The Office of Human Research Protections (OHRP) has issued revised guidance about research subject compensation. And, although it has not attracted a great deal of fanfare, it deserves attention because the new guidance offers greater flexibility to investigators and to the Institutional Review Boards (IRBs) charged with reviewing proposed human research studies. Under its list of Frequently Asked Questions (FAQ) related to informed consent, there is a question (7) which reads, “When does compensating subjects undermine informed consent or parental permission?” (http://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf).
Aside from the fact that it’s still a very leading question (asking “when does it?” implies that, in fact, it does…), the new answer provided by OHRP clarifies that compensation in and of itself is not necessarily coercive or a source of undue influence. It says that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for some individuals agreeing to participate in research.
That is a real paradigm shift.
The old OHRP response to this FAQ included the following sentence. “The level of remuneration should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the remuneration.” That (now outdated) guidance created real problems for IRBs. They understandably inferred that OHRP would consider any degree to which level of remuneration was based on research risks unacceptable (and, therefore, out of compliance).
By issuing revised guidance, OHRP is promoting a much more autonomy-affirming interpretation of 45 CFR 46.116, which says, “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”
Upon issuing the revised FAQ answer, OHRP said “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.”
This is a win for subjects. Because the previous paradigm, which understandably was designed to prevent exploitation, had the unintended consequence of preventing people from access to fair compensation for their time, inconvenience and, yes, even the risks they were asked to undergo in the name of science.