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.
- Co-learning about issues of concern
- Reciprocal transfer of expertise
- Sharing of decision-making power
- 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.