SAJBL Vol 8, No 1 (2015)

ISSN 1999-7639

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW May 2015 Vol. 8 No. 1

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

SAJBL is published by the Health and Medical Publishing Group.

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW MAY 2015 Vol. 8 No. 1

CONTENTS

EDITORIAL 2 Medico-legal litigation: Balancing spiralling costs with fair compensation

A Dhai

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MoH ADDRESS Doctors call for lawyers to get out of hospitals Dr Aaron Motsoaledi

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LETTER TO THE EDITOR Correction to letter on VMMC by Professor Peter S Millard G Masukume

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FORUM Does withdrawing treatment from a pregnant persistent vegetative state patient resulting in her death constitute a termination of pregnancy D McQuoid-Mason

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ARTICLES Laws and regulations associated with ownership of human biological material in South Africa K P Mahesh

14 Things may not be as expected: Surprising findings when updating workload at the Wits Human Research Ethics Committee (Medical)

P Cleaton-Jones, E S Grosssman 22 Boni mores and consent for child research in South Africa

A E Strode, J Toohey, P Singh, C M Slack 26 Reflecting on BCMP students’ experiences of professionalism during clinical rotations

N Mapukata-Sondzaba, A Dhai 30 Is the seclusion policy of mental healthcare users a necessary evil?

G Chiba, U Subramaney 35 Youngest first? Why it is wrong to discriminate against the elderly in healthcare

C S Wareham 38

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 SCIENTIFIC EDITOR Ingrid Nye TECHNICAL EDITORS Emma Buchanan Paula van der Bijl CEO AND PUBLISHER Hannah Kikaya HEAD OF PUBLISHING Robert Arendse PRODUCTION MANAGER Emma Jane Couzens ART DIRECTOR Brent Meder DTP & DESIGN Carl Sampson HMPG BOARD OF DIRECTORS M Lukhele M Mbokota G Wolvaardt M R Abbas G Steyn H Kikaya M J Grootboom E L Mazwai Y Lemmer 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

CPD

The SAJBL is published by the Health and Medical Publishing Group (Pty) Ltd, Co registration 2004/0220 32/07, a subsidiary of SAMA. Suites 9 & 10, Lonsdale Building, Gardner Way, Pinelands, 7405 All letters and articles for publication must be submitted online at www.sajbl.org.za Tel. 072 635 9825 . E-mail: publishing@hmpg.co.za

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

SAJBL is published by the Health and Medical Publishing Group.

EDITORIAL

Medico-legal litigation: Balancing spiralling costs with fair compensation

Ames Dhai Editor amaboo.dhai@wits.ac.za A Medico Legal Summit was convened by the National Minister of Health, Dr Aaron Motsoaledi, on 9 and 10 March this year. In his keynote address (published in full on page xx), Dr Motsoaledi stated that the summit was long overdue. He expressed concerns, and rightfully so, that medico-legal litigation had reached a crisis of epic proportions in the country. It became clear as the summit unfolded over the two days that the triggers to litigation in the healthcare context are primarily two-fold: medical malpractice and/or professional negligence and patient safety reasons. While the private sector grapples largely with the former, the state sector healthcare facilities deal with a combination of both causes. This editorial discusses some of the causes and impact of increasing medical litigation, and considers possible interventions in this regard.

Intentional unlawful or negligent conduct by practitioners resulting in injury or damage to their patients or property leads to medical malpractice claims, e.g. intentional breach of a patient’s confidentiality.[1] Professional negligence stems from healthcare practitioners negligently failing to exercise the degree of skill and care of a reasonably skilled practitioner in his or her field of practice.

[2] It follows therefore that a specialist would be expected to effect a higher degree of skill as compared to a family practitioner and the more complicated the procedure undertaken, the greater the degree of skill and care necessary.[3] Hence competent management of patients is essential if valid claims of professional negligence are to be avoided.

Patient safety, on the other hand, can be defined very simply as ’… the prevention of errors and adverse effects to patients associated with health care’.[4] Hence, there should be the absence of preventable harm at healthcare facilities when managing patients there. Patient safety is a component of good quality healthcare services and understandably, this would contribute to improved health outcomes. Currently, globally, 10% of patients in healthcare facilities are harmed as a result of preventable errors or adverse events, 14% of patients suffer from hospital-acquired infections and between 20 and 40% of health spending is wasted because of poor quality of care and safety failures.[5] There are obviously additional

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costs associated with safety failures. Costs to patients include those to cover disability where this occurs, lost productivity and future medical expenses. Costs to the healthcare facility include those of treating infections, further hospitalisations and, of course, litigation.

The presentation from the office of the Chief Litigation Officer, Department of Justice and Constitutional Development at the summit, highlighted that the increasing litigation faced by the Department of Health was due to medico-legal claims, motor vehicle accidents, access to information, labour-related and human resource matters and non-compliance or poor compliance with court orders. It went on to describe the challenges faced by state attorneys in the management of litigation of medical negligence claims. These include lack of capacity at the office, shortage of skilled support staff, poor accountability, shortage of medico-legal specialists to advise the Department, inadequate and untimely instructions including those instructions to settle, late submission of medical records, difficulties with consulting with expert witnesses, budget constraints by state hospitals and opportunistic litigation. The total claim in terms of contingency liability at the level of this office is in the region of R25 billion (Presentation at the Medico Legal Summit from the Office of the Chief Litigation Officer, Department of Justice and Constitutional Development) While there is compelling argument to be made that contingency liability is a potent factor towards the spiralling costs of medical litigation, the reality is that it does respond to the principle of compensatory justice for poor and disenfranchised patients who have been harmed as a result of neglect or safety failures and cannot afford access to litigation.

With regard to professional negligence in the private sector, the spiralling inflation is due to, in the main, a substantial increase in the magnitude of the claims while the claims frequency has increased only moderately. The highest settled claims in South Africa by the Medical Protection Society (MPS), a key medical insurer in the country were R6 million in 2006, R14 million in 2008 and R33 million in 2013. The MPS’s highest current claim (from 2013) is R80 million.

In obstetrics, the highest settled claim was R24 million in 2014.

With obstetrics, neurosurgery and spinal surgery being the ‘high risk’ categories (Presentation by Dr Graham Howarth, MPS at the Medico Legal Summit) it is not surprising that reports have started surfacing of practitioners shying away from managing patients in these disciplines. The reality is that practitioners will not specialise in certain disciplines, resulting in skills shortages in these fields. Clearly this could result in deterioration of care for patients at large.

The increase in medico-legal litigation stems from a number of causes and no one single factor can be blamed for this. Addressing the problem requires a multidisciplinary approach and includes tackling the systems failures, ensuring competent, compassionate management of patients and striving towards ensuring the delivery of good quality healthcare services. The actual dilemma though, is that of balancing fair compensation for harms with the public good. The law will not help in this regard because currently there

EDITORIAL is no specific legislation that addresses medical litigation and these claims are dealt with by the common law, and more specifically the law of delict where negligence is determined by the criteria of reasonableness and foreseeability[1] and little regard is given to the impact of the magnitude of quantum of claims on society at large.

Law reform has been resorted to in several jurisdictions around the world with legal remedies ranging from no fault to capped regimes. It is advisable that ‘capping’, if considered in South Africa, is approached with caution as it could result in constitutional challenge.

Without doubt, urgent interventions are necessary to improve our current situation. However, these must be implemented responsibly and in line with justice in order to ensure that compensation, where indicated, is fair. Prevention is key and the responsibility of both health administrators and practitioners. Risks need to be contained and only claims which are defensible should be defended. In the state sector, it is important to remember that public money used for the settlement of claims is much needed financial resources that will otherwise be lost to the hospital services. Prevention applies to practitioners too and they would do well in recognising and

avoiding the risks that have potential for malpractice and professional negligence claims. Perhaps the time has arrived for the establishment of a statutory national litigation authority or council where litigation claims could be considered and settled by mediation.

References 1. McQuoid-Mason DJ. Medical malpractice and professional negligence. In: Dhai A, McQuoid-Mason DJ, eds. Bioethics, Human Rights and Health Law. Principles and Practice. Cape Town: JUTA, 2011:92-96.

2. Castell v. De Greef 1993 (3) SA 501 (C).

3. Van Wyk v Lewis 1924 AD 438-457.

4. World Health Organization. Health Topics, Health Systems, Patient Safety. Europe: World Health Organization, 2014. http://www.euro.who.int/en/health-topics/ Health-systems/patient-safety (accessed 4 April 2015).

5. World Health Organization. World Alliance for patient safety. Summary of the evidence on patient safety: Implications for research. Geneva: World Health Organization, 2008. http://www.who.int/patientsafety/information_ centre/20080523_Summary_of_the_evidence_on_patient_safety.pdf (accessed 4 April 2015).

S Afr J BL 2015;8(1)xx-xx. DOI:10.7196/SAJBL.xxx

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MoH ADDRESS

Doctors call for lawyers to get out of hospitals Dr Aaron Motsoaledi, MP, Minister of Health, South Africa Keynote Address at the Medico-Legal Summit, St George’s Hotel, Pretoria 9 - 10 March 2015

Let me welcome you heartily to this very important Summit, which needless to say, has been long overdue. There is definitely a lot of anxiety within both the medical and the legal professions on the expected outcome of this Summit, albeit for totally different and opposing reasons.

Please get used to the idea that from now, henceforth, whenever we meet in this fashion, I am going to keep on reminding you that South Africa has a plan – the National Development Plan (NDP) or Vision 2030.

This is because every summit, conference, plan, strategy, resolution, declaration, and debate in health, will have to align itself with the NDP. For those who do not or did not read the NDP, let me remind you what it says about health: ‘We envisage that in 2030, South Africa has a life expectancy rate of at least 70 years for men and women. The generation of under20s is largely free of HIV. The quadruple burden of disease has been radically reduced compared to the two previous decades, with an infant mortality rate of less than 20 deaths per thousand live births and an under-five mortality rate of less than 30 per thousand. There has been a significant shift in equity, efficiency, effectiveness and quality of health care provision.

‘Universal coverage is available. The risks posed by the social determination of disease and adverse ecological factors have been reduced significantly.’

It goes on to say that: ‘This vision will only be achievable if the major problems that currently exist in the three perspectives are addressed effectively’.

Ladies and gentlemen, we are determined, as a government, to achieve Vision 2030 as outlined. We have to, we do not have any option. If we are to achieve the goal of a long and healthy life for all South Africans, we have to!

There are three main events, or should I say issues, that will be major determining factors of whether we indeed can achieve the goals of the NDP. In fact, these three issues, which are all going to happen this year – 2015, will make or break the health system in this country. The three of them are going to change the health system as we know it today.

Unfortunately, the change they may bring may be either positive or negative, depending on our attitude as South Africans.

These three are: • the outcomes of the White Paper on the National Health Insurance (NHI); • the outcome of former Chief Justice Ngcobo’s public market inquiry into the cost of private health as set out by the Competition Commission; and • the outcome of this very Summit on medico-legal litigation tomorrow.

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I repeat – these three will make or break the health system as we have come to understand it in South Africa.

Let me leave the Competition Commission’s Market Inquiry and NHI White Paper because their time is coming – soon for that matter.

Let me focus on the third – which brought us here today, and that is – medico-legal litigation.

Has medico-legal litigation reached a crisis point in South Africa?

The answer is definitely a big Yes. It is a crisis of large proportions.

It is the same crisis that engulfed Australia a decade-and-a-half ago when their general insurance collapsed, followed immediately by the provisional liquidation of Australia’s largest medical defence organisation – the United Medical Protection.

It is the same crisis that occurred in the United States (US) in the early 1970s which was described as a crisis of insurance availability as many insurers exited. The second in the mid 1980s was a crisis of affordability with price hikes that meant that doctors found they could not afford to pay for cover.

Both of these crises prompted a concern about access to certain services – obstetrics and emergency care in particular.

The most recent crisis in the US was precipitated when certain companies exited the market en masse, which led to a crisis of affordability as well as availability.

Unfortunately, we in South Africa seem to be heading very fast in that same direction.

Yes programme director, we are certainly headed in the direction which hit the United Kingdom (UK) in the not so distant past when a big debate in the House of Commons dubbed ’The Big Storm‘ ensued.

What is the nature of this crisis in South Africa today? Are we faced with our own ‘Big Storm’?

The nature of the crisis is that our country is experiencing a very sharp increase – actually an explosion – in medical malpractice litigation which is not in keeping with generally known trends of negligence or malpractice.

The cost of medical malpractice claims have sky-rocketed and the number of claims increased substantially.

When it first started being noticed, those who have made a habit of rubbishing the Public Health system at every available opportunity jumped in without an iota of research and concluded that the reason is the rising negligence or what they call the ‘don’t care attitude’ in public healthcare in our country – and started lambasting the State about it.

Let me make it very clear – the crisis we are faced with is not a crisis of public healthcare in our country – it is a crisis faced by everybody in the healthcare profession – public and private – it does not matter where you are. As long as you are in health, the crisis affects you.

Ominously, the crisis does not affect all medical specialities in the same manner. From the trends, we notice that certain specialities are being targeted more than others.

MoH ADDRESS There are four medical specialities that are continuously, persistently and mercilessly being targeted for litigation.

These are: • Obstetrics and Gynaecology • Neurosurgery • Neonatology • Orthopaedics.

Whether you are in public or private as long as you practise in these specialities, you are a major target.

No rocket science is needed to figure out why these are the specialities that are specifically targeted.

I am painfully aware that at this present moment in our country, there are many divergent views as to the cause of this explosion in medico-legal litigation.

When Australians were faced with a similar fate, as I mentioned earlier, there was considerable disagreement at the time about the factors that led to the crisis: some commentators blamed insurers’ poor business practice and the cyclical nature of the insurance industry. The government and the insurance companies held the justice system responsible, arguing that it was too lenient and that damage awards were too generous. Some claimed that doctors have become too careless etc. etc.

Whichever view you hold, whoever you wish to blame, the fact that needs to be confronted is that this is a crisis that is destructive to the health system of a country - not just the healthcare system, but the whole system of health.

When this crisis reached a boiling point in Ireland in the 1990s, the commercial insurance market had reached a point whereby it was no longer willing to provide insurance cover for obstetricians and gynaecologists or to hospitals with obstetric units due to the escalation in the size of court awards and costs in cases of birthrelated cerebral dysfunction.

The latter fact, i.e. birth-related cerebral dysfunction, is the one we are faced with in South Africa today – a quarter of a century later.

In our country, the cost of indemnity insurance for private specialists in neurosurgery increased by a whopping 573% within a period of eight years between 2005 and 2013, and is still going up and up.

I believe the Medical Protection Society will give the recent figures today.

The cost of indemnity insurance for private specialist in obstetrics increased by 382% within a similar period, and is still growing. Again, the Medical Protection Society will hopefully give the most recent figures.

All these issues have devastating consequences to a health system of a country.

We know that some doctors who were interviewed by the Medical Protection Society made chilling statements like: ‘I now consider every patient in front of me as a potential enemy’. ‘I now consider that every consultation may end in a claim’. ‘I now refer more patients to other doctors, I now choose which conditions to treat and which to reject’. ‘I am thinking of a career change’.

This last statement holds a potential disaster to the welfare of all women in our country because from where I am, we are getting reports that doctors are now reluctant to specialise in obstetrics and gynaecology.

Those who are too old to change are resorting to procrastinating gynaecology and refuse to see the woman once she falls pregnant.

Just close your eyes tightly and imagine a country with many many super-rich lawyers but no obstetricians at all! That will be back to the Stone Age. It is tantamount to declaring a death sentence to women and children.

It is this prospect that prompted the British Secretary of State for Health, the honourable Frank Dobson, during the debate dubbed ’The Big Storm’ in the UK on this very same issue when he said: ‘I had a slogan: keep doctors out of courts and lawyers out of hospitals. I once made the unseemly suggestion that the only place for a lawyer in a hospital was on the operating table. Apart from visiting, that still broadly applies. We must change the law and take seriously what happens outside the hospital if we are to improve what happens inside it. I strongly support the report’s recommendation 119 to replace the current inadequate, slow, unsatisfactory, grotesquely expensive and lawyers’ pocket and handbag-lining system of dealing with clinical negligence.

‘The system’s main fault is that it is bad for patients’ safety. My right hon. friend the Secretary of State said that patients and their safety must come first in the NHS. They must also come first in our legal system.

‘I welcome the chief medical officer’s work in bringing people together to try to find a compensation system that is fair to those who have suffered but does not damage others who will be treated in future. When the government present their proposals and we consider them, we should revert to the point that patients and their safety must be the top priority.’

Programme director, I believe that this speech by the honourable Dobson, Minister in the House of Commons, perhaps summarises better the gist of what brought us here today!

Patient safety should be our major concern and the central core of the outcomes of this Summit.

I am painfully aware that this statement may lead the cynics and sceptics to conclude that the explosion of medical litigation is a direct result of patients’ safety being severely compromised. A few weeks ago, when an unauthorised report about the workshop of the stakeholders I convened to prepare for this Summit was wrongfully released, many lawyers who commented took this view – yes if they are not negligent, there will be no litigation. If patients are all safe, there will be no problem.

Let us be brutally honest, many of the highly litigating lawyers care less about the concept of patient safety. They are driven by this pocket-lining phenomenon described by the British Minister. They are simply in hospitals because the platform from which they have been lining their pockets – and not that of the wronged patients – has now changed.

Yes, the RAF (Road Accident Fund) has changed. It has been bankrupted by this pocket-lining behaviour.

That behaviour had nothing to do with safeguarding patients who were injured on our roads. You do not safeguard their interest by bankrupting the scheme that has been established for their benefit.

In the same vein, you cannot guarantee patient safety in South Africa by litigating caregivers out of practice or by depriving the healthcare system of its much needed resources by devising schemes that suck out money from the healthcare system, so fast that the system cannot even replenish itself.

Hence programme director, it is us in health who must safeguard the safety of patients. That is why the British, in dealing with this

May 2015, Vol. 8, No. 1 SAJBL

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MoH ADDRESS problem, established a British Quality Care Commission alongside the British Litigation Authority.

This means that the solutions we must adopt to resolve this problem will be: • first and foremost medical • then administrative • then legal.

Our medical solutions will be centred on patient safety and patient welfare.

I can announce to you today that we shall soon advertise the position of the country’s first Health Ombudsperson who would enforce patient safety and welfare.

I am encouraging the Office of Health Standards Compliance to work around the clock to make sure that inspectors are ready and their presence is felt in hospitals.

The Health Ombud will examine breaches of standards and norms, for both patient redress and system improvement. It will complement the existing investigations of professional negligence.

Let me also take this opportunity to inform you that tomorrow, I wish to make an announcement about the HPCSA (Health Professions Council of South Africa) on this very issue.

Other initiatives to improve quality of care will be: • improvement in clinical governance • accelerate the training in ESMOE • rehabilitation of health infrastructure • a non-negotiable approach on procurement and maintenance of equipment and medical devices.

We shall appeal to the chief procurement officer in the Treasury to expedite this issue of procuring all equipment and devices for our health facilities.

I will not venture into the legal solutions. I will leave them to the Summit – safe to mention two things: • We are not going to escape the changes RAF is making to safeguard the Fund, but without jeopardising the interest of accident victims. That is why RAF is here to share with us how it is being done.

• We are very much aware that the same syndicates which bankrupted RAF are very much busy in health.

People are working in syndicates – to achieve their aim which is one – to line their pockets in the name of patients who might have been victims in one way or the other.

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We are aware that these syndicates consist of lawyers and some within the health profession itself to make as much money from the State and other doctors as possible.

We are aware that members of these syndicates in the various State Attorney Offices are mismanaging cases deliberately, so that the State must lose at all times.

We are aware that some hospital CEOs are not doing anything to safeguard the welfare of patients but instead deliberately jeopardise the welfare of patients and immediately report to the legal members of these syndicates to start litigation.

We regard these people as having declared war on the health system of the country and hence will deserve no mercy when they are finally caught.

In conclusion programme director, let me make it very clear, that the final loser in this state of affairs, is not necessarily the government and the health profession as many seem to be thinking. Of course the government is the loser if things are not going well in any aspect of life within a country. The healthcare profession is the loser if things go wrong, but the ultimate loser is the public.

Why? • Doctors are now forced to practice medicine in the way they have been taught, but are forced to apply the principles of law within clinical practice, and these are not always compatible.

• Because doctors are forced to order investigations or to perform tests for the benefit of lawyers and not patients, many patients are subjected to unnecessary physical and emotional pain, but also they have to pay for these unnecessary tests.

• Healthcare inflation has sky-rocketed and people are forced to pay more for their medical aid subscription because doctors, especially obstetricians, neurosurgeons, neonatologists and orthopaedic surgeons have to charge more, because they are forced to pay huge amounts of money in purchasing indemnity even before they start practising.

• The healthcare budget will have to be increased tremendously just to cater for this escalating litigation. When budgets are forced to increase, taxes also increase, affecting the public. I do not have to remind you that the Minister of Finance has increased the fuel levy in order to cover the shortfall in RAF, which was caused by this excessive litigation and fraud as reported in last week’s papers.

Ladies and gentlemen, I declare this very challenging Summit officially open! I thank you.

S Afr J BL 2015;8(1):xx. DOI:10.7196/SAJBL.xxx

LETTER

Correction to letter on VMMC by Professor Peter S Millard To the Editor: I thank Professor Millard for his interest[1] in my article[2] on some ethical aspects surrounding voluntary medi­ cal male circumcision (VMMC). He presents Table 1 (study data), which has a range for the Kenyan relative risk reduction (RRR) and the number needed to prevent HIV infection (NNT) but he presents no range of values for South Africa and Uganda. In addition, he does not present the point estimate and 95% confidence intervals for the RRR and NNT. Finally, he does not show how the RRR and NNT were calculated. By him presenting Table 1 in this way, one cannot readily make like for like comparisons.

I provide here, so that Table 1 can be interpreted in a more informed manner, (see Table 2 and the supplementary appendix available at: http://.......................... ..................), the source of my data[3], and the methods used for calculation[4,5] (I do not include 95% confidence intervals so as to facilitate comparison of the two tables). The source of my data is a meta-analysis which is generally regarded as the highest level of evidence[6]. The two meta-analyses[3,7] on the three VMMC randomised controlled trials[8-10] used rigorous methodology to directly assess the three trials. On the

other hand, Table 1 is central to Professor Millard’s correspondence; however he does not provide sufficient information on how he came up with this table. Table 1 inflates the NNT for South Africa and Uganda and deflates the Kenyan NNT creating the notion that NNT varies widely and is unstable.

Professor Millard writes: ‘The RRR is stable over wide variations in the risk of the population being studied, while the NNT varies widely with risk.’ In brief, NNT = 1/(RRR x control event rate)[4,5]. Thus if the RRR is unstable, then the NNT will also be unstable.

Please see the additional file (an infographic) for further details. (available at: http://........... .................)

Scientific endeavour is advanced by discussion; I welcome Professor Millard’s response, more so regarding his methodology and presentation style for Table 1. I hope he can make his methods publicly available for scrutiny, as I have done for mine.

Gwinyai Masukume Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa parturitions@gmail.com

Table 1. From Peter S Millard[1] Study location

HIV incidence in control group (%)

Relative risk reduction (%)

Number needed to prevent HIV infection

Kenya

4.2

53 - 60

40 - 47

South Africa

2.1

60

80

Uganda

1.3

50

149

References 1. Millard PS. The ethics of claiming a 60% reduction in HIV acquisition from voluntary medical male circumcision. S Afr J BL 2014;7(2):78. [http://dx.doi. org/10.7196/sajbl.329] 2. Masukume G. The ethics of claiming a 60% reduction in HIV acquisition from voluntary medical male circumcision. S Afr J BL 2014;7(1):4. [http://dx.doi. org/10.7196/sajbl.313] 3. Mills E, Cooper C, Anema A, Guyatt G. Male circumcision for the prevention of heterosexually acquired HIV infection: A meta-analysis of randomized trials involving 11,050 men. HIV Med 2008;9(6):332-335. [http://dx.doi.org/10.1111/ j.14681293.2008.00596.x] 4. Pai M, Filion K. McGill University. An overview of measurements in epidemiology [VER 3, 2007]. 2007. http://www.teachepi.org/documents/courses/ An%20Overview%20of%20Measurements%20 in%20Epidemiology.pdf (accessed 10 November 2014).

5. Barratt A, Wyer PC, Hatala R, et al. Tips for learners of evidence-based medicine: 1. Relative risk reduction, absolute risk reduction and number needed to treat. CMAJ 2004;171(4):353-358. [http://dx.doi.org/10.1503/cmaj.1021197] 6. Oxford Centre for Evidence-based Medicine – Levels of Evidence (March 2009). 2009. http:// www.cebm.net/oxford-centre-evidence-basedmedicine-levels-evidence-march-2009/ (accessed 10 November 2014).

7. Siegfried N, Muller M, Deeks JJ, Volmink J. Male circumcision for prevention of heterosexual acquisition of HIV in men. Cochrane Database Syst Rev 2009;2:CD003362. [http://dx.doi. org/10.1002/14651858.CD003362.pub2] 8. Auvert B, Taljaard D, Lagarde E, et al. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: The ANRS 1265 Trial. PLoS Med 2005;2: e298. [http://dx.doi. org/10.1371/journal.pmed.0020298] 9. Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: A randomised trial. Lancet 2007;369(9562):657–666. [http://dx.doi.org/10.1016/S0140-6736(07)60313-4] 10. Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: A randomized controlled trial.

Lancet 2007;369(9562):643–656. [http://dx.doi. org/10.1016/S0140-6736(07)60312-2]

S Afr J BL 2015;8(1):xx. DOI:10.7196/SAJBL.367

Table 2. For comparison with Table 1.

Study location

n

Intervention

Control

Absolute risk reduction (%)

Relative risk reduction (%)

Number needed to prevent HIV infection

Kenya

2 780

19/1 388*

46/1 392

1.9

59

52

South Africa

3 128

20/1 546

49/1 582

1.8

58

55

Uganda

4 996

22/2 474

45/2 522

0.9

50

111

*19/1388 means that there were 19 HIV positive participants out of 1 388 participants in the intervention (VMMC) arm of the trial (see supplementary appendix for calculations).

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FORUM

Does withdrawing treatment from a pregnant persistent vegetative state patient resulting in her death constitute a termination of pregnancy?

D McQuoid-Mason, BComm LLB, LLM, PhD David McQuoid-Mason is Professor of Law at the Centre for Socio-Legal Studies, University of KwaZulu-Natal, Durban, South Africa, and publishes and teaches in medical law Corresponding author: D McQuoid-Mason (mcquoidm@kzn.ac.za)

A recent article on the Texas case of Munoz v. John Peter Smith Hospital, begs the question of whether if the pregnant woman had been in a persistent vegetative state (PVS) the courts in South Africa would have ordered the withdrawal of life-support treatment because she had expressed her wish not to be treated under such conditions in an advance directive, and that keeping her alive against her wishes would violate her constitutional rights to equality, dignity, privacy and bodily integrity. The answer seems to be yes in both instances. This applies even if the withdrawal of such support is opposed by the persons legally capable of consenting on her behalf in terms of the National Health Act. Where there is no advance directive – provided the treating clinicians conclude that any further treatment will be futile or that the benefits of further treatment are outweighed by the burdens and risks involved – life-support treatment may be withdrawn even against the wishes of persons entitled to consent on her behalf in terms of the National Health Act. Such legally competent persons may, however, apply to court to prevent the implementation of the decision of the clinicians.

S Afr J BL 2015;8(1):xx-xx. DOI:10.7196/SAJBL.336

In the Texas case of Munoz v. John Peter Smith Hospital,[1] the court granted a husband a court 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. It has been suggested that a South African (SA) court would have come to a similar decision but for different reasons.[2] A recent article commenting on the Munoz case,[3] begs the question of whether if the pregnant woman had been in a persistent vegetative state (PVS) the courts in South Africa would have reached the same conclusion on the basis that she had expressed her wish not to be kept alive in an advance directive, and that keeping her alive against her wishes would have been a violation of her constitutional rights to equality, dignity, privacy and bodily integrity.[3] To answer this question it is necessary to consider the following in the context of SA law: • the meaning of ‘persistent vegetative state’ • the constitutional rights of PVS patients • the legal status of advance directives • when life support treatment may be withdrawn from PVS patients • whether such withdrawal of treatment from a pregnant PVS patient, that results in the death of the fetus, constitutes a termination of pregnancy • whether the fetus has any legal right to be kept alive in its PVS mother until birth.

Meaning of persistent vegetative state Persistent vegetative state has been described by the SA courts[4] as ‘a neurological condition where the subject retains the capacity to maintain the vegetative part of the neurological function but has

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no cognitive function’. The body ‘functions entirely in terms of its internal controls’ and ‘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 behavioral evidence of either self-awareness or awareness of the surroundings in a learned manner’.[4] Although PVS patients are not mentally capable of making decisions for themselves because they are brain-damaged rather than brain-dead, they are still alive and entitled to all the legal rights and protections of natural persons that are set out in the Constitution.[5]

Constitutional rights of PVS patients In terms of the Constitution[5] PVS patients have the same rights as anyone else to equality (section 9), dignity (section 10), life (section 11), bodily security (section 12) and privacy (section 14). However, although the right to life in the Constitution (section 11) may not be derogated from, in a situation where a patient has refused livesaving medical treatment, or further medical treatment is futile[4] or unavailable because of a shortage of resources,[6] the court is likely to regard such derogation as legally justifiable.[4] Therefore if a PVS patient has made an advance directive regarding withholding or withdrawal of life-saving treatment this should be respected or at least taken into account.[4] Likewise, if further lifesaving treatment is futile it may be withdrawn.[4] Furthermore, if there is a shortage of medical resources necessary to provide lifesupport for a PVS patient and the criteria for refusing to provide such life-saving medical treatment are reasonable and justifiable, such treatment may be withheld or withdrawn.[6]

FORUM Legal status of advance directives The courts have not yet pronounced on the legality of advance directives such as ‘living wills’, but have indicated that such directives may be taken into account when determining a PVS patient’s wishes.[4] The SA Law Commission has made recommendations regarding the statutory recognition of ‘living wills’,[7] but such recommendations have not yet been included in legislation. Until such time as suitable legislation is passed, ‘living wills’ may be recognised using common law principles, in situations where the medical practitioner concerned is satisfied that the conditions in the ‘living will’ for withholding or withdrawing treatment have been met and that such a will reflects the current wishes of the patient.[8] Where there are no directions in the patient’s ‘living will’ concerning her wishes should she be pregnant at the time she becomes PVS, in terms of the National Health Act [9] a court appointed curator, or her spouse or partner, parent or grandparent, adult child or adult sibling – in that order of priority – may make a decision on her behalf (section 7(1)(b)). The same applies to a proxy appointed by her in writing in terms of the National Health Act to act on her behalf should she become mentally incapacitated (section 7(1)(a)(i)).

The Health Professions Council of South Africa recognises the value of ‘living wills’, and in its Guidelines for the Withholding and Withdrawing of Treatment states that patients ‘should be given the opportunity and be encouraged to indicate their wishes regarding further treatment and to place in writing their directives for future care in possible critical circumstances’, and that an ‘appropriately drafted “living will” may be used for this purpose’.[10]

When life support treatment may be withdrawn from PVS patients

transfer the patient or not to apply for a court order – provided that the doctors are satisfied that treatment is futile, or the burdens and risks outweigh the benefits to the patient, and this is confirmed by an independent health care practitioner – the treatment may be withheld or withdrawn.[12]

Does withdrawal of treatment from a pregnant PVS patient resulting in the death of the fetus constitute a termination of pregnancy in terms of the Choice on Termination of Pregnancy Act? The Choice on Termination of Pregnancy Act[12] 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’ (section 1). Therefore, unless a termination of pregnancy procedure is used to separate or expel the fetus of a PVS pregnant woman, the Choice Act does not apply.

If life support treatment is withheld or withdrawn from a PVS pregnant patient with the result that she dies and the fetus with her, this is not classified as a termination of pregnancy for the purposes of the Choice Act. It is merely the natural consequence of a pregnant PVS mother dying.[2]

Does a fetus have a legal right to be kept alive in its PVS mother until it is born?

The fetus is not regarded as a person in SA law and is not protected by the Constitution or the common law unless it is born alive.[13] 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. Therefore, nobody will be appointed by the court to ensure that the fetus of a PVS mother is kept alive until it is born.[13] However, if the prognosis indicates the healthy development of the fetus until it is born – and with the consent of the persons who have legal capacity to consent to treatment on behalf of the PVS patient in terms of the National Health Act – the doctors concerned may provide life-support to the PVS mother until the child is born.[2]

Life support treatment may be withdrawn from PVS patients in three situations: • where a patient has made an advance directive (e.g. a ‘living will’) • when the treating clinicians conclude that any further treatment will be futile because the patient is dying from an irreversible condition[4] • when, after discussions with the patient’s next-of-kin, an agreement is reached that the benefits of further treatment are outweighed by the burdens and risks involved.[11]

Conclusion

If the PVS patient is pregnant the treating doctors should respect the patient’s advance directive to withhold or withdraw treatment if the conditions for such termination are satisfied and the directive includes a clause that covers pregnancy situations. If the advance directive contains no such clause the physicians should obtain consent from the patient’s curator, next-of-kin (in the order of priority set out in the National Health Act)[9] (section 7(1)(b)), or nominated proxy as mentioned above (section 7(1)(a)(i)).

Where the prognosis for both the PVS patient and the developing fetus is hopeless and attempts to provide life support for mother and fetus until full term will be futile, or the burdens and risks outweigh the benefits to the patient, the doctors may withhold or withdraw treatment – even against opposition by the persons legally able to consent to withholding or withdrawal of treatment.[11] In such cases the persons concerned should be given the opportunity to transfer the patient to another facility where such treatment is available, or if necessary to apply for a court order to prevent the withholding or withdrawal of treatment. Where they decide not to

Where a pregnant PVS patient has expressed in an advance directive her wish not to be subjected to life support treatment – even if pregnant – keeping her alive against her wishes would be a violation of her constitutional rights to equality, dignity, privacy and bodily integrity.

If a pregnant PVS patient had not made an advance directive requesting withholding or withdrawal of treatment while pregnant she may be subjected to life-support until the baby is born with the consent of her curator, next-of-kin or proxy as provided for in the National Health Act – provided that carrying the fetus to term is medically justifiable.

Where the prognosis for a PVS pregnant patient and her fetus is hopeless, and the treating clinicians conclude that any further treatment will be futile or the benefits of further treatment are outweighed by the burdens and risks involved, the life-support treatment may be withheld or withdrawn – even if it is against the wishes of the curator, next-of-kin or proxy legally competent to consent in terms of the National Health Act. However, such persons must be given the opportunity to transfer the PVS patient to another

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FORUM health facility or may apply for a court order should they wish contest the decision of the clinicians.

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

2. McQuoid-Mason DJ. Terminating the pregnancy of a brain-dead mother. S Afr J BL 2014:7(2):44-46. [http://dx.doi.org/10.7196/SAJBL.317] 3. Nienaber A. Pregnant, dead, and on a ventilator: A few thoughts in response to Prof McQuoid-Mason. S Afr J BL 2014:7(2):47-50. [http://dx.doi.org/10.7196/SAJBL.330] 4. Clarke v. Hurst NO 1992 (4) 636 (D).

5. Republic of South Africa. Constitution of the Republic of South Africa.

Government Gazette 1996.

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

7. Republic of South Africa. Euthanasia and the artificial preservation of life. Paper 71: Project 86. Pretoria: South African Law Commission, 1997.

8. McQuoid-Mason D. The legal aspects of the Living Will. Continuing Medical Education 1993:59.

9. Republic of South Africa. The National Health Act. Pretoria: Government Gazette 2004.

10. Health Professions Council of South Africa. Guidelines for the Withholding and Withdrawing of Treatment. Pretoria: HPCSA 2008: paragraph 2.3.

11. McQuoid-Mason D. Withholding or withdrawal of treatment and palliative treatment hastening death: The real reason why doctors are not held legally liable for murder. S Afr Med J 2014;104:102-103. [http://dx.doi.org/10.7196/ samj.7405] 12. Republic of South Africa. Choice on Termination of Pregnancy Act No. 92, Pretoria: Government Gazette 1996.

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

ARTICLE

Laws and regulations associated with ownership of human biological material in South Africa K P Mahesh, BSc Hons, MScMed Medical scientist, Academic co-ordinator, University of Pretoria, South Africa Corresponding author: K P Mahesh (kishen411@hotmail.com)

Ownership with regard to human biological material (HBM) is addressed to some extent within South African law, specifically in chapter eight of the National Health Act (NHA) and its associated regulations. However, members of the legal fraternity struggle to conceptualise ownership of such materials without objectifying a person or people and risking reducing such individuals to a state of property. This then infers a reduction in human dignity by rendering one-self or parts of that same self as a commodity. The complexity of the issue raises much debate both legally as well as ethically.

S Afr J BL 2015:8(1)xx-xx DOI:10.7196/SAJBL.354

South Africa’s laws with regard to human biological material (HBM), specific to that of genetic research, have over the years proved to be a fairly prominent topic of discussion. This in turn has led to the drafting and now enacted legislation, chapter eight of the National Health Act (NHA). However, several questions have arisen, post promulgation, with regard to the issue of ownership of such biological materials. One of the major issues identified is lack of a clear enough definition of HBM. Various acts and regulations related to research and the diagnostic use of HBM define such materials in various ways. The lack of a universal definition therefore creates room in the legislature from which exploitative acts may arise. This article aims to highlight some of these gaps as well as put forward recommendations for a universal definition to be used by all involved with HBM.

Defining ownership The description of ownership stems mainly from South African common-law.[1] Ownership has been defined in various decisions as ‘the most complete real right which gives the owner the most complete and absolute entitlement to a thing. Even so, it is a right which can be limited by objective law and by the rights of others’. A ‘thing’ is defined ‘in terms of characteristics, as a corporeal or tangible object external to persons and which is, as an independent entity, subject to judicial control by a legal subject, to whom it is useful and of value’.[1] HBM such as genetic material (DNA and RNA) in this sense is reflective of what a ‘thing’ would be. Genetic material meets the criteria that are used as definable characteristics of a thing. It is corporeal, in belonging to a physical body and tangible, in being material that can be made visible, of definite substance and can be quantified.[1] According to Regulation 180(S26) in chapter eight of the NHA, an exclusive right in human tissue is acquired by any person who obtains the human tissue, subject to informed consent and the provisions and restrictions of the NHA or any other law.[2] Such regulation pertaining to biological material capable of yielding genetic material within the NHA portrays a sense of exclusive property rights from donor to donee, the latter being a researcher, doctor, or research institute, for example.[3]

This transfer of exclusive rights therefore implies that when elements of the human body are separated from a person, the material gained loses its identity and is to be considered a biological material that no longer has relatedness to the person who has donated it. This may be true for biological material removed from a person when the sample is coded or made anonymous but the genetic information within those materials are capable of identification. For example, if a population group under genetic investigation is found to hold in their genomic sequence a rare variant or Single Nucleotide Polymorphism (SNP) that specifically clusters within that group, it then acts as an identifiable marker to that population. Depending on the type of genetic association predicted to be linked to that SNP, a population may become vulnerable to further genetic exploitation and cultural intrusion. Therefore, while national regulations exhibit exclusive rights in biological and genetic materials as a property that can be transferred from one person to another, subject to certain restrictions, the intimate nature of genetic material begs the question of: To whom does such material truly belong?

Redefining ownership for human biological material Redefining ownership in respect of materials obtained from human beings proves to be a formidable task as various aspects need to be taken into consideration. The question to be considered in redefining the concept of ownership within current legal understanding is described as follows: How do we develop a legal definition for ownership of HBM without making humanity appear as a commodity or without loss of human dignity? The legal definition of HBM and tissue as they stand is poorly defined, with variations occurring in different segments of legislation related to human bodily materials[4] such as tissue, blood and blood products.

HBM removed from a human being either living or deceased should be entitled to the rights attributed to the body as a whole. Under these conditions I propose the following definition: A human biological sample shall include all cell types capable of being removed, by a trained professional, from a human body either intravenously and/or surgically without causing serious harm to a living individual provided informed

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ARTICLE consent has been granted prior to the removal. The cell types should be classified based on the cell potency, which is defined as a cell’s ability to differentiate into one or more cell types within an organism[5] from which these specific cell types form, that is, totipotency, pluripotency, multipotency, oligopotency and unipotency. In this way, all cell types are covered, from stem cells and blood and blood products to all forms of tissue which can be defined as a set of specialised cells that aggregate together to perform a specific function as a single unit.[6] A totipotent cell is a stem cell capable of becoming any cell in the body. They are usually produced during the first few cell divisions of embryogenesis. It is from these stem cells that all other stems cell form.[5] From these cells another set of stem cells are formed, known as pluripotent stem cells. These cells have the potential to differentiate into nearly all cells within the body but are sectionalised based on which of the three germ layers[5] they enter into. Pluripotent stem cells have self-renewal properties as well as the potential to form all cell types of an adult organism.[7] Multipotent stem cells are the next set of stem cells to form following a cascade of cell differentiation towards unipotent cells.

These cells are capable of differentiation in various cell types but only with a certain family.[5] They are therefore limited in the cell types they can become. For example, the bone marrow contains multipotent stem cells that give rise to all the cells of the blood but not to other types of cells. Adult haematopoeitic stem cells are multipotent.[8] Oligopotent stem cells can differentiate into only a few cells within in a cell type family, such as lymphoid or myeloid stem cells.

The corneal epithelium is a squamous epithelium that is constantly renewing and is oligopotent.[8] Lastly, unipotent cells are only able to produce one type of cell, their own, but still maintain the property of self-renewal, which distinguishes them from non-stem cells. Most epithelial tissues self-renew throughout adult life due to the presence of unipotent progenitor cells.[5,9] Serious harm as adapted from the Unites States Code can be defined as any form of protracted or obvious loss of impairment of the function of a bodily member, organ or mental faculty (physical and/or mental disability), protracted or obvious disfigurement, extreme physical pain or risk of death that can occur during the extraction of cellular material from a living human host body.[10] For example, the unintended awakening, of a patient during an extraction of cellular material by surgical procedures from their body, due to the administration of an insufficient amount of anaesthesia.

The effect of such an event could result in the patient experiencing extreme pain as well as many other unintended consequences including the risk of death should the patient react in a manner that endangers his or her life due to the level of pain experienced.

Genomics and gene patents Prior to the recent international ownership issues relating to genetic material such as that of patent laws, the common understanding was that such material was an open source with no one having exclusive rights to ownership over any piece of it. This allowed all countries to share their genetic resources freely.[11] An example of open source in genetics is the Human Genome Project, an endeavour that required the collaboration of a number of different institutes sharing their information and data, therefore forcing each of them to decide on flexible research standards.

The realisation that both scientific and commercial gains can be made from human biological material has led to more stringent control over such materials nationally. Safrin[11] refers to this as the ‘legal enclosure of genetic material’, which she attributes to two developments:

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• the patenting of genetic material by predominantly developed countries • a response to the privatisation of genes through the patent system and the extension of sovereignty over genetic resources by developing countries.

This patent action has led to a reaction by many in the developing world, implementing state sovereign rights or a form of national control over genetic resources. The interaction between the patent system and the sovereign-based system is described by Safrin as a ‘corrosive interplay’ eventually leading to a system she describes as ‘hyperownership’ of genetic material to the anticommons trap.

The anticommons is a concept introduced by Micheal Heller[12] as ‘the mirror image of common property’ which plays in contrast to Hardin’s Tragedy of the Commons.[13] The philosophical idea expressed

by Hardin sets forth the consequences of overuse of a natural resource, such that access to that resource becomes overrun. The anticommons however, proposes the opposite: a tragedy is likely to arise ‘when these individuals or entities employ their rights to veto the use of a given resource and in so doing waste the resource by it’s under consumption compared with the social optimum’.[12] Hardin’s Tragedy of the Commons represents over-consumption and exploitation of a resource without giving back to the entity from which it was taken. Heller’s anticommons approach aims to identify the lack of willingness to allow others access and share in the benefits of that resource. From a genomics point of view this represents the effects of ‘safari or helicopter’ research, whereby genomic samples were collected from communities without proper consent or fair compensation, consequently leading to many nations seeking sovereign mandates over their genetic materials. In either case the action of both these groups incurs both social and economic repercussions. Additionally, the development of excessive sovereign control or ownership of genetic material is likely to lead to over-regulation,[11] with bureaucratic red tape impeding important genetic research.

Although UNESCO’s declaration states that the human genome in its natural state should not give rise to financial gain,[13] it does not offer any protection over segments of the human genome. Many developed countries allow for genes that have been isolated, extracted and functions determined, to become a commodity, gain commercial value and allow for their patenting.[11,12] In South Africa, current laws, such as the Biodiversity Act,[14] restrict access to genetic material for the purpose of acquiring remuneration but the exclusion of human genetic material from the Act once again leaves a gap for exploitative means.

Globally, many developing countries such as Mexico, Brazil and India for example have in place regulatory guidelines[15] that view human genetic material as a natural resource based on the concept of Genomic Sovereignty described as ‘the capacity of a people, country or nation to own, to control both access and use of samples, data and knowledge emanating from genetic material’.[16] With the awakening of the wealth of genetic data available in their respective countries the so-called traditional distinctions in legal understanding between human and non-human genetic resources is slowly being eroded, with international bodies calling for amendments to the Convention of Biological Diversity to be made that govern access to human genetic material as well.[1]

Patenting of DNA in biotechnology South Africa is fairly silent with regard to patenting any form of human genetic material and has in place laws, regulations and guidelines such

ARTICLE as the Biodiversity Act as well as the guidelines for South Africa’s bioprospecting, access and benefit-sharing regulatory framework issued by the Department of Environmental Affairs.[17] Within these laws, issues surrounding patenting of biological resources are mentioned but indicate that these laws and guidelines exclude human genetic material. Nonetheless extrapolation of relevant information from such legal documents is still relevant in relation to human genetic material and could therefore be used as a stepping stone in an effort to set in motion regulatory legislature for human genetic resources.

Patents Act No. 57 of 1978 In 2005, section 2 of the Patents Act No. 57 of 1978[18] was amended to include certain definitions as well as the requirement for an applicant of a patent to furnish information relating to any role played by an indigenous biological or genetic resource or traditional knowledge. Those who wish to file an application to the Patents Office using indigenous knowledge are obligated to disclose their source, therefore creating space to work out an equitable and fair compensation mechanism to the relevant community.

Section 25(1) of the Act states that a patent is granted for any new invention which involves an inventive step, and is capable of being used or applied in trade, industry or agriculture. For human genetic material patents, the definition itself poses major challenges.

‘Patent is granted for any new invention’ A specific gene sequence or partial thereof is not novel. Such sequence data has existed prior to its scientific investigation and takes into account the Supreme Court ruling in Myraid Genetics[19]that DNA isolated in its natural form cannot be patented or classified as a ‘new invention’.

‘Which involves an inventive step’ This statement implies that something new was created or an inventive step arose out of a process. For genetic information such as targeted gene isolation and expression, it is difficult to prove; as such biological processes already occur in nature, whether they are ancestral or mutant. In addition research that finds evidence of a gene or other genomic data that is or could be linked to a specific disease or disorder, constitutes more an event of discovery rather than an invention. Furthermore, the scientific theory applied to such a discovery is not eligible for patenting under the condition of an inventive step.[20] This is justified by the need for scientific research to be continuously validated through reproducibility and proven robustness of a technique in order to either support or disprove a scientific theory.

‘Being used in trade, industry or agriculture’ Trade can be taken to include all activities in society where services or com­ mo­dities of any kind are exchanged for money or other goods of value.[19,22] If an invention is to be patented it must be capable of being utilised or used in trade, industry or agriculture. Generally, South African law excludes discoveries, scientific theories and any human or animal treatment method including surgery, therapy or diagnostics as patentable inventions.[19] ‘Agriculture covers the science of farming, whether animals or crops, and in its broad sense also includes forestry, gardening and horticulture.’[21] The wide range that an invention can cover makes it difficult to conceive its lack of utility, that is, not capable of being used or applied in trade, industry or agriculture, except for medical methods of treatment that are specifically excluded in the Patents Act. Section 25(1) of the Act[19] does not define what a patent is but rather only provides clarification of what it cannot be.

Legal conclusion Overall, the Patents Act leaves one with a feeling that information pertaining to human biological resources (that are relevant to genetics and other human associated studies) are overlooked and, upon review, one may question the apparent general lack of regulation of such material. However, the amendment requiring disclosure of the use of indigenous knowledge is noteworthy as this provides for a means to ensure fair compensation to the relevant communities through various benefit-sharing mechanisms. The question of ownership of human biological material undoubtedly raises the need for re-evaluation of how the concept of property is understood, interpreted and defined with regard to human genetic material. This in turn, should provide a link between open source data and biotechnology, as well as genomics as a whole with humanitarian objectives. Therefore, the potential to re-negotiate and re-design biotechnology with regard to human genetic material and information does exist.

References 1. Van der Walt AJ, Pienaar GJ. Chapter 4: Introduction to ownership. In: Introduction to the Law of Property. 5th ed. Cape Town: Juta, 2006:39-47.

2. Republic of South Africa. National Health Act No. 63 of 2003, Regulation 180. Regulations regarding the general control of human bodies, tissue, blood and blood products and gametes. Government Notice R180. Government Gazette No. 35099 2012.

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

4. Mahomed S, Nöthling-Slabbert M, Pepper MS. The legal position of the classification of human tissue in South Africa: Can tissues be owned? South African Journal of Bioethics and Law 2013;6(1):16-20. [http://dx.doi.org/10.7796/SAJBL.258] 5. Hima BA, Srilatha B. Potency of various types of stem cells and their transplantation. J Stem Cell Res Ther 2011;1(115):1-6. [http://dx.doi.org/10.4172/2157-7633.1000115] 6. Defining Tissue: http://www.oxforddictionaries.com/definition/english/tissue (accessed 25 June 2014).

7. Horie M, Ito A, Kawabe Y, Kamihira M. A genetically engineered STO feeder system expressing E-Cadherin and leukemia inhibitory factor for mouse pluripotent stem cell culture. J Bioprocess Biotech 2011;S3(001). [http://dx.doi. org/10.4172/2155-9821.S3-001] 8. Weissman IL. Stem cells: Units of development, units of regeneration and units of evolution. Cell 2000;100(1):157-168. [http://dx.doi.org/10.1016/S0092-8674(00)81692-X] 9. Murnaghan I. Explore Stem Cells-Unipotent Stem cells: http://www. explorestemcells.co.uk/unipotentstemcells.html (accessed 12 August 2014).

10. Unites States of America. Office of the Law Revision Council: Unites States Code. Title 18-Crimes and criminal procedure, Part I, Chapter 109A, §2246(4).

Serious bodily injury. http://uscode.house.gov/view.xhtml?req=%28title:18%20 section:2246%20edition:prelim%29 (accessed 25 June 2014).

11. Safrin S. Hyperownership in a time of biotechnological promise: The international conflict to control the building blocks of life. Am J Int Law 2004;98(4):641-685.

12. Heller MA. The tragedy of the anticommons: Property in the transition from Marx to markets. Harvard Law Review 1998;111(3):621-622.

13. UNESCO: Universal Declaration on Bioethics and Human Rights. http://portal. unseco.org/en/ev.php-URL_ID=31058andURL_DO_TOPICandURL_section=201. html. (accessed 9 March 2012).

14. Republic of South Africa. Biodiversity Act No. 10. Government Gazette 2004.

15. Sequin B, Hardy BJ, Singer PA, Daar AS. Genomic medicine and developing countries: Creating a room of their own. Nat Rev Genet 2008;9(6):487-493.

16. Slabbert MN, Pepper M. A room of our own? Legal lacunae regarding genomic sovereignty in South Africa. Journal of Contemporary South African Roman-Dutch Law 2010;73:432-450.

17. Republic of South Africa. Department of Environmental Affairs. South African Bioprospecting, access and benefit-sharing regulatory framework: Guidelines for providers, users and regulators. Pretoria 2012. https://www.environment.gov.za/sites/default/files/legislations/ bioprospecting_regulatory_framework_guideline.pdf (accessed 25 September 2013).

18. Republic of South Africa, Patents Act No. 57. Government Gazette 1978.

19. Association for Molecular Pathology et al, Petitioners V Myraid Genetics, Inc, et al. Supreme Court Opinion. Pretoria June 2013. http://www.supremecourt.gov/ opinions/12pdf/12-398_1b7d.pdf (accessed 25 September 2013).

20. World Health Organization. Human Genetics Programme. Genetics, Genomics and the patenting of DNA: Review of potential health implications in developing countries. Geneva: World Health Organization, 2005. http://www.who.int/ genomics/FullReport.pdf. (accessed 25 September 2013).

21. Mukuka GS. Chapter 5: Intellectual property laws in South Africa. In: Reap what you have not sown, Indigenous Knowledge Systems and Intellectual Property Laws in South Africa. Pretoria: Pretoria University Law Press, 2010:137-143. http:// www.pulp.up.ac.za/pdf/2010_16/2010_16.pdf (accessed 25 September 2013).

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ARTICLE

Things may not be as expected: Surprising findings when updating workload at the Wits Human Research Ethics Committee (Medical) P Cleaton-Jones,1 MB BCh, PhD, DSc (Dent), FCD; E S Grossman,2 BSc Hons, MSc (Dent), PhD 1 2

Steve Biko Centre for Bioethics, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa P O Box 14, Cannon Rocks, 6186 South Africa

Corresponding author: P Cleaton-Jones (pcleatonjones@gmail.com)

Objectives. To compare numbers of applications to the University of the Witwatersrand Human Research Ethics Committee (Medical) for clearance by the full committee during 2011 - 2013; to see the proportion of clinical Master’s applications in 2013 and to look for the influence of eight variables in applications reviewed from January to June 2013.

Methods. A retrospective extraction of data from committee minutes (2011-2013) and application forms (January – June 2013) was done.

Statistical analysis was completed using SAS for Windows (version 9.4). Variables examined were committee decision, choice of research method, supervision or not, supervisors’ research degree, supervisors’ publication group, university administrative entity, registered degree and month of approval after first review.

Results. Total numbers were 685 (2011), 845 (2012, a 23.4% increase from 2011) and 769 (2013, a 9.0% decrease on the previous year). In 2013, 22% of applications were for clinical Master’s degrees required by the Health Professions Council of South Africa (HPCSA) for specialist registration. A number of cross-tabulations of variables are presented. Logistic regression analysis (Proc Catmod) showed that three variables significantly influenced the committee’s initial review decision, namely school (p=0.03), applicants’ registered degree (p=0.01) and the research method chosen (p=0.03). The month of committee approval was also significantly affected by school (p=0.002). Preferred research methodologies for supervised and independent research applications differed within and between schools.

Conclusion. A predicted continuous increase in number of applications from 2011 to 2013 did not happen for unknown reasons. Research method, school, and registered degree significantly influenced the committee’s decision at the initial review of applications. For clinical Masters, and other Masters, a supervisor’s degree had no effect on the committee’s decision at the initial review of applications; however undergraduate and honours applicants having supervisors without a research degree had more than double the approval rate at first review than when supervisors had either a Doctorate or a Master’s (p=0.008). Supervisors’ possession of a research degree did not increase approval rate of applications nor did a supervisor’s publication grouping.

S Afr J BL 2015;8(1):xx-xx. DOI:10.7196/SAJBL.339

In 2011 the Health Professions Council of South Africa (HPCSA) brought in a new requirement for the registration of clinical specialists in South Africa namely the completion of ‘… a relevant research study … reported in the format of a dissertation’.[1] Since the National Health Act requires health research studies to be approved by a ‘… registered health research ethics committee, which is registered with the National Health Research Ethics Council …’,[2] the Wits Human Research Ethics Committee (Medical) (Wits HREC (Medical)) began planning for an increase in application numbers from registrars in medicine and dentistry enrolled for the MMed and MDent degrees which fulfill the new HPCSA requirement. Such pre-emptive forward planning recognises that the facilitation of ethical conduct among researchers is an institutional governance issue which should best be imbedded within the institution’s broader governance framework.[3] In addition, transparent, visible preparedness goes a long way to improving the relationship between researchers and ethics committees.

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May 2015, Vol. 8, No. 1 SAJBL

At the time, based on the numbers of specialist registrars in the Faculty of Health Sciences, it was estimated that there would be 250 extra applications for ethics clearance per year from 2012 probably until 2015 when a plateau could be expected.[4] Therefore, additional administrative staff and streamlining of procedures were put in place to meet the predicted upswing in applications. Concurrently, universities have extended their efforts to escalate the numbers and quality of candidates to meet the high-level skills demanded of our emerging economy.

Recommendations highlighted in the 2011 National Development Plan: Vision for 2030 proposes that the number of PhD graduates rises fourfold by 2030.[5] This, in turn, will require a concomitant increase in Masters candidates to supply the PhD pipeline[6] over and above the number of clinical Master’s envisioned by the HPCSA requirement.

All these candidates, be they for a specialist clinical qualification, conventional Masters or PhD, will probably ask for advice from their supervisors about ethical approval requirements laid down by their institution.[6] In addition, postgraduate completion has been directly

ARTICLE

Methods An audit of applications to the Wits HREC (Medical) was undertaken under ethics clear­ ance from the committee (clearance M12014).

Source documents were minutes of monthly meetings 2011 - 2013, expedited application reports for 2013 and application forms for January to June 2013. Sponsored clinical trials submitted through the Wits Research Consortium ethics secretariat were excluded as were applications for waivers from ethics clearance or case reports in journals or at con­ gresses. The latter two are managed at chair level, not by the full committee, and number about 50 waivers and 25 case reports per year.

The standard procedure of the committee is as follows. After applications have been received by the monthly deadline (usually the seventh of each month) they are scrutinised by a chair and subdivided into: • expedited (retrospective clinical record reviews, or secondary data analyses of established databases) • regular applications.

be tabled for the committee at each monthly meeting, the last Friday of the month. This report has the following headings – applicant name, department or organisation, title of proposed study, type of study, dates of study data col­ lection, permissions to do the study, data sheet showing the data to be collected, and any comments which include the registered degree if present. The final section is a recommendation to the committee under three headings: • approve (if all requirements are fulfilled) • approve subject to conditions (e.g. provision of written permission from a hospital CEO to do the study) • for discussion by the full committee to make a decision.

searching PubMed using the surname and initials of the person. Qualifications of these individuals were obtained from university records in the public domain.

Statistical analysis was completed using SAS for Windows (version 9.4, Cary, NC, USA). Descriptive statistics were used as well as χ2-test (initial screening) and logistic regression analysis (Proc Catmod with maximum likelihood estimates) as the definitive test. The p-value for statistical significance was set at p<0.05 and p-values shown are for the logistic regression analysis.

Graphs were drawn using Prism (Version 4, GraphPad Software Inc., San Diego, CA, USA).

A global decision is made for recommended approvals for the first two bullet points above; applications in the discussion group are each evaluated as regular applications. Administrative procedures take approximately 10 - 14 working days to convey committee decisions to an applicant. Time taken to obtain approval, subject to conditions or amendments, relies on speed of feedback and compliance by applicants before final clearance can be issued. From January 2013 the type of a higher degree linked to an appli­ cation has been recorded for possible auditing.

Publication record for each supervisor or independent researcher was obtained by

Numbers of applications 2011 - 2013

160

actual 2012 actual 2013

140

Results

The trends in application numbers for 2011 tho­rough 2013 are shown by month in Fig. 1.

The wave-like monthly pattern is influenced by departmental deadlines for submission of research proposals, grant application deadlines, university vacations and public holidays. Easter usually closes the university first term and is regarded as a strategic academic calendar milestone. Based on an estimated additional 250 applications per year from 2011[4] the expected increase to 2012 was from 685 to 935 (36%) and for 2012 to 2013 from 935 to 1 185 (27%). Actual

Jan - Nov, Total Expedited % 2011: 685 35% 33% 2012: 845 31% 2013: 769

actual 2011

150

predicted 2013

130 Number of applications

linked to the level of research activity within the postgraduate environment[8] which by extension, encompasses supervisor research experience. For this reason a number of per­ tinent variables were included in the study to assess their influence on ethics application success, committee recommendation and time taken for approval. These variables were: qualifications and publication record of the supervisor; school of applicant origin; type of research method and degree for which the research is intended (if any). In the case of supervisor publication record, a threshold of four or more publications was used as an indicator of independent research expertise.[9] The current study was undertaken with three objectives: • To assess the total number of general research applications evaluated by the full HREC (Medical) from 2011 through 2013 and to substantiate or refute predicted changes from year to year • To determine the proportion of clinical Master’s applications (MMed, MDent) of all applications in 2013 • To examine trends in types of applications and influencing variables in applications reviewed in January through June 2013.

120 110 100 90 80 70 60 50 40 30

Note: expedited applications = retrospective record reviews and secondary data analysis 1

2

3

4

5

6

7

8

9

10

11

12

Months

All the expedited applications are allocated to a chair and one committee member for preparation of a concise standardised report to

Fig 1. Pattern of actual applications by month for 2011 – 2013 and predicted number for 2013 assuming the same proportion per month as the actual applications in 2013.

May 2015, Vol. 8, No. 1 SAJBL

15

ARTICLE

Table 1. Clinical Masters (MDent / MMed) and other applications by type of review evaluated by the full HREC (Medical) in 2013 Type of reviews Expedited

Regular

Total

Category

n

col %

row %

n

col %

row %

n

col %

row%

MDent / MMed

94

39

55

78

15

45

172

22

100

Undergraduate / honours degrees / Other M degrees / PhD

35

15

18

165

31

82

200

26

100

Not for higher degrees

110

46

28

287

54

72

397

52

100

Total

239

100

530

100

769

100

col = column

changes (2011 - 2012) were a 23% increase from 685 to 845 followed by a 9% decrease (20122013) from 845 to 769. The total number seen in 2013 (769) was 416 applications less than the predicted 1 185 for 2013. The predicted spread, assuming the same proportion per month, is shown in Fig. 1 and illustrates the potential increase in workload.

Numbers of applications for clinical Masters and other degrees in 2013 In 2013 it was possible to tabulate, from committee minutes, the purpose of appli­ cations throughout the year (Table 1). Clinical Master’s candidates affected by the HPCSA regulation numbered 172/769 (22%) of applications. Other degrees (undergraduate or honours) and other Masters and Doct­ orates, comprised 26% while the majority, 52%, was not for higher degrees. Expedited applications (retrospective clinical record reviews and secondary data analyses num­ bered 239 (45%). Within the three appli­cant categories the row percentage showed that clinical candidates had a slight preference for expedited applications; the other two categories had strong preferences for regular applications.

Trends in applications: January – June 2013 The rest of this article describes trends in the 407 applications reviewed for January through June 2013, for which anonymous detailed records were kept. Table 2 shows decision rates, at the initial review of an application, then the rates of final decisions including initial approvals and the outcome of revisions. Of the 407 applications during the 6-month study period, 24% were approved at the initial review, two-thirds needed minor revision, 4% required major revision, and 6% were not approved in the

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May 2015, Vol. 8, No. 1 SAJBL

Table 2. Decision rates for applications to full HREC (Medical) January – June 2013 Decision at initial review Approved row %

Minor revision row %

Major revision row %

Not approved row %

Expedited n=127

37

62

0

1

Regular n=280

18

68

6

8

Total n=407

24

66

4

6

Type of applications

Final decisions Approved row %

Removed from agenda row %

Not approved row %

Expedited n=127

95

5

0

Regular n=280

78

22

0.4

Total n=407

83

17

0.3

Type of applications

Table 3. Research method by cluster January – June 2013 Independent research Method

Supervised research

row %

col %

row %

col %

Epidemiology n=64

28

19

72

15

Intervention n=48

33

17

67

10

Interview / focus group n=53

32

18

68

12

Laboratory n=46

22

11

78

12

Observation n=30

3

1

97

9

Record review – prospective n=24

37

10

63

5

Record review – retrospective n=106

10

12

90

30

Secondary data analysis n=64 Total n=405*

32

12

n

row %

col %

93

23

100

68 n row% 312

77

7 col % 100

*data for two individuals missing

form submitted. The final review increased approvals to 83%, and lowered the number not approved to 0.3% but 17% were removed from the agenda for reasons of non-response (done at the end of three months after the first review month). Expedited applications had higher approval rates and a lower proportion removed from the agenda than regular applications.

The applicants were subdivided into two clusters; an independent research group with no supervisor, and a supervised research group consisting of students working towards a higher degree and individuals needing supervision but not towards a higher degree. Table 3 lists the eight research methods by rates of independent and supervised research overall. The most

34 8 106 26

0 0

24 6 30 8 46 11

0 37

53 13 48 12

13 25 Supervised 8

64 16 Total

col n col %

405 100

13

13

8 0

0 39

0

17

0

8 0

23 8

25 42

11 Supervised 28

Independent 12 Non-Wits

19

0

0 17

2 5

0

0

2

17 17

27 13

33 17

29 Supervised 55

Independent 6 Wits miscellaneous

20

2

33 0

25 17

0

0

8

0 0

0 17

33 33

25 Supervised 12

Independent 3 Therapeutic Sciences

0

8

0 0

6 46

0

0

40

0 43

0 0

0 57

4 Supervised 48

Independent 7 Public Health

0

4

22 11

10 39

0

0

6

44 22

8 9

0 0

14 Supervised 145

Independent 9 Pathology

7

7

13 17

6 6

0

13

33

8 21

6 39

19 9

0 Supervised 18

Independent 53 Clinical medicine

0 0 67 Independent 3

0

11

0

0 0

Schools

Anatomy/Oral Health/ Physiology

Research cluster row n

33

0

Secondary data analysis Independent col n=11 Supervised col n=23 row % Record review – retrospective Independent col n=11 Supervised col n=95 row % Record review – prospective Independent col n=9 Supervised col n=15 row % Observation Independent col n=1 Supervised col n=29 row %

Method

Laboratory Independent col n=10 Supervised col n=36 row % Epidemiology Independent col n=18 Supervised col n=46 row %

Intervention Independent col n=16 Supervised col n=32 row %

Interview / focus group Independent col n=17 Supervised col n=36 row %

Table 4. Research method by school for independent researchers (n=93) and supervised research (n=312). Cell row percentages are highlighted when clear preferred research methodologies per research cluster within each school occur

ARTICLE common method was a retrospective record review (n=106) followed by epidemiology and secondary data analysis both at n=64. Least frequent was observation (n= 30). There were no statistically significant differences between research methods in the two clusters.

Next, the research method used was examined across seven academic groupings (schools) for independent researchers and for supervised researchers (Table 4). For independent researchers epidemiology showed the highest percentage in three groupings: • The combination of the schools of Ana­ tomical Sciences, Oral Health Sciences and Physiology • Public Health • Non-Wits applications.

Intervention was favoured by Wits miscellaneous applications; interview/ focus groups by Clinical Medicine and the School of Pathology preferred laboratory studies. An important caveat in Table 4 is the small sample sizes of the independent research methodologies, which is between 1 and 17, low for firm, statistically based conclusions. Supervised research had larger numbers (ranging from 15 to 95) utilising the research methods, thereby strengthening the rigour of conclusions. The comparison of percentages show distinct variations in preferences with independent researchers using research methodologies quite dif­ ferent from those used by supervised candidates within a single school.

Statistically significant influences on committee decision at initial review were weak for research method (p=0.03; Table 5), strong for school (p=0.003) and none for cluster.

In Table 5 the decision rates at initial review for the study methods are listed. For statistical analysis major revisions and ‘not approved’ decisions were combined into ‘serious revision’. The highest approval rates were for retrospective record reviews, secondary data analyses and laboratory studies; these also had the lowest rates of serious revisions.

Logistic regression analysis showed a strong statistical role of research method (p=0.001) but no significance for cluster (supervised or independent research).

Rates of research method use by registered degree are shown in Table 6. Within each degree group there is a spread of method

May 2015, Vol. 8, No. 1 SAJBL

17

ARTICLE choices. The highest rates are as follows: no degree – prospective record review; undergraduate degree – retrospective record review; honours degree – observation; clinical Master’s – retrospective record review; other Masters – observation; and Doctorate – laboratory. Initial review decisions (Table 7) show the highest approval rate for honours degrees (57%) with a steady decline through to the lowest for Doctorates (14%). The highest serious revision rate was for doctorates and the lowest for undergraduates. Statistically there was a strong influence of research method (p=0.002) and a less powerful effect of registered degree (p=0.01) on the initial review decision.

The effects of a supervisor research degree and publication group on initial review decisions are shown in Table 8. Faculty regulations require Doctoral students to be supervised by a person with a Doctorate; someone with a Masters may only be a co-supervisor. The four instances of the latter were excluded from the analysis. Approval rates by a supervisor’s research degree ranged from 17 to 26% with irregular variations in approval rate for the type of registered degree (13 to 53%). The only statistically significant influence was for the undergraduate and honours degrees where supervisors without a research degree had double the approval rate (p=0.01) of supervisors with a research degree. This is

Table 5. Decision rates at initial review for all applicants by research method.

Method

Approve row %

Minor revision row %

Serious revision row %

Epidemiology v=64

14

69

17

Intervention n=48

17

62

21

Interview / focus group n=53

19

70

11

Laboratory n=46

33

65

2

Observation n=30

7

70

23

Record review – prospective n=24

8

83

8

Record review – retrospective n=106

37

62

1

Secondary data analysis n=64

32

65

3

Total n=405

probably due to simpler research projects.

Candidates having a supervisor with a PhD were more likely to submit an application requiring serious revision compared to those whose supervisor had a Master’s degree. No significant influence was found on approval rates for supervisors in the two publications groups.

Table 9 displays the month in which an application was approved by school grouping; the same month as the meeting is the ideal. Greater than four months after the first review month indicates no res­ ponse forthcoming from the applicant. The greatest delay was in the non-Wits group (20%) which also had the highest rate for no response. Absence of a response was lowest in Public Health (5%) and Pathology (11%), with the remaining school groups between 18 and 20%. The highest approval rate in the same month was in Pathology.

When the cumulative percentages, from the same month to the fourth after a committee meeting are examined, the Wits schools have three-quarters of applications approved by the third month. The only variable that influenced the rates was school (p=0.002).

Discussion

n

col %

n

col %

n

col %

96

24

270

67

39

9

The 23.4% increase in applications for 2011 to 2012 fitted fairly closely into the anticipated annual increase because of the new HPCSA requirements of completion of a dissertation in order to register as a clinical specialist.[1] However, the 9% decrease from 2012 to 2013 was a surprise because the number of clinical Masters registrations in the Faculty of Health Sciences was the same

Serious revision = major revision + not approved

Table 6. Research method by registered degree January – June 2013 No degree row %

Undergraduate row %

Honours row %

Clinical Masters row %

Other Masters row %

Epidemiology n=64

41

11

3

22

17

6

Intervention n=48

35

4

6

17

23

15

Interview / focus group n=53

34

13

5

13

24

11

Laboratory n=46

28

6

7

17

22

20

Observation n=30

7

17

23

7

37

10

Record review-prospective n=24

54

8

0

21

8

8

Record review-retrospective n=106

19

20

17

35

9

0

Secondary data analysis n=64

32

15

6

20

8

9

Method

Total n=405* *Data for two individuals missing

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May 2015, Vol. 8, No. 1 SAJBL

Doctorate row %

n

col %

n

col %

n

col %

n

col %

n

col %

n

col %

120

30

52

13

37

9

88

22

74

18

34

8

ARTICLE

Table 7. Decision rates at initial review for all applicants by registered degree.

Approve row %

Minor revision row %

Not for degree n=120

20

69

10

Undergraduate n=52

17

77

6

Honours n=37

57

35

8

Masters – clinical n=89

21

71

8

Masters – other n=74

23

66

11

Doctorate n=35

14

66

20

Registered degree

Total n=407

Serious revision row %

n

col %

n

col %

n

col %

96

24

271

66

40

10

Serious revision = major revision + not approved

Table 8. Decision rates at initial review for supervised applicants by research degree and by publication group of supervisor. Mean column percentages are shown in bold.

Decision at initial review Supervisor’s research degree n

Doctorate

Masters

113

148

None

52

Approve row %

Minor revision row %

Serious revision row %

Registered degree

n

Doctorate Clinical Masters Other Masters Undergraduate / honours

30 13 34 36

13 0 32 25 18%

67 85 47 58 64%

20 15 21 17 18%

Clinical Masters Other Masters Undergraduate / honours

59 29 56

25 17 22 21%

66 79 71 72%

9 4 7 7%

Clinical Masters Other Masters Undergraduate / honours

16 4 32

25 0 53 26%

75 100 44 73%

0 0 3 1%

Doctorate Clinical Masters Other Masters Undergraduate / honours

30 47 28 49

13 21 29 21 21%

67 75 57 63 66%

20 4 14 16 13%

Doctorate Clinical Masters Other Masters Undergraduate / honours

0 41 40 75

0 22 23 37 27%

0 66 67 59 64%

0 12 10 4 9%

Supervisor’s publication group

≥ 4 publications n=154

≤ 3 publications n=156

Serious revision = major revision + not approved

in 2012 and 2013; so far the reason for the decrease is unknown.

Of the 769 applications, clinical Masters comprised 22% almost equally split between expedited and regular applications. We had anticipated that the expedited type

would proportionately be about double the regular sort for clinical Masters because of the relative ease of that type of study. There were almost equal numbers of applications from postgraduates and from individuals not attempting a higher degree.

Biomedical ethics approval is a very specific type of application and different to other research fields. This has been used to justify the extended times often encountered in the healthcare-based ethics approval process. For instance, Hunter[7] reports that approximately 15% of medical applications receive approval immediately. By contrast, Doyle, Mullins and Cunningham[12] report that a business school ethics committee approved 62% of applications immediately.

Despite additional staffing and the introduction of procedural efficiencies, our results show that only 24% of applications got immediate approval at the monthly meeting during which applications are first reviewed (Table 2), rising to 34% in the same month as the committee meeting. By the second month after the initial assessment, two-thirds of applications had been approved and three-quarters by the third month (Table 9). This means that, allowing for the submission month prior to the initial meeting and the administrative procedures linked to clearance, most applicants are able to pursue their research four months after submitting their application, a finding corroborated by Clarke.[13] Within the compressed time frames of clinical registrar training, a four-month down time in their research programme is onerous. Ideally, supervised research applications should be submitted well before research begins to allow optimal use of registrar training time frames; in reality this seldom happens. The lack of response from applicants, 17% by the fifth month, is a phenomenon previously seen.[4] Discussions with other South African university research ethics committee chairs report the same pattern. The reasons are unknown but speculation suggests possible loss of interest in a project or inability to raise research funds. To the committee’s knowledge such studies are not embarked upon without ethics approval.

Unfortunately the resources spent in terms of time and energy, for the 76% of applications which were returned for clarification or amendment, are heavy for both committee members and researchers. Additionally, the ‘back-andforth’ research ethics review and decision process also imposes further work on already overburdened faculty postgraduate supervisors.[11] A conundrum often faced by our committee, when returning the 76% of applications for ‘compliance problems’[3] has

May 2015, Vol. 8, No. 1 SAJBL

19

ARTICLE

Table 9. Cumulative month of ethics approval in relation to committee meeting for all applicants by school

Faculty of Health Sciences schools

Same month

Month after committee meeting

cum %

1 cum %

2 cum %

3 cum %

4 cum %

No response %

Clinical medicine n=199

33

48

66

74

81

19

Anatomical/Oral Health Sciences/Physiology n=21

33

48

71

76

81

19

Pathology n=57

70

77

84

86

90

10

Public health n=19

37

47

74

90

95

5

Therapeutic sciences n=58

21

35

68

76

81

19

Wits miscellaneous n=33

21

42

70

79

82

18

Non-Wits n=20

10

45

50

60

80

20

Total n=407

n

cum %

n

cum %

138

34

201

49

n cum % 274

67

n

cum %

n

cum %

col

n%

312

77

337

83

407

100

cum = cumulative

been described by Doyle et al[12] as follows: ‘Should poorly completed applications with multiple grammatical and typing errors, providing vague and/or contradictory information about what appears to be nevertheless a completely innocuous project be approved on the basis that there are no ethical issues involved? Should they be rejected on the basis that the applicants have failed to engage properly with the process and have demonstrated a lack of respect for research ethics review? Should the committee be concerned with ensuring that the researcher has demonstrated that he/she has taken the time to thoughtfully consider all potential harm that may be caused by the research by completing the application form carefully and comprehensively or should standard answers copied from other application forms that have been approved, suffice?’ It is our experience that supervisors frequently sign applications that fit into Doyle et al’s[12] description, influenced we believe by time and deadlines as much as anything else. The Wits HREC (Medical) has yet to reach consensus on this conundrum when weighing up its dual accountabilities: firstly towards the university which, after all, bears the responsibilities of research conducted within it and secondly the postgraduates who entrust their intellectual growth and efficient throughput to the very same institution.

A statistically significant effect on the committee’s initial review decision was found for three variables: research method (at two values depending on the variable grouping (p=0.03, p=0.002); school (p=0.002) and registered degree (p=0.01). Our view is that these variables are proxies for interactions of the variables studied and others not known. A particularly unexpected finding was that within the statistically significant effect of supervisors’ research degree (p=0.002), supervisors without a research degree (Masters or Doctorate) had the highest committee approval rate and lowest serious revision rate.

Supervisors with a Doctorate had the lowest approval and highest serious revision rates. It had been anticipated that supervisors with a higher publication rate would have better committee decision results but this too was not seen. Perhaps the threshold for research expertise was set too low. The ≥4 publications chosen was originally calculated in a review of postgraduates over 53 years;[9] it showed that persons with that number of publications continued to do research in their lifetimes. Other speculative explanations include that supervisors with

20

May 2015, Vol. 8, No. 1 SAJBL

a PhD may be so busy that they have little time to spend with their postgraduates or may suggest supervision of particularly complicated projects. Likewise, having gained a PhD, the supervisor may regard the ethics application procedure as a beneficial independent learning exercise and prefer to stand back to allow candidates to learn for themselves. Tilley[10] raises the issue of supervisors who do not take the task of correctly completing an ethics application form seriously, thereby making the work of the ethics review board much more difficult when dealing with such cases involving postgraduates.

Undergraduate research projects are generally at a lower level which may have influenced the higher approval rate seen with supervisors without a higher degree since such supervisors frequently gain initial experience aiding undergraduates.

It seems that having a supervisor with a PhD or with an independent research record does not mean a candidate is able to submit a competent application. Facilitation of the ethics approval process all depends on the ability and experience of the supervisor in understanding the nuances of the ethics process. Buttery, Richter and Filho[11] opine that a supervisor with no or little experience adds nothing to the research process (and by extension obligations of ethical approval) as far as the student is concerned. Worse still, a poorlytrained supervisor compounds the effects of poor supervision by exacerbating rather than overcoming the complexity of ethical issues related to research. To overcome such problems Hunter[6] suggests that a supervisor should be encouraged to attend ethics meetings with the candidate as this improves the chances of applications being approved. This is echoed by Tilley[10] who suggests that understanding how to shape an ethics application that would be approved in an efficient manner will be greatly beneficial to all stakeholders. Our belief is that supervisors need formal training and should begin by being a co-supervisor with an experienced supervisor for perhaps two projects before appointment as the sole supervisor.

The last surprising finding of this study was that research methodologies used in supervised research were quite different to those used by independent researchers within the same school.

This implies that two deliberate research tracks are at play. In the postgraduate research track, research topics are tailored to optimally meet the requirements of the degree. Pertinently, the retrospective

ARTICLE record review is regarded as a ‘simple’ study method and was utilised by the majority of clinical Masters candidates, a finding supported

by Clarke.[13] On the other hand an independent research track fulfills either a school research programme or follows a personal research interest requiring more complex research strategies. It is also not clear whether limited research resources are preferentially being funnelled towards postgraduate research outputs to meet university targets of increasing graduation throughputs. Exactly what knock-on effect this has on the current paradigm, where the creation of new knowledge is a cornerstone of the goals of a knowledge-based economy, can be only speculated upon. It would be interesting if our finding of dichotomous research methodologies supporting independent and supervised research is substantiated by others.

Finally, this article does not deal with reasons for the HREC (Medical) not approving applications at first review; an earlier publication gives insight into this matter.[14]

Conclusion The results of a retrospective examination of applications to the Wits HREC (Medical) have shown some surprising features. A predicted continuous increase in number of applications from 2011 to 2013, based on an HPCSA requirement for a dissertation by clinicians to register as specialists, did not happen in spite of no change in numbers of registered clinical postgraduates. While statistically significant influences on the decision at first review of applications were found for method of research, school, and registered degree, expected roles of categorising supervisors by research degree held and publication grouping had no influence other than a minor one for undergraduate/honours degree applicants. This article shows that ethics application data can be used as a barometer to indicate early grassroots movements by faculty to meet demands in postgraduate throughput and as a feeler to shifting faculty research currents.

Given the current emphasis on research output and pressure on staff, including inexperienced individuals, to supervise research we recommend completion of at least a short basic training in supervision including what ethics committees look for in applications. Hopefully this would help supervisors, supervisees and ethics committees and increase the speed though the latter.

Acknowledgements. We are grateful to the HREC (Medical) secretariat, Mrs Anisa Keshav and Ms Zanele Ndlovu for assistance with tracing some application details and to Prof. Paul Fatti, emeritus professor of statistics at the University of the Witwatersrand for his statistical advice.

References 1. Health Professions Council of South Africa: Subcommittee for Postgraduate Education and Training. New requirements for the registration of specialists in South Africa. 2012 http://www.hpsa.org.sa/downloads/medical_dental/new_ requirements_for_registration_of_specialists_in_sa.pdf (accessed 24 February 2011).

2. Republic of South Africa, National Health Act, No. 61. Government Gazette 2004. http://www.section27.org.za/wp-content/uploads/2010/03/national-health-act. pdf (accessed 25 November 2013).

3. Allen G. Getting beyond form filling: The role of institutional governance in human research ethics. J Acad Ethics 2008;6(2):105-116. [http://dx.doi.org/10.1007/ s10805-008-9057-9] 4. Cleaton-Jones P. Applications and secretariat workload at the University of the Witwatersrand Human Research Ethics Committee (Medical). S Afr J BL 2012;5(1):38-44.

5. Republic of South Africa. National Development Plan – Vision for 2030. Pretoria: The Presidency 2011. http://www.npconline.co.za/medialib/downloads/home/ NPC%20National%20Development%20Plan%20Vision%202030%20-lo-res.pdf. (accessed 27 May 2014).

6. Academy of Science of South Africa. The PhD Study. Pretoria: Academy of Science in South Africa, 2010.

7. Hunter D. A hands-on guide on obtaining research ethics approval. Postgrad Med J 2011; 87(1030):509-513. [http://dx.doi.org/10.1136/pgmj.2010.109348] 8. Park C. The research student experience: Lessons from PRES. York: Higher Education Academy, 2009. http://www.heacademy.ac.uk/assets/York/documents/ourwork/ postgraduate/PRES2009.pdf (accessed 15 November 2010).

9. Grossman ES, Cleaton-Jones PE. What becomes of dental research trainees once they leave the Dental Research Institute? An analysis over 53 years. Eur J Dent Educ 2008;12(2):69-74. [http://dx.doi.org/10.1111/j.1600-0579.2008.00471.x.]

10. Tilley SA. A troubled dance: Doing the work of research ethics review. J Acad Ethics 2008;6:91-104. [http://dx.doi.org/10.1080/03075079.2012.709495] 11. Buttery EA, Richter EM, Filho WF. An overview of the elements that influence efficiency in postgraduate supervisory practice. Int J Educ Management 2005;19:7-26. [http://dx.doi.org/10.4236/ce.2014.522214] 12. Doyle E, Mullins M, Cunningham M. Research ethics in a business school context: The establishment of a review committee and the primary issues of concern. J Acad Ethics 2010;8:43-66. [http://doi/10.1007/s10805-010-9108-x] 13. Clarke DL. Auditing the process of ethics approval for Master’s degrees at a South African university. S Afr J BL 2014;7(1):23-25. [http://dx.doi.org/10.7196/ SAJBL.301] 14. Cleaton-Jones P. Process error rates in general research applications to the Human Research Ethics Committee (Medical) at the University of the Witwatersrand; a secondary data analysis. S Afr J BL 2010;3(1):20-24.

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ARTICLE

Boni mores and consent for child research in South Africa A E Strode, BA LLB, LLM, PhD; J Toohey, LLB; P Singh, BCom, LLB, LLM; C M Slack, BA Hons, MA 1

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

Corresponding author: A E Strode (strode@ukzn.ac.za)

Consent is required for almost all health research. In order for consent to be valid a number of requirements must be met including that the consent cannot be contra bonos mores or contrary to public policy. This principle has its roots in the common law and it is used to ensure that the consent to harm, or the risk of harm, is permitted or ought to be permitted by the legal order. Recently, it has also become a statutory requirement embedded in the consent obligations relating to non-therapeutic health research with minors. Section 71 of the National Health Act provides that the Minister of Health (or potentially his or her delegated authority) must provide consent to non-therapeutic research with minors. However, such consent may not be granted if ‘the reasons for the consent to the research or experimentation are contrary to public policy’. Limited work has been done on how to determine when consent to health research with children would be contrary to public policy.

This article attempts to begin the debate by describing the boni mores principle, setting out some of the general factors that could be used to assess whether consent is consistent with it and suggesting how they could be applied to health research.

The article concludes by stating that simply requiring proxy consent for non-therapeutic health research with children is insufficient as it cannot always be assumed that proxy consenters will act in the best interests of the child. Thus the boni mores principle acts as a limit on autonomy in order to protect the child participant. It is further submitted that establishing when consent to health research is consistent with public policy requires an assessment of whether the research is consistent with constitutional values, prevailing legal norms regarding children, and an assessment of the legal convictions of the community.

S Afr J BL 2015;8(1):xx-xx. DOI:10.7196/SAJBL.346

It is a well-established international law principle that participation in most forms of health research is dependent on participants or their proxies providing informed consent.[1,2] Likewise, South African law provides that consent is required for almost all health research.[3,4] Section 71 of the National Health Act (NHA) requires that if the participants in health research are minors, proxy consent must be provided by their parent or legal guardian[4] and minors who are ‘capable of understanding’ may also provide consent alongside their parent or guardian.[4] If participants or their proxies have consented to the health research, the legal maxim volenti non fit injuria (to one consenting no harm is done) applies, and this can be used as a defence by researchers or sponsors. However, in order for it to operate as a defence, four statutory and common law requirements must exist:[5] • the consent should have been provided in writing[4] • it should have been voluntarily given[6] • the consent should have been informed by an appreciation of any possible negative or positive health consequences that the research may pose[7] • the consent may not be contra bonos mores (against good morals or public policy)[8] The fourth requirement for informed consent – that of requiring it not to be contra bonos mores, i.e. contrary to the legal convictions of the community or inconsistent with public policy – has its roots in the common law principles which were adopted from Roman and Roman Dutch law.[8] It applies to all forms of consent and is used to ensure

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that the consent to harm, or the risk of harm, is permitted or ought to be permitted by the legal order.[8] Recently, it has also become a statutory requirement embedded in the consent obligations relating to non-therapeutic health research with minors.[4] Section 71 of the NHA provides that the Minister of Health (or potentially his or her delegated authority in terms of section 92 of the NHA) must provide consent to non-therapeutic research with minors.[4] However, such consent may not be granted if ‘the reasons for the consent to the research or experimentation by the parent or guardian and, if applicable, the minor are contrary to public policy’.[4] Although these sections in the NHA were operationalised on 1 March 2012 they were not accompanied by regulations so some Research Ethics Committees (RECs) did not require compliance with them. However, on 19 September 2014 the Minister of Health published regulations relating to research with human participants.[9] These regulations included a potential delegation of his authority to provide ministerial consent to non-therapeutic research with minors to RECs.[9] This means that further legislative consent requirements have now been introduced and added to the current requirements described above and RECs must comply with all of them.

This article attempts to address the lacunae of research into when consent is contrary to public policy by describing the boni mores principle, setting out some of the general factors used to assess whether consent is consistent with it and also suggesting how these factors could be applied to the issue of granting ministerial consent for non-therapeutic health research with children. This article does not critique the restrictive nature of current consent norms as that has been done elsewhere. [10,11]

ARTICLE Contra bonos mores

Boni mores and child research

Our courts have long held that consent can only validly operate as a defence if the act being consented to is not contra bonos mores.[8] At the heart of this principle is an acceptance that consent – even voluntarily given – must be consistent with public policy. For example, the courts have held that consent to a caning as a form of discipline in the workplace was invalid.[12] Likewise, consent to dangerous car racing in the street was considered contra bonos mores.[13] In essence, this principle places a limit on individual decision-making by requiring the reason for the consent to meet an objective legal standard – regardless of voluntariness. In this context, the perception of the consenter regarding the validity of their consent is not relevant.[8] Key factors used to establish whether the consent is valid include constitutional values, prevailing legal norms and public opinion, discussed in more detail below:

The issue of when research with children would be contrary to public policy has been rigorously debated, with most writers focusing on the vexing issue of non-therapeutic research given that it does not typically offer participants any direct benefit and requires them to act altruistically. Key issues have included: • Whether parental consent to research investigating illegal activity would be contra bonos mores? [19] • Whether unacceptable levels of risk are illegal?[18] • Whether proxy consent for non-therapeutic research should be limited?[20,21]

Constitutional values The constitution is founded on a number of values – including human dignity, the achievement of equality and the advancement of human rights and freedoms, non-racialism, and non-sexism.[3] These values are used as both a tool of interpretation (with courts having to favour an approach which protects the constitutional values) and as an objective standard against which conduct can be measured.[14] The courts have held that the concept of boni mores is ‘now deeply rooted in the constitution and its underlying values’.[5]

Prevailing legal norms Consent must be consistent with prevailing legal norms.[12] This requires consideration of the legal norms governing the act being consented to – in order to establish whether the consent is lawful.[12]

Public opinion In some instances the courts take note of public opinion or morality, in establishing whether consent is contra bonos mores.

In other words the principle is partially shaped by religious, ethical and moral perceptions of right and wrong. The courts will, however, only consider public opinion when the views of the society strongly require legal sanction for the type of behaviour that was consented to.

Using the boni mores principle to establish the validity of consent to health research There has been limited academic discussion about when health research would be contra bonos mores. At a macro level, it has been argued that participants should not be allowed to consent to research if it is likely to result in the discovery of knowledge that is inappropriate for human beings to process,[16] or when such knowledge may be misused in human hands, for example, developing instruments for killing or injuring humans.[16] At a more micro level, it has been argued that research would be contra bonos mores if it is not being conducted properly, or the risks to participants are unacceptably large and not sufficiently offset by the benefits to participants or society.[7,17-19] Others submit that if researchers do not comply with substantive and procedural requirements for approving research – for example, if a study does not obtain ethical approval for consent to participation – this would be contra bonos mores.[7]

For example, prior to the NHA, Van Wyk submitted that nontherapeutic research with children should only be possible if it was classified as being observational in nature and did not pose more than a minor increase over minimal risk.[18] We submit that when assessing whether consent to health research with children is contrary to public policy RECs should consider the nature of the study, how it will be carried out and make an assessment of whether consent would be appropriate in the broad circumstances. Possible concerns could include, among others: consent to research investigating illegal behaviours (such as drug use or prostitution) or legal but sensitive behaviour (such as adolescent same-sex activity); or the possible motivation of potential consentors.

We argue that the general principles articulated above could form a useful framework for evaluating the validity of such consent. We suggest that these principles could be applied in the following way:

Constitutional values The consent would need to be consistent with constitutional values.

In other words, the research should not violate the basic constitutional and human rights of child participants – including their rights to dignity and equality (especially on the grounds of race and gender). It is hard to imagine research that could be ethical but still violate these constitutional values – given that a core part of an REC’s mandate is to protect the rights of participants. National ethical guidelines require RECs to ensure that human subjects are treated with dignity, that their well-being is promoted, and that consent procedures are adequate.[22] Key questions that could be asked to establish if the study is consistent with constitutional values – and hence public policy – would include the following: • To what extent does the study treat the child participants with respect, and protect their constitutional rights?

• Does the study select potential child participants fairly and avoid the unjustified targeting of a particular sub-group?

• Does the study include appropriate and justified incentives for enrolment of child participants?

Prevailing legal norms The consent needs to be consistent with prevailing legal norms governing research with children – which are established in the constitution, the NHA, and other relevant legislation such as the Children’s Act.[3,4,23] A key legal norm in this context is the concept of the best interests of the child. Section 28(2) of the constitution states that a child’s best interests are of paramount importance in every matter concerning the child.[3] Our courts have generally held that in applying this

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ARTICLE principle a wide range of factors should be considered to establish if a decision concerning a child will promote their physical, moral, emotional and spiritual welfare. Section 7 of the Children’s Act contains a non-exhaustive list of the factors that ought to be used when applying this principle.[23] None of these principles are research specific but many are broad enough to be useful in this context.

Other relevant legal norms are those in the NHA which provide that both therapeutic and non-therapeutic research with minors is lawful if the requirements in the Act are met.[4] The NHA requires children to be scientifically indispensable to the non-therapeutic study and an obligation is placed on researchers to demonstrate why the data cannot be obtained from adults.[4] It also sets a standard of acceptable risk by stating that the non-therapeutic research with minors must not pose a significant risk to their health.[4] The other key piece of legislation describing children’s health rights is as mentioned above, the Children’s Act.[23] It requires adults to promote a child’s well-being and to protect children from discrimination, exploitation and any other physical, emotional or moral harm.[23] It also describes a number of other health rights of children, such as the age at which they may consent for example to medical treatment, HIV testing, and use contraceptives.[23] It is possible that other legal norms would also have to be considered – depending on the nature of the study. For example, if researchers are investigating child labour, consideration may need to be given to the norms in employment laws. It is worth noting that consent to research that does not comply with legal norms may be inconsistent with public policy if we follow the approach in English law[24] where courts have consistently held that one can never consent to illegal activity as this is by its nature contra bonos mores.

For consent to health research to be accepted as legal consent it must be permitted by the legal order. The complexity with applying this principle is that the approach to children’s health rights in the NHA and the Children’s Act are divergent. For example, while the Children’s Act recognises the evolving capacity of children to consent independently to certain health interventions the NHA does not.[11] Key questions that could be used to establish whether consent is consistent with prevailing legal norms include: • Has the child research met all the procedural requirements established by law – such as ethical approval?

• Will all substantive requirements that need to be met – such as compliance with mandatory reporting requirements – be complied with?

• Is it in the best interests of the child?

• What are the potential risks and harms of research participation, and do they fall below the accepted legal standards?

• Will children be exploited by, for example, asking them to assume an unfair level of risk in relation to the expected benefit for them or the group they represent?

Public opinion or community morals The consent would need to be acceptable to community morals, as reflected by the community’s legal convictions – i.e. its laws. This is a complex factor and it cannot be equated to public opinion. For example, even though public opinion may be opposed to terminations of pregnancy (TOP) below the age of 18, this would not necessarily mean that research into TOP would be inconsistent with public policy.

Likewise, research per se into illegal or ‘immoral’ behaviours is not

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necessarily against public policy – even though the community may disapprove of the behaviour. For example, research exploring factors that impact on risky sexual practices of adolescents might be frowned upon by some stakeholders but this would not mean that research on the topic would be against public policy if conducted in accordance with the legal framework.

Furthermore, ethical guidelines form an important indicator of public policy, as in many instances they reflect the moral convictions of the community. Therefore, if the research complies with current national ethical guidelines it is likely to be consistent with the boni mores principle. The complexity with applying this principle is that in some instances research may comply with key ethical norms but not with legal norms, for example, current ethical guidelines allow caregiver consent for certain forms of child research while the NHA prohibits such an approach.

Key questions that could be used to establish whether consent is consistent with community morals include: • Is it ethical?

• Is the research lawful?

• Will the study violate a child’s constitutional rights?

• Would the research be acceptable to the community?

Using the boni mores principle to determine whether ministerial consent may be granted for non-therapeutic research in children Section 71(3) of the NHA provides that ministerial consent for nontherapeutic research with minors may not be given if the reasons for ‘the consent to the research or experimentation by the parent or guardian and, if applicable, the minor are contrary to public policy’[4] Form A in the regulations (the application for ministerial consent) simply states that researchers ought to ‘explain why consent would be acceptable, for example, that the study poses acceptable risks and promotes the rights of minors’.[9] Although no further detail is provided it would appear from the wording of this section of the NHA that the drafters were concerned about the potential motivations consenters may have for agreeing to research participation.[4] We interpreted this to mean that the minister or their delegated authority should consider possible reasons consenters may have for enrolling children in the study, for example the appropriateness of incentives for study participation, and their potential influence on consent. This assessment cannot be an individual, subjective assessment of each individual consenter’s motivation but should rather be a general consideration of possible reasons potential participants may have for joining the study. We would argue further that the general principles articulated above would apply to this assessment. It is, however, a narrower approach because for the purposes of ministerial consent there is no need to establish that the study itself is consistent with public policy, just the reasons for the consent.

Conclusions Requiring consent to be consistent with the boni mores principle or public policy acts as a limit on the personal autonomy of the consenter or proxy consenter. It is not uncontroversial in our constitutional era, as it limits autonomy which is an inherent part of the right to bodily integrity. While it may be argued that the principle is outdated, paternalistic and intrusive regarding adults – such arguments are

ARTICLE less likely to be justified when considering proxy consent to research with minors. There is a constitutional obligation to protect children from harm and to act in their best interests. Simply requiring proxy consent is insufficient as it cannot always be assumed that proxy consenters will act in the best interests of the child when electing whether to enrol them in health research.[25] Hence, it appears that the NHA places the obligation to establish whether the health research is consistent with the boni mores in the hands of the regulators of research rather than the proxy consenters as a protective measure.

It is submitted that establishing when consent to health research with minors is consistent with public policy requires an assessment of whether the research is consistent with constitutional values, prevailing legal norms regarding children, and the legal convictions of the community. This assessment is inextricably wound up in the review of whether the study is ethical. It is likely that a study judged by an independent REC to comply with prevailing national ethical standards would be consistent with public policy. Also, given that the public policy requirement in the granting of ministerial consent has been limited to a consideration of the potential reasons for consenting, it simply requires an assessment of whether agreeing to be in such a study would be consistent with the legal convictions of the community.

Acknowledements and disclaimer: The work described here was supported by the South African AIDS Vaccines Initiative (SAAVI) and the National Institutes of Health and entitled CHAMPS (Choices for Adolescent Methods of Prevention in South Africa) award number 1RO1 A1094586. The content is solely the responsibility of the authors and does not necessarily represent the official views of SAAVI or the National Institutes of Health.

This paper does not necessarily reflect the views of any institution or committee or council with which the authors are affiliated.

References 1. Nuremburg Code, 1946. http://www.state.nj.us/health/irb/documents/ nuremburg_code.pdf (accessed 1 June 2015).

2. International Convention on Civil and Political Rights, 1966. http://ec.europa.eu/ justice/policies/privacy/docs/16-12-1996_en.pdf (accessed 1 June 2014).

3. Republic of South Africa. Constitution of the Republic of South Africa, Government Gazette 1996;17678.

4. Republic of South Africa. National Health Act No. 61. Government Gazette 2003; 26595. http://www.info.gov.za/gazette/acts/2003/a61-03.pdf (accessed 2 June 2014).

5. R v. McCoy (1953) 1 All SA 459 at 11 D-H. 6. Esterhuizen v. Administrator, Transvaal 1957 (3) SA 710 (T) at 722.

7. Van Oosten F. The law and ethics of information and consent in medical research.

Tydskrif vir Hedendaagse Romeins-Hollandse 2000;63:18-31.

8. Neethling J, Potgieter JM, Visser PJ. The law of delict. 6th ed. Durban: LexisNexis Butterworth, 2010:36-40.

9. Republic of South Africa. Regulations relating to Research with Human Participants No. R719. Government Gazette 2014. http://www.google.co.za/ url?url=http://www.gov.za/documents/download.php%3Ff%3D214372&rct=j&f rm=1&q=&esrc=s&sa=U&ei=K9cuVI7lOczB7AbZvoDgDQ&ved=0CBMQFjAA&us g=AFQjCNFzstJM- YYP30mB55vAvWrZyCfWA (accessed 9 January 2015).

10. Strode A, Richter M, Wallace M, Toojey J, Technau K. Failing the vulnerable: Three new consent norms that will undermine health research with children. S Afr J HIV Med 2014;15(2):46-49.

11. Strode A, Slack C, Wassenaar D, Singh J. One step forward, two steps back – requiring ministerial approval for all forms of non-therapeutic health research with minors. S Afr Med J 2007:97(3):200-202.

12. S v. Collett 1978 (3) SA 206 (RA).

13. Santam Insurance Co v. Vorster 1973 4 SA 764 (A).

14. United Democratic Movement v. President of the Republic of South Africa and Others, (African Christian Democratic Party and Others Intervening; Institute for Democracy in South Africa and Another as amici curiae) (No 2) 2003 (1) SA 495 (CC) para 19.

15. African Dawn Property Finance 2 (Pty) Ltd v. Dreams Travel and Tours CC and Others 2011 (3) SA 511 (SCA) at paragraph 22.

16. Shapiro MH, Spece R.G. Bioethics and the law: Cases, materials, and problems.

West, Supplements 1981;118.

17. Kennedy I, Grubb A. Medical Law: Text and Materials. 3rd ed. Durban: Butterworth, 2000:1727.

18. Van Wyk C. HIV preventative vaccine research on children: Is it possible in terms of South African law and research guidelines? Tydskrif vir Hedendaagse Romeins Hollandse 2005;68:00.

19. WHO/UNAIDS/AAVP International Expert Group, Osmanov, S. Executive summary and recommendations from WHO/UNAIDS and AAVP consultation on: ‘The inclusion of adolescents in HIV vaccine trials’. 16-18 March 2006 in Gaborone, Botswana. AIDS 2007;21(14):W1-W10. [http://dx.doi.org/10.1097/ QAD.ob013e3282f086f5] 20. Smit RC. Clinical trials, children and the law. S Afr Med J 1977;2:155.

21. Burchell J. Non therapeutic medical research on children. S Afr Law J 1978;95(part 2):193-216.

22. Republic of South Africa. Department of Health. Ethics in health research: principles, structures and processes, 2004:59. http://ww.doh.gov.za (accessed 1 June 2014).

23. Republic of South Africa. Children’s Act, No. 38. Government Gazette 2005; 28944. http://ci.org.za/depts/ci/plr/pdf/bills/childrensAct38-2005.pdf (accessed 2 June 2014).

24. R v. Brown [1993] 2 All ER 75 http://www.cirp.org/library/legal/UKlaw/ rvbrown1993// (accessed 1 April 2015).

25. Coyne I. Research with children and young people: The issue of parental (proxy) consent. Children & Society 2010;24:227.

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ARTICLE

Reflecting on BCMP students’ experiences of professionalism during clinical rotations Nontsikelelo Mapukata-Sondzaba,1 MSc, BTech; Ames Dhai,2 MB ChB, FCOG (SA), LLM Division of Rural Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

1 2

Corresponding author: Nontsikelelo Mapukata-Sondzaba(Nontsikelelo.Sondzaba@wits.ac.za)

Background: The professional standards expected of individuals who commit to the practice of medicine require that they possess character traits that are consistent with and reflect the core values, principles and competencies of the medical profession.

Objective: The aim was to evaluate final year Bachelor of Clinical Medical Practice (BCMP) students’ experiences of professionalism during clinical rotations.

Method: Hatem’s definition of professionalism was the stimulus that guided 25 final year BCMP students’ reflections on their experiences of professionalism during clinical rotations. The students’ responses documented as portfolio entries were distilled into quantitative core values and subjected to an ethical analysis according to the guidelines as provided by the Health Professions Council of South Africa.

Results: There was a positive association between frequency of reflections and the positive nature of the experiences of professionalism for the majority of the contextual attributes (53.8%). Negative experiences of professionalism (46.2%) were context-specific and perceived by students as denying them an opportunity to attain professionally required skills.

Conclusion: BCMP students reflected on their professional development as a process that was influenced by individuals and a competency that was determined by the extent to which the team pulled together for the benefit of the patients and the students. The study has highlighted some of the ethical dilemmas related to context.

S Afr J BL 2015;8(1):xx-xx. DOI:10.7196/SAJBL.372

This article is a second article emanating from a larger study titled: Reflecting on professionalism: An analysis of Bachelor of Clinical Medical Practice (BCMP) students’ portfolios during clinical rotations. An article is already published as open access by BMC: Medical Education.[1] The aim of this article is to report on the experiences of professionalism as reflected on by final year BCMP students’ during clinical rotations.

The professional standards expected of individuals who commit to the practice of medicine require that they possess character traits that are consistent with and reflect the core values, principles and competencies of the medical profession.[2] As medicine is no longer considered only as a profession par excellence, the humanistic element is critical in the development of a professional identity.[3] Health sciences students are not yet professionals, but rather are professionals in training, and should be trained in the same environment in which they will practise.[4] As today’s healthcare provision is patientcentred, the requirement to maintain professional standards must be facilitated and modelled in the training environment to simulate a real setting, maintained and sustained in all heathcare facilities for the good of the patient.[5] This exposure allows students to meet the expectations of their patients and also be afforded an opportunity to simulate professional behaviour that is modelled on the conduct of their supervisors in the clinical setting. [6,7] This understanding of the attainment of professionalism not as an event but rather as a process obligates both the academic and the clinical environment to engage students in the attainment of a sound and professional ethic that will benefit patients and society.[5] Further to

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this, universities are required to meet the standards of professional education and training as prescribed by the Health Professions Council of South Africa (HPCSA) and prepare students for professional practice.[8] This was true for the BCMP programme which accepted its first cohort of students at the University of the Witwatersrand (Wits) in January 2009.[1] With a unique and integrated curriculum, the students are based in District Education Campuses in urban and/or underserved facilities in Gauteng or in rural facilities in the North West Province. On completion of their studies, these healthcare practitioners are known as Clinical Associates and are based in district hospitals where they work under the supervision of a family physician.[1] Contextual attributes of professionalism – also referred to as core elements by the HPCSA – are attributes or domains that constitute a spectrum of behaviours that should be exhibited by all categories of healthcare practitioners (HCPs) at the end of the training period.[10] They are the desired qualities in any doctor-patient relationship that need to be displayed in the contexts in which they practise and are associated with the physician as a healer in society.[5,6] In this study, the contextual attributes were assessed in terms of the thirteen core values of professionalism as described by the HPCSA, namely: respect for persons; beneficence; non-maleficence; human rights; autonomy; integrity; truthfulness; confidentiality; compassion; tolerance; justice; professional competence and selfimprovement, and community.[10]

Methods Hatem’s[9] definition of professionalism (Box 1) adopted as a working definition for the BCMP programme was the stimulus that

ARTICLE guided the 25 final year BCMP students’ reflections. The students’ experiences of the contextual attributes of professionalism during clinical rotations were received as portfolio entries. As research instruments, the benefits of employing portfolios are well documented.[11] In total, 71 portfolios reflecting the experiences of BCMP students in individual departments in facilities designated as District Education Campuses were analysed as follows: 100% (n=25) in Emergency Medicine (EM), 92% (n=23) each for adult in-patient wards (AIPW) and Paediatrics (Paeds). For a detailed description on the research design – a retrospective, descriptive, analytical case – based study as well as data collection methods, the reader is directed to the published article.[1] Ethical clearance was obtained from the Human Research Ethics Committee (HREC – Medical: M110740) of the Faculty of Health Sciences at Wits. BCMP students’ responses informed by Hatem’s definition, were open-ended and not grouped into categories. However, for the purpose of the analysis, the core values were distilled according to the HPCSA guidelines that direct the practice of healthcare professionals in South Africa.[10] The identified contextual attributes were analysed by grouping the students’ experiences in Paeds, EM and AIPW into sub-themes. The findings were then computed using simple descriptive statistical

methods captured on an Excel spreadsheet.

[11] Presented as per­ centage values they demonstrated frequency distribution and the relationship of grouped data that was then subjected to an ethical analysis.

Results The BCMP students reported on all the attributes of professionalism described as the core values by the HPCSA (Table 1). There was a positive association between frequency of reflections and the positive nature of the experiences of professionalism for the majority (53.8%) of the attributes including: respect for persons, beneficence, integrity, truthfulness, compassion, tolerance, and professional com­ petence and self-improvement. For some of the attributes, at 23.1%, (confidentiality, autonomy, community) students had a range of experiences leading to on-going debate and internal conflict as they had to navigate parents or family interests, as well as traditional and cultural practices. For the remaining attributes (non-maleficence, justice and human rights), also at 23.1%, the reflections were guided by negative experiences.

Discussion Respect

Many of the BCMP students’ experiences of respect shown to patients were in the Paeds department, similar to a study

Table 1: Contextual attributes of professionalism (n=25) Core Elements

Adult in-Patients Ward (AIPW)

Paediatrics (PAEDS)

Emergency Medicine (EM)

n=23

%

n=23

%

n=25

%

Respect

18

78.2

12

52.2

10

40.0

Beneficence

9

39.1

5

21.7

2

8.0

Non-Maleficence

6

26.1

3

13.0

2

8.0

Human rights

5

21.7

6

26.1

8

32.0

Autonomy

11

47.8

6

26.1

8

32.0

Integrity

14

60.9

12

52.2

7

28.0

Truthfulness

9

39.1

9

39.1

7

28.0

Confidentiality

8

34.7

14

60.9

10

40.0

Compassion

14

60.9

6

26.1

8

32.0

Tolerance

13

56.5

7

30.4

5

20.0

Justice

8

34.8

7

30.4

10

40.0

Professional competence /selfimprovement

18

78.2

14

60.9

30

120.0

Community

9

39.1

9

39.1

6

24.0

commissioned by a university in the USA. One of the students reflected on respect that was extended to a third party – a parent to one of the patients. The only difference was that the findings of the US study were based on a narrative undertaken by medical students doing an EM clerkship.[12]

Beneficence The BCMP students reflected on the same issues reported by Bernard[11] when they considered the limits of their practice, the need for ongoing learning and being the best you can be for your patients. In AIPW it was the plight of admitted patients to which students were sensitised.

Non-maleficence, justice and human rights violation In this study BCMP students observed patients being hurt by an HCP as one of the students made reference to instances where an HCP refused to attend to a homeless person.

In this regard, BCMP students observed discrimination towards patients at three levels.

In the first instance they observed different standards of care for different patients depending on who they were and their social standing in society. Secondly, they referred to the treatment meted out to patients who were classified as non-South Africans when they failed to present an identity document on admission. The third violation was cited as instances where patients were compromised by their presenting illness. One student referred to an incident in theatre where the attending doctor made fun of a patient who presented with an inguinal hernia. Similar findings are reported in studies conducted in other universities.[14-17]

Autonomy BCMP students engaged with the complexity of the consent process and subsequent challenges in obtaining informed consent.[15,18] Students referred to the ‘dynamics of the consent process “The extended set of responsibilities that include the respectful, sensitive focus on individual patient needs that transcends the physician’s self-interest, the understanding and use of the cultural dimension in clinical care, the support of colleagues, and the sustained commitment to the broader societal goals of medicine as a profession”.

Box 1. Hatem’s definition of professionalism

May 2015, Vol. 8, No. 1 SAJBL

27

ARTICLE that are unique to South Africa’ as they linked the health-seeking behaviour of the parents in Paeds with their traditional belief system.

The experiences of the students are supported by Tsotsi[19,20] who refers to the process of attaining informed consent in developing countries as a complex issue or a contentious issue that is context-specific.[20]

Truth-telling BCMP students observed that for many of the adolescents, poor communication between HCPs and the patients was contrary to the best interests of the patients. The dilemma around the issue of trust that students faced was based on the fact that there was no consensus, e.g. when was the right time to tell a child that he was HIV-infected or the reason why his parents died? With the majority of patients expecting to be told the truth about their condition[21] the students felt it was unfair for patients to be expected to take chronic medication for life if they did not understand the associated value. While truth-telling is not always encouraged for various reasons, e.g. emotional status of the patient, withholding or giving false information to patients and/or families is considered to be unethical conduct.[22]

Confidentiality The privacy of patient information was seen as a contentious issue that led to many violations of confidentiality due to systemic issues. It presented a challenge especially in AIPW as a result of the economic setup of the wards. BCMP students reflected on instances where the family demanded to know intimate details about their relative, thereby creating a dilemma for the HCP who could not disclose information without violating the rights of the admitted adult patient. This entitlement to patient information is often associated with particular settings as similar findings were reported in Uganda and elsewhere in Africa.[20]

Compassion and care BCMP students reflected on the value of demonstrating compassion and care in the clinical setting as an attribute mainly observed in Paeds similar to findings reported in two studies conducted in the USA.[11,12] The positive reflections that BCMP students experienced in Paeds were consistent with and met the recommendations of the HPCSA that require HCPs to always show regard for their patients as their primary professional duty.[10]

Tolerance The expectation for HCPs to be culturally competent is considered a moral requirement that informs the professional conduct of HCPs. Students were conscientised to the clinician’s dilemma and the required tolerance in negotiating with parents when they demanded that critically ill children be discharged or with relatives who refused to accept healthcare such as therapeutic amputation of a limb, if it was not culturally or religiously acceptable.[20] In teaching professionalism, due consideration should be given to respect for local customs and related to the different cultures within that context.[24]

Community experience Many of the BCMP students’ reflections on their community experience that informed and motivated students to contribute to the betterment of society were born out of frustration. Students reflected not only on their experiences but also on what they

28

May 2015, Vol. 8, No. 1 SAJBL

felt should be taken into account to improve the plight of the community regarding the number of patients who refused hospital treatment (RHT) in Paeds and in AIPW and to a lesser degree in EM.[23] Traditional practice in rural communities was the most likely reason underpinning the request for RHT. While patients have a right to refuse treatment, the decision must be rational and fully informed.[18] Concerns expressed by the BCMP students with regard to observed RHT practice are supported by Crain[25] as he considered morality and rights-based healthcare to be informed by the propensity of the healthcare community to preserve the value of life.

Professional integrity As an observed attribute for many of the admitted patients as reflected in portfolios in Paeds and in AIPW but not so much in EM, BCMP students witnessed a virtue that requires both moral and intellectual excellence and a measure that limits violations to the profession.[26]

Professional development BCMP students reflected on their professional development as a process acquired either through observed role modelling or their experiences of being mentored, as students enjoyed exceptional positive experiences in EM but also in Paeds and in AIPW.[7] Teamwork was a critical area of development that was noted by students as contributing to their learning and improvement of skills. Students were of the view that their own competence was determined by the extent to which the team cooperated and pulled together for the benefit of the patient and the student as a trainee HCP.[12] Appraising medical students’ reflection-inlearning, Sobral[13] makes reference to a positive correlation between quality of reflections and a readiness to self-regulate as well as perceived learning autonomy. The present data support the assertion by Swick[6] when the value of professionalism is considered from two levels – namely the individual and the collective. Students were motivated to do more when they were in teams. In instances where the experience was negative, students perceived this as denying them an opportunity to attain desired and professionally required skills.[16]

Limitations It should be noted that the data in this study were not primarily intended for research purposes.[1] Nonetheless rich data sets, obtained using acceptable scientific methods, had to be compressed to answer critical questions for this programme.

Conclusion Hatem’s definition of professionalism as a stimulus for this research facilitated for context-specific learning and experiences of role modelling especially in Paeds. Overall, the findings in this study support a valuable approach to learning about professionalism and exposed students to community issues. The BCMP students had to consider the cultural dimensions in clinical care as they interacted with patients in their context. The value of learning about professionalism was considered at two levels where the BCMP students considered not only their role as individuals but also the extent to which their competencies were influenced by a team approach. The study has highlighted some of the ethical dilemmas related to context that need to be considered when students are based in local communities.

ARTICLE Competing interests. The authors declare that they have no competing interests.

Funding. This study was self-funded.

Authors’ contributions. Nontsikelelo Mapukata-Sondzaba concep­ tualised the research and drafted the article. Ames Dhai provided critical review during the writing phase, read and approved the final manuscript.

Acknowledgements. Gratitude is extended to the BCMP class of 2011, to Professor Ross and Dr Norma Tsotsi who provided valuable advice during the research process.

References 1. Mapukata-Sondzaba N, Dhai A, Tsotsi N, Ross E. Developing personal attributes of professionalism during clinical rotations: Views of final year bachelor of clinical medical practice students. BMC Med Educ 2014;14:146 [http://dx.doi. org/10.1186/1472-6920-14-146] 2. Dhai A, McQuoid-Mason D. Editorial: What does professionalism in healthcare mean in the 21st Century? S Afr J BL 2008;1(1):2-3.

3. Mueller PS. Incorporating professionalism into medical education: The Mayo Clinic experience. Keio J Med 2009;58(3):133-143. [http://dx.doi.org/10.2302/kjm.58.133] 4. Asghari F, Fard, NN, Atabaki A. Are we proper role models for students? Interns’ perception of faculty and residents’ professional behaviour. Postgrad Med J 2011;87(1030):519-523 [http://dx.doi.org/ doi: 10.1136/pgmj.2010.110361] 5. Cruess SR. Professionalism and medicine’s social contract with society. Clin Orthop Relat Res 2006;449:170-176.

6. Swick HM. Toward a normative definition of medical professionalism. Acad Med 2000;75(6):612-616.

7. Harris GD. Professionalism: Part I – Introduction and being a role model. Fam Med 2004;36(5):314-315.

8. Health Professions Council of South Africa. Core curriculum on human rights, ethics and medical law for health care professionals. Pretoria: HPCSA. 2006.

9. Hatem CJ. Teaching approaches that reflect and promote professionalism. Acad Med 2003:78(7):709-713.

10. Health Professions Council of South Africa. Guidelines for Good Practice in the Health Care Professions. General ethical guidelines for health care professions. Booklet 1.

2008. http://www.hpcsa.co.za/hpcsa/default.aspx (accessed 8 May 2008).

11. Bernard AW, Malone M, Kman NE, Caterino JM, Khandelwal S. Medical Student Professionalism Narratives: A Thematic Analysis and Interdisciplinary Comparative Investigation. BMC Emerg Med 2011;11:121 [http://dx.doi. org/10.1186/1471-227X-11-11]]

12. Curry SE, Cortland CI, Graham MJ. Role-modelling in the operating room: Medical student observations of exemplary behaviour. Med Educ 2011;45(9):946-957 [http://dx.doi.org/doi: 10.1111/j.1365-2923.2011.04014.x.]

13. Sobral DT. An appraisal of medical students’reflection-in-learning. Med Educ 2000;34(3):182-187.

14. Szauter K, Williams B, Ainsworth MA, Callaway M, Bulik R, Camp MG. Student perception of the professional behaviour of family physicians. Med Educ 2003;8:17.

15. Kaldjian LC, Rosenbaum ME, Shinkunas LA, Woodhead JC, Antes LM, Rowat JA, Forman-Hoffman VL. Through students’ eyes: Ethical and professional issues identified by third-year medical students during clerkships. J Med Ethics 2012;38(2): 130-132 [http://dx.doi.org/doi: 10.1136/ medethics-2011-10003310.1136/medethics-2011-100033] 16. Feudtner D, Christakis DA, Christakis N.A. Do clinical clerks suffer ethical erosion?

Students’ perceptions of their ethical environment and personal development.

Acad Med 1994;69(8):670-79.

17. Vivian LMH, Naidu CS, Keikelame MJ, Irlam J. Medical students’ experiences of professional lapses and patient rights abuses in a South African health sciences faculty. Acad Med 2011;86(10):1282-1287 [http://dx.doi.org/10.1097/ ACM.0b013e31822be4b8] 18. Health Professions Council of South Africa. Seeking Patients’ Informed Consent: The Ethical Considerations, 2nd Edition. Booklet 10. 2007. http://www.hpcsa. co.za/hpcsa/default.aspx (accessed 8 May 2008).

19. Tsotsi N. Informed Consent In Research In Developing Countries: Is There Some Unfinished Business? Dissertation submitted in partial fulfilment of the requirement of the degree Master of Science in Medicine (Bioethics and Health Law), 2009. Faculty of Health Sciences. University of the Witwatersrand, 2012.

20. Baingana K, Nakasujja N, Galukande M, Omona K, Mafigiri DK, Sewankambo NK. Learning health professionalism at Makerere University: An exploratory study amongst undergraduate students. BMC Med Educ 2010;10:76. [http://dx.doi. org/10.1186/1472-6920-10-76] 21. Vangu MDTW. Truth telling in a South African tertiary hospital. S Afr J BL 2010;3(1):38.

22. Kovatz S, Shenkman L. Unethical behaviour witnessed by medical students during their medical studies. The Open Ethics Journal 2008;2:26-28.

23. O’Sullivan M, Martin J, Murray E. Students’ perceptions of the relative advantages and disadvantages of community-based and hospital-based teaching: A qualitative study. Med Educ 2000;34(8):648-655. [http://dx.doi.org/10.1046/ j.1365-2923.2000.00623.x] 24. Cruess SR, Cruess RL, Steinert Y. Linking the teaching of professionalism to the social contract: A call for cultural humility. Med Teach 2010;32(5):357-359 [http:// dx.doi.org/10.3109/01421591003692722] 25. Crain WC. Kohlberg’s stages of moral development. Theories of Development.

New Jersey: Prentice-Hall,1985:118-136.

26. Chervenak FA, McCullogh LB. Professional integrity, respect for autonomy, and the self-regulation of reproductive endocrinology. Am J Obstet Gynecol 2009;201(1)3-4 [http://dx.doi.org/10.1016/j.ajog.2009.05.029]

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ARTICLE

Is the seclusion policy of mental healthcare users a necessary evil?

G Chiba, MB BCh, FCPsych (SA), MMed (Psych); U Subramaney, MB BCh, BSc Hons (Psych), FCPsych (SA), MMed (Psych), PhD 1

Department of Psychiatry, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Corresponding author: gchiba@mweb.co.za

Background. Seclusion in the psychiatric context is the involuntary confinement of an agitated, unstable person alone in a contained, controlled environment. Differing views on seclusion presents clinicians with an ethical dilemma. Significant morbidity and mortality have been associated with seclusion. No data exist in South Africa on rates of seclusion for psychiatric purposes. Consequently neither the need for seclusion nor alternatives to seclusion have been explored.

Objective. To determine the number of patients secluded over six months, provide a profile of patients that were secluded, and to ascertain the reasons for seclusion.

Methods. A retrospective record review of patients secluded at Sterkfontein Hospital, over a six-month period.

Results. A total of 112 patients were secluded over the six-month period. Users were secluded for a total of 59 415.5 hours and on 4 814 separate occasions. A total of 84.8% of the users secluded were male. The mean age of users secluded was 29 years. Just under half the users (49.1%) were secluded for their own safety and 40% of users were secluded for aggression (either physical or verbal). The most common diagnosis was schizophrenia (31.4%) followed by cognitive impairment (20.6%) and bipolar mood disorder (13.7%). The most commonly used medication was sodium valproate (17%), followed by haloperidol (11%) and risperidone (11%).

Conclusion. Younger male patients with psychosis were most likely to be secluded. More research should be conducted locally to compare seclusion rates and patient profiles so that we may improve seclusion practices.

S Afr J BL 2015;8(1):xx-xx. DOI:10.7196/SAJBL.358

Seclusion can be defined as the involuntary confinement of an agitated, unstable person alone in a contained, controlled environment.[1] The use of seclusion for patients who are at a risk of harm to themselves or others has been a generally accepted medical practice for many years.[2] Seclusion and restraint are not ‘benign’ interventions. Significant morbidity and mortality have been associated with them, such as attempted suicide or self-harm while in seclusion.[1] There is are also a risk of bringing up old trauma in patients with a history of trauma, loss of dignity and other emotional injury.[3] There are differing views on seclusion: ‘The seclusion of psychiatric patients is viewed by some as a violation of basic human rights, by others as a necessity for the control of violence, and by still others as a therapeutic modality’[4]. In a paper discussing the legal issues of seclusion in Australia and New Zealand, this lack of clarity was revealed in Mental Health Acts and seclusion policies internationally.[5] The ethical conflict arises when one considers balancing the patients’ right to autonomy versus the paternalistic responsibility to prevent harm to self and others.[6] Fisher et al. in their review of restraint and seclusion from 1977 to 1994 in the USA concluded that seclusion is effective,[7] while Busch et al. found little evidence to guide clinical practice regarding the relative benefits and risks of seclusion. They also found inconsistencies in the application of seclusion.[8] Despite the ethical debate and risks associated with seclusion, there have been limited data on procedures that will lead to the decreased use of seclusion.[9]

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May 2015, Vol. 8, No. 1 SAJBL

Sterkfontein Hospital’s seclusion policy is in accordance with the Mental Health Care Act (MHCA) in South Africa.[10] The act states that seclusion may only be used in patients with ‘severely disturbed behaviour’ for containment and not as punishment.

Observation must be done every 30 minutes and documented in clinical notes. A register must be signed by a doctor, the time period and reason for seclusion must be documented and the head of the health establishment must be notified daily of all seclusion incidents. A transcript of the register must be submitted by the health establishment to the Review Board on a quarterly basis using form MHCA 48.

Although numerous studies have been done in USA, UK, Australia and some European countries, there are no recent South African data on seclusion. Consequently little attention has been paid to alternatives or factors that could decrease rates of seclusion in South Africa.

Objectives To determine the number of seclusions, reasons for seclusion and the clinical profile of patients secluded over a six-month period at a tertiary psychiatric facility.

Methodology Study design

This was a retrospective cross-sectional record review.

Study site The study was conducted at Sterkfontein Hospital which is the largest of the specialist hospitals associated with the University of the Witwatersrand,

ARTICLE Department of Psychiatry. It caters for involuntary users, forensic cases (observandi) and ‘State Presi­dent's Detainees’. The hospital has lock up facilities and open wards and admits both adults and adolescent users.

Sample population The study population consisted of all users secluded during a six-month period in 2006.

Of the 612 usable beds at Sterkfontein Hospital, female beds comprise 74 beds.

Table 1. Seclusions per month over six months at Sterkfontein Hospital Seclusions

March

April

May

June

July

August

Total

No. of users

38

33

41

44

39

36

Total hours

11 814

8 375

10 621.5

10 755

9 526

8 324

59 415.5

Occasions

933

669

826

889

806

691

4 814

Hours (mean)

311

253

259

244

250

237

259

Hours (minimum)

2

2

1

2

1

1

1.5

Hours (maximum)

568

430

529

595

640

546

551

Occasions (mean)

24.5

20

20

20

20

19

20.6

Measurements Data were collected from clinical records (providing the age, diagnosis and discharge medication) and the MHCA 48 forms (providing the date, time, ward and reason for seclusion). The user status was derived from the ward from where the user was admitted.

Statistical analysis Data were analysed using the statistical analysis software (SAS) version 9.2 statistical program (SAS, Cary, NC, USA). Results are expressed as mean and standard deviation or median [range] for nonnormal distribution or frequencies and percentages for categorical variables. To assess differences by gender, user status, diagnosis and medication, and the reasons for seclusion, the Mann-Whitney Wilcoxon test for scores or continuous non-normal distributed variables was used. Significance was assumed at a both-sided value of p <0.05.

Ethics Permission was obtained from the CEO of the hospital to obtain access to records for data collection. The study was approved by the University of the Witwatersrand’s Human Research Ethics Committee (HREC).

Data were collected and stored in a confidential manner. The user’s name remained anonymous and was not recorded on the data sheet. Only the researcher kept and had access to a separate register recording the user’s name and study number.

None of the data was disclosed to sources outside of the research process.

Results

Number of seclusions over a sixmonth period A total of 112 users were secluded over the six-month period.

Table 2. Demographic profile of users secluded during a six-month period at Sterkfontein Hospital Gender (%)

Male

84.82 (n=95)

Female

15.18 (n=17)

Age (years)

Mean

29 (SD=10.4)

Youngest

13

Oldest

67

User status (%)

Involuntary (male and female)

35.71

State (male and female)

35.71

Adult male (observation and state)

8.04

Adult female (observation and state)

5.36

Adolescent male (state and observation)

15.18

All 112 users had seclusion documents; however, the clinical records of 26 users were not found.

The number of seclusions per month is summarised in Table 1.

The total amount of time spent by all the users who were secluded during a particular month is indicated in hours. The ‘occasions’ secluded refers to the number of separate episodes that users were secluded in that month.

On average there were 802 seclusion occasions per month and the average total time per month was 9 902 hours. The mean number of users secluded per month was 38.5. The mean number of hours spent in seclusion every month per user was 259 hours.

The mean number of episodes of seclusion per user was 20.6 per month. The mean number of hours spent in seclusion per occasion was 12.5 hours.

Demographic profile Table 2 illustrates the demographic profile of users that were secluded during the sixmonth period.

A total of 33% of users secluded are in the 21 - 30 year age group, followed by 29.7% in

the 31 - 40 year age group and 24.2% in the 11 - 20-year-old group.

A total of 35.7% (n=40) of users secluded were involuntary users, the rest were forensic users (either state patients or observandi).

Reasons for seclusion Fig. 1 illustrates the reasons users were secluded.

Collectively 37.40% (n=42) of users were secluded for aggression (either physical or verbal or both).

A grouping was made to look at the data in terms of those secluded as per MHCA indications i.e. ‘aggression/risk of violence’ (i.e. physical aggression, verbal aggression, both physical and verbal aggression, threat of violence, other, no reason documented) and ‘users own safety’, the latter is not an indication for seclusion as per MHCA. Males were marginally more likely to be secluded for their own safety (56.8%, n=54) than for aggression/risk of violence (43.2%, n=41). Females were mostly secluded for aggression/risk of violence (94.1%, n=16) compared to being secluded for their own safety (5.88%, n=1).

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ARTICLE

2.67%

6.25%

6.25% Physical aggression (n=7) Verbal aggression (n=26)

23.21%

Physical and verbal aggression (n=9) 8.03%

49.10%

Risk of violence (n=5) User’s own safety (n=55)

4.46%

Other (n=3)

Fig 1. Reasons for seclusion during a six month period at Sterkfontein Hospital.

Table 3. Diagnoses of users secluded during a six-month period at Sterkfontein Hospital

Diagnosis

*1

*2

Total number of users

%

1

Schizophrenia

32

32

31.4

2

Bipolar mood disorder

14

14

13.7

3

Cognitive impairment

18

3

21

20.6

4

Epilepsy

2

2

4

3.9

5

Conduct disorder

1

1

2

2.0

6

Personality disorder

1

1

1.0

7

Dementia

1

2

3

2.9

8

Substance abuse

2

2

2.0

9

Substance-induced psychosis

3

3

6

5.9

10

None

3

3

2.9

11

Psychotic disorder not otherwise specified

4

4

3.9

12

Schizoaffective disorder

4

2

6

5.9

13

Frontal lobe syndrome

1

1

1.0

14

Disruptive behavioural disorder

1

1

1.0

15

Organic brain syndrome

1

1

1.0

16

Mood disorder secondary to HIV

1

1

1.0

*1= first diagnosis *2= second diagnosis

Only one involuntary user was secluded for his own safety and 39 for aggression or the threat of violence.

In the forensic wards close to three quarters of the users (n=54) were secluded for their own safety and 17 users were secluded for aggression or threat of violence.

Clinical diagnosis The diagnostic system that applied at the time of the study is the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (text revised) (DSM IV-TR). There were 16 diagnoses found collectively. Of the 86 clinical records found, 16 users had 2 diagnoses. Table 3

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May 2015, Vol. 8, No. 1 SAJBL

depicts the number of users and percentage at which the diagnoses were documented.

Of the 16 users who had a second diagnosis recorded, 11 had schizophrenia, 4 had cognitive impairment (CI) and 1 had epilepsy.

Both schizophrenia and cognitive impairment occurred in 3 users.

When users were secluded for their own safety the most common diagnosis was schizophrenia, followed by cognitive impair­ ment (CI). Collectively these two diag­noses made up 71.4% of users who were secluded for their own safety. Those with a second diagnosis who were diagnosed for their own safety had the diagnosis of CI and dementia.

Schizophrenia was the most common diagnosis in users who had documented reports of physical aggression and both physical and verbal aggression, respectively (83.3% and 50%). A total of 40% of users secluded for verbal aggression had bipolar mood disorder (BMD). The most common diagnosis of users who were secluded because of risk of violence, was schizophrenia (50%), followed equally (25% each) by BMP and CI. Table 4 compares the three most common diagnoses (which make up 74% of the diagnoses of users), with reasons for seclusion, when the reasons for seclusion are divided into aggression/risk of violence (i.e. physical aggression, verbal aggression, both physical and verbal aggression, threat of violence, other, no reason documented) and user’s own safety. The percentages refer to the percentage of users with that specific diagnosis, e.g. 18.6% of users who were secluded for their own safety had a diagnosis of schizophrenia.

Medication Table 5 illustrates the medication that users were given on discharge. Nearly half the users were on antipsychotics (48, 76%) and just over a third were on a mood stabiliser (35.80%).

Discussion An international review of the incidence of seclusion showed a vast range in the frequency and duration of seclusion,[11] from seclusion episodes of 300 hours in the Netherlands to rare seclusions in the UK. Very limited data exist in developing countries.[11,12] This research study reveals seclusion episodes between these two ranges with a mean of 12.5 hours per seclusion episode.

The mean hours/month per user of 259 hours represent about 11 (24-hour) days per month which is a lot of time spent in seclusion. The MHCA does not specify a minimum time that users may be secluded, neither does it state after what time period or after what number of seclusions a new order of seclusion should ordered.

This allows clinicians carte blanche on the number of times and hours a user might be secluded. With such freedom comes great responsibility to ensure that the human rights of the user are not abused and that seclusion is prescribed only for very specific

ARTICLE

Table 4. Comparison of reasons for seclusion in the commonest diagnoses of users secluded during a six-month period at Sterkfontein Hospital Diagnosis

Schizophrenia

Bipolar Mood Disorder

Cognitive Impairment

Remaining diagnoses

Total

Reasons for seclusion

n

%

n

%

n

%

n

%

n

%

Own safety

16

18.60

1

1.16

14

16.28

11

12.79

42

48.84

Aggression/risk of violence

16

18.60

13

15.12

4

4.65

11

12.79

44

51.16

Total

32

37.20

14

16.28

25.58

86

18

20.93

22

Table 5. Medication classes of users who were secluded during a six-month period at Sterkfontein Hospital Medication

Frequency

%

Nil

11

6.79

Mood stabilisers

Na Valproate

28

17.28

Lithium

11

6.79

Carbamazepine

8

4.94

Haloperidol

18

11.11

Chlorpromazine

12

7.41

Trifluoperazine

2

1.23

Clozapine

3

1.85

Risperidone

18

11.11

Olanzapine

1

0.62

Sulpiride

2

1.23

Fluanxol Depot

5

3.09

Clopixol Depot

15

9.26

First-generation antipsychotic

Second-generation antipsychotic

Depot antipsychotic

Modecate

3

1.85

Benzodiazepine

Clonazepam

7

4.32

Other

Androcur

5

3.09

Orphenadrine

11

6.79

Propranolol

1

0.62

Galantamine

1

0.62

indications and after other measures have been tried and proven unsuccessful.

Fisher et al[7] revealed no clear cut demo­ graphic trends. A fairly consistent find­ ing was that younger users are more likely to be secluded, as is evident in this study. The fact that males were secluded more often than females may be due to more male admissions at that time.

One would expect that the involuntary users were more likely to warrant seclusion than their counterparts in the forensic wards, as the latter are often chronic users and stable.

Involuntary users are admitted under section 33/34 of the MHCA and would, by definition, have a mental illness of such a nature that

they were likely to inflict serious harm to self or others. The study reveals that 64% of users secluded were from the forensic wards; however, reasons for seclusion indicate own safety in three quarters of cases. This would be expected as some of these users were adolescents who would require protection of their safety. Of the adult users in the forensic wards those with cognitive impairment would warrant protection of their safety by virtue of their diagnosis.

Close to half the study population were secluded for ‘user’s own safety’ (49.1%). These were users that were vulnerable and not safe if bedded with rest of the ward population, as they may have been at risk of sodomy/

sexual exploitation. The MHCA[10] states that seclusion may only be used to contain severely disturbed behaviour, which is likely to cause harm to others. The regulations of the MHCA only provide for seclusion if the safety of others is involved and not when ‘own safety’ is involved. These users did not exhibit any dangerous or disturbed behaviour and should not have been secluded in terms of the MHCA indications for seclusion. The practice of secluding vulnerable users for their own safety should be avoided as it impacts on their human rights and does not contain the actual perpetrators of violence in these settings. This reflects strongly on the capacity and the type of facilities, as well as the inappropriateness of the grouping of vulnerable individuals together with violent aggressive individuals.

It also gives us an inflated number of seclusions that should occur, as indicated by the MHCA. As these users’ clinical profiles were noted and included in data analysis we get an imprecise clinical profile of users that are likely to be secluded for containment of aggressive behaviour. To compensate for this, the reasons for seclusion were separated into two groups: ‘user’s own safety’ and physical and verbal aggression, and risk of violence.

The remaining users in our study (48%) were secluded for aggression or the risk of violence (in keeping with the reasons outlined in MHCA).

The most common diagnosis of users secluded in our study was schizophrenia, followed by intellectual disability and BMD. This is consistent with findings in the Australian study and that found in the review by Fischer in 1994, who found that the diagnoses associated with higher seclusion rates were psychosis, manic symptoms, character disorders, mental retardation and abnormal EEGs.[7, 13] When correlating the reasons for seclusion with diagnosis, CI seemed to be a factor in users being secluded for their own safety as evidenced by schizophrenia, CI and dementia being the most common diagnoses. This is possibly due to the nature of their disability as they are vulnerable and open to abuse by other users in the ward.

When users were secluded for aggression/ risk of violence; schizophrenia and BMD were the most common diagnoses. Paranoid ideation and perceptual disturbances in such users might account for the agitated

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ARTICLE behaviour that required the use of seclusion. In the manic state of their illness, users with BMD could become agitated and aggressive and require seclusion for containment.

Limitations The clinical records of 26 users were not found and therefore the clinical profile of these users could not be included. The medi­cation and management of users could be affected by different prescription styles of clinicians. In wards with both observation and state users it was not differentiated whether the users were observation or state users.

As this was a retrospective review the reasons for seclusion were recorded directly from the MHCA form 48, the way in which various clinicians distinguished ‘risk of violence’ from ‘verbal aggression’ depended on the clinician prescribing the seclusion. The study does not describe what medication the user was given, if any, prior to seclusion.

Data on the number of users that were admitted during the study period could not be obtained and therefore the percentage of users that were secluded could not be calculated.

Conclusions and recommendations Just under half the seclusions occurred ‘for user’s own safety’. Perhaps these users should be termed as being ‘bedded alone’ instead of recorded as being secluded. This would give us a better indicator of seclusion as indicated by the MHCA. These users had to be recorded on the seclusion register (form 48) as they had been placed in a locked room. This is in keeping with the MHCA, which states that if a user is isolated in a space, where his or her freedom of movement is restricted, he or she is by definition being secluded and requires observation and a register to be completed. To ensure that, while in the locked room, these users were not overlooked perhaps a policy and/or protocol could be drawn up stating that these users should be observed at regular intervals and a separate register be kept for them. The recommendation should be made to the National Department of Health to modify these regulations when users are placed in a locked room for their own safety.

Younger male users with psychosis were most likely to be secluded.

Perhaps greater caution and care can be taken when dealing with this profile of users so that seclusion might be prevented. The outcome of these patients being secluded may, however, indicate the usefulness of the practice of seclusion.

Mental health care users, particularly those admitted involuntarily, pose a distinct challenge from a human rights perspective. They represent a vulnerable population, yet may themselves cause harm to themselves and/or others by virtue of mental illness. Their

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management is enshrined within the auspices of the MHCA, which has a policy on seclusion. Ideally, it is preferable to manage patients in a seclusion-free environment. Other ways to improve seclusion practices would be to ensure that it is only prescribed in accordance with the MHCA of South Africa, which is for those at risk of harming themselves and/or others and not for those who are at risk of harm from others. These measures can be implemented with minimal expense by regular training of staff.

Seclusion rates and patient profiles were compared to studies done internationally. No data exist in South Africa to do such comparisons. More research could be conducted in South Africa, of a longitudinal nature, to formulate a clinical profile of users most likely to be secluded, the need for seclusion, and to clarify other factors that might be involved in seclusion practices, to ascertain the effect of and the outcome after seclusion.

References 1. Michael K, Champion MD. Commentary: Seclusion and Restraint in Corrections - A Time for Change. J Am Acad Psychiatry Law 2007;35(4):426-430. http://www. jaapl.org/content/35/4/426.full.pdf+html (accessed March 2008).

2. Pollard R, Yanasak EV, Rogers SA, Tapp A. Organizational and Unit Factors.

Contributing to reduction in the use of seclusion and restraint procedures on an acute psychiatric inpatient unit. The Psychiatr Q 2007;78(1):73-81. [http://dx.doi. org/10.1007/511126-006-9028-5] 3. Huckshorn KA. Re-designing state mental health policy to prevent the use of seclusion and restraint. Admin Policy Ment Health 2006;33(4):482-491. [http:// dx.doi.org/10.1007/s10488-005-0011-5] 4. Brown JS, Tooke SK. On the seclusion of psychiatric patients. Soc Sci Med 1992;35(5):711-721.

5. Muir-Cochrane E, Holmes C, Walton JA. Law and policy in relation to the use of seclusion in psychiatric hospitals in Australia and New Zealand. Contemp Nurse 2002;13(2-3):136-145.

6. Bloch S, Green SA. An ethical framework for psychiatry. Br J Psychiatry 2006;188:712. [http://dx.doi.org/10.1192/bjp.188.1.7] 7. Fisher WA. Restraint and seclusion: A review of the literature. Am J Psychiatry 1994;151(11):1584-1591.

8. Busch AB, Shore MF. Seclusion and restraint: A review of recent literature. Harv Rev Psychiatry 2000;8(5):261-270.

9. Mohr WK, Petti TA, Mohr BD. Adverse effects associated with physical restraint.

Can J Psychiatry 2003;48(5):330-337.

10. Republic of South Africa. Mental Health Care Act No. 17. Pretoria: Government Gazette, 2002.

11. Steinert T, Lepping P, Bernhardsgrutter R, et al. Incidence of seclusion and restraint in psychiatric hospitals: A literature review and survey of international trends. Soc Psychiatr Epidemiol 2010;45(9):889-897.

12. Gaskin CJ, Elsom SJ, Happell B. Interventions for reducing the use of seclusion in psychiatric facilities: Review of the literature. Br J Psychiatry 2007;191(10):298303. [http://dx.doi.org/10.1192/bjp.bp.106.034538] 13. Tunde-Ayinmode M, Little J. Use of seclusion in a psychiatric acute inpatient unit. Australas Psychiatry 2004;12(4):347-351.[http://dx.doi.org/10.1111 /j.1440-1665.2004.02125]

ARTICLE

Youngest first? Why it is wrong to discriminate against the elderly in healthcare C S Wareham, BA, MA, PhD Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: Christopher Wareham (christopher.wareham@wits.ac.za)

In South Africa and abroad the elderly are systematically discriminated against at all levels of healthcare allocation decision-making. Such discrimination is perhaps surprising in light of the National Health Act and the Older Persons Act, which explicitly recognise the elderly as a vulnerable group whose equal rights require special protection. However, ethical theory and public opinion offer some reasons to think that discrimination against the elderly may be justified. This paper examines possible ethical grounds for age discrimination. I claim that there are very few cases in which the aged may be discriminated against, and that age alone is never sufficient grounds for discrimination.

S Afr J BL 2015;8(1):xx-xx. DOI:10.7196/SAJBL.374

The South African (SA) Constitution is committed to the progressive realisation of the right to healthcare.[1] However, in South Africa and abroad, it is not always possible for optimal medical treatment to be provided for every patient. This is due to resource scarcity: shortfalls in equipment, personnel, and funds make it impossible for every person to receive the treatment that would be best for them.[2] Practitioners and policymakers alike are painfully aware that such shortfalls mean that allocation decisions will involve trade-offs, prioritising some patients or patient groups at the expense of others.

But on what basis are such trade-offs made? What criteria should be used to decide who gets treatment and who does not? It is important that these criteria are explicit and ethically defensible as they affect who gets treatment and who does not, who lives and who dies.

It has become increasingly common for ethical theorists in the developed world to consider employing the criterion of age: where there is competition for health resources, the young should be favoured.[2–6] This type of discrimination can be employed at micro-, meso-, and macro-levels[7] of healthcare allocation. For instance, at the micro-level of individual practitioner decisions, it could mean that practitioners do not refer the elderly to more specialised secondary and tertiary levels of care. At the meso-level of hospital and practitioner policy, training for geriatric care may be deprioritised. At the macro-level of national or provincial health decisions, policies may favour the treatment of HIV/AIDS at the expense of geriatric medicine programmes because the former predominantly afflicts the young.

Significantly, age discrimination is already practised both tacitly and explicitly: all of the above are real examples from a South African health context and many more could be supplied.[8] This is worrisome, not least since the elderly are a vulnerable population whose rights require special protection.[9] The Older Persons Act explicitly states that the elderly are entitled to be respected, to be treated fairly and equitably, and to be protected against ‘unfair discrimination on any ground’.[10] This means that it is vitally important to bring out potential justifications for age discrimination and question whether examples like those above involve unfairness.

Developed world bioethicists have debated these justifications extensively. However, bioethicists, healthcare practitioners, and legal experts in developing world contexts such as SA have been slower to comment on the ethical significance of age discrimination.

In focussing on a SA context, this article contributes a different perspective to the broader debate about age-based rationing.

However, the central contribution of the paper is to draw attention to highly questionable premises that underlie age discrimination, which nonetheless remain largely unquestioned in SA bioethics and health policy.

Many argue that there are good, principled reasons for favouring the young. In particular, it is sometimes suggested that the elderly provide a reduced social contribution, that the elderly have already had their fair share of life, and that they will benefit less from health resources. I will assess the criteria implicit in each of these claims, and the extent to which they apply to the elderly, and suggest that they fail to justify age discrimination.

Social contribution It’s sometimes thought that the degree to which individuals contribute to society should play a role in who gets medical resources. For instance, prioritising breadwinners is thought to be justified because they have many dependants who rely on them.[11] The elderly on the other hand are often regarded as a burden on society. Older people extract a pension and after pensioning age may not contribute as much economically.

Interestingly, this type of consideration is reflected in one of the most prominent measures of the burden of disease: the Disability Adjusted Life Year (DALY) is endorsed by the World Health Organization and increasingly by health researchers and the South African government. The measure commonly ‘weights’ unhealthy middle years as contributing more to the burden of disease than unhealthy later years, since those in middle age are likely to provide a greater social and economic contribution.

However, the social contribution criterion, and the idea that the elderly contribute less are, respectively, morally and factually

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ARTICLE dubious. If social contribution is a relevant criterion, it requires discriminating in favour of those regarded as making greater economic, social and cultural contributions, such as presidents, politicians, celebrities, factory owners, and rich people who pay more tax. We would also be forced to discriminate against individuals who make smaller contributions, such as poor people, children, those without dependants or jobs, and the mentally ill. All of these provide a reduced contribution, but healthcare decisions that discriminate against these groups are rightly regarded as unacceptable.

The social contribution criterion therefore provides grounds for preferring people we don’t think deserve preference, and for dis­ criminating against groups who require the most social support.

Such a criterion should be rejected. Even if we accepted it, however, it is false to claim that the elderly contribute less to society. A brief look at the pages of history will show many elderly figures who have made disproportionate social contributions. Nelson Mandela is a prime example of a person who contributed massively well beyond his 75th year, but the contributions of elderly people are not limited to those who are famous. In SA, in particular, the aged are responsible for looking after families decimated by HIV/AIDS.[8] They are also stores of cultural knowledge that have immense social value.

It might still be maintained that the elderly make a reduced economic contribution, since they draw from benefit schemes and do not earn a wage or pay taxes. However, this contention entirely ignores the lifetime contributions of the elderly, which surely incur an obligation of reciprocity. Moreover, it should be noticed that, to the extent that there is a reduction of economic contribution, this is in part due to the fact that the elderly are often forced to retire by mandatory retirement ages. It would be grossly unfair to prevent someone from working, and then deprive them of medical treatment because they no longer work.

The social contribution criterion is deeply problematic, as is the idea that the elderly provide a reduced social contribution.

Discriminating against the elderly in resource allocation decisions cannot be justified on this basis.

Fairness A further attempt at justifying age discrimination is provided by the idea of a fair innings. Some argue that one goal of health services should be to ensure that each person has the same opportunity for a fair number of healthy years: we should all get a fair opportunity to play the game of life for the same time. Williams[3] suggests that, on this basis, it may sometimes be justified to discriminate against the elderly, since they have had a greater share of the good of life. The young should get healthcare resources, so as to give them a better opportunity for a ‘complete life’.[2] The fair innings criterion is certainly more convincing than the social contribution criterion, and evidence suggests that many people endorse this reason for deprioritising the elderly.[12] However, the fair innings view is also ethically questionable. Once again, employing the criterion would mean discriminating in favour of individuals we do not think should be preferred. For instance, fetuses have had only a fraction of their fair innings. Nonetheless, only the most zealous pro-lifer would think that we should save a fetus’s life over that of its mother, who has had a greater share of her fair innings.

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It could be claimed that the preference for mothers in this case is due to the fact that the fetus is not a fully-fledged person. As a nonperson, perhaps its share of life should not figure substantially in our weighing-up. Although many reject the idea that the unborn embryo is not a person, accepting this controversial view might rescue the fair innings criterion from one counter-intuitive consequence.

There are, however, additional, less easily escapable criticisms of the fair innings view. The fair innings requirement might also condone extreme discrimination against the very old. If one lives 110 good years one has drastically exceeded one’s quotient. Because the extreme elderly have already had much more than their fair share, the fair innings argument may recommend denying them any opportunity to access interventions even if they would benefit much more than a younger person. Similarly, even inexpensive care or treatments might be entirely denied to the elderly just because they have exhausted their fair share of resources. A criterion that recommends such neglect must be rejected.

Moreover, even if the fair innings criterion were accepted, being old is an unreliable indicator of fairness: it is often false to say that an older person has had his or her fair share of life’s goods. Many older persons will have lived lives of deprivation, hardship and disability. This is particularly true in nations, such as SA, in which the vast majority of elderly people have been the victims of unjust deprivation and discrimination throughout their lives. Often elderly black persons who have lived through apartheid will not have had their fair share of life’s goods. If applied correctly, then, the fair innings criterion may require favouring the elderly in nations such as our own.

The fair innings requirement seems to have a degree of appeal.

Nonetheless it should once again be clear that the criterion is flawed. And even if it was not, it provides inadequate grounds for discriminating against the elderly, particularly in SA.

Degree and likelihood of benefit The strongest basis for discriminating against the elderly is the principle that we should do the most good and provide the most benefit with the resources at our disposal. This common sense idea is related to the bioethical principle of beneficence and has a theoretical foundation in utilitarian ethical theory.[13] On the face of it, it seems likely that more benefit will accrue by treating the young rather than the elderly. A person who receives a heart transplant at the age of 40 is likely to gain many more healthy life years than a person who receives a transplant at the age of 85. The older person is likely to have poorer health and die from other causes before he or she can enjoy the full benefit of the intervention.

Despite its intuitive appeal, though, the benefit criterion has some unpalatable implications. If we accept it, we should discriminate against all groups with reduced life expectancy. Smokers and the overweight become obvious candidates to be deprioritised in health allocation decisions. Some find this consequence acceptable. Less easy to defend, though, is the implication that we should discriminate on grounds of race, class, or occupation. It is an unfortunate fact that certain races and classes live shorter lives.[14] Similarly, those in dangerous professions such as soldiers, policemen, and miners are likely to have reduced life expectancy. The benefit requirement unacceptably provides grounds for health decisions to discriminate against these groups along with the elderly.

ARTICLE Nonetheless, as discussed earlier, we do need some method of making allocation decisions, and perhaps a refined benefit criterion is the best of a bad bunch. Even if we accepted a benefit requirement, though, this would not provide grounds for generalised discrimination against the elderly. This is because the range of treatments from which the elderly are less likely to benefit appears to be extremely limited. These include life-saving treatments with very long-term benefits, such as organ transplants and heart surgery. Moreover, even deciding that the elderly should not get these is questionable. There is huge variability in humans’ age-relative health profiles, which gives rise to differences in expected healthy life years. This means that it would be far better to assess individual chances of benefit rather than generalise according to chronological age.

Once again, the benefit criterion is flawed. And once again, even its acceptance would not justify blanket discrimination against the elderly.

An objection: the elderly are willing to take a back seat Before concluding, it is worthwhile to pre-empt a common objection to the claim of this paper. The objection is that the elderly themselves often wish for young people to be treated ahead of them. It is certainly true that the opinions and decisions of the elderly, with regard to their own care, must be respected. It is arguably wrong for a practitioner to supply care that any capable patient, old or young, does not want.

Even so, two responses should be made to this objection. First, it is highly likely that the elderly themselves may have internalised some of the above flawed arguments for discrimination. When an elderly person offers such arguments for favouring the young, there may be a moral obligation to try to make the person aware of the unsound basis of their preference.

The second response is that, like many of the arguments in favour of age discrimination, it rests on a claim that is no more applicable to the elderly than it is to others. While it is certainly true that some elderly people prefer that others should be helped first, this is also true of many younger altruistic people. Moreover, it is true of the elderly far less often than many people think.[15] It is incorrect to assume that elderly people simply accept that they should fall further down the pecking order in resource allocation decisions. Policymakers and healthcare practitioners should not base discriminatory resource allocation decisions on this false assumption.

Conclusion It is not just abuse of the elderly that is wrong. Although such abuse is abhorrent and must be remedied, it is important to note that the elderly are discriminated against in more subtle, passive, and systematic ways. The non-provision of interventions to which they are as ethically and legally entitled as younger people can be as damaging as active abuse. As it stands, the elderly are tacitly, explicitly, and systematically discriminated against at all levels of healthcare.

Policymakers and healthcare practitioners have an ethical and legal obligation to ensure that the vulnerable elderly should not bear an unfair burden due to unjustified resource allocation decisions.

In case this obligation to others is not motivational enough, it is also worth pointing out that it is in each individual’s interest to undermine unfair discrimination: we all grow old, so it makes sense to defend our rights before we become vulnerable to their violation.

Acknowledgements. This paper has benefitted from fruitful discussions with members of the Philosophy Department at the University of Johannesburg, as well as participants at the Philosophy Spring Colloquium 2014. Thanks also to the two anonymous reviewers for probing comments.

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

Government Gazette 1996.

2. Persad G, Wertheimer A, Emanuel EJ. Principles for allocation of scarce medical interventions.

Lancet 2009;373(9661):423–431. [http://dx.doi.org/10.1016/S0140-6736 (09)60137-9] 3. Williams A. Intergenerational equity: an exploration of the ‘fair innings’ argument.

Health Econ 1997;6(2):117–132.

4. Callahan D. Aging and the ends of medicine. Ann N Y Acad Sci 1988;530(1):125–132.

5. Shaw A. In defence of ageism. J Med Ethics 1994;20(3):188–191.

6. Harris J. Does justice require that we be ageist? Bioethics 1994;8(1):74–83.

7. Dhai A, McQuoid-Mason DJ. Bioethics, Human Rights and Health Law: Principles and Practice. Cape Town: Juta 2010.

8. Chenwi L (Ed). Economic and social rights in South Africa. Special edition on the rights of older persons. ESR review 2011;12(1) 9. Republic of South Africa, National Health Act No. 61. Government Gazette 2003.

10. Republic of South Africa. Older Persons Act No. 13. Government Gazette 2006.

11. Murray CJL, Acharya AK. Understanding DALYs. J Health Econ 1997;16(6):703–730.

12. Dolan P, Tsuchiya A. It is the lifetime that matters: public preferences over maximising health and reducing inequalities in health. J Med Ethics 2012;38(9):571–573. [http://dx.doi.org/10.1136/medethics-2011-100228] 13. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. Oxford: Oxford University Press, 2001.

14. Adler NE, Boyce WT, Chesney MA, Folkman S, Syme SL. Socioeconomic inequalities in health. No easy solution. JAMA 1993;269(24):3140–3145.

15. Zweibel NR, Cassel CK, Karrison T. Public attitudes about the use of chronological age as a criterion for allocating health care resources. Gerontologist 1993;33(1):74–80.

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CPD QUESTIONNAIRE

May 2015 True (A) or false (B) Regarding surprising findings when updating workload at the Wits Human Research Ethics Committee: 1. The National Health Act requires that all health research is to be approved by a registered Research Ethics Committee prior to being conducted.

2. Research ethics application data cannot be used as a barometer to indicate early grassroots movements by Faculty to meet demands in postgraduate throughput.

Regarding Boni mores and consent for child research in South Africa: 3. A requirement for informed consent to be valid is that it should not be contrary to the legal convictions of the community or inconsistent with public policy.

4. Section 28(2) of the Constitution states that a child’s best interests are of paramount importance in every matter concerning the child.

5. In terms of South African law there is no requirement for adults to promote a child’s well-being and to protect children from physical, emotional or moral harm.

6. The Children’s Act does not contain any guidance on what factors should be considered when applying the child’s best interest’s principle.

Regarding laws and regulations associated with ownership of human biological material in South Africa: 7. The description of ownership of human biological materials in South Africa stems mainly from South African common-law.

8. The realisation that both scientific and commercial gains can result from human biological material has led to more stringent control over such materials nationally.

9. The Biodiversity Act of South Africa does not restrict access to genetic material for the purpose of acquiring remuneration.

Regarding whether the seclusion policy of mental healthcare users is a necessary evil: 10. Seclusion in the healthcare context can be defined as the voluntary confinement of an agitated, unstable patient alone in a contained, controlled environment.

11.

The regulations of the Mental Health Care Act provide for seclusion if the safety of others is at risk and not when ‘own safety’ is at risk.

12. The Mental Health Care Act specifies a minimum time that patients may be secluded and after what number of seclusions a new order of seclusion should ordered.

Regarding BCMP students’ experiences of professionalism during clinical rotations: 13.

As medicine is no longer considered only as a profession par excellence, the humanistic element is not critical in the development of a professional identity.

14. The Health Professions Council of South Africa does not assist practitioners with understanding professionalism as it does not describe any associated core values.

15. Integrity, truthfulness, compassion and professional competence are some core values associated with professionalism in the healthcare context.

Regarding why it is wrong to discriminate against the elderly in healthcare: 16. The South African Constitution is committed to the progressive realisation of the right to healthcare.

17. Trade-offs in the healthcare context do not include prioritising some patients or patient groups at the expense of others.

18. While the Older Persons Act explicitly states that the elderly are entitled to be respected, it is silent on their protection against unfair discrimination.

Regarding doctors call for lawyers to get out of hospitals: 19. Professional negligence results when healthcare practitioners negligently fail to exercise the degree of skill and care of a reasonably skilled practitioner in that field of practice.

20. Patient safety is a component of good quality healthcare services and contributes to improved health outcomes.

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

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.

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

Accreditation number: MDB015/164/02/2015 (Ethics)

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