“The first sentence has been struck because this FAQ focuses on potential undue influence in the consent process (45 CFR 46.116) rather than on IRB considerations under 45 CFR 46.111. However, OHRP continues to assert that IRBs should not consider remuneration as a way of offsetting risks.
With regard to the second sentence, several members of the research ethics community have brought to our attention the implication of these sentences, which is that in most cases any level of remuneration based on research risks could be considered unacceptable. This implication is not consistent with OHRP’s interpretation of 45 CFR 46.116. In deciding whether to participate in research, subjects should have the opportunity to assess when risks and benefits (including remuneration) are balanced in light of their individual circumstances. Thus, the second sentence referenced above has been struck from the response.“
I found the HHS’ statement rather contradictory on the surface, but after a closer reading, the change began to make more sense. The contradiction: remuneration can’t be used to offset risks, but subjects should be able to weigh risks and benefits (including remuneration). What the OHRP is saying, though, is that while the Institutional Review Board of an organization shouldn’t consider remuneration as a way to offset risks, patients can. This makes sense to me. The IRB is there to protect subjects from harm, ensuring risks are at an appropriate level to proceed with a study. Once an IRB has determined that (meaning there’s already the assumption of an acceptable level of potential risk), then the patients can decide whether or not they want to take on that level of risk given the potential benefits.
What are your thoughts on this change? I certainly see where Public Citizen is coming from. On the surface, the language being stricken is concerning, but it seems to me, the language still ensures strong protections to patients through the long-standing IRB processes. And anyone who has stood in front of one of these boards knows just how strictly they take potential patient harm.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
