Research Subject Advocates

The primary function of the Research Subject Advocates (RSA) is to ensure that studies in their General Clinical Research Centers (GCRC) are designed and conducted safely and ethically with protection of human subjects accorded the highest priority. Each RSA acts as a liaison with the institutional Offices of Human Protections (or equivalent), including the Institutional Review Boards (IRBs). The RSA develops and guides implementation of policies and procedures for timely and appropriate reporting of adverse events, development and adherence to the Data and Safety Monitoring (DSM) Plan, approval and recording of all protocol amendments and changes in informed consent documents, performance of regulatory responsibilities in a complete and timely manner, and conduct of the research as written in the most recently approved protocol. While the RSA cannot and should not take on the above responsibilities of others, he or she will monitor activities in the GCRC and recommend appropriate corrective action if deficiencies are found.

The RSA should be informed of all issues related to human subject protection in the GCRC. In addition, the RSA should receive copies of all correspondence to and from the IRB, FDA, and the sponsor related to conduct, safety, clinical holds, removal of holds, changes, and other relevant information concerning protocols in the GCRC. The RSA should provide educational and training opportunities for GCRC staff on human subject protection. The RSA should reflect the views of the research participants to GCRC staff when appropriate.

The RSA works closely with and keeps the Program Director (PD) and GAC informed of activities related to human subject safety and protection on the GCRC. However, the RSA reports to the Principal Investigator (PI) of the GCRC grant and not to the PD or GAC. This reporting structure ensures that the RSA has the appropriate independence from those involved in the design, approval, and conduct of studies, as well as the implementation of activities related to human subject protections.

Excerpted from page #3 of the Guidelines for the General Clinical Research Centers Program, October 2005. (674KB PDF file, requires free Acrobat Reader)

Contact Information

For more information about research subject advocates in the General Clinical Research Centers program, contact:

Elaine Collier, M.D.
Assistant Director for Clinical Research
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, Room 918
6701 Democracy Boulevard, MSC 4874
Bethesda, Maryland 20892-4874
Telephone: 301-435-0794
Fax: 301-480-3661
E-mail: CollierE@mail.nih.gov