http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4214066/MONEY, COERCION, AND UNDUE INDUCEMENT: A SURVEY OF ATTITUDES ABOUT PAYMENTS TO RESEARCH PARTICIPANTS
Emily A. Largent, BSN, Christine Grady, PhD, RN, Franklin G. Miller, PhD, and Alan Wertheimer, PhD
IRB. 2012 Jan-Feb; 34(1): 1–8.
PMCID: PMC4214066
NIHMSID: NIHMS636894
The practice of offering payment to research participants exhibits a tension between the aims of investigators to recruit subjects and the aims of IRBs to protect them by determining the ethical acceptability of protocols and payment schedules. On the one hand, payment is offered – nearly universally to healthy participants and increasingly to patient participants – to incentivize enrollment and compensate for participation.1 On the other hand, institutional guidance often cautions against undue inducement through offers of payment, and anecdotal evidence suggests that members of Institutional Review Boards (IRBs) and professionals involved in research oversight are concerned that payment may coerce or unduly influence prospective research participants, thereby compromising the voluntariness of consent.2 Insofar as they reflect sound ethical thinking, these concerns appropriately influence payment practices; if they are misguided, however, valuable research may be impeded because no payment or insufficient payment is being offered when such payment is compatible with informed consent.
Provision of informed consent to participate in research requires: a competent decision maker; adequate disclosure and comprehension of pertinent information; and a voluntary decision. While payment is thought to influence decision-making and may thereby compromise the voluntariness of consent, the various laws, regulations, and ethical guidelines that govern the conduct of human subjects research offer relatively little specific guidance about payment. According to the Federal Policy for the Protection of Human Subjects or the “Common Rule”: “An investigator shall seek such consent only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”3 Yet, the Common Rule does not define either coercion or undue influence. The Belmont Report, upon which many rely for authoritative guidance, states, “Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance;” by contrast, undue influence “occurs through an offer of excessive, unwanted, inappropriate or improper reward or other overture in order to obtain compliance.”4 Although other documents and institutional guidelines make similar statements and scholars have explored these concepts, we do not know how IRB members actually understand and apply these concepts.5
To remedy this gap in our understanding of research regulations, we undertook a survey of IRB members and research ethics professionals to address the lack of systematic data concerning attitudes about payment generally, and to determine how they think of coercion and undue influence specifically.
...
Conclusion
We conducted a national survey of the attitudes of IRB members and human subjects protection professionals towards payment of research subjects. Respondents indicated considerable ethical concern that payment could constitute coercion or undue inducement.
Most agreed that subjects are coerced if the offer of payment makes them participate when they otherwise would not or when the offer of payment causes them to feel that they have no reasonable alternative but to participate. Most respondents had similar views about undue influence. The excessively expansive or inconsistent views about coercion and undue influence held by IRB members and human subjects professionals
may interfere with the recruitment of research participants by needlessly limiting the payments offered to them and thereby impede valuable research without true cause.
Topic: MONEY, COERCION, AND UNDUE INDUCEMENT: A SURVEY OF ATTITUDES ABOUT PAYMENTS TO R (Read 2910 times)