Research Subject Advocate (RSA) Core Main Page

In 2001, the National Institute of Health (NIH) stipulated that every Clinical Research Center (CRC) have a Research Subject Advocate. In part, this was a response to the rapidly growing national concern over the safety of subjects in clinical trials. The primary responsibility of the RSA is to ensure that studies at the CRC are designed and conducted safely and ethically with protection of human subjects accorded the highest priority. The RSA represents and promotes research subject interests, and works collaboratively with the CRC Scientific Advisory Committee (SAC), the UConn Health Center (UCHC) Human Subjects Protection Office (HSPO) and Institutional Review Boards (IRBs), and the Office of Audit, Compliance and Ethics (OACE).

Some examples of RSA responsibilities include:

·         Review research plans to identify safety and/or ethical concerns before a study begins;

 

·         Serve as an unbiased observer and counsel to potential subjects and research study staff on the informed consent process, as requested; 

·         Advise investigators in the development and implementation of Data and Safety Monitoring Plans (DSMPs);

·         Facilitate investigator’s reporting of adverse events;

·         Review protocols and consent forms of ongoing CRC studies to confirm IRB-approval and communicate any changes to the CRC Scientific Advisory Committee;

·         Serve as a resource to research participants, study coordinators, investigators, and nurses for consultation, education, and research subject advocacy.