Walter S. Davis
   Assistant Professor of Physical Medicine and Rehabilitation
   Director of Education, Center for Biomedical Ethics

  eMail: wsd3e@virginia.edu
  Voice:(434)-924-5974 or 924-5492
  FAX: (434)-982-3971
 
 

The Research Subject Advocate (RSA)

Federal regulations and policies protect human subjects in clinical research protocols, ensuring that their safety is given the highest priority.  These regulations complement the policies of academic institutions that host the GCRC's.  Proper performance of research consent and oversight procedures is complex and makes demands on the time of already-busy clinician researchers.  To address these demands, the National Center for Research Resources (NCRR) has created a Research Subject Advocate (RSA) position within each GCRC.  The purpose of this position is to assure that all steps are taken to maximize subject safety as detailed in the protocols approved by the Institutional Review Board (IRB).

At the University of Virginia, the Office of Research Subject Advocacy was created in January 2001. The position of Research Subject Advocate is shared by two individuals who work together to facilitate patient safety in the GCRC. These two individuals are Walter Davis, MD, Director, and Wendi Price, RN, Clinical Research Compliance and Education Coordinator. Both the Director and Research Coordinator of the Office of Research Subject Advocacy report to the Principal Investigator of the GCRC grant. 

RSA Responsibilities

  The RSA's are available to assist Investigators with: 

• Formulating and reviewing data and safety monitoring plans (DSMPs)
• Serving as an unbiased observer during the consent process when requested  by either the subject, investigator. pr a Regulatory body.
• Ensuring patients understand the consent process
• 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-HSR, inclusion/exclusion criteria are followed, # of patient visits and specimen collections do not exceed the protocol guidelines
• Facilitate the reporting of Serious Adverse Events and conflicts of interest to the IRB-HSR and Federal agencies
• Provide information regarding IRB-HSR and compliance issues and training.
• Educating Principal Investigators and Research team members in the many details of safe conduct and data capture in human research.