Addressing Protection of Human Subjects in PCORI Applications and Merit Review

At PCORI, we are always working to improve the way we do our work. As part of that work, we are now providing additional guidance and resources for applicants and reviewers to ensure that applications for our research funding and review of applications appropriately address the protection of human subjects.

Roots in the Common Rule

PCORI expects research that we fund to comply with the US Department of Health and Human Services’ (HHS) Federal Policy for the Protection of Human Subjects, reflected in HHS regulation 45 CFR 46. This regulation includes the Common Rule, which outlines the basic provisions for establishment and functioning of institutional review boards (IRBs) and requirements for informed consent of human research subjects. We also rely on National Institutes of Health (NIH) guidance and its interpretation of the Common Rule. We understand, of course, that many of our awardees are also funded by federal agencies and that some institutions already extend Common Rule and other federal protections to all research conducted at their institutions, federally funded or not.

Information for Applicants

PCORI’s Application Guidelines now include more comprehensive information on how PCORI expects applicants for PCORI research funding to address human subjects protections. Specifically, we designate up to five pages in the Research Plan where applicants may describe how they propose to protect human subjects in their research. PCORI requires that all applicants adhere to the NIH policy on the protection of human subjects in research, including the requirement that all key personnel on PCORI applications complete human subjects training, which may be fulfilled through the NIH Protecting Human Research Participants training tutorial or another program. More information about the training requirement and resources can be found on the NIH website.

Information for Merit Reviewers

For merit reviewers who will be participating in the review of applications for PCORI funding, we have created a new How to Evaluate Human Subjects Protections checklist to help them identify relevant issues relating to human subjects protections that they may see in applications. Researchers also might find the checklist helpful in developing their description of human subjects protections in their applications.

The checklist outlines four topics relating to human subjects protection for merit reviewers to keep in mind as they review applications:

• Potential risk to human subjects
• Adequacy of protections against risks
• Potential benefits of the proposed research
• Importance of the knowledge to be gained.

If human subjects protections issues are identified by reviewers in applications being considered for funding, PCORI staff can work with potential awardees to address those issues.

This updated guidance for applicants and reviewers is designed to support the quality of research funded by PCORI and the experience of study participants. Protection of human subjects is integral to our mission to produce high-quality, useful health information. We welcome your thoughts on our efforts. Please contact us to share your ideas.

Note: This page was changed on May 13, 2016, to indicate that our requirement for human subjects protection training can be fulfilled by either the NIH Protecting Human Research Participants training tutorial or another program.