. Missing case reports were obtained from the service provider’s data archives department. All PRFs in which EMS personnel attended a patient who refused transport were included. The following were excluded: when patient transport occurred, when handwriting was illegible, and cases in which patients refused transport between two medical facilities.

Criteria for assessing the case reports were grouped according to four categories, namely: dispatch information, demographic information, medical information, and legal information. All the

ARTICLE

• Cases for evaluation after exclusion criteria applied

229

Fig. 1. Study sample selection diagram.

Table 1. Distribution of refusal cases according to call type Case type

Refusals, n

% of all refusals

Other medical

138

60.3

Assault

37

16.2

MVA

16

7.0

Asthma

16

7.0

Other trauma

9

3.9

Diabetes

4

1.7

Overdose

3

1.3

Bites and stings

2

0.9

Burns

1

0.4

CVA/stroke

1

0.4

Ischaemic cardiac event

1

0.4

Accidental poisoning

1

0.4

MVA = motor vehicle accident; CVA = cerebrovascular accident

30 25 20 15 10

23:00 - 23:59

21:00 - 21:59 22:00 - 22:59

20:00 - 20:59

18:00 - 18:59 19:00 - 19:59

17:00 - 17:59

15:00 - 15:59 16:00 - 16:59

14:00 - 14:59

12:00 - 12:59 13:00 - 13:59

11:00 - 11:59

09:00 - 09:59 10:00 - 10:59

08:00 - 08:59

06:00 - 06:59 07:00 - 07:59

05:00 - 05:59

0

04:00 - 04:59

5 03:00 - 03:59

The gender of patients who refused transport was evenly distributed (93 males and 94 females). Gender was not recorded in 42 of the PRFs examined.

Ages were not recorded for 89 of the 229 patients; 73 (32%) were in the 18 – 39-yearold group; 20 were minors, of whom 16 were

• Total refusal cases

240

02:00 - 02:59

Demographic characteristics of patients who refused transport

• Total cancelled cases

785

01:00 - 01:59

Ambulances based at the EMS station were dispatched on 5 873 cases during the month of September 2013, of which 3 043 cases were related to primary responses (Fig. 1). This service classifies cases into 35 general case types. Other trauma and other medical categories are used if the patient does not fit into these specific categories.

Unspecified medical conditions accounted for most (n=138) of the refusal of transport cases (Table 1). Peak call volumes, calculated by ambulance arrival on the scene, were achieved between 10h00 and 16h00 with a call volume of more than 300 cases per hour (distributed over the study period), with a second peak, with similar volumes, between 19h00 and 21h00. During the day-shift hours of 07h00 - 19h00, 3 506 cases (including 96 refusal cases) were attended, while the night shift attended 2 367 (including 133 refusal cases) (Fig. 2).

• Primary responses

3 043

00:00 - 00:59

Results

• Total cases

5 873

Cases, n

required fields (n=36, scoring 0 = absent, 1 = present) were evaluated and entered into a table created in Microsoft Excel, version 2010. Age and gender were the only patient details recorded for analysis.

Other patient details were only assessed and recorded for analysis as being either present or absent in the documentation.

Confidentiality of the practitioners attending the case was also ensured, as their names were not recorded for analysis. The practitioner qualification was recorded either as basic life support (BLS), intermediate life support (ILS) or advanced life support (ALS).

ALS includes the Emergency Care Technician (ECT), the Critical Care Assistant (CCA), the National Diploma: Emergency Medical Care (ND EMC), and the BTech: Emergency Medical Care (B EMC) qualifications. ILS refers to the Ambulance Emergency Assistant qualification (AEA), and BLS refers to the Basic Ambulance Assistant (BAA) qualification.

Time of day

Fig. 2. Distribution of refusal cases according to time of day.

November 2014, Vol. 7, No. 2 SAJBL

65

70+

60 - 69

50 - 59

40 - 49

30 - 39

18 - 29

Comparing the average scores achieved for the document as a whole showed a small, but non-statistically significant (p=0.1356) change in the median scores in favour of the higher qualifications (Fig. 4). Performance in the legal criteria was unanimously poor, with the most frequent score achieved being 1/9 for all of the qualification groups.

12 - 17

40 35 30 25 20 15 10 5 0

0 - 11

Patients, n

ARTICLE

Age group

Fig. 3. Distribution of refusal cases according to age group.

30

Total score

25

20

15

10

BLS

ILS

ALS

NQ*

Fig. 4. Comparison of total scores achieved between qualification levels (BLS = basic life support; ILS = intermediate life support; ALS = advanced life support; NQ = no qualification).

below the age of consent (12 years); and nine patients were >70 years old, the oldest being 98 (Fig. 3).

Dispatch information. Criteria related to dispatch information were normally well documented, with 163 (71%) of the 229 cases of the required dispatch-related data fields being completed. The crew qualification section was most often found incomplete, with 24% of the PRFs not containing the qualification details of either of the crew members.

Demographic information. This infor­ mation is required to identify and/or contact the patient or the next of kin. Only 12 PRFs contained sufficient information to achieve 100% compliance in all data fields. The patient’s name was recorded in only 89% of the PRFs (n=204). A name for the next of kin/witness was documented in only 39% of the PRFs (n=89). The age of the patient was recorded in only 61% (n=140)

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November 2014, Vol. 7, No. 2 SAJBL

of the cases, although a date of birth or ID number was recorded more frequently (n=156), and therefore the age could have been calculated.

Medical information. A chief complaint was documented in only 162 (71%) of the PRFs; however, only 117 PRFs contained any current history relating to the chief complaint. Vital signs were recorded in 147 (64%). A differential diagnosis was only recorded in six (3%) cases, and this impacted on three PRFs (1.3%), which met all medical criteria.

Legal information. No PRF met all of the legal criteria. The patient signature in 165 (72%) was the only data field that was regularly completed.

The cases were grouped according to the crew member in attendance with the highest qualification, BLS (n=30), ILS (n=98), and ALS (n=47); 54 cases had no qualification recorded.

Discussion A common saying regarding patient records is: ‘If it was not documented, it was not done’.

We found that many of the recommended and required steps during the refusal of transport process were omitted. The Consti­ tution of the Republic of South Africa[4] affords the right to emergency medical treatment to all patients. It is therefore illegal to place the patient under duress to accept treatment or transportation.[5] The decision should be made voluntarily by the patients or the person responsible for their care, should they be incapable of making the decision.[6] Of major concern is the number of cases (n=25) in which the patient’s name was not recorded. Some may be explained by patients being unco-operative or unknown.

However, only six record such a situation and the HCP should have attempted to find a witness to corroborate that an uncooperative patient had refused transport.

‘Who refused transport and with whom were the discussions held for the refusal to be considered informed?’ are two questions linked to the absence of patient names. An absent patient name on a case report could be viewed as evidence that disclosure of relevant details did not occur. Any person involved with the incident could later claim that they suffered adverse medical consequences owing to the HCP not providing the disclosure and possibly claim that they were abandoned at the scene. The PRF would probably not provide sufficient legal protection without a patient name recorded.

The other major concern is the lack of medical evaluation of patients. HCPs in the prehospital environment lack access to many diagnostic tools and rely on history taking and physical examination to make the diagnosis. Without a full examination it is not possible to know what is wrong with a patient. Lack of diagnostic information results in a lack of information relating to the risks of refusing transport and the available treatments that could be offered at the

ARTICLE

Table 2. Recommended elements for inclusion in refusal of transport documentation The decision to refuse transport was made voluntarily by the patient.

The patient was deemed to have sufficient mental capacity to make an informed decision.

The patient was informed of his/her current condition.

The patient was informed of the possible risks of refusing further care and the benefits of accepting the proffered medical assistance.

The patient was advised that the current refusal of transport does not waive the patient’s right to contact or receive future medical management.

The patient was able to understand all the information provided and the patient was able to relay back to the healthcare provider (in his/her own words) what was discussed.

The patient and a witness (preferably a family member of the patient) should sign the completed document.

hospital.[1] Failure to obtain the information required to make a diagnosis for HCPs to fully understand the risks of the patient’s condition(s) limits their ability to provide full disclosure, which could invalidate the refusal of transport process.[1] Should the patient not wish to submit to an examination, or the knowledge of the crew be insufficient to determine the diagnosis, the limitations of the examination and the conclusions that could be drawn should be explained to the patient and properly documented.[7] PRFs that contain evidence of all the recommended procedural elements (Table 2) for the refusal of transport process should provide the best chance of defence against claims of misconduct by a patient. Of the PRFs, 97% contained three or fewer of the nine possible criteria that were evaluated.

The service provider and the HCPs who were on the scene could be held liable if any such cases result in a claim of misconduct resulting from possible related adverse events. Insufficient evidence was recorded to show that the correct procedure was followed in allowing the patient to make an informed decision.

The PRF assessment method did not allow for a detailed analysis of the ability of the patient to understand the discussion and thereby make an informed decision.

This could be the focus of future qualitative studies in which the patient is interviewed.

The high incidence of refusal of transport in cases of assault and motor vehicle accidents (MVAs) could be explained by the patients feeling that their injuries did not warrant transport and evaluation by an emergency department doctor. A study of the incidence of refusal of transport among head-injured patients found that

young adult male patients were more likely to refuse transport.[8] Patients might underestimate their current condition owing to their situational physiological and psychological stress.

To counter this situation, the assessment by the emergency care practitioner should be sufficiently detailed to ensure that possible delayed adverse events can be predicted or that consequences are minimal or excluded.

Follow-up instruc­tions should be provided to the patient regarding warning signs and symptoms of deterioration for possible emergent conditions, and instructions on how and when to access further medical care.[9] This study revealed that the highest percentage of refusals occurred during the night. Considering the socioeconomic status of the population for whom the EMS station caters, this finding could be related to the lack of public transport to return home. Despite hospital evaluation and management being completed within a reasonable period, the patient may still be unable to obtain transport home after discharge until the next morning. Possibly confounding and exacerbating this situation might be the impact of the cold and rainy conditions during the study period.

Society may also utilise EMS response as a ‘safety net’ as it is available at all times.[10] Refusal of medical transport might be related to the cost of transport,[11] although in SA costs are usually waived for indigent patients.

Another possibility could be that patients use the ambulance service for a free mobile medical consultation while not considering acceptance of transport as a possibility.

The stratification phase of the analysis shows no major variation in the quality of PRF completion. This indicates that despite improved medical knowledge, there seems

to be no significant improvement in the knowledge and application of medical law and ethics pertaining to prehospital medicine. Studies showed that improved knowledge of the HCP could decrease the number of refusal cases[12,13] and were based on a system using consultation with physician-manned, on-line medical command. A confounding factor to consider is that this study assigned the PRF to the qualification level based on the highestqualified member of crew on the vehicle.

The HCPs with the highest qualification might not necessarily have completed the documentation process, although they would still ultimately be responsible for its quality.

Study limitations To ensure that the patient’s right to an informed refusal of transport has not been violated, the documentation does not necessarily reflect that the patient under­stood the discussion. In SA, with 11 official languages, the language barrier that might exist between the patient and the healthcare provider could often lead to information relayed by the practitioner not being understood by the patient. This would therefore still infringe the patient’s right to informed decision making. The present study did not assess the use of an interpreter. Service providers each have variations of PCRF documentation that may require other levels of detail and include specific refusal- of-transport sections for added guidance to the HCP at the scene.

Therefore the results of this study cannot be generalised to the overall population of HCPs within all EMS services.

Conclusion We found that the refusal of transport process and its documentation are poorly understood and practised by prehospital HCPs. The implication is that some patients’ rights might potentially be infringed, which could lead to possible grounds for litigation, for which the defence would also hinge on the adequacy of the documentation.

The implementation of a standardised refusal-of-transport document and addi­ tional training in medical law and ethics is advisable to correct the current practices and to limit future risks to the patient and the HCP and/or service provider.

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ARTICLE References 1. Levy F, Mareiniss D, Iacovelli C. The importance of a proper against-medicaladvice (AMA) discharge: How signing out AMA may create significant liability protection for providers. J Emerg Med 2012;43(3):516-520. [http://dx.doi. org/10.1016/j.jemermed.2011.05.030] 2. Queensland Ambulance Service. Clinical Practice Manual. Brisbane: Queensland Government, 2011. https://ambulance.qld.gov.au/docs/cpm_introduction.pdf (accessed 12 October 2013).

3. Health Professions Council of South Africa. Guidelines for Good Practice in the Health Care Professions. Pretoria: HPCSA, 2008.

4. Republic of South Africa. Constitution of the Republic of South Africa, Act No. 108 Government Gazette 1996.

5. Oosthuizen H, Verschoor T. Ethical principles becoming statutory requirements.

SA Fam Prac 2008;50(5):36-40. [http://dx.doi.org/10.1080/20786204.2008.10873 757] 6. Republic of South Africa. National Health Act, No. 61 of 2003. Government Gazette, 2005.

7. Monaco E. ‘Against Medical Advice’ in the ED: Where are we in 2009. ED Legal Letter 2009;20(6):61-65.

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8. Shah MN, Bazarian JJ, Mattingly AM, Davis EA, Schneider SM. Patients with head injuries refusing emergency medical services transport. Brain Inj 2004;18(8):765773. [http://dx.doi.org/10.1080/02699050410001671801] 9. Liametz A. Patients who leave AMA: Understand your risks and responsibilities.

ED Legal Letter 2009;20(11):121-129.

10. Brown JF. Ethics, Emergency medical services, and patient rights: System and patient considerations. Adv Emerg Nurs J 1999;21(1):49-47. [http://dx.doi. org/10.1177/0969733006069694] 11. Pringle RP Jr, Carden DL, Xiao F, Graham DD Jr. Outcomes of patients not transported after calling 911. J Emerg Med 2005;28(4):449-454. [http://dx.doi. org/10.1016/j.jemermed.2004.11.025] 12. Hoyt BT, Norton RL. Online medical control and initial refusal of care: Does it help to talk with the patient? Acad Emerg Med 2001; 8(7):725-730. [http://dx.doi. org/10.1111/j.1553-2712.2001.tb00192.x] 13. Stuhlmiller DFE, Cudnik MT, Sundheim SM, Threlkeld MS, Collins TE Jr. Adequacy of online medical command and emergency medical services documentation of informed refusals. Acad Emerg Med 2005; 12(10):970-977. [http://dx.doi. org/10.1197/j.aem.2005.06.004]

ARTICLE

Can private obstetric care be saved in South Africa?

G Howarth,1 MB ChB, MMed (O&G), MPhil (Bioethics); P Carstens,2 BLC LLB, LLD Head of Medical Services: Africa, Medical Protection Society, and part-time lecturer Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 2 Associate member of the Pretoria Bar; Head of the Department of Public Law and Professor of Medical Law, University of Pretoria, South Africa 1

Corresponding author: G Howarth (graham.howarth@mps.org.uk)

This article examines the question of whether private obstetric care in South Africa (SA) can be saved in view of the escalation in medical and legal costs brought about by a dramatic increase in medical negligence litigation. This question is assessed with reference to applicable medical and legal approaches. The crux of the matter is essentially a question of affordability. From a medical perspective, it seems that the English system (as articulated by the Royal College of Obstetricians and Gynaecologists) as well as American perspectives may be well suited to the SA situation. Legal approaches are assessed in the context of the applicable medicolegal framework in SA, the present nature of damages and compensation with reference to obstetric negligence liability, as well as alternative options (no-fault and capping of damages) to the present system based on fault. It is argued, depending on constitutional considerations, that a system of damages caps for noneconomic damages seems to be the most appropriate and legally less invasive system in conjunction with the establishment of a state excess insurance fund.

S Afr J BL 2014:7(2)69-73. DOI:10.7196/SAJBL.319

The sustainability of private obstetric care will soon be under threat. Claims inflation leads to increasing indemnity costs, which means that private obstetric in­ demnity cover will probably be unaffordable by the end of the decade. This not only has serious consequences for private obstetricians and private parturients of the future, but there are also serious public health sequelae. As obstetrics is the vanguard of the threat we are concentrating on private[1] obstetrics, but private neurosurgery and spinal surgery face similar imminent threats.[1] Invariably there is an unhappy story behind every case of litiga­ tion involving obstetric care where a child has been compromised.

As these children now often survive, and then live longer as a result of sophisticated expensive care, obstetric claims are inevitably extremely high value and run into millions of rands. While an individual obstetrician may be at relatively low risk of having a claim of the magnitude of an obstetric claim, the claim’s value can be so high that a single individual could not afford to compensate a deserving claimant. The financial risk has to be transferred to an insurer or shared by a not-for-profit indemnifier.

Those accepting the financial risk of obstetric claims require sufficient reserves to meet future administrative and claims costs.

Insurers are already avoiding the market and, as a result of claims inflation, not-for-profit indemnifiers are becoming progressively unaffordable as their subscription rates reflect actuarially calculated obstetric risk. Based on the claims inflation and subsequent subscription inflation, there are concerns that indemnity for obstetric risk will be unaffordable by the end of the decade.[2] Obstetricians who are not indemnified would be poorly advised to continue practising obstetrics. A single case would leave them financially ruined, and a deserving patient would be inadequately compensated. Additionally they may be precluded from practising by regulation or by the private hospital where they deliver – it is unlikely

that private hospital groups would knowingly allow an obstetrician who is not indemnified to deliver at their facility.

Patients will continue to fall pregnant and require delivery. If they cannot deliver in private facilities, they will have to deliver in state facilities. This will increase the workload of already heavily burdened state facilities by an additional 10% nationally, but inevitably more in the urban areas where private patients tend to reside, which already act as referral centres for rural state patients. Not only will the increased workload shift across to state facilities, but the obstetric liability will move from private care to the state. Already overburdened facilities will have to cope with patients who expect private healthcare and the system will be placed under even more stress – probably increasing the litigation burden on the state.[3] Who are the potential losers here? Private patients are unlikely to be endeared by the prospect of delivering in state facilities. Private obstetricians’ income may fall. Already busy state facilities will be placed under increased strain, and this burden will be disproportionately placed on units that already accept referrals from urban areas. State patients will be inconvenienced; their labour wards will become busier with an influx of demanding patients. There is likely to be an increased litigation burden that will further disadvantage state patients, as the state does not budget independently for litigation and every rand spent out of the health budget is a rand no longer available for healthcare or to improve facilities. Private patients, private providers, public patients, public providers, policymakers and politicians all have a vested interest in resolving the problem.

Medical approaches The intuitive response from the medical profession is to blame and vilify lawyers. Lawyers will rightfully argue that obstetricians are responsible for the predicament in which they find themselves. There is either a problem with the care offered by individual obstetricians, or

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ARTICLE there is a problem with the system rendering the care. In reality, a relatively small number of repeated errors lead to most preventable adverse outcomes.

The model of private intrapartum obstetric care delivery has been described previously and consists of remote obstetricians reliant upon the expertise of labour ward staff of varying qualification and quality.[1] While the obstetrician is ultimately responsible for the patient, the obstetrician being remote precludes the model from being considered a consultant-led service as described by the Royal College of Obstetricians and Gynaecologists (RCOG). Although midwives may be pri­ marily responsible for the labouring patient’s admission and first-stage care, the model is also not that of a midwife obstetric unit.

The system is vulnerable; medical involve­ ment is remote, nursing care is of varying qualification and quality, and there is no uniformity of process.[4] Liability is complicated by the fact that obstetricians are independently indemnified while the employer of the labour ward staff is vicariously liable for their acts or omissions. Indeed, the high caesarean section rate, justified as a response to increasing litigation, is perhaps an acknowledgement of the frailties of the current system.

The English system as advocated by the RCOG, using both qualified midwives and doctors, including consultants, in the labour ward, will be well understood by virtually all medical and nursing staff. It is the system that is utilised, to a greater or lesser extent, in the training of undergraduate and postgra­ duate medical and midwifery personnel in South Africa (SA). Regulatory changes and an appetite by private hospital groups to adopt the model would be necessary to implement any system compatible with RCOG recommendations.[5] Labour ward doctors, including obstetricians, would no longer be independent contractors but private hospital employees. Understandably this approach may not be appealing to many obstetricians currently in private practice.[6] An approach utilised by the largest private obstetric healthcare provider in America may be more applicable to private practice in SA. The Hospital Corporation of America does not employ doctors and may be the most appealing approach both to SA obstetricians and SA private hospital groups. Since the inception of the programme there has been an improvement in outcomes, a dramatic decline

70

in litigation claims, and a reduction in the primary caesarean section rate. Importantly the approach has been amenable to expansion beyond the initial pilot and sustainable.

Claims frequency continues to fall despite an increasing claims frequency nationally.[7] The basic principles and subsequent addi­ tions are set out in Table 1. The approach utilises well-described risk management tools.[8] When confronted with so many interventions, it is difficult to identify the interventions most likely to have made a significant difference.

It is interesting to note that a relatively small number of repeated errors lead to most preventable adverse outcomes. Uniformity of process and clearly defined unambiguous practice guidelines would assist in decreasing the number of repeated errors.[9] Perhaps two points are particularly salient.

Firstly, if the current care system cannot do the job, then trying harder will not make it work; changing the system of care will. Secondly, the changes could not be coerced and were dependent upon pure leadership.[10] An organisation, perhaps either private hospital groups or the South African Society of Obstetricians and Gynaecologists (SASOG), would to have to take the leadership role.[11] While changes to the medical system may alleviate the problem, these changes would take a considerable time to implement and it would be even longer before the benefits would be such that they would influence subscription rates. Even the American model considers the possibility of 24-hour labour ward obstetricians. One very quick solution would be for the private hospital groups to

November 2014, Vol. 7, No. 2 SAJBL

employ obstetricians and implement either another or the English or American models described.[12] As employers the hospital groups would be vicariously liable for the acts or omissions of their employees – the obstetricians. Instead of transferring obstetric liability to the state, it could be transferred to the private hospital groups.

Legal approaches

The medicolegal framework Any legal assessment of the posed title of this article should be approached with refer­ ence to the guiding medicolegal framework consisting of the supreme Constitution of the Republic of South Africa,[13] the common law, the applicable healthcare legislation, and consideration of applicable medical ethics.[14] Any solution to the posed title, viewed from a legal standpoint, will have to resonate in the legal framework in the context of legal compliance. It is also evident that complex health problems (as the present topic under discussion) have remained largely unsolved in the 21st century and are indicative of conflicts between public interests and individual rights as part of evolving health crises in many countries (including SA).

The regulation of healthcare practitioners, the determination of liability for clinical negligence and the issue of funding and costs pose specific challenges. It is to be noted that without adequate funding there can be no access to justice for the victims of clinical medical negligence. Funding and costs (inclusive of compensation) go handin-hand as together they determine the

Table 1 Principles and additional points of the redesigned system • Uniform process and procedure.

• Every member of the obstetric team should be required to halt any process that is deemed to be dangerous.

• Caesarean delivery is best viewed as a process alternative, not a source of outcome or a quality endpoint.

• Malpractice is best avoided by reduction in adverse outcomes and the development of unambiguous practice guidelines.

• Effective peer review is essential to quality medical practice.

• Expansion of online provider education/communication programme.

• Ongoing process standardisation.

• Development of national quality metrics.

• Elective early term delivery.

• Prevention of post caesarean venous thromboembolism.

• Perinatal/neonatal collaboration.

ARTICLE bigger picture – namely the financial context in which the specialist physician operates. This economic reality should also underpin the patient’s or health user’s right to healthcare in an integrated and accessible health system.[15] Interpreted as equal access to necessary healthcare facilities (private or public), the notion of access to care (in context, and including reproductive healthcare) raises various fundamental questions within the obstetrician-patient relationship. Clearly access to healthcare includes the absence of unjust discrimination in the rendering of obstetric care and begs the question of whether funding and costs (or capping or absence thereof ) will negatively impact on the level, quality and availability of obstetric services a patient would constitutionally and ethically be entitled to. Access to healthcare (reproductive healthcare) is therefore dependent on the quality assurance of obstetric care as amplified by proper funding and costs in cases where damages are claimed based on clinical obstetric negligence.

The present nature of damages and compensation in SA law: Liability and compensation based on fault In terms of the Law of Obligations (contract and delict), the same medi­ cal negligence may constitute both a breach of contract and delict.

Liability for medical negligence is firmly rooted in a system based on fault. Therefore a plaintiff-patient may rely on the breach of contract or alternatively on delict. Only pecuniary damages (patrimonial damages) may be recovered in contract, while pecuniary and non-pecuniary (non-patrimonial) damages may be recovered in delict. Recoverable pecuniary damages include medical costs (past as well as future), loss of income (past and future earnings), maintenance, etc. The ambit for recoverable non-pecuniary damages includes not only compensation for actual physical pain, but also shock, discomfort and mental suffering, disfigurement, loss of amenities of life and disability, and loss of expectation of life – called loss ‘for pain and suffering’.[16,17] It is also possible to claim for detectable psychiatric injury, provided that there was actual psychological injury caused by medical negligence and the psychological harm is significant.[18-20] The calculation of non-pecuniary damages is more often than not complex and controversial, and in this regard the courts are, in principle, guided by policy considerations and comparable precedent.[21,22] Provision is also made in the Apportionment of Damages Act[23] for instances of contributory negligence. In addition, SA law makes provision for a so-called ‘contingency fee’ conditionally allowed since 1999 in terms of the Contingency Fees Act.[24] Pivotal, however, is the rule which serves as the most powerful deterrent against medical negligence litigation, namely that the patient-plaintiff runs the risk that an order of costs will be made against him/her if the case fails. It is also to be noted that punitive damages (as known in the USA) are not awarded in cases of medical negligence in SA.[25] In addition, the advent of the Consumer Protection Act[26] (in the context of healthcare services) has also contributed to patients (as consumers) asserting their rights to compensation in an already litigious society, specifically in the context of obstetric negligence.[27,28]

Alternative options to the present system, based on fault Various options in response to systems, based on fault, have been postulated (inclusive of dispute resolution, the establishment of special medical negligence courts, adjudication by way of expert screening

panels, mediation,[29] periodical or staggered pay-outs[30] and defensive professional training).[31-33] In an attempt to curtail the meteoric rise in legal and insurance costs emanating from medical negligence litigation, it is specifically the implementation of a substantive nofault system and/or the statutory capping of compensation that have received considerable attention in some countries.[34] In addition, there is the radical option for government subsidisation by way of the establishment of a state excess insurance fund thereby providing victims of medical negligence a quid pro quo for the potential loss of complete compensation.[30] The focus of the discussion here will be on the no-fault system and the capping of damages as possible sustainable or substantive options for obstetric negligence in SA.

The no-fault option Medical no-fault schemes (where provision is made for compen­ sation for medical and other injuries independently of liability) were first introduced from the 1970s in the Nordic countries (Sweden 1975, Finland 1984, Norway 1988 and Denmark 1992) and as part of the comprehensive accident compensation scheme introduced in 1974 in New Zealand.[30,35,34] Birth injury no-fault compensation schemes were established in the 1980s in the US states of Florida and Virginia.[36,37] No-fault legislation was introduced in Austria in 2001 and a no-fault component was included in the new medical injury scheme in France in 2002, while Belgium followed suit in 2007 and Poland in 2011 (under the influence of the Swedish scheme). In Japan a new scheme was introduced in 2009 to deal with obstetric injury involving severe brain damage. An obstetric injury scheme, similar to that in Japan, was recommend for England and Wales in 2003, but was not carried through to the subsequent legislation.[37] The main arguments for no-fault compensation are considerations of fairness; speedier resolution of cases; lower administrative and legal costs than court action; the increased certainty for complainants on the circumstances in which compensation is payable and increased consistency between claimants; the reduced tension between clinicians and claimants; and the greater willingness by clinicians to report errors and adverse events.[38] Critics of no-fault compensation argue that overall costs will be higher than under a tort system; that it will open the floodgates to compensation payments and fuel a compensation culture; that disputes about causation remain, even if fault is removed; that disputes about the amount of damages remain, unless there is a tariff-based approach; that it is difficult to distinguish injury from the natural progression of the disease in some cases; that explanations and apologies are not necessarily provided in a system that focuses on financial recompense alone; and that a no-fault system, in itself, does not improve accountability or ensure learning from adverse effects.[38] However, Ken Oliphant, former director of the European Centre of Tort and Insurance Law in Vienna, Austria, correctly states that it seems that no-fault liability schemes are back on the reform agenda internationally, even if only a limited number of countries have actually implemented such schemes.[38,34]

The capping option Proponents of damages caps have argued that damages caps benefit consumers by reducing the rate of increase in health insurance.[39] Ultimately the question to be posed is whether victims of medical negligence are sufficiently compensated for the smaller amount of

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ARTICLE expected damages by a reduction in the cost of healthcare. Research indicates that damages caps are the most controversial aspect of medical negligence reform.[39] Central to the debate, emanating mostly from the USA, is the constitutionality of damages caps as policymakers expect liability insurers to give effect to the passage of caps by reducing premiums in response to their improved risk exposure and ability to predict their payouts.[39] The research of authors Kelly and Mello [40] indicates that in the USA there have been five major constitutional grounds for challenging medical liability for reform: • Damages caps have been challenged using the open-courts guarantee contained in many state constitutions.

• Damages caps have been said to violate the right to trial by jury.

• Damages caps have been perceived to violate both federal and state equal protection guarantees.

• Damages caps have been challenged using due process provision in federal and state laws.

• Damages caps are occasionally challenged in terms of the doctrine of the separation of powers.[30] It is specifically in the context of non-economic damages that legislative caps were introduced in a number of states in the USA (ranging from a total cap of a minimum of $250 000 to a maximum of $500 000, with courts in some states having the authority to increase the maximum cap to $1 million).[40] Although the constitutionality of damages caps in the USA has been successfully challenged in a minority of states,[41-43] comprehensive research[39] indicates that this issue has now largely been resolved in the sense that rigorous empirical analyses conducted since 1990 found that malpractice premiums, in principle, are lower in the presence of damages caps. However, the effects of damages caps on the practice of defensive medicine, the subsequent increase in the availability of doctors in certain locations and the cost of healthcare to consumers are less clear. Some researchers state that the evidence about damages caps’ effectiveness remains mixed and concerns about their equity implications persist.[40,44] The possible introduction of damages caps for medical negligence (in the context of private obstetric negligence) in SA will undoubtedly, by analogy to the experience in the USA, also face constitutional challenges, specifically with reference to the equality clause,[45] access to courts provisions,[46] and the doctrine of the separation of powers.[47] Taking the cue from the salient American law it may be stated that, traditionally, in terms of equal protection clause challenges, experience has taught that challenges in this regard arise as a result of so-called differential treatment of plaintiffs in medical negligence cases. The differentiation translates into pitting plaintiffs in a medical negligence action against plaintiffs in other personal injury cases (who can obtain full recovery) – in the words of author Gfell: ‘the equal protection argument against damages caps becomes fairly obvious: those who suffer the most severe injuries will go without full compensation for their non-economic damages, while those who suffer relatively minor injuries from other personal injury will be entitled to full recovery of non-economic damages’.[30] It is, however, to be noted that mere unequal treatment in terms of legislation is not per se unconstitutional. This will also be the case if section 36 (the limitation clause) of the SA Constitution is invoked and such limitation is reasonable and justifiable in an open and

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democratic society.[47] In terms of the access-to-courts provision in our Constitution (militating against a system of damages caps), it is trite law that all victims of medical negligence should have the right to have justifiable disputes settled by a court of law or, where appropriate, by another independent and impartial forum.[47,48]

Conclusion In our view, private obstetric care can be saved in SA – it remains a matter of affordability. It is to be noted that the issue is not about the merits of the medical negligence case (which will be served well by the current applicable substantive medical law), but rather about the quantum of damages, and more in particular non-economic damages to be awarded for obstetric negligence. One solution, in our opinion, from a medical approach, points to the importation of the English system advocated by the RCOG as discussed above.

From a legal approach, it is submitted that the only viable and substantive options, as indicated from international perspectives, are the establishment of a no-fault compensation system, or the introduction of a system of damages caps for non-economic damages only – both systems, as discussed, offer distinct advantages and disadvantages. The most recent comparative research pertaining to no-fault systems indicate that if no-fault is to displace liability systems based on fault, this should be accompanied by additional mechanisms to ensure the goals of prevention and accountability.

To date there is insufficient evidence to assess whether the steps taken in jurisdictions where no-fault systems were introduced (e.g.

New Zealand and the Scandinavian countries) have been effective, specifically with regard to the promotion of patient safety. On the other hand, however, there is no clear evidence that the substitution of a liability system with a no-fault system has had a detrimental effect on patient safety.[48] In the context of the question posed in this article, however, the economic realities and the unprecedented rise in obstetric negligence in SA, a considered system of damages caps for noneconomic damages (non-patrimonial damages) only, seems to be the more appropriate and legally the less invasive option. The adoption of such a limited system will still ensure access to the courts in terms of the substantive merits of the law pertaining to the case, but will undoubtedly curtail the quantum proceedings. In addition, this option may be further enhanced by government subsidisation by way of the establishment of a state excess insurance fund (or ‘top-up’ fund) which could cover any shortfall in compensation in deserving cases of obstetric negligence. It goes without saying that the introduction of a system of damages caps will have to withstand constitutional muster.

References 1. Howarth GR. The threat of litigation: Private obstetric care – quo vadis? South African Journal of Bioethics and Law 2011;4(2):85-88.

2. Malherbe J. Counting the cost: The consequence of increased medical malpractice litigation in South Africa. S Afr Med J 2013;103(2):83-84. [http:// dx.doi.org/10.7196/SAMJ.6457] 3. Bateman C. Medical negligence pay-outs soar by 132% – subs follow. S Afr Med J 2011;101(4):216-217.

4. Hoffman DN. The medical malpractice insurance crisis, again. Hastings Center Report 2005;35(2):15-19. [http://dx.doi.org/10.135/hcr.2005.0022] 5. Clark SL, Belfort MA, Byrum L, Meyers JA, Perlin JB. Improved outcomes, fewer cesarean deliveries, and reduced litigation: Results of a new paradigm in patient safety. Am J Obstet Gynecol 2008;199:105,e1-7. [http://dx.doi.org/10.1016/j.ajog.2008.02.031]

ARTICLE 6. Ransom SB, Studdert DM, Dombrowski MP, Mello MM, Brennan TA. Reduced medicolegal risk by compliance with obstetric clinical pathways: A casecontrolled study. Obstet Gynecol 2003;101(4):751-755. [http://dx.doi. org/10.1016/S0029-7844(02)03129-0] 7. Clark SL, Belfort MA, Dildy GA, Meyers JA. Reducing obstetric litigation through alterations in practice patterns. Obstet Gynecol 2008;112(6):1279-1283. [http:// dx.doi.org/10.1097?AOG.0b013e31818da2c7] 8. Howarth GR, Bown S, Whitehouse S. The importance of comprehensive protection in today’s healthcare environment. S Afr Med J 2013;103(7):453-454. [http://dx.doi.org/10.7196/SAMJ.7107] 9. Bateman C. Clumsy patient-friendly regulations could strip 25 000 of MPS cover.

S Afr Med J 2010;100(10):696-697.

10. Royal College of Obstetricians and Gynaecologists (RCOG). Safer Childbirth: Minimum Standards for the Organisation and Delivery of Care in Labour. London: RCOG, 2007.

11. RCOG. Standards for Maternity Care. Report of a Working Party. London: RCOG, June 2008.

12. RCOG. London. Labour Ward Solutions. Good Practice No. 10. London: RCOG, January 2010.

13. Republic of South Africa. Constitution of the Republic of South Africa.

Government Gazette 1996. www.gov.za/documents/constitution/1996/a108-96. pdf (accessed 13 March 2014).

14. Carstens PA, Pearmain D. Foundational Principles of South African Medical Law. 1st ed. Durban: LexisNexis, 2007;1-3:229.

15. Lewis C, Buchan A. Clinical Negligence. 7th ed. Haywards Heath: Bloomsbury, 2012:591-619.

16. Boberg P. The Law of Delict. 1st ed. Cape Town: Juta, 1984:516.

17. Coetzee L, Carstens P. Medical Malpractice and Compensation in South Africa.

Medical Malpractice in Global Perspective. Berlin: De Gruyter, 2013:397.

18. Accident Fund v Sauls 2002 (2) SA 55 (SCA).

19. Barnard v Santam 1999 (1) SA 202 (SCA).

20. Clinton-Parker v Administrator Transvaal 1996 (2) SA 37 (W).

21. Corbett MM, Honey DP. The Quantum of Damages in Bodily and Fatal Injury Cases. 1st ed. Cape Town: Juta, 2010.

22. Corbett MM, Buchanan JL, Gauntlett JJ. The Quantum of Damages in Bodily and Fatal Injury Cases. 3rd ed. Cape Town: Juta, 1985.

23. Republic of South Africa. Apportionment of Damages Act 34. Government Gazette 1956.

24. Republic of South Africa. Contingency Fees Act 66. Government Gazette 1997.

25. Collins v Administrator Cape 1995 (4) SA 73 (C).

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

27. Ntsele v MEC for Health Gauteng Provincial Government, unreported Case nr 2009/52394 dated 24 October 2012.

28. Carstens PA. Judicial recognition of the application of the maxim res ipsa loquitur to a case of medical negligence. Obiter 2013;34(2):348-358.

29. Mulcahy L. Can leopards change their spots? An evaluation of the role of lawyers in medical negligence mediation. Int J Legal Prof 2001;8(3):203-224. [http:// dx.doi.org/10.1080/09695950220141025] 30. Gfell KJ. The constitutional and economic implications of a national cap on noneconomic damages in medical malpractice actions. Ind L Rev 2004;37(3):775-809.

31. Strauss SA. Doctor, Patient and the Law. 3rd ed. Pretoria: Van Schaik, 1991.

32. Studdert DM, Mello MM, Sage WM, et al. Defensive medicine among high risk specialist physicians in a volatile malpractice environment. JAMA 2005;293(21):2609-2617 [http://dx.doi.org/10.1001/jama.293.21.2609] 33. Pepper MS, NĂśthling Slabbert M. Is South Africa on the verge of a medical malpractice litigation storm? South African Journal of Bioethics and Law 2011;4(1): 33.

34. Farrell A, Devaney S, Dar A. No-fault compensation schemes for medical injury: A Review: Interim Report (Scottish Government Social Research) 2010: 6-11.

35. Oliphant K. Medical malpractice and compensation: Comparative Observations in Medical Malpractice and Compensation in Global Perspective. Berlin: De Gruyter, 2013:522-523.

36. Siegal N, et al. Adjudicating severe birth injury claims in Florida and Virginia: The experience of a landmark experiment in personal injury compensation. Am J Law Med 2008;34(4):493-537.

37. National Health Service. Redress Act 2006, chapter 44. London, United Kingdom.

38. Stauch M, Wheat K. Texts, Cases and Materials on Medical Law and Ethics.

London: Routledge, 2012:293.

39. Nelson LJ, Morrisey MA, Kilgore ML. Damages caps in medical malpractice cases.

The Milbank Quarterly 2007;85(2):259-286.

40. Kelly C, Mello M. Are medical malpractice damages caps constitutional? An overview of state legislation. J Law Med Ethics 2005;33(3):515-527. [http://dx.doi. org/10.1111/j.1748-720X.2005.tb00515.x] 41. Moore v Mobile Infirmary Association 592 So 2d 156 (Alabama 1991).

42. Ferdon v Compensation Fund 701 NW 2d 444 (Wisconsin 2005).

43. Lebron v Golllieb Memorial Hospital No 2006 L 12109 (Illinois 2007).

44. Studdert DM, Mello MM, Brennan TA. Medical malpractice. N Engl J Med 2004 15;350(3):283-292 [http://dx.doi.org/10.1056/NEJMhpr035470] 45. Republic of South Africa. Constitution of the Republic of South Africa, Section 9, Government Gazette 1996.

46. Republic of South Africa. Constitution of the Republic of South Africa, Section 34, Government Gazette 1996.

47. Currie I, de Waal J. The bill of rights handbook. 5th ed. Cape Town, Juta, 2005: 229, 703.

48. Bernstein v Bester NO 1996 (2) SA 751 (CC) para 105.

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73

OPINION

The battle against stem cell hype: Are we doing enough?

Can the medical and scientific community do more to support regulatory boards in advocating ethical evidence-based medicine?

R J Burman Fourth-year medical student, University of Cape Town, South Africa Corresponding author: R J Burman (burman.richard@gmail.com)

This article highlights the current controversies around stem cell research and its application in clinical medicine. It aims to discuss the ethical concerns around how corporate involvement is corrupting the ethical progression in this field of research. The author appeals to medical and scientific communities to take cognisance of current practices and to facilitate the regulation of new stem cell therapies being advertised to the public.

S Afr J BL 2014:7(2)74-75. DOI:10.7196/SAJBL.318

It is human nature to believe in hope and the possibility of a better outcome no matter what the circumstances. In many degenerative disorders, the affected persons are desperately seeking such hope to bring them the strength to face their lifelong suffering.

This desire has led many to view the ‘new’ stem cell therapies as the solution, with the conviction of their beliefs often blinding them to accepting the limitations. The vulnerability of these patients is totally understood, acknowledged and accepted by the broader medical community. Yet, in spite of this realisation, some medical scientists and doctors have adopted a more entrepreneurial approach, seeking profit from this established business opportunity.[1] The focus of this article is on the continuation of caution regarding the stem cell hype.[2-5] Its purpose is to highlight the current ethical controversies around the way in which the corporate mindset is corrupting sound and ethical science. This topic of discussion needs refreshing so that all may be reminded of how past bad practices sometimes still prevail today.

Before dealing with the stem cell controversy directly, it may be important to review how global medicine has reached the point whereby corporate interest is manipulating proper scientific rigour.

The concept of translational research has come to the forefront where there remains a desperate need to transform scientific discovery into clinical results; thereby bridging the so-called ‘valley of death’ between basic bench research and appropriate clinical application.[6] The idea of translational medicine is not without its own flaws, and in his published appeal in the prestigious journal Nature, Prof.

P Bianco from the University of Rome (2013) cautions the scientific community to address these shortcomings.[7] The most pertinent of such limitations is undoubtedly the length of time needed to complete the ‘translation’ process. Biotechnology companies have

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therefore opted to do ‘translational medicine in reverse’,[7] with corporate interest advertising as the expected benefit of therapies before conclusive scientific evidence can be found to support them, giving an inaccurate impression of current scientific understanding.[8] This is not an unfamiliar ploy, as over the years the pharmaceutical industry has led the way in shaping unethical, profit-orientated medical science in pursuit of its own benefit.[9] In recent times, the baton has been passed to the various private companies offering ‘revolutionary’ therapies, with stem cell research being one of the more publicised examples of such hype v hope controversies.[10] The past decade has seen both the media and the medical world broadcast the unfolding of the stem cell saga. Some preach its wonder, while others desperately try to instil reality and caution. Even though stem cell research has evolved significantly, crossing vast technological and ethical barriers, it is well known that such therapy is largely unproven and still a long way away from clinical trials. There therefore remains a need to distinguish the ‘should I’ from the ‘can I’ approach, as introduced by Liao.[11] With the ever-multiplying number of stem cell therapy distributors – or ‘hope providers’ – rushing into the market around the globe, medical control boards have recently been put under pressure to implement some form of regulation. While embarking on their quest to purge unethical practice, their greatest opponent is not the providers of the services but their customers.

It would appear that the public are refusing to take note and accusing the regulatory boards of withholding potentially ‘lifechanging’ therapies that they believe they are entitled to. Cyranoski’s[1] article in Nature, entitled ‘Stem cells in Texas: Cowboy culture’ depicts such a battle between the Food and Drug Administration (FDA) and the ‘revolutionary’ company Celltex, which has left many of the Texas population starting to question the motives of the FDA, which is mandated to protect them.

OPINION Referring back to the original ethical controversies around stem cell research prior to the induced pluripotent stem cell era,[4] it is interesting to observe the initial reaction of the public to the introduction of such technology. There was a huge uproar when the harvesting of embryonic stem cells was announced, and many voiced their moral objections and interrogated the ethical reasoning behind this technology. Where has such passion for ethical consideration gone? In the light of what is currently happening, it appears that bioethics has fallen to its knees in the face of corporate investment, with many of the medical community bowing in submission to this allure – a distressing reality.

These points inevitably lead to the question of whether the medical and scientific community is doing enough to support regulatory boards in upholding ethical, evidence-based medicine.

The consequences of involvement in this ethically cavalier behaviour do not provide the necessary disincentive. It may now be the time to instil harsher punishments to ensure that medical ‘cowboys’ are held accountable for ‘playing with’ the idea of stem cell therapy without prior experience or qualification. After all, is it not within the Consumer Protection Act in South Africa (SA) that companies provide approved and truthful services?

There is no doubt that a novel regulation system needs to be implemented to help control corporate involvement in science before things proceed further down the path of ethical neglect.

Many scientists in SA are probably familiar with the life science and diagnostic activity monitoring initiative proposed by the Academy of Science of South Africa (ASSAf ).[12] Such a notion has the potential to identify and ‘police’ scientifically unjust diagnostic and therapeutic services before they are advertised via the media.

This may provide a much-needed solution to current stem cell abuse and could initiate further advances in the regulation of these therapies in SA. The public looks to medical scientists and healthcare workers in the belief that as professionals, they have profound competency

in their calling. Although some may abuse this in pursuit of fame, fortune and excessive financial gain, it remains the duty of the remainder to fight the good fight.

Acknowledgments. Thanks are given to Prof. Jacquie Greenberg and Emeritus Prof. Peter Beighton from the Division of Human Genetics, University of Cape Town, for their contribution to the preparation of this article.

References 1. Cyranoski D. Stem cells in Texas: Cowboy culture. Nature 2013;494(7436):166168. [http://dx.doi.org/10.1038/494166a] 2. Pepper MS. Cell-based therapy – navigating troubled waters. S Afr Med J 2010;100(5):286-288. [http://dx.doi.org/10.7196/samj.4131] 3. Kidson SH. Stem cell transplantation – a collegial conversation. S Afr Med J 2013;103(1):8-9. [http://dx.doi.org/10.7196/SAMJ.6598] 4. Ballo R, Greenberg LJ, Kidson SH. A new class of stem cells in South Africa: iPS cells. S Afr Med J 2013;103(1):16-17. [http://dx.doi.org/10.7196/samj.6604] 5. Willyard C. Stem cells: A time to heal. Nature 2013;503(7475):S4-6. [http://dx.doi. org/10.1038/503S4a] 6. Roberts SF, Fischhoff MA, Sakowski SA, et al. Perspective: Transforming science into medicine. How clinician-scientists can build bridges across research’s ‘valley of death’. Acad Med 2012;87(3):266-270. [http://dx.doi.org/10.1097/ ACM.0b013e3182446fa3] 7. Bianco P. Don’t market stem-cell products ahead of proof. Nature 2013;499(7458):255. [http://dx.doi.org/10.1038/499255a] 8. Jacobs BM. Stemming the hype: What can we learn from iPSC models of Parkinson’s disease and how can we learn it? J Parkinsons Dis 2014;4(1):15-27. [http://dx.doi.org/10.3233/JPD-130268] 9. Beil L. Stem cell treatments overtake science. New York Times, 2013. http://www. nytimes.com/2013/09/10/health/stem-cell-treatments-overtake-science.html?_ r=0 (accessed 2 March 2014).

10. Sismondo S. Ghost management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med 2007;4(9):14291433. [http://dx.doi.org/10.1371/journal.pmed.0040286] 11. Liao J. Should I recommend stem cell therapy to my patients with vision loss?

Presented at the 39th Annual Neuro-Ophthalmology Society North America (NANOS) Meeting, 9-14 February 2013. http://content.lib.utah.edu/utils/getfile/ collection/ehsl-nam/id/4413/filename/4489.pdf (accessed 18 July 2013).

12. Bezuidenhout L, Gould C, Farrant J. Academy of Science of South Africa launches a mapping survey of life science research and diagnostic activity in South Africa.

S Afr Med J 2013;103(7):437. [http://dx.doi.org/10.7196/samj.7025]

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OPINION

The war in Gaza: A humanitarian crisis M A Sathar Dr Mahomed Aslam Sathar is an independent medical scientist and bioethicist, and a member of the Medical Rights Advocacy Network (MERAN). There is no conflict of interest. The author is not sponsored by any private enterprise. The opinions expressed are those of the author, and where they are not, they are referenced. Dr Sathar is the author of the book Human Biological Materials in Collaborative Research-Ethical Issues.

Corresponding author: M A Sathar (aslamsathar@ymail.com)

Justice, sovereignty and self-determination for all human beings are fundamental foundations for healthcare and human rights. In any civilised society, the balance between medical ethics and human rights is critical for the delivery of healthcare. War is a deeply ethical issue.

Combatants, whose violations of international conventions, laws and codes of ethics during war and political conflict are detrimental to civilian non-combatants, including healthcare workers, commit crimes against humanity. The war in Gaza is a humanitarian crisis.

S Afr J BL 2014;7(2)76-77. DOI:10.7196/SAJBL.356

‘War is the continuation of policy (governance) by other means (violence instead of peace).’

(Carl von Clausewitz)

After the murder of Stephen Bantu Biko, the iconic dissenting voice of the South African (SA) liberation struggle, in which apartheid medicine was complicit, SA academics and healthcare professionals vowed never to remain silent when such human rights abuses are committed not only against our fellow countrymen and women but against humanity at large.[1] It is painfully difficult to write something about the war in Gaza, for no matter what I say, it will be denounced by one side or the other. However, to remain silent would suggest support for the violation of international law. While most medical journals, including those in SA, have not commented on the war in Gaza, a prestigious medical journal, The Lancet, bravely published a commentary on the war.[2] The publication elicited several responses from academics, clinicians and ethicists, some of whom expressed sympathies with the Palestinians,[3,4] while others were openly personal and defamatory, accusing the authors and the editors of bigotry and of being biased, political, anti-Semitic, unscientific, unprofessional, etc.[5-8] In response, the journal defended its editorial policy and declared that: ‘It is surely the duty of doctors to have informed views, even strong views, about these matters; to give a voice to those who have no voice; and to invite society to address the actions and injustices that have led to this conflict. Our responsibility is to promote an open and diverse discussion about the effects of the war on civilian health ... the role of the doctor is to protect, serve, and speak up for life. That, too, is the role of a medical journal.’[9] War zones are not easy places to collect statistics, because they are subject to change. After 50 days of conflict in Gaza, from a population of 1.8 million, 2 143 Palestinians were dead (including 577 children, 263 women and 102 elderly), 11 230 were injured, 10 800 buildings had been destroyed and 8 000 partially destroyed, 40 000 homes had been damaged, and more than 350 000 people had been displaced from their homes.[10-12] Among the buildings that were damaged

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were 277 schools, 11 hospitals, 14 clinics, 70 mosques, 2 churches and 10 hospitals.[10-12] On the Israeli side, there were 71 dead, among them 66 soldiers, 2 civilians and 1 child.[10-12] It is estimated that it will take decades to rebuild Gaza and its infrastructure. The war in Gaza is a humanitarian crisis.

Justice, sovereignty and self-determination for all humans are fundamental foundations for health and human rights. In any civilised society, the balance between medical ethics and human rights is critical for the delivery of healthcare. The killing of civilian non-combatants, impeding healthcare workers in their attempts to deliver care, interrupting and destroying civilian infrastructure such as hospitals and clinics, and deliberately targeting services that support healthcare, such as electricity and sanitation, is criminal and flagrantly illegal. These are in direct contravention of the Geneva and Hague conventions,[13] the Rome Statute,[14] occupational law,[15] and international and humanitarian law,[16] all of which assure protection and respect for civilians, non-combatants, healthcare personnel and healthcare facilities in occupied territories and conflict zones.

Combatants, whose violations of international conventions, laws and codes of ethics during war and political conflict are detrimental to civilian non-combatants, including healthcare workers, commit crimes against humanity.[13-16] At the Nuremberg Trials, the Nazis were tried for war crimes, for carrying out the intentional killing of civilians and for the destruction of civilian infrastructure. Likewise, the International Criminal Court (ICC) is obliged to investigate and prosecute all those who allegedly commit or are complicit in war crimes, irrespective of who they are, if the ICC wishes not to be seen as being ‘biased’ or ‘partisan’.[17] Medical journals often take sides on issues such as medical male circumcision, euthanasia, healthcare, etc. Why not war? Because war is a deeply ethical issue and not just a utilitarian calculus. The Lancet was brave, perhaps right, in inviting and encouraging comments on

OPINION the war in Gaza, while other medical journals may have been remiss, even cowardly, in ignoring it. Critical and untempered debate is a central pillar for academic discourse. It must be encouraged and continued without fear of academic reprisals and loss of scholarly autonomy, if we are serious about advancing human knowledge and improving the human condition.

‘If you are neutral (silent) in a situation of injustice, you have chosen the side of the oppressor ...’

(Archbishop Desmond Tutu, Nobel Peace Laureate)

References 1. Sathar MA, Govind U. Politics and ethics: Should the twain never meet? South African Journal of Bioethics and Law 2013;6(1):34-35. [http://dx.doi.org/10.7196/SAJBL.269] 2. Manduca P, Chalmers I, Summerfield D, et al. An open letter for the people in Gaza. Lancet 2014;384(9941):397-98. [http://dx.doi.org/10.1016/S01406736(14)61124-7] 3. Sousa C, Hagopian A, Stoller N, and 17 signatories. Israel-Gaza Conflict. Lancet 2014;384(9943);578-579 [http://dx.doi.org/10.1016/S0140-6736(14)6310-6] 4. Hind K. Israel-Gaza Conflict. Lancet 2014;389(9943):580. [http://dx.doi.org/10.1016/ S0140-6736(14)61312-X] 5. Qanta A, Avidan AY, Ciechanover A et al. Israel–Gaza conflict. Lancet 2014; 389(9943);580. [http://dx.doi.org/10.1016/S0140-6736(14)61312-X]

6. Eidelman L, Afek A. Israel–Gaza conflict. Lancet 2014;384(9944):e32-33. [http:// dx.doi.org/10.1016/S0140-6736(14)61313-1] 7. Leiba A, Pinkert M, Kreiss Y. Israel-Gaza Conflict. Lancet, 2014;384( 9943):578 [http: //dx. doi.org/10.1016/S0140-6736(14)61304-0] 8. Blachar Y. Israel-Gaza Conflict. Lancet 2014; 324(9943);579-580. [http://dx.doi. org/ 10.1016/ S0140-6736(14) 61310-6] 9. Editorial. Gaza: An urgent call to protect civilian life and health. Lancet 2014;384(9942):384-469 [http://dx.doi.org/10/1016/S0140.6736(14)61297-6] 10. Reuben A. Caution needed with Gaza casualty figures. BBC News Middle East. http://www.bbc.com/news/world-middle-east-28688179 (accessed 29 September 2014).

11. Avnery U. The War for Nothing. http://original.antiwar.Com/avnery/2014/08/29/ the-war-for-nothing/Antiwar.com (accessed 30 August 2014).

12. Solberg K. Gaza’s health and humanitarian crisis. Lancet 2014;7(384):389-390 [http://dx.doi.org/10.1016/S0140-6736(14) 61125-9] 13. The Geneva Conventions of 1949 and their additional protocols I and II of 1977. http://www.icrc.org/en/war-and-law/treaties-customary-law/en (accessed 10 September 2014).

14. The Rome Statute of the International Criminal Court. http://www.un.org/law/ icc/index.html (accessed 10 September 2014).

15. Occupation and International Humanitarian Law: Questions and Answers. http://www.icrc.org/eng/resources/documents/misc/634kfc.htm (accessed 10 September 2014).

16. War and International Humanitarian Law. International Committee of the Red Cross. http://www.icrc.org/en/war-and-law (accessed10 September 2014).

17. Bensouda F. Africa Question. Is the International Criminal Court (ICC) targeting Africa inappropriately? http://iccforum.com/africa (accessed 10 September 2014).

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LETTER

The ethics of claiming a 60% reduction in HIV acquisition from voluntary medical male circumcision To the Editor: Dr Masukume[1] recommends that we avoid using the relative risk reduction (RRR) statistic in counselling men on the benefits of voluntary medical male circumcision (VMMC). He makes the following important points that epidemiologists frequently em­phasise: RRR is a measure of association that is difficult for patients to understand and a different statistic, i.e. number needed to treat (NNT) (or in this case, number needed to prevent HIV infection), is often a preferable statistic to use when counselling patients about any medical intervention.[2] There is a good reason why RRR has historically been used as a shorthand in communicating the risks and benefits of medical interventions. The RRR is stable over wide variations in the risk of the population being studied, while the NNT varies widely with risk. For example, the three large randomised controlled trials of VMMC in Africa each showed a similar reduction in risk of HIV acquisition, but the NNT varied substantially according to the population studied (Table 1).

The advantage to using RRR, and the reason why it has historically been used, is because it is simple. RRR remains relatively constant; there is, therefore, ‘one number’ that we can quote when counselling patients. As we can see from Table1 below, there is not one number for RRR; rather, it varies widely depending on the baseline risk. HIV incidence rates vary substantially by country, over time, and even

more widely by community and demographic/risk characteristics of the individual patient. Therefore, we would ideally have to individualise the NNT for each patient. We might say that a 20-yearold single man with multiple sexual partners would be much more likely to benefit (a low NNT) than a 50-year-old married man from the same geographical area (a high NNT).

When communicating with patients, we try to keep things as simple and straightforward as possible. While the NNT does have well-recognised benefits over RRR, it is certainly hyperbole to call use of the RRR statistic ‘unethical’.

Peter S Millard Adjunct Professor, Graduate Programme in Public Health, University of New England, Maine, USA pmillard@mac.com References 1. Masukume G. The ethics of claiming a 60% reduction in HIV acquisition from voluntary medical male circumcision. South African Journal of Bioethics and Law 2014;7(1):4. [http://dx.doi.org/10.7196/sajbl.313] 2. Cook RJ, Sackett DL. The number needed to treat: A clinically useful measure of treatment effect. BMJ 1995(2);310:452-454. [http://dx.doi.org/10.1136/ bmj.310.6977.452]

Table 1: Study data Study location

HIV incidence in control group (%)

Relative risk reduction (%)

Number needed to prevent HIV infection

Kenya

4.2

53 - 60

40 - 47

Uganda

1.3

50

149

South Africa

2.1

60

80

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November 2014, Vol. 7, No. 2 SAJBL

LETTER

Health promotion is ethical To the Editor: We are responding to the article ‘Ethical issues in public health promotion’, which misrepresents health promotion.[1] Debate about health promotion ethics is important, as some practices may be coercive, e.g. using financial incentives to change behaviour.[2] However, the article does not sufficiently address the balance between individual and collective rights, nor does it differentiate between evidence- and profit-driven communications. These two points are essential for any exploration of health promotion.

Health promotion aims to improve population-level health, and not to limit individual autonomy by dictating lifestyles. The Ottawa Charter’s only individually focused health promotion pillar is about developing skills, such as helping a person distinguish between fact and fiction in the complex marketplace of health claims.[3] Another pillar promotes healthy public policies, and includes ‘coercive’ policies such as banning smoking in public places. However, Gardner[1] omits how policies are often informed by public participation (ano­ther health promotion pillar), such as movements to reduce exposure to second-hand smoke.[4] A smoker’s autonomy to smoke anywhere is contravened by policies that defend non-smokers’ right to a smokefree environment, with both evidence and popular support.

The article misconstrues how health promoters apply theory.

For individual behaviour change to benefit population health, we use theories to design interventions. From an efficacy perspective, theory-based interventions are superior.[5] However, theories are only tools to explore and explain how and why people think and act; people aren’t forced to follow theoretical constructs. If messages present the best evidence available, drawing on theory is not unethical. However, the ethics of shaping messages that are neither theoretically nor evidence-based is another story. Equating health promotion with marketing messages overlooks the evidence used for the former.

Health promotion uses evidence to inform ethical decisions. When individual rights are contradictory, the collective benefit is considered (see earlier smoking example). Industry regulation, such as limiting salt in bread, is an ethical act designed to reduce population-level hypertension costs while not infringing on an individual’s right to eat bread.[6] Gardner[1] suggests that a doctor’s advice to exercise infringes on a patient’s autonomy if it wasn’t solicited or causes embarrassment. On the contrary, enhancing patient health literacy is fulfilling the Hippocratic Oath. Withholding such evidence would allow marketers unfettered opportunities to mislead.

While unethical communication happens, e.g. omitting facts, this isn’t the status quo. True health promotion avoids making moral

judgements. Rather, it seeks to empower individuals to make choices that are empirically in their best interests. For instance, Soul City’s engagement with multiple concurrent partnerships in series 9 dramatised the issue without moralising. The series used medical evidence of increased HIV risk, linked to higher exposure, as well as inputs from community members.

To conclude, we encourage readers to revisit the principles of the Ottawa Charter. Not only is health promotion ethical, it promotes health equity and empowers individuals.

Sara Nieuwoudt Division of Social and Behaviour Change Communication, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa Sara.nieuwoudt@wits.ac.za

Dr Susan Goldstein Programme Director, Soul City: Institute for Health and Development Communication and Honorary Senior Lecturer, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa

Alex Myers Priority Cost Effective Lessons for Systems Strengthening, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa

Dr Nicola Christofides Coordinator, Masters of Public Health, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa

Prof. Karen Hofman Director, Priority Cost Effective Lessons for Systems Strengthening, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa

References 1. Gardner J. Ethical issues in public health promotion. South African Journal of Bioethics and Law 2014;7(1):30-33. [http://dx.doi.org/10.7196/sajbl.268] 2. Gneezy U, Meier S, Rey-Biel P. When and why incentives (don’t) work to modify behavior. J Environ Prot 2011;25(4):191-210. [http://dx.doi.org/10.1257/ jep.25.4.191] 3. World Health Organization. Ottawa Charter for Health Promotion. Ottawa: World Health Organization, 1986. http://www.who.int/healthpromotion/conferences/ previous/ottawa/en/ (accessed 12 March 2014).

4. Bayer R, Colgrove J. Science, politics, and ideology in the campaign against environmental tobacco smoke. Am J Public Health 2002;92(6):949-954. [http:// dx.doi.org/10.2105/AJPH.92.6.949] 5. Rimer B K, Glanz K. Theory at a glance: a guide for health promotion practice, 2nd ed.

Bethesda, Maryland: National Institutes of Health, National Cancer Institute, 2005. http://www.popline.org/node/276257 (accessed 15 July 2014).

6. Hofman K, Tollman S. Population health in South Africa: A view from the salt mines. Lancet Glob Health 2013;1(2):e66-e7. [http://dx.doi.org/10.1016/S2214109X(13)70019-6]

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FORUM

Quality healthcare: An attainable goal for all South Africans?

N P Moyakhe Nolonwabo Patronella Moyakhe is a sixth-year medical student in the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. This article is published as Nolonwabo won the University of Witwatersrand’s Ethics Alive MPS Undergraduate Bioethics essay competition for medical students sponsored by the Medical Protection Society.

Corresponding author: N P Moyakhe (nolomoyakhe@gmail.com) Our national Minister of Health, Dr Aaron Motsoaledi, described publicly the challenges facing our healthcare system and discussed the national and provincial measures that are being implemented to allow all South Africans to obtain quality healthcare. One would then certainly argue that the issue of quality healthcare has been debated to its ultimate exhaustion, but at what point do we begin to be silent about pertinent issues, especially those affecting the livelihood of a whole nation? This paper addresses many of the issues highlighted above; it attempts to define what quality healthcare is, in the South African context, and its relationship to the branch of bioethics. It cites current views on ethics and rights in healthcare and the role of individuals and healthcare professionals in improving the provision of healthcare in our country.

S Afr J BL 2014;7(2)80-83. DOI:107196/SAJBL.355

The issue of quality healthcare has been debated to its ultimate exhaustion and it has been deliberated beyond a conceivable alternative to its status quo. But at what point do we begin to be silent about pertinent issues, especially those affecting the livelihood of a whole nation? Is it safe to say that we should be completely resigned to the current state of our healthcare system and merely make do with the few resources available to us?

The question of quality of care raises critical ethical questions, for example, why has this nation seen such an unprecedented and rapid depreciation of the value of human life? And how can we as healthcare professionals assure that this deterioration is halted? Can our healthcare system begin to provide healthcare that is not only of quality but reflects the hard-earned gains of democracy that this still developing country has achieved?

This article addresses many of the issues highlighted above; it attempts to define what quality healthcare is, in the South African (SA) context, and its relationship to the branch of bioethics. It cites current views on ethics and rights in healthcare and the role that individuals and healthcare professionals should have and can have in improving the provision of healthcare in our country. Ultimately this article intends to remind the reader that, as utopian as it may sound, quality of healthcare should never be a privilege but a right.

‘I think it will help us to start sifting fact from fiction. Fact number one: We are a country, which is spending more money on health but having poorer outcomes – that is a fact.’

(Dr Aaron Motsoaledi, SA Minister of Health)[1]

yet our health outcomes are surpassed by other developing countries with significantly less of their GDPs dedicated to healthcare services.[2] Health indicators recommended by the WHO include life expectancy, child and maternal health and healthcare coverage. In many of these healthcare indicators, SA is ranked among the poorest-performing countries.[3] Dr Motsoaledi attributes these poor outcomes to a hospitalcentred approach, with a strong curative focus and fragmentation in management approaches. This may be related to programmes or service delivery and uncontrolled commercialism, which undermines principles of health as a public good. He goes on to further convey that, based on all these outlined factors, our country has a major problem of deteriorating quality of healthcare.[1] Government’s solution to halting this deterioration and revitalising our healthcare system is National Health Insurance (NHI). NHI is a financing system that will make sure that all citizens of SA (and legal long-term residents) are provided with essential healthcare, regardless of their employment status and ability to make a direct monetary contribution to the NHI Fund.[4] The government believes that the NHI will substantially improve the quality of healthcare in the following ways: • It will result in a radical improvement in the quality of services in public health facilities. This means massive investment in improvement of health infrastructure, both buildings and equipment.[4] • In every single health institution, certain basic core standards must be complied with; for this reason, the Office of Health Standards Compliance was established.

The quote above highlights the concern about the SA health system status quo and brings attention to a much contested topic in SA, that of quality of care. The World Health Organization (WHO) advises that countries should spend at least 5% of their gross domestic product (GDP) on healthcare.[2] SA spends more than the recommended percentage. As a country we dedicate 8.5% of our GDP to healthcare,

The formation of this office and the implementation of NHI is a very controversial subject in SA. It is commendable that our government acknowledges the deprived state of our current healthcare system and is introducing this new system to ensure the provision of quality healthcare. As compelling as this idea of change is, many fear that the same errors in management of resources will still be present

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FORUM and the poor will still be victims of inadequate healthcare. Will the formation of the Office of Health Standards Compliance be sufficient to supervise the management of resources and prevent a recurrence of past errors?

Change has to come, and if it comes in the form of NHI, may it not be an empty promise that has no effect on the lives of SA citizens, especially those who require change the most. With adequate planning, accurate organisation and constant monitoring, NHI can begin to equalise the level of healthcare provision in SA, so that even the poorest can benefit from our economic gains.

The SA reality In SA there are still entrenched disparities separating the rich from the poor. The level of healthcare that one receives is determined by one’s economic class. This goes against the grain of what is clearly outlined in our Constitution (section 10), which says ‘everyone has inherent dignity and the right to have their dignity respected and protected’.[5] I argue that dignity is not protected in healthcare if it is determined by one’s economic class. Drastic re-evaluation of our healthcare system should therefore be done, to ensure that the gap in the provision of healthcare between the rich and poor is narrowed, this will facilitate congruence between what is promised and what is actually delivered.

Quality healthcare can be described according to two principal dimensions: access and effectiveness.[6] When this principle is applied in the SA context, it provokes two critical questions. Are individuals able to access healthcare? And when they do access healthcare, is the clinical care and interpersonal care effective?[6] These two questions highlight the fact that quality healthcare has three main stakeholders: the government, health professionals and civil organisations.

The duty of the government is to provide healthcare resources.

The responsibilities of healthcare professionals are to provide quality clinical care and management. The role of civil society is to act as a watchdog on government and healthcare professionals. The level of quality healthcare can therefore be measured according to the effectiveness of these three stakeholders. Quality healthcare can therefore be assessed according to healthcare systems, processes of care and outcomes resulting from care.[6] Other criteria often used to assess quality care primarily revolve around patient outcomes, environmental factors and specific clinical-patient interactions.[7] Patient outcomes refer to mortality and morbidity after care. The provision of quality health services is proportional to low mortality and morbidity rates, indicating a high level of clinical management and adequate resources or supplies available.

Environmental factors refer to the structural factors that are often fixed aspects of health delivery, including building infrastructure and modifiable factors such clean and safe wards. Nosocomial infections often occur in a setting of poor sanitation and inadequate infection control, usually because of non-modifiable conditions, such as improving staff hygiene practices.[7] The efficacy of our healthcare system is deeply rooted in the joint efforts of government and healthcare professionals and civil societies.

Each of these stakeholders has duties that they must follow to allow future generations to have equal provision of services. As a country, we must work towards a point where a child born in a remote village in the Eastern Cape has equal and quality opportunities to live and thrive as one that is born in any opulent suburb in SA.

In order to improve and ensure that quality standards are upheld in the health system, the Office of Health Standards Compliance was established by the President on 24 July 2013. The office serves to protect and promote the health and safety of users of health services by monitoring and enforcing compliance by health establishments prescribed by the Minister in relation to the national health system.[8]

Intersection between quality care and bioethics principles The four ethical principles that should guide a healthcare professional in interacting with patients are autonomy linked to respect for persons, beneficence, non-maleficence and justice. One of the elements of autonomy is respect for persons.[8] Low or non-existence of quality of care erodes the principle of autonomy if a patient’s dignity is not observed. If a patient is recognised as a rational human being who thinks and has feelings worthy of respect, that person should not be given substandard care.

Aspects relating to respect for persons can be found in both inter­ national and national human rights instruments and codes.[8] Section 12(2) of the SA Constitution, emphasises that everyone (patients included in this instance) has the right to bodily and psychological integrity,[5] this highlights the significance of the patient’s ability to be actively involved in decisions, pertaining both their physical and mental healthcare.

Beneficence recognises the duty of healthcare professionals to do good for the patient.[8] This principle in summary emphasises the fact that health professionals should maximise good to the patient, in other words do as much as you can to improve the lot of your patients as a professional duty. It can be argued, therefore, that poor standards of care are maximising harm. The Constitution advocates for access to healthcare for all within available resources. This means that the state should and must provide resources and quality basic care to improve the lot of the people.[8] Non-maleficence recognises the duty of the health professional not to harm the patient.[8] The African Charter advocates for the prohibition of all forms of exploitation and degradation, including cruel, inhumane or degrading treatment.[8] The last pillar of ethical principles, justice, is arguably the most important as it deals with fairness and recognises the duty of the health professional to treat patients justly and fairly. It is recognised in the International Bill of Rights, Article 1 of which states that everyone is born free and equal and must not be faced with discrimination on any basis.[9] Partiality and injustice therefore have no role in healthcare provision in SA and are possible barriers to provision of quality healthcare to all citizens.

The Bill of Rights in the Constitution, Act 108 of 1996, section 24,[5] states that everyone has ‘the right to an environment that is not harmful to their health or well being’. This is a clarion call not to harm patients and to ensure quality of care.

Human rights are the rights we have by virtue of being a human being. They are defined by international human rights instruments and codes.[8] From the moment a child is born in SA and registered as a citizen of this country, they are entitled to the best social, economic and educational services that the country can provide. This statement is true whether a person is born in the lowest economic conditions or into affluence. This notion is further reverberated in our Constitution, which affirms equality regardless of racial or socioeconomic differ­ ences.[5] Healthcare is included in this concept of equality.

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FORUM Human rights are categorised into civil, political, economic, cultural and environmental rights.[8] Observing the rights of individuals therefore includes respecting all categories of their rights. They are, in most cases, universal and are interdependent of each other.[8] The link between these different classes of rights is illustrated by the fact that all the categories advocate for the provision for quality healthcare for all.

Political and civil rights promote the autonomy of the individual, indicating that the patient has a right not to be subjected to medical or scientific experimentation.[8] Economic and political rights advocate for all patients to have access to healthcare, regardless of the individual’s socioeconomic status.[8] The human rights paradigm in relation to ethical principles therefore provides a framework within which healthcare pro­ fessionals may begin to fight for health promotion and protection[8] of their patients. It is therefore critical that healthcare professionals understand the significance of human rights in the provision of quality healthcare.

Our hands and our knowledge are the main tools for the provision of healthcare. The government undeniably facilitates our daily duties by provision of resources, but at the end of the day, healthcare provision is determined by our level of commitment to our profession and our duties to the countless individuals who put their lives in our hands.

The patient’s role and responsibilities The role of the patient in ensuring that they receive quality healthcare is often greatly underestimated. We as health professionals often conclude that patients seeking medical assistance have no say in how they are managed. This notion should be reconsidered, because SA is currently in an era of legal freedom, where the average South African is fully aware of his or her rights and quick to act against medical negligence. The issue now is making patients understand that when entrusted with the right to free healthcare provision, they also have responsibilities.

As outlined in our Patients’ Rights Charter, patients’ responsibilities include: respecting the rights of other patients and health providers; complying with the prescribed treatment or rehabilitation procedures; and utilising the healthcare system properly and not abusing it.[10] It is important that patients keep their records safely to ensure seamless care, and more importantly that they do not abuse the health system, including health workers. These responsibilities will go a long way in ensuring quality of care.

The effect of patients practising these responsibilities is often not visible, but has a huge impact on the efficacy and quality of healthcare provided. For instance, we are often not aware of the huge expenses incurred when re-treating a defaulting patient, especially for chronic illnesses such as tuberculosis. The cost of re-treating one patient does not only result in monetary loss, but it literally means that less money is spent on treating other people in need. This will ultimately be a perpetual cycle that needs to be broken for the sake of the health of this country.

Conclusion • The WHO ranks South Africa among the poorest-performing countries in terms of healthcare indicators. These poor outcomes are directly linked to the quality of our healthcare. Many factors

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•

•

•

•

have been attributed to this deteriorating quality of healthcare, including national economic instability, poor service delivery and shortage of healthcare professionals.[11] NHI is a financing system that has been put in place to improve the current state of our healthcare system, and the Office of Health Standards Compliance has also been established by our government to ensure the success of the NHI. The implementation of the NHI is a step in the right direction to ensure that all South Africans receive quality healthcare.

In the interim, many South Africans are still lacking adequate healthcare, and the greater proportion of these individuals are those living in poverty. Access to quality healthcare in SA is currently determined by economic class, and this goes against international and national human rights laws, which affirm equality regardless of racial or socioeconomic differences.

To ensure accessibility of quality care to all South Africans, the role of the government, healthcare professionals and civil society must be clearly outlined, and each of these three entities must be aware of the international and national instruments and codes that guide them. This is particularly important in relation to healthcare professionals who use the human rights paradigm and ethical principles as a framework within which they may begin to fight for patient health promotion and protection.

It is my recommendation, therefore, that greater efforts should be made to banish continuing inequalities and imbalances. A significant and sustained difference in the current state of our healthcare system can only happen in the setting of united efforts of the government, health professionals and civil societies.[11]

As a country we have a vast and unfortunately long-standing history of social division and lines of separation. These lines have taken various forms as our country has evolved. They have stood as lines by race and lines by culture, and now we are seeing a barrier that is determined by economic class. I believe that it is a crime against human rights to allow people’s financial means to determine the level of healthcare provision they receive. If we, as a country, want to get to a point where quality healthcare is the norm, we need to level out these inequities and break down barriers to access healthcare.

The official national vision stated by our Department of Health is a brave declaration summarised in one statement: ‘A long and healthy life for all South Africans’.[4] The operative word in that statement is all; that one single word should direct our governmental policies and govern our resource allocation.

The current move towards a nationalised healthcare system is a step in the right direction, but much still needs to be done. The mere fact that there are still South Africans dying because of poor healthcare is an indication that we still have a great task ahead of us. As healthcare professionals we must always be conscious of the fact that in SA, the right to quality healthcare often directly equates to staying alive. There will never be grounds on which we can deny anyone the right to life.

Acknowledgements: Dr Norma Tsotsi, director of the undergraduate programme and lecturer at the Steve Biko Centre for Bioethics, University of the Witwatersrand, Johannesburg, South Africa, for her invaluable assistance in the publication of this paper.

FORUM References 1. Competition Law Conference. Keynote Speech for South African Minister of Health Aaron Motsoaledi. South Africa: Competition Law Conference. 6 September 2012. Updated in 2012. http://www.scribd.com/doc/105521872/ Keynote-Speech-for-South-African-Minister-of-Health-Aaron-Motsoaledi-at-theCompetition-Law-Conference-6-Sept-2012 (accessed 10 February 2014).

2. World Health Organization. Global Health Expenditure Atlas. Geneva: World Health Organization, 2010. http://www.who.int/nha/atlas.pdf (accessed 10 February 2014).

3. World Health Organization. World Health Statistics, Part III. Geneva: World Health Organization. Updated 2012. http://www.who.int/healthinfo/EN_WHS2012_ Part3.pdf (accessed 10 February 2014).

4. Republic of South Africa. Department of Health, National Health Insurance.

Updated 2014. http://www.health.gov.za/ (accessed 11 February 2014).

5. Republic of South Africa. Constitution of the Republic of South Africa. Government Gazette 1996. Updated 2014. www.gov.za/documents/constitution/1996/a10896.pdf (accessed 13 February 2014).

6. Campbell SM, Roland MO, Buetow SA. Defining quality of care.

Soc Sc Med 2000;51(11):1611-1625. [http://dx.doi.org/10.1016/S02779536(00)00057-5] 7. Cooperberg MR, Birkmeyer JD, Litwin MS. Defining high quality care. Urol Oncol 2009;27(4):411-416. [http:/dx.doi.org/:10.1016/j.urolonc.2009.01.015] 8. Dhai A, McQuoid-Mason D. Bioethics, Human Rights and Health Law Principles and Practice. Cape Town: Juta, 2011:35-47.

9. International Bill of Rights. Article 24. Updated 2014. www.ohchr.org/documents/ publications/compilation1.1en.pdf (accessed 13 Febraury 2014).

10. Republic of South Africa. Department of Justice, Patients’ Rights Charter. Updated 2007. http://www.justice.gov.za/vc/docs/policy/Patient%20Rights%20Charter. pdf (accessed 11 February 2014).

11. Hassim A, Heywood M, Berger J. Health and Democracy: A guide to human rights, health law and policy in post apartheid South Africa. Cape Town: Siber Ink, 2007: 2-25.

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BOOK REVIEW

Global Health Law

By Lawrence Gostin. Cambridge, USA: Harvard University Press, 2014. ISBN 978-0-674-72884-4 This book provides an excellent systematic account of global health law by: defining the field of global health law within the broader currents of global governance for health; systematically describing and analysing the major sources of law together with their institutional frameworks; and developing critical themes to guide global health in this century. Gostin sets the backdrop to this by starting off with personal stories from the daily lives of young people living in poverty.

The book is then divided into four parts.

Part 1 deals with ’failures in Global Health and Their Consequences‘.

It lays the foundation for the themes that permeate the book, i.e. health equity; global solidarity; health in all policies (HiAP); multiple regimens; good governance; health-promoting priorities; and the right to health. However, the main and recurring refrain throughout the book is that of global health with justice, in which all people live and work in conditions that allow them to lead healthy, productive lives. Part 1 is made up of three chapters. Chapter 1 deals with the most pressing and fundamental issues in global health, i.e. that of services universally guaranteed under the right to health; obligations of the state to safeguard the health of their populations; obligations of international players to contribute to improved health in lower-income countries; and the governance that would ensure that all states live up to their mutual responsibilities. The forces of globalisation and their impact on health are explored in chapter 2, and the boundaries between law and governance together with the categories of the major sources of global health law are described in chapter 3.

Part 2, through descriptive and normative discussion, focuses on the institutional structures that underpin global governance for

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health. Part 3 considers the role of international law in global health.

It systematically explores the interconnections between health and human rights. It also shows how the right to health could be more robust, paving the way for meaningful improvements in health and in health justice. It concludes with an examination of the relationship between trade and health and underscores the adverse health effects of trade liberalisation and the impact of neoliberalism and intellectual property protection on the weakening of health systems in the poorer south. The emphasis in part 4 is on global social justice and how to achieve it. Global health equity is explored through a series of case studies on prominent health threats of global significance that demand substantial public attention and action; and social, economic and political factors that have driven major reform. The book ends by asking some questions that are fundamental to achieving global health with justice. It asks what a state of genuine global health would look like, especially where this is embedded in a just world; and what it would take to achieve global health equity. It concludes by offering, as a recommendation, the Framework Convention on Global Health in which good governance, sustainable funding, research and development, and affordable access are all shown to be necessary components of global social justice in health.

The book, while highly scholarly and comprehensive, is written in easy-to-read and understandable language. It will be an invaluable resource to academics, practitioners, advocates in global health, policymakers and civil society organisations and is a must for health sciences and humanities faculties globally, and in particular in South Africa, as it resonates closely with our history and current struggle for access and equity in healthcare in an increasingly unequal society.

Ames Dhai (amaboo.dhai@wits.ac.za) Editor

CPD QUESTIONNAIRE

November 2014 True (A) or false (B): Regarding the Ebola crisis and ethical challenges in the African context: 1. The World Medical Association condemns the use of unproven interventions to treat patients infected with the Ebola virus.

2. 90% of research conducted globally is aimed at about 10% of the world’s privileged populations.

Regarding the termination of pregnancy of a brain-dead mother: 3. The Choice on Termination of Pregnancy Act defines a termination of pregnancy as the separation and expulsion, by medical or surgical means, of the contents of the uterus of a pregnant woman.

4. In South Africa, the dead lose all their legal rights.

Regarding Prof. McQuoid-Mason’s article: 5. The Constitution of South Africa defines brain death as ‘death’.

6. There is no clinical nor legal difference between brain death and a persistent vegetative state.

7. The law respects the living’s wishes on whether they want to donate their organs when they die.

Regarding article 6 of the UNESCO Universal Declaration of Bioethics and Human Rights: 8. The right and principle of individual informed consent arises from the right and ethical value of autonomy.

Regarding moral perspectives on covert research: 9. Arguments defending covert research are usually utilitarian in that risks are offset by the benefits that follow from the research.

10. Autonomy is generally not a pivotal value in morally legitimate research.

Regarding research ethics review committees in Kenya: 11.

Research participants involved in clinical trials in Africa sign informed consent documents and are therefore are not exploited.

Regarding medical legal documentation in cases where the patient refuses treatment and/or transport: 12.

Patients in South Africa are not afforded the right to refuse treatment.

Regarding whether private obstetric care can be saved in South Africa: 13. The high caesarean section rate in South Africa is justified as a response to increasing litigation.

14. Liability for medical negligence is firmly rooted in a system based on fault.

15. A single civil case could leave an unindemnified obstetrician finan­ cially ruined and a deserving patient inadequately compensated.

16. South African law makes provision for a ‘contingency fee’ in cases of litigation in terms of the Contingency Fees Act. Regarding whether quality healthcare is an attainable goal for all South Africans: 17. Child and maternal health are health indicators recommended by the World Health Organization.

18. The Office of Health Standards Compliance has been established to ensure that certain basic core standards must be complied with in health facilities.

19. The principle of beneficence recognises the duty of healthcare professionals not to harm the patient.

20. The principle of nonmaleficence recognises the duty of health professionals to benefit the patient.

A maximum of 5 CEUs will be awarded per correctly completed test.

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

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

Accreditation number: MDB001/019/01/2014 (Ethics)

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