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:

• Conducting a review of clinical trial study documentation including but not limited to making certain that adverse events are reported, protocol amendments are filed with the IRB, inclusion/exclusion criteria is followed, # of patient visits and specimen collections do not exceed the protocol guidelines
• Ensuring patients understand the consent process
• Reviewing data and safety monitoring plans
• Continually reassessing each protocol to ensure subject safety
• Keeping GCRC protocol source books up to date
• Being a resource to all Principle Investigators and Study Coordinators to assist in avoiding potential problems and issues