OHRP revises its response to the question "When does compensating subjects undermine informed consent or parental permission?"

OHRP has revised its response to the Frequently Asked Question (FAQ) "When does compensating subjects undermine informed consent or parental permission?" (http://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html).

Human subjects often are provided payment for their time, inconvenience, and out-of-pocket expenses. Remuneration for risk, however, has been a source of controversy because it is challenging to assign a reasonable level of payment and because it is difficult to assess what constitutes undue influence. In reality, however, many subjects would not participate in research involving risk absent some level of remuneration.

The previous version of the response to this FAQ included the following sentences. "In no case should remuneration be viewed as a way of offsetting risks; that is, it should not be considered a benefit to be weighed against study risks. 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."

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.

In addition, the previous version contained the following sentence, which has been struck because it is focused on IRB considerations under 45 CFR 46. 111 rather than on informed consent, and was misplaced in this FAQ: "IRBs may need to request of the investigator some plan for monitoring subject recruitment to ensure that such inducements do not result in inequitable subject recruitment (e.g., recruiting only economically disadvantaged individuals)."

In sum, this FAQ has been changed to clarify 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. It has also been revised to focus more specifically on issues related to consent.

Other minor changes have been made for clarity.

If you have specific questions regarding the issues discussed in this FAQ, please contact OHRP by phone at (866) 447-4777 (toll-free within the U.S.) or (240) 453-6900, or by e-mail at ohrp@hhs.gov.