Coercion in the Recruitment and Retention of Human Research Subjects, Pharmaceutical Industry Payments to Physician-Investigators and the Moral Courage of the IRB

Abstract

subjects research demand that persons not be coerced to become research subjects. The regulations governing studies covered by the Common Rule (45 CFR 46.111(b)) and the U.S. Food and Drug Administration (21 CFR 56.111(b)) articulate this requirement explicitly. That initial consent from prospective subjects and continuing consent from research participants must not be coerced or unduly influenced is clear and unequivocal in both sets of regulations. Clear and unequivocal, also, is that protecting prospective subjects and research participants from coercion and undue influences is the responsibility of the institutional review board (IRB). Until very recently, in general, the public has trusted that the IRB system, coupled with the integrity of the physician-investigator, has been sufficient to meet the task. But the pressures to recruit and retain subjects are evolving in ways that increase the prospect for coercion at the same time that serious questions are being raised about the ability of the IRB system to do its job.1 In the wake of highly visible shut-downs of respected state and university research programs, and with the advent of increasingly aggressive recruitment and retention strategies by the pharmaceutical industry, media attention is fueling public fears that human research subjects are not well protected.2 As these legitimate but alarming concerns about coercion and undue influence in the recruitment and retention of human research