samj forum - South African AIDS Vaccine Initiative

SAMJ FORUM

OPINION

Payment of trial participants can be ethically sound: Moving past a flat rate Jennifer Koen, Catherine Slack, Nicola Barsdorf, Zaynab Essack The South African Medicines Control Council (MCC) policy that trial participants be paid a flat rate of R150 per visit in clinical trials has been criticised in the press.1 The literature argues that it is an excessive or inappropriate reward;2 it neglects salient factors such as the design or nature of the study,2,3 and non-industry-funded trials may not be able to afford it.3 Also, this amount could be regarded as an ‘undue inducement’ for participants to enrol.

for direct research-related expenses. Incentive payments encourage participation either intentionally, when payment is given over and above compensation and reimbursement, or inadvertently, when payment unintentionally exceeds direct costs and burdens. Appreciation payments are bonuses given after participation to thank participants for their efforts.6

In our view, the main problem is that the MCC policy violates the ethical principle of justice in that participants are paid the same amount but do not do the same things or incur the same expenses.4 It has been argued that it would be more appropriate to have a broad contextualised policy5 and that participants should be paid for their time and expenses.2 To take these recommendations forward, we apply two theoretical models of payment (the Wage Payment and Reimbursement models) for time, inconvenience and expenses (TIE). We recommend that participants be paid for their time at a rate similar to national unskilled labour rates, with increments for inconvenient procedures (determined nationally), and that they are refunded their direct expenses; this is operationally complex but ethically sound.

Although a few hold that research participants should never be paid,7 controversy centres largely on what should be paid for, and a sum that is appropriate. The principal justification for payment is that it facilitates recruitment of participants.8 When research is scientifically valid, has a favourable balance of risks and benefits, and meets other ethical criteria,9 recruitment is an ethically sound objective. Payment reduces financial obstacles to participation by making participation a ‘revenue-neutral activity’6,8,10 and respectfully acknowledges the burdens that participation in research involves.6

Our recommendations for stakeholders include that the National Health Research Ethics Council (NHREC) assumes control of payment norms and endorses payment for TIE. A new payment approach may experience some resistance because of community expectations and researchers who have enjoyed a simple administrative procedure.

Types of payment Four types of payment have been identified. Compensation payments are intended to compensate for time, inconvenience, discomfort and other research-related burdens (not risks). Reimbursement payments are refunds to participants 6

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The authors are members of the HIV AIDS Vaccines Ethics Group (HAVEG) of the School of Psychology, University of KwaZulu-Natal, Pietermaritzburg.

Corresponding author: J Koen ([email protected])

December 2008, Vol. 98, No. 12 SAMJ

The debate about payment

There are four main objections to payment. Firstly, payment to participants leads to the ‘commodification’ of what should be an altruistic venture.8 However, people who contribute to society’s welfare in other areas (e.g. fire-fighters) receive pay; therefore, receiving pay can be compatible with altruistic motives.8,11,12 Research has long been commercialised,12 so it is not clear why participants should be singled out as having to have altruistic motives. Participants are apparently motivated by many factors, including money.2 It would be sensible to acknowledge this and to concentrate on reducing any negative effects of that influence.13 Secondly, payment could be more attractive to indigent participants, leading to their over-representation in research and to a disproportionate burden on them;8 for example, poor people may be willing to undergo risks in return for rewards that better-off people would reject.14 However, the logical response of decreasing payment amounts would make it even harder for poor people to participate.8 It may be more logical to increase payment amounts to make participation more worthwhile to better-off people.11 Thirdly, payment could influence participants to be dishonest about information that would lead to their exclusion;8,14 but more objective eligibility criteria would be more logical than eliminating payment.8 While participants in lower-risk studies may be willing to conceal information, this does not seem to

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be associated with payment.8 In any event, payment may not influence participants to conceal health information.2 Fourthly, payment may undermine the quality of participants’ decisions8 and can tend to be coercive.8 However, coercion is decision-making under threat of harm and not in terms of limited options or a strong influence.8 Payment is an offer and not a threat8 and, while ethically complicated, is not coercive. Others assert that payment can be an ‘undue inducement’, but an inducement is merely an offer that encourages or changes a particular behaviour.11 Payment may well be a financial inducement in research (better medical care may be a non-financial inducement) but is not necessarily ethically objectionable. An undue inducement is an excessive offer that distorts decision-making or impairs judgement by blinding research participants to potential study risks or causing them to minimise their concerns.14 This definition includes participants who are led to enrol in potentially seriously harmful research11 and acknowledges that payment becomes more controversial when there are doubts that an expert Research Ethics Committee (REC) has determined that the study risks are acceptably low.11 A suitable response may be to put a reasonable cap on payment amounts,8 improve consent processes regarding risks11 and ensure that competent ethical review has reduced risks to acceptable levels.8,11 There are no data confirming that payment leads to impaired judgement.11 Objections to paying patient-participants are that it makes the patient-provider relationship more complex, and that patients may receive a direct benefit that healthy volunteers will not. However, payment may actually reduce the ‘therapeutic misconception’, and some trial procedures do not confer direct benefit.4 Objections to payment for child participation include that payment can distort the judgement of parent and child, and that it seems unfair to pay parents when children bear the research burdens. Therefore, compensatory payments should be made to the party assuming the burden (usually the child) at rates comparable with what children would receive for similar activities. Payment should be in kind (e.g. vouchers) to protect children’s assets from parents.6 Reimbursement payments should go to the party incurring costs, and cash seems most appropriate.

Ethical guidance on payment Many ethical guidelines raise the issue of payment to research participants as being potentially problematic, frequently because of concerns about informed consent or justice. South African guidelines are not completely concordant, but all South African ethical guidelines endorse reimbursement payments. Guidelines governing research funded by the Medical Research Council (MRC) endorse compensation payments for time and inconvenience, whereas the Department of Health tends to endorse incentive payments (payment may be a ‘financial benefit’).


Many international ethical guidelines are silent on payment (e.g. Belmont Report, Declaration of Helsinki). Those that address the topic endorse reimbursement payments and compensation payments for time and inconvenience but do not provide operational guidance on the latter (e.g. UNAIDS, 2007; CIOMS, 2002).

Models to operationalise payment for TIE Two models go some way towards delineating payment in a way that broad ethical guidelines do not.6,8,10,11

Paying for time The Wage Payment model10 advocates compensation payment for time and inconvenience. Payment for time is calculated at an hourly rate commensurate with that for other unskilled but essential jobs.8,10 While participants do not need any specific skills or training, participation does entail the expending of time and effort.10 Therefore, to be fair, payments to research participants should be consistent with payments for other similar activities,11 and participants should be paid the same for the same amount of ‘work’.8,10 The tendency for undue inducement is lessened as participants receive similar money-making opportunities in the community.8,10 Also, standardisation of payment reduces inter-study competition.8,10 However, payment for time at these rates may not facilitate recruitment,10 especially of higher wage earners.15 Rate differentials between rural and urban settings or various sectors of unskilled labour16 need to be considered. (In South Africa, sectoral unskilled labour rates are currently under review, and the general category of unskilled labour no longer exists. At present, domestic workers are paid approximately R5.00/hour when rural and urban sectors are averaged; and construction workers in certain urban regions get approximately R10.00/hour.) In their application of the wage payment model, Dickert and Grady10 used a national average wage. It is possible that averages could exceed region-specific payments for similar activities (causing participants to conceal information or devalue risks). However, where rural-urban or sector differences are negligible, this is not likely, and a national average seems reasonable. Where stakeholders insist that it is fairer to implement rural-urban distinctions in payment for participants at different sites, the difference could be placed in a fund for community development activities. Even in settings with high unemployment, offering time-related payments at unskilled labour rates is arguably fairer and less likely to be an inappropriately high incentive than rates determined by a market model,10 or even a flat rate.

Paying for inconvenience The Wage Payment model advocates additional payments for inconvenient procedures8,10 (which acknowledges that participation sometimes entails discomfort10) and may make

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participation more attractive. However, this requires complex evaluation, for which there is little available guidance. Paying for inconvenience, but not for risk, can be problematic. Inconvenient procedures are trouble- or bothersome, or disturb routine.17 Risky procedures hold the possibility of physical, psychosocial or economic harm. Consequences such as embarrassment could be viewed as either inconvenience or risk. These ramifications can probably be offset by further conceptual work defining the differences, and building the capacity of gatekeepers such as RECs, to apply the distinctions. While experiences of inconvenience will be subjective and differ among participants, the standard is to estimate what a ‘reasonable person’ would find inconvenient – a concept routinely applied by RECs when making risk estimations.11 Payment for inconvenience seems hard to apply without seeming arbitrary. According to the National Institutes for Health (NIH),18 the study’s principal investigator determines inconvenience rates. Dickert and Grady10 suggest amounts for inconvenience but not how they classed procedures as such or how they arrived at the amounts. Determining rates for inconvenient procedures will always tend to be arbitrary or complex. This can be offset if legitimate institutions, through collective and informed decision-making, reach consensus and make preliminary recommendations on amounts paid for inconvenient procedures that can be adopted in trials by researchers and enforced by RECs.

Paying for expenses The Reimbursement model10 advocates payment for participants’ direct expenses (e.g. transport costs, meals and child care). Participants are therefore not out of pocket. Because only actual costs are covered, concerns regarding participants’ misrepresentation or failure to consider risks are minimised, and indigent people are not especially encouraged to participate.8,10 However, since participation is not incentivised, it may be difficult to meet recruitment targets.8,10 It must also be decided whether time away from work will be reimbursed and, if so, if participants are paid according to their income, which could cause researchers to target low-wage earners to reduce costs.8 Therefore, it has been argued that this cost be excluded.

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Since reimbursement will differ among participants, administration of this approach will be more complex. It may be difficult to prove what each participant has spent, as receipts may not be available. To simplify the procedure, and for budgeting purposes, researchers should engage in formative research and consult Community Advisory Boards (CABs) to assess expected costs to participants, e.g. transport to the research site. Anecdotally, researchers already appear to implement this approach, as in the case of participants presenting for repeated unscheduled visits. Researchers could consider separating reimbursement payments from standardised time and inconvenience payments.


The MCC’s payment policy for trials The MCC policy does not fit the model of ‘compensation for time or inconvenience’ as participants are not paid according to time spent or inconvenience, e.g. participants who take 30 minutes to complete a simple questionnaire are paid the same as those who undergo hours of uncomfortable procedures – participants are paid the same but are not doing the same things or making the same contributions, which is unfair.4 The MCC flat rate does not fit the model of ‘reimbursement of expenses’ as participants are not reimbursed for their actual expenses, e.g. owing to differing transport costs, some participants may incur a loss while others may score financially. The flat rate could become an incentive if remuneration exceeds actual expenses or burdens. However, our primary concern is not with ‘undue inducement’ but with fairness. Another concern is that the ruling on participant payment is beyond the MCC’s mandate.5 In South Africa, the mandate for setting norms and standards for research falls on the NHREC (s73, NHA, 2003),19 which is more suited for setting standards for payment.

Conclusions The MCC’s policy of participants being paid a flat rate of R150 per trial visit has two apparent advantages: it is simple to administer and appears to be fair because all trial participants ostensibly receive the same amount; however, it is fundamentally unjust as participants are paid the same amount regardless of their differing inputs and outlays.4,14 When research stakeholders acknowledge that paying participants the same amount for different contributions is unfair, alternative approaches should be seriously considered. Participants should be paid for their actual expense and time outlays at a rate that approximates national unskilled labour rates, with additional payment for inconvenient procedures. If TIE payment is implemented, trial payments will differ. A trial with fewer, shorter visits and less inconvenient procedures will pay participants less than one with many, longer visits and complex procedures. When participants are paid for their actual expenses, their remuneration will differ, which will require participants (and participating communities) to understand what is being paid for, so that the differences are understood to be fair. It is pertinent that participants are routinely expected to understand much more complex concepts (such as placebo/ controls) than differing payment rates. A new payment schedule that takes into account the nature of the study (length, procedures) and the individual costs to participants will not be seen as legitimate unless ‘fair differences’ are understood. Limiting payment to reimbursement of expenses and payment for time and inconvenience may also be the best way to keep financial inducements ‘due’.12 While this approach may involve logistical challenges and complex administration, it reflects a payment policy underpinned by thoughtful, ethical reflection.

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Recommendations for stakeholders

1. G ovender P. Girls bunk school to cash in on HIV trials: School kids offered money to test gel product each time they have sex. Sunday Times 13 November 2005.

1. The MCC should revoke its payment policy.

2. B urgess L, Sulzer N, Emanuel S. Clinical trial remuneration: the patients. S Afr Med J 2008; 98(2): 95-97.

2. R esearch organisations, including their RECs, should audit the payment practices that prevailed prior to the flat rate.

4. D ickert N, Emanuel E, Grady C. Paying research subjects: An analysis of current policies. Ann Intern Med 2002; 136(5): 368-373.

3. T he NHREC should adopt TIE payment, draft standardised rates for procedures, discuss these with stakeholders, recommend their implementation for a trial period, and ratify these rates. 4. S outh African guideline developers should revise ethical guidelines to endorse TIE payment and engagement with communities on aspects of payment. 5. R esearchers should estimate expenses in consultation with communities and, using national time and inconvenience rates, prepare payment schedules for presentation to RECs. 6. R ECs should implement TIE payment and stipulate that it be included in the consent process because it is material to volunteers deciding on participation. RECs should be familiar with rates for unskilled labour around the country. HAVEG is funded by the South African AIDS Vaccine Initiative (SAAVI), and Ms Slack is a member of the NHREC. The views expressed in this article do not necessarily reflect those of either body. We gratefully acknowledge the assistance of Richard Mukuka. Thanks are also due to Debbie Budlender for helping to clarify the notion of ’unskilled labour’.

3. Horn L. Payment of clinical trial participants. S Afr Med J 2008; 98(2): 93-94.

5. M oodley K, Myer L. Participant renumeration for research? How much is enough? S Afr Med J 2003; 93(9): 677-679. 6. W endler D, Rackoff JE, Emanuel EJ, Grady C. The ethics of paying for children’s participation in research. J Pediatr 2002; 141(2): 166-171. 7. M cNeill P. A response to Wilkinson and Moore: Paying people to participate in research: Why not? Bioethics 2002; 11(5): 373-396. 8. Grady C. Payment of clinical research subjects. J Clin Invest 2005; 115: 1681-1687. 9. E manuel E, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283(20): 2701-2711. 10. D ickert N, Grady C. What’s the price of a research subject? Approaches to payment for research participation. N Engl J Med 1999; 341(3): 198-203. 11. Emanuel E. Undue inducement: Nonsense on stilts. Am J Bioeth 2005; 5: 9-13. 12. P entz R. Spreading it around: money for researchers and research participants. Mt Sinai J Med 2004; 71(4): 266-270. 13. Heath E. On considering (what I might do for) money. Am J Bioeth 2001; 1(2): 63-64. 14. M acklin R. ‘Due’ and ‘undue’ inducements: On paying money to research subjects. IRB 1981; 3(5): 1-6. 15. Reid L. Nice work if you can get it. Am J Bioeth 2005; 5(5): 27-29. 16. D epartment of Labour. Sectoral Determination. Pretoria: Department of Labour. http://www. labour.gov.za/legislation/sectoral-determinations/sectoral-determination (accessed 2 May 2007). 17. T hompson D. Inconvenience. The Concise Oxford Dictionary of Current English. 9th ed. Clarendon: Oxford University Press, 1995. 18. N IH Clinical Center. Are Clinical Studies for You? Bethesda, MD, USA: National Institutes of Health (NIH). http://clinicalcenter.nih.gov/participate/studies.shtml (accessed 2 May 2007). 19. S trode A, Slack C, Mushariwa M. HIV vaccine research: South Africa’s ethical-legal framework and its ability to promote the welfare of trial participants. S Afr Med J 2005; 95(8): 598-601.

Accepted 26 September 2008.

MEDICINE AND THE LAW

The Children’s Amendment Act and the Criminal Law (Sexual Offences and Related Matters) Amendment Act: Duty to report child abuse and sexual offences against children and mentally disabled persons David McQuoid-Mason The Children’s Amendment Act1 and the Criminal Law (Sexual Offences and Related Matters) Amendment Act2 (Sexual Offences Act) impose duties on medical practitioners and others to report child abuse and sexual offences against

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

Corresponding author: D McQuoid-Mason ([email protected])


children and mentally disabled persons that go beyond those in the Child Care Act3 and the Prevention of Family Violence Act.4 The latter Acts will be repealed once the relevant provisions of the Children’s Amendment Act come into effect.5 The Sexual Offences Act came into effect on 16 December 2007.6

Ill-treatment of children under the Child Care Act Until the provisions regarding the duty to report ill-treatment of children in terms of the Child Care Act7 are repealed, the existing provisions apply.

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The Child Care Act provides that every dentist, medical practitioner, nurse, social worker or teacher, or any person employed by or managing a children’s home, place of care or shelter, who examines, attends or deals with any child in circumstances giving rise to the suspicion that that child has been ill-treated, or suffers from any injury which probably might have been deliberately caused, or suffers from a nutritional deficiency disease, must immediately notify the Director-General of Social Development or a designated officer of such circumstances.7 In practice, such cases are often reported to the police or a provincial social development official. Even if they were mistaken, such persons shall not be liable for any notification given in good faith in accordance with the Act.7 However, it is a criminal offence for such person to fail to report abuse or neglect when required to do so by the Act,7 and they could be held civilly liable for damages if the child suffers further injury as a result.8

Ill-treatment of children under the Prevention of Family Violence Act As in the Child Care Act, until the duty to report ill-treatment of children in terms of the Prevention of Family Violence Act9 has been repealed, the existing provision applies. The Prevention of Family Violence Act provides that any person who examines, treats, attends to, advises, instructs or cares for any child in circumstances that give rise to a reasonable suspicion that such child has been ill-treated, shall immediately report such circumstances to a police officer or a Commissioner of Child Welfare or a social worker.9 Unlike the Child Care Act, this Act does not specifically provide protection for persons who report in good faith and in terms of the Act. Therefore, medical practitioners and other health care professionals will probably feel more secure when reporting in terms of the Child Care Act than the Prevention of Family Violence Act. However, the common law defences of statutory authority10 and qualified privilege11,12 would provide protection for persons who report in good faith in terms of the Prevention of Family Violence Act, which was introduced to include categories of persons wider than those in the Child Care Act to combat family violence.

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Child abuse and neglect, or children in need of care, under the Children’s Amendment Act provisions not yet in force When the provisions of the Children’s Amendment Act13 come into effect, they will replace those in the Child Care Act7 and Prevention of Family Violence Act.9 A wider list of persons is required to report in terms of the Children’s Amendment Act than in the Child Care Act, including members of the health care professions.


The Children’s Amendment Act provides that any correctional official, dentist, homoeopath, immigration official, labour inspector, legal practitioner, medical practitioner, midwife, minister of religion, nurse, occupational therapist, physiotherapist, psychologist, religious leader, social service professional, social worker, speech therapist, teacher, traditional health practitioner, traditional leader or member of staff or volunteer worker at a partial care facility, drop-in centre or child and youth care centre who on reasonable grounds concludes that a child has been abused in a manner causing physical injury, sexually abused or deliberately neglected, must report such conclusion in the prescribed form to a designated child protection organisation, the provincial department of social development or a police official.13 The Act imposes a mandatory duty on the designated categories of persons to report instances of abuse or neglect to the relevant authorities. Failure to comply is a criminal offence14 and may also result in civil liability for damages if the child concerned suffers further injury as a result of failure to report.8 The Children’s Amendment Act also provides for discretionary reporting by anyone who on reasonable grounds believes that a child is in need of care and protection, and may report that belief to the provincial department of social development, a designated child protection organisation or a police official.13 This provision is wider than that in the Prevention of Family Violence Act,9 which is restricted to persons who examine, treat, attend, instruct or care for children who are reasonably suspected of having been ill-treated. The reporting duty in the Prevention of Family Violence Act is mandatory, but is discretionary in the Children’s Amendment Act. Consequently, there is no criminal liability for exercising discretion not to report that a child is in need of care. However, where such failure to report results in foreseeable harm to the child and there is a common law duty on the person concerned to prevent such harm (e.g. because of a special relationship such as that between doctor and patient), that child may institute a civil action for damages.8 Persons who report child abuse or neglect, or that a child is in need of care in accordance with the provisions of the Act, must substantiate their conclusion or belief to the relevant provincial department of social development, a designated child protection organisation or a police official, and will not be liable for civil action on the basis of such report if made in good faith.15

Sexual abuse against children and mentally disabled persons under the provisions of the Sexual Offences Act now in force The Sexual Offences Act2 provides that a person who has knowledge that a sexual offence has been committed against

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a child must report such knowledge immediately to a police official.16 A person who has knowledge, reasonable belief or suspicion that a sexual offence has been committed against a person who is mentally disabled must report this immediately to a police official.17 Failure to report in terms of the Act amounts to a criminal offence for which the convicted person may be liable to a fine or imprisonment.18 Sexual offences against children in terms of the Act (apart from offences where there is no consent such as rape and sexual assault) include: (i) acts of consensual sexual penetration with certain children (statutory rape); (ii) acts of consensual sexual assault with certain children (statutory sexual assault); (iii) sexual exploitation; (iv) sexual grooming; (v) exposure or display of or causing exposure or display of child pornography or pornography; (vi) using children for or benefiting from child pornography; (vii) compelling or causing children to witness sexual offences, sexual acts or self-masturbation; and (viii) exposure or display of or causing of exposure or display of genitals, anus or female breasts to children (‘flashing’).19 Similar sexual offences against mentally disabled persons are provided for in terms of the Act.20 In sexual offences against children, the duty to report only arises if the person (e.g. a medical practitioner) has knowledge that such an offence has been committed. The Act does not exempt from legal liability persons who report in good faith and in accordance with the Act, but they will be protected by the common law defences of statutory authority10 and qualified privilege.11,12 In any event, failure to report which results in foreseeable harm to a child, where there is a common law duty on the person concerned to prevent such harm, such as resulting from the special relationship between a doctor and patient, may give rise to a civil action for damages.8

reasonably believes or suspects that a sexual offence has been committed against such a person. A person who in good faith reports this shall not be liable to any civil or criminal proceedings as a result of it.15 Furthermore, if the person reports knowledge of such a sexual offence being committed, the report will be protected by the common law defences of statutory authority10 and qualified privilege.11,12 Conversely, in the event of failure to report resulting in foreseeable harm to a mentally disabled person, where there is a common law duty on the person concerned to prevent such harm (e.g. because of a special relationship such as that between a psychiatrist and a mentally disabled patient), the mentally disabled person may sue for damages.8 1. Children’s Amendment Act No. 41 of 2007. 2. Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007. 3. Child Care Act No. 74 of 1983. 4. Prevention of Family Violence Act No.133 of 1993. 5. See Schedule 4 of the Children’s Act No. 38 of 2005. 6. S ection 72(1) of the Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007. 7. Section 42 of the Child Care Act No. 74 of 1983. 8. Cf. Minister van Polisie v. Ewels 1975 (3) SA 590 (A). 9. Section 4 of the Prevention of Family Violence Act No.133 of 1993. 10. Johannesburg Municipality v. African Realty Trust Ltd 1927 AD 163. 11. Cf. Borgin v. De Villiers 1980 (3) SA 556 (A) at 577. 12. M cQuoid-Mason D. Disclosing the health status of public figures: Privacy versus public interest – when may doctors make disclosure? S Afr Med J 2007; 97(5): 334-338. 13. Section 110 of the Children’s Amendment Act No. 41 of 2007. 14. Section 305(1) of the Children’s Act No. 38 of 2005. 15. Section 110(3) of the Children’s Amendment Act No. 41 of 2007. 16. S ection 54(1) of the Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007. 17. S ection 54(2) of the Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007. 18. S ection 54(1) and (2) of the Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007. 19. C hapter 3 of the Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007. 20. C hapter 4 of the Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007.

Regarding mentally disabled persons, the duty to report arises if there is knowledge and also if the person concerned

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