Office of Research Integrity

Community-Engaged Research

“Community-engaged research” is an approach to conducting research that requires partnership development, cooperation and negotiation, and commitment to addressing local health issues of the community of interest. Community input is incorporated in the development of the research question, implementation of the research project, analysis of the results and/ or dissemination of the findings to community stakeholders. Community engagement is an important element of the successful translation of research from bench to bedside and community(1). Community-engaged research is a framework or approach for conducting research, not a methodology in and of itself. This approach is characterized by applying the Principles of Community Engagement and the partnerships between the communities and academic researchers. At the heart of all community-engaged research is the understanding that community members will be involved in some meaningful way in the research process.

Community engagement can take many forms, and “community partners” can include organized groups, agencies, institutions, or individuals within the community. Community partners represent community interests, needs, and/or concerns because they are both knowledgeable about and empowered to represent that community. Community partners are sought for research collaborations based on this expertise and not simply because they control the resources to facilitate the study(1). Community engagement exists on a continuum, with much variation in the strength and intensity of the community-academic collaboration. This varies by research objective, project, participants, community history and local politics, among others. Each partnership will develop its own way of working together.

(1) Collaboration with Community-Based Organizations and Agencies: A Quick Guide for UCSF Researchers From the Series: CTSI Guides to Community-Engaged Research

The MUSC IRB Community-Engaged Research Approval Process

The involvement of individuals from non-MUSC community sites, as members of the research team, often necessitates consideration of additional federal human subjects protections regulations in order to gain MUSC IRB approval for the research. Examples of additional regulatory considerations include community members’ completion of CITI training, or the need to apply for a certificate of Federal Wide Assurance (FWA).

The Federal Office for Human Research Protections has developed guidelines for determining the engagement of institutions in human subjects research. These guidelines are used by the MUSC IRB to determine whether or not community partners are “engaged” in human subjects research for regulatory purposes. Specific activities in which community partners may take part, as a member of the research team, will require that the non-MUSC, community organization obtain a certificate of Federal Wide Assurance and non-MUSC, community individuals to complete training in the protection of human subjects. Examples of these activities include:

(1) obtaining data about research participants through intervention or interaction with them; or

(2) obtaining identifiable private information or identifiable specimens about the participants of the research – even if not directly interacting with them; or

(3) obtaining informed consent of human subjects for the research.

The MUSC IRB has developed forms to facilitate identifying the level of engagement of the community partners in human subjects research to determine if additional regulatory steps are required to gain MUSC IRB approval of the community-engaged research.

The following is a listing of forms and guidance that will assist in submission of Community-Engaged Research to the IRB:

Documents Provided to Assist in the Completion of the Community Engagement Submission Materials:

1. Community-Engaged Research Flow Chart/Decision Tree 
2. Community-Engaged Research Process Checklist 
3. Approval Process for non-MUSC Research Site Guidance

Documents for Initial Submission of a Community-Engaged Research Application (as applicable):

1. IRB Scientific Protocol Template
2. Community-Engaged Research Protocol Addendum
3. Off Campus Study Site Form
4. Approval Process for non-MUSC Research Site Guidance  
5. Documentation of CITI training for Community Partners

Documents for Submission of a Personnel Amendment or any Type of Change Involving the Off Site Location (as applicable):

1. IRB Scientific Protocol Template
2. Community-Engaged Research Protocol Addendum
3. Off Campus Study Site
4. Documentation of CITI training for Community Partners

For Additional Education, Training and Information Concerning Community-Engaged Research, please visit the South Carolina Clinical and Translational Institute Community Engagement website.