IRB: Ethics & Human Research

Community-Engaged Research Ethics Review: Exploring Flexibility in Federal Regulations

Some proponents of community-engaged research (CEnR) have suggested that federal regulations governing research with humans (the Common Rule) should be fundamentally altered and that institutional review boards (IRBs) should incorporate the broader goals of CEnR into their review of protocols for this type of research. Yet we should be cautious of prematurely adding new review considerations for IRBs and revising the Common Rule for one specific research approach. Researchers and IRBs may judge the Common Rule to be incompatible with the priorities, values, activities, and timelines of CEnR. There are also important ethical concerns in CEnR, such as equity among academic and community partners, sustainable programs, or other community-level benefits, that are beyond IRBs’ narrow charge to protect individual research participants. Expanding IRBs’ responsibilities in reviewing CEnR may diffuse focus while slowing the translation of research findings into practice. Therefore such broader ethical concerns in CEnR may be best left to the authority and expertise of communities. Rather than requiring special or additional rules for reviewing CEnR, IRBs should recognize the flexibility that exists within current regulations. This manuscript explores the ways in which IRBs can appropriately apply the flexibility that exists within the current Code of Federal Regulations to the ethical review of CEnR.