Money, Coercion, and Undue Inducement: Attitudes Vary about Payments to Research Participants

research(Garrison, NY) Researchers almost always offer money as an incentive for healthy volunteers to enroll in research studies, but does payment amount to coercion or undue inducement to  participate in research? In the first national study to examine their  views on this question, the majority of institutional review board  members and other research ethics professionals expressed persistent  ethical concern about the effects of offering payment to research  subjects. But they differed in their views of the meaning of coercion  and undue influence and how to avoid these problems in concrete research  situations. The study appears in IRB: Ethics & Human Research.  
The findings are important because the  federal regulations for the protection of human subjects — known as the Common Rule — state that investigators should seek consent from potential research volunteers under circumstances that “minimize the  possibility of coercion or undue influence.” The regulations do not  define these terms. 
The study consisted of an online survey that  asked a random sample of IRB members and others involved with upholding  ethical standards in biomedical research about their views about  different kinds of payments, including money, nonmonetary offers, and medical care.  Of the 610 respondents, 61 percent “reported  feeling somewhat, moderately, or very concerned that payment of any amount might influence a participant’s decision or behaviors regarding research participation.” The higher the payment, the greater the  concern. 
“Most respondents expressed concern that substantial payment  could compromise a participant’s ability to think clearly about study risks and benefits (85%), lead individuals to enroll in a trial they  otherwise would not enroll in (88%), or remain in one from which they would like to withdraw (84%),” the authors write.  Most respondents agreed that researchers could offer money to reimburse expenses, and many thought that offering  money as compensation for time and inconvenience was acceptable. 
But the authors conclude that the  respondents’ views of coercion and undue influence were “excessively  expansive, or inconsistent.” For example, while more than 90 percent  agreed with a definition of coercion tied to threat of harm, most also  agreed that research participants are coerced when an offer of payment  — not the threat of harm — gets them to participate when they  otherwise would not. 
The findings pose a dilemma to those charged  with ethical oversight of human subjects research. According to the authors, unless researchers can offer payment as an incentive to participate in research, people might not enroll in studies and,  therefore, much valuable research “is unlikely to be conducted in a  timely manner or even conducted at all.” And yet IRBs should not approve  protocols — whatever their social or scientific value — unless the  possibility of coercion or undue influence has been minimized. To get  around this dilemma, the authors recommend that policy and educational  efforts be undertaken to clarify when payment practices actually constitute coercion and undue influence. 

Source: The Hastings Center

Leave a Reply