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In 2001, the National Center for Research Resources (NCRR) stipulated that every GCRC have a Research Subject Advocate (RSA). 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 on the GCRC are designed and conducted safely and ethically with protection of human subjects accorded the highest priority. The RSA works closely with the GCRC Scientific Advisory Committee, the Human Subjects Protection Office, the Institutional IRBs and the Office of Research Compliance. Some examples of RSA responsibilities include:

• Observe the informed consent process
• Ensure that all GCRC studies have a Data Safety Monitoring Plan (DSMP) that is appropriate based on the subject risk level
• Assist investigators in the development of suitable DSMPs
• Facilitate investigator’s reporting of adverse events
• Serve as an unbiased observer and counsel to potential subjects and research study staff on informed consent
• Insure that all active GCRC protocols and consents are updated and approved
• Serve as a resource for research subjects, study coordinators, investigators, nurses, etc.