November 2010

 Research is often designed to address issues affecting the well-being of specific groups of people and has a community focus. The groups of people could be affiliated by geographic proximity, special interests, ethnicity, social status, or economic status.   Such research may be referred to as Community-Based Participatory Research (CBPR) and would involve a research topic of importance to either a broad-based a community or a specific identified subset of an identified community.  Researchers who wish to conduct research to address community issues should consider whether the research plan would benefit from informal or formal community consultation or input.

There are existing community groups with which JHM researchers have established working relationships when planning new research protocols. Such relationships should be mentioned in the protocol when submitted for JHM IRB review.  In cases where research teams have not established such relationships, there is a new option available for community input and guidance.  The Johns Hopkins Institute for Clinical and Translational Research formed a Community Research Advisory Council (C-RAC).  The mission of C-RAC is to help ensure that research conducted by Hopkins and its partners is relevant and applicable to the needs and interests of patients, families, and residents of Baltimore City and surrounding counties. The goals of C-RAC are:

• Improve community knowledge and awareness of research at Johns Hopkins and other agencies through education and dissemination of information within communities that they serve.
• Offer guidance on how to conduct research that is accessible and relevant to the needs of the community, especially among underserved or vulnerable local populations.
• Help develop strategies to disseminate research results to study participants and the community.
• Create a forum for community members to discuss research.

The JHM IRB review process will include an assessment of whether the application has a community based research focus.  To assist in the review process, the eIRB application includes questions regarding community-based research. The application should address  the relationship between researchers and community members, any individual and group considerations used in developing the protocol, any plan to provide data and results to the community at the completion of a study, and whether community consultation has been or will be obtained.  In cases where the researchers believe community input is not essential, the application should provide the rationale for the decision.  The JHM IRBs may determine that an application does or does not require either additional community input or request that an application that did not have such input be discussed with a community group.