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The Secretary’s Advisory Committee on Human Research Protections has finalized recommendations to assist IRBs dealing with “pay-for-participation” studies, which raise numerous ethical issues but may produce meaningful data if properly vetted.
The Secretary’s Advisory Committee on Human Research Protections used a series of questions in crafting recommendations on the complex issue of requiring research subjects to pay to participate. While still subject to some wordsmithing, the unpublished, finalized draft discussed at the SACHRP meeting included five questions and committee answers.
The number of exempt determinations is increasing as IRBs and research organizations adjust to the new Common Rule’s expanded definition of what types of research are exempt from IRB review.
Federal regulations provide some room for interpretation in how IRBs might handle exempt determinations under the revised Common Rule. Research programs need to revise their own rules about who makes the determination and how these are handled, given the expansion of the exempt status.
The risk-benefit ratio can be different when studies are proposed in response to a national bioemergency, such as Ebola outbreaks and epidemics. Researchers may need to tolerate greater risk to subjects, experts say. The bioemergency research tradeoff is that there might be a greater amount of benefit to society.
The next frontier in transplant medicine includes bioengineered organs, which raise ethical issues but could help alleviate a critical shortage that leaves more than 100,000 people on organ wait lists annually in the United States.
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Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.
