IRB Policies on Research Recruitment Examined

March 2, 2009—In a study of 121 US medical schools' institutional review boards' (IRBs) policies, published in IRB: Ethics & Human Research Research, Leslie E. Wolf, JD, MPH, conducted an analysis that sought to determine whether the policies addressed matters involving investigator finder's fees and role conflicts in recruiting participants for research (2009;31:14-19). The IRBs' policies were found online by a search of relevant Web sites. IRB: Ethics & Human Research is a publication of The Hastings Center (Garrison, NY), a bioethics research institute that addresses issues of care and decision-making at the end of life, public health priorities, and new and emerging technologies.

According to Professor Wolf, analysis of the policies reveals that IRBs vary considerably in their approach to investigator conflict issues. Most IRBs ban recruitment payments, but few restrict recruitment when role conflicts exist. Although IRBs often acknowledge concerns about role conflicts, they seldom indicate how to resolve them. Because recruitment payments and role conflicts may compromise study recruitment and potentially harm research participants, IRBs should strengthen their policies to avoid unnecessary conflicts and minimize the potential risk of harm that these conflicts pose for research participants, the study concluded.

In regard to incentive payments, 49% of IRBs in the study state that they must be mentioned as a conflict, 28% prohibit them, 6% allow but discourage them, and 4% ask for information regarding them. As for physicians recruiting their own patients, 22% require that it be mentioned as conflict, 14% consider it potentially coercive, and 4% require disclosure to and consent of patients.

According to a review of the study by the American Medical News, a publication of the American Medical Association (AMA), the AMA, the American College of Physicians, and others have declared the practice of paying doctors finder's fees for recruiting patients as clinical research subjects to be unethical. Because these finder's fees can range from $2,000 to $10,000 per patient enrolled in a clinical trial, the AMA considers recruiting one's own patients as a potential conflict of interest. The survey of IRB policies does not shed light on what is happening outside the academic context where most clinical research takes place and is directly funded by pharmaceutical companies, noted the American Medical News.