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.

in the 30 years since the belmont Report, the role of the community in research has evolved and has taken on greater moral significance. Today, more and more translational research is being performed with the active engagement of individuals and communities rather than merely upon them. This engagement requires a critical examination of the range of risks that may arise when communities become partners in research. In attempting to provide such an examination, one must distinguish between established communities (groups that have their own organizational structure and leadership and exist regardless of the research) and unstructured groups (groups that may exist because of a shared trait but do not have defined leadership or internal cohesiveness). In order to participate in research as a community, unstructured groups must develop structure either by external means (by partnering with a Community-Based Organization) or by internal means (by empowering the group to organize and establish structure and leadership). When groups participate in research, one must consider risks to well-being due to process and outcomes. These risks may occur to the individual qua individual, but there are also risks that occur to the individual qua member of a group and also risks that occur to the group qua group. There are also risks to agency, both to the individual and the group. A 3-by-3 grid including 3 categories of risks (risks to well-being secondary to process, risks to well-being secondary to outcome and risks to agency) must be evaluated against the 3 distinct agents: individuals as individual participants, individuals as members of a group (both as participants and as non-participants) and to communities as a whole. This new framework for exploring the risks in community-engaged research can help academic researchers and community partners ensure the mutual respect that community-engaged research requires.

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.

No abstract