Nine Key Functions for a Human Subjects Protection Program for Community-Engaged Research: Points to Consider

Abstract

She provided intellectual guidance for the entire project, developing agenda for the weekly phone calls and for the two stakeholder meetings. She developed the analytical framework for understanding risks in community-engaged research and played a major role in all of the drafts of the manuscripts. She provided content expertise in research ethics and human subjects protections. Mr. Loup was the research associate for this project and worked with Dr. Ross in the intellectual development of the three manuscripts. He also worked on multiple draft revisions, performed library searches, organized weekly conference calls for the writing group, and coordinated the two stakeholder meetings. Dr. Nelson was a key member of the writing group; attended both stakeholder meetings and many phone meetings; and commented, critiqued, and provided detailed constructive criticisms on numerous drafts. He provided content expertise in human subjects protection. The work reported in this article was conducted prior to Dr. Nelson joining the U.S. Food and Drug Administration, and do not represent the views and/or policies of the FDA or the Department of Health and Human Services. Dr. Botkin was a key member of the writing group; attended both stakeholder meetings and many phone meetings; and commented, critiqued, and provided detailed constructive criticisms on numerous drafts. Dr. Kost was a key member of the writing group; attended the initial stakeholder meeting and many phone meetings; commented, critiqued, and provided detailed constructive criticisms on numerous drafts; and provided content expertise in human subject protections and research subject advocacy. Mr. Smith was a key member of the writing group; attended both stakeholder meetings and many phone meetings; and commented, critiqued, and provided detailed constructive criticisms on numerous drafts. He provided content expertise on the role of community research partners and helped ensure that the manuscripts provided a balance between the needs of the academic research community and their community partners. Dr. Gehlert worked with Dr. Ross as a content expert in community-engaged research. Dr. Gehlert was instrumental in inviting a broad range of stakeholders and helped ensure that the manuscripts reflected current communityengaged research practice and policy.

Perceptions toward establishing a biobank and clinical data warehouse: Voices from the community

“…To this end, we chose to use CEnR as the guiding principle for this study because it presents an avenue for the public to influence the direction of project development. This is supported by studies [25,26] and is in line with project transparency and open-mindedness at all levels.…”

Comparative Effectiveness of a Faith-Based HIV Intervention for African American Women: Importance of Enhancing Religious Social Capital

“…The creation of a CAB that assisted in the fair selection of participants, reviewed informed consent protocols, assisted in creating P4 for Women and dissemination efforts, and facilitated minimizing risks associated with the implementation of an HIV-prevention study within a faith-based setting. 30 …”

“…30 Facilitating the CAB's decision for this integration was SISTA's established efficacy with sexually active African American women (SISTA is a tier 1, CDC-defined, evidence-based …”

Triggers for Research Ethics Consultation

“…Moreover, various models of community engagement exist. Consultation with RECS personnel could be useful in developing best practices and methods of community consultation (25).…”