Research Subject Advocate

The National Center for Research Resources (NCRR) established the Research Subject Advocate (RSA) position within the GCRC as part of the response to the rapidly growing national concern over the safety of human research subjects in clinical trials. The role was funded to further enhance Federal regulations and policies that protect patients in clinical research protocols.

As stated by NCRR the RSA role is to “assure such compliance and conduct as detailed in the IRB approved protocol to maximize patient safety.” Some examples of the RSA’s oversight activities include:

• Assisting investigators in the development of safety monitoring plans
• Reviewing adverse events
• Observing the informed consent process
• Performing quality assurance reviews of research protocols
• Education of investigators and other research staff
• Acting as an advocate for the rights of the research subject