The safe and ethical conduct of research is accorded the highest priority in the Clinical Research Center (CRC). Studies conducted in the CRC must meet all institutional requirements and must be reviewed and approved by the Institutional Review Board (IRB).
The Research Subject Advocate (RSA) is a professional advocate who represents and promotes research subjects’ interests.
- The RSA works collaboratively with the CRC Scientific Advisory Committee (SAC), the UConn Health Human Subjects Protection Office (HSPO) and Institutional Review Boards (IRBs), and CRC Leadership and Core Directors.
- The RSA is available to talk with patients and volunteers who are participating in any studies in the CRC.
- RSA services are available for projects that are reviewed and approved by the CRC SAC.
- Advise investigators in the development and implementation of Data and Safety Monitoring Plans (DSMPs)
- Review research plans to identify safety and/or ethical concerns prior to implementation within the CRC
- Serve as an unbiased observer and counsel to potential subjects and research study staff on the informed consent process, as requested
- Facilitate investigators’ reporting of adverse events and protocol deviations
- Review protocols and consent forms of ongoing projects to confirm IRB-approval and communicate any changes to the CRC SAC
- Serve as a resource to research participants, study coordinators, investigators, and nurses for consultation, education, and research subject advocacy
- For the convenience of research participants and staff, the RSA office is located in the Clinical Research Center (main floor).
Kristen Tremblay, MPH, CCRP
Research Subject Advocate