As of May 2001 the NCRR stipulated that every GCRC protocol have a Data and Safety Monitoring Plan (DSMP) and that each GCRC shall have a Research Subject Advocate (RSA), in order to proactively assure the safety of research subjects.  At UTMB, Michele A. Carter, PhD occupies this position.  The GCRC RSA program is committed to facilitate the new patient and safety monitoring process for investigators.

The purpose of this position is to ensure research subjects' safety and protection, and the integrity and quality of ongoing clinical research in the General Clinical Research Center.

Specifically, the RSA is responsible for the following:

• To ensure adequacy of the data and safety monitoring plans (DSMPs), which may include a data and safety monitoring board (DSMB) if required by an NIH Institute or GCRC Advisory Committee (GAC).
• To facilitate Principal Investigators' reporting of adverse events
• To serve as a source of information for research subjects, investigators, nurses, study coordinators and other key personnel
• To serve as an unbiased observer and counsel to potential subjects and research teams on informed consent

To request assistance from the RSA program, please contact:  Michele A Carter, PhD, Research Subject Advocate  Phone: 409-772-1208 or email: mcarter@utmb.edu

Updated: 01/26/05