by Emily Butler, content coordinator
Early phase clinical trials depend on the enrollment of healthy volunteers, who usually receive compensation for participation. Those in the research community, with input from bioethicists, have spent a great deal of time trying to determine what constitutes “fair” and “appropriate” compensation for subjects.
Researchers, sponsors, and IRBs/HRPPs are rightly concerned that excessive or otherwise “inappropriate” payments could constitute an undue inducement, thereby interfering with the prospective subject’s judgment and decision-making. In fact, some normal volunteers have come to regard clinical trials participation as a job, and, in those cases, the compensation they receive becomes their primary source of income.
A new book by Roberto Abadie uses an anthropological lens to examine the lives of paid research subjects. In The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects, Abadie documents the experiences of several repeat research participants in Philadelphia.
This recently released Time video highlights one subject’s story.
Repeat trial participation exposes participants to a multitude of risks, which raises concerns not only for the subjects’ health, but also for the reliability of the research data. We are curious to hear your thoughts on this issue. How do you think researchers and IRBs/HRPPs might address these concerns?
Fortunately, the NIH has been collecting survey data on the issue of payment for participation, and we will let you know when those results are made public.
When I was an undergraduate I frequently served as a healthy volunteer in research studies. Some of these studies were clinical trials, others were clinic-based investigations that may have included the use of approved drugs and devices. Regardless, they paid well, and that was one of my two main inclusion criteria. The other was that I would have a family member – an experienced nurse – take a look at the consent form and give me an opinion about the proposed research or provide me with a few questions to ask the investigator.
In most cases, I have no issues with paying people to take on risks as research subjects, provided that the informed consent process is appropriate. We, as a society, currently pay many people to take high-risk jobs – Marines, police officers, firefighters, etc.
Whether or not this impacts the quality of the data is an important, but to me separate, question.