DESCRIPTION (provided by applicant): The Bronx Community Research Review Board (BxCRRB) is an academic-community partnership between the Institute for Community and Collaborative Health (ICCH) and Bronx Center to Reduce and Eliminate Ethnic and Racial Health Disparities (Bronx CREED) of the Albert Einstein College of Medicine and the Bronx Health Link (TBHL). Our Specific Aims are to collaboratively develop (1) an independent research review board of volunteer community residents and representatives at the Bronx Health Link that pilot tests a model of community consultation, dialogue, and "informed consent" by reviewing community-based research applications; (2) a curriculum in the protection of human subjects and communities for community residents and representatives to become BxCRRB members; (3) appropriate evaluation measures of the BxCRRB's success in promoting community trust, academic-community research partnerships, and public understanding of the clinical research process; and (4) increased understanding of and participation in clinical research in the Bronx. Rather than asking each clinical investigator to create their own unique process for community consultation, we propose to develop an innovative, structural approach to achieve community consultation in research planning, implementation, and reporting that at the same time deeply involves and educates the public in the clinical research process. TBHL will recruit and with two Einstein faculty bioethicists train 30 community residents and representatives in the protection of human subjects and their communities in order to yield a 20 member Board whose membership reflects the demographics of the Bronx (i.e., half Latino and one-third African-American members). The BxCRRB will develop its own by-laws under the direction of TBHL and review research protocols voluntarily from researchers recruiting subjects in the Bronx and from investigators-in-training sponsored by Bronx CREED and Einstein's Institute for Clinical and Translational Research. The BxCRBB will review written and oral presentations, thus, opening a face-to-face dialogue between the investigators and BxCRRB about community perspectives on all phases of the proposed research. Rather than the paperwork-laden IRB regulatory process, the BxCRRB will advise the investigator on recruitment, incentives, sensitivities, and effective communications. Follow-up of revisions and research outcomes will be encouraged. The BxCRRB will communicate with the investigator's IRB and funding agencies about its unique process of community consultation and whether or not the Board's research standards for protecting individuals and communities have been met. Summary-Bronx Community Research Review Board The Bronx Community Research Review Board (BxCRRB) will create a model structure and ethical process for community consultation in clinical research that protects both individuals and communities and promotes more effective, relevant, and community-sensitive research. The BxCRRB will educate community members about clinical research, build community and individual capacity to review and judge research, promote timely and local dissemination of research findings, and strengthen the public's trust in the research process as a whole. BxCRRB will also train the next generation of clinical investigators in an innovative and model approach to community consultation that will ripple far beyond the Bronx.
|Effective start/end date||9/25/08 → 8/31/11|