Community IRB Membership: How to get Involved
The meaning of "community"
The term "community" denotes a group of people who have a common set of interests, a common set of characteristics, or who live in an identified neighborhood or location. See below for information on the following community related concepts:
- Community Members on the IRB
- Community Engaged Research
- Community Consultation (FDA)
- Community Based Participatory Research
Community Members on the Institutional Review Board (IRB)
An IRB community member is someone from outside the organization or institution who serves on the IRB. The community member is usually non-scientific and is not affiliated with the institution. Community members come from a variety of backgrounds and are chosen for particular experience, knowledge, or relationship to the types of studies reviewed by the IRB. These members often are drawn from the community in which an institution resides. Former research subjects, patient advocates, teachers, nurses, members of vulnerable populations, retirees or experts in multicultural affairs may be sought for IRB service.
IRB Community Member Resources
The IRB Reviewer Guidelines are available for to aid IRB members and staff in the review of applications. They are consistent with FDA and OHRP regulatory requirements.
Community Engaged Research
Community-engaged research is a framework or approach for conducting research, not a methodology in and of itself. It is characterized by the principles that guide the research and the relationships between the community and the academic researcher. Community-engaged research requires partnership development, cooperation and negotiation, and commitment to addressing local issues of concern, most often health.
FDA regulations allow certain planned emergency research to be undertaken when the intervention or interaction will be used on subjects unable to provide consent because of the emergency situation. A novel mechanism called community consultation must be utilized to alert the relevant community of this planned research before the IRB can give final approval. The regulations require consultation with representatives of (and public disclosure to) the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation.
Additionally, the therapeutic window does not allow sufficient time to contact a legally authorized representative (as defined by the state in which the research is being conducted) to obtain prospective consent. Further, the possibility must exist that the subject will directly benefit from participation in the study.
FDA Guidance on Exceptions from Informed Consent
Community Based Participatory Research (CBPR)
Community Based Participatory Research (CBPR) is a collaborative research approach that is designed to ensure and establish participation by affected communities, representatives of local organizations, and researchers in all aspects of the research process.
(1) co-learning about issues of concern
(2) reciprocal transfer of expertise
(3) sharing of decision-making power
(4) mutual ownership of the products and processes of research
The end result is incorporating the knowledge gained to improve the health and well-being of community members.
This approach is useful to academic and public health professionals addressing health care disparities in a variety of populations (identified by factors such as social or economic status, lack of health insurance, or membership in various racial and ethnic groups).
The NIH supports the push towards CBPR through training workshops and increased funding opportunities. Click here for an NIH presentation on CBPR.