Ethics of clinical research within a community-academic partnered participatory framework.

Recommendations for reducing racial and ethnic disparities in health and health care suggest that clinical researchers try community-based participatory research (CBPR). While the body of literature discussing the ethics of CBPR continues to grow, we are not aware of a specific attempt to provide a structure for analyzing the ethics of clinical research using a CBPR approach. We adapt a framework developed by Emanuel, Wendler, and Grady articulating seven requirements for ethical clinical research to clinical research using a CBPR approach. We incorporate findings from the literature on CBPR and identify some of the ethical and practical challenges from our experiences working in CBPR as academics and community members. We find Emanuel et al's framework easily adaptable for CBPR. Six of the requirements are flexible enough to accommodate the needs of CBPR; they are: social or scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, and informed consent. We suggest that the seventh requirement, respect for potential and enrolled participants, be amended to respect for potential and enrolled participants, community, and research partners to acknowledge that separate attention should be paid to relationships on these three levels. This adapted framework can guide community-academic partnerships as they evaluate whether to proceed with potential clinical research studies and as they work to enhance the ethics of clinical research studies using a CBPR approach.