IRB Cases: Comment
IRB Research Ethics Case: Payments to subjects who are substance abusers
This case study raises a number of interesting issues including: coercion, undue inducement, fair compensation and issues specific to research with substance abusers including potential facilitation of drug use and protection from relapse. My commentary will focus primarily on the issues of undue inducement and fair compensation.It is important to recognize the technical difference between coercion and undue inducement. Coercion involves a threat to harm, whereas undue inducement involves a gratuitously large, and therefore distorting, offer of benefit. Coercion is a threat to make someone worse off unless they comply with a given demand. In the context of research ethics, coercion is actually quite rare. One example of coercion in research would be where a physician threatened to stop providing care to a patient unless they joined a clinic trial. Undue inducement, by comparison, occurs when the reward offered to potential research participants is so great that it undermines the participants’ ability to rationally weight up the costs and benefits of research participation. Debate about undue inducement in research is comparatively common.
This distinction is not merely academic; different ethical harms require different solutions and IRBs must be able to correctly identify issues if they are to offer appropriate ethical guidance to researchers. Attention to coercion requires the IRB to look for implicit threats of negative consequences if the patient decides not to participate in the research. Attention to undue inducement requires the IRB to determine whether the benefits offered to participants are disproportionate..
Ethical research must walk the line between fair compensation and undue inducement. ‘The general concern is that potential participants will be ‘blinded’ by the offer of money and might therefore underestimate the risks of research, overestimate the benefit of the cash payment or adequately weigh the risks but decide to act against their best interests in order to access the payment.1
There is limited empirical evidence about the effect of payments on research subjects’ capacity to give voluntary and informed consent. Recent empirical research assessing the impact of financial rewards on patients’ willingness to participate in risky research suggests that concerns about undue inducement may be exaggerated. However Halpern et al’s research was not conducted with a vulnerable research population and is not clear how the results might be applied to the substance abuse community.
In the absence of a good evidence base, IRBs establish local standards for appropriate compensation. Unsurprisingly these standards vary between committees and there is no national normative standard against which to assess varying levels of payment. The best IRBs can do is to consult, ideally, with representatives of the research population in question, and at a minimum with researchers familiar with the research population. In this case, the IRB relied on advice from the researchers who had considerable research expertise with substance abusers. This I think is adequate.
Delaying full payment until the point of study completion satisfies the requirement of incentivising participants to complete the study and therefore serves the needs of the researchers. However it fails to respect the rights of participants to fair compensation for the risks and discomfort they have endured, if only for part of the study. The protocol only allows for pro-rated payment if the participant suffers adverse affects. However participants should have the freedom to withdraw from the study at any point, for any reason, without forfeiting their financial compensation for the time already contributed and the risks and discomforts already endured. Justice would be better served if the payment was split so that $500 was paid as a pro-rated compensation payment and $500 was paid at completion of the study as an incentive payment.
This case study also raises often stated concern that research-related cash payments might enable drug users to procure drugs. Nonetheless research demonstrates that such payments are common: with 99% of clinical researchers working with drug users paying their research subjects, and 86% paying in cash.2 Recent empirical research on drug relapse indicated that neither the magnitude nor mode of the payment had a significant effect on rates of new drug use.3 In light of this evidence is would seem paternalistic to deny the research volunteers, in the case study under consideration, cash payments. The IRB’s requirement of three months continuous buprenorphine treatment as a condition for study enrollment is a good compromise that plausibly minimizes the risks of relapse without denying research subjects fair compensation.
Festinger DS, Marlowe DB, Croft JR, Dugosh KL, Mastro NK, Lee PA, Dematteo DS, Patapis NS. (2005). Do research payments precipitate drug use or coerce participation? Drug Alcohol Depend. 78(3):275-81.