When IRBs fall short: Creating a cultural safety system for community based participatory research with American Indians

Issue: American Indians (AI) have some of the poorest documented health outcomes of all racial/ethnic groups in the US. Research is necessary to evaluate and create effective clinical and public health approaches to address these outcomes. Historical and recent events have generated mistrust of research among AI. To address these concerns, the Center for American Indian Community Health (CAICH) created a cultural review and monitoring committee (CRMC) to supplement our institutional review board (IRB).  Purpose: In collaboration with the IRB, CAICH-CRMC reviews all human subject research that proposes to work with AI to ensure that AI’s cultures, values and wishes are respected.  Description: CAICH-CRMC has twelve members. It is comprised of nine AI community members, one AI researcher and two non-AI researchers. The two non-AI committee members, skilled in CBPR with expertise in qualitative and quantitative methods, serve as the scientific reviewers but do not vote on the cultural aspects reviewed by the committee. The AI committee members review all protocols, consent forms, data collection instruments, CBPR plans, and written materials to be seen or heard by AI participants. The committee comments on the cultural appropriateness of recruitment plans and data collection tools. Additionally, it reviews biospecimen collection, particularly what is collected/tested, where specimens are stored, and what happens to them at study end. Provisos are issued that must be address prior to receiving approval. Lessons Learned: CAICH-CRMC has received favorable feedback from the AI community and has been a positive step towards addressing AI’s concerns about unethical research.