Yale School of Medicine.    
General Clinical Research Centers  
Grants & Contracts. Human Investigation Committee. Yale-New Haven Hospital. National Center for Research Resources. National Institutes of Health.
 

 

Research Subject Advocate (RSA)

The primary responsibility for the Research Subject Advocate (RSA) at Yale Universit's General Clinical Research Center (GCRC) is to insure that GCRC protocols are performed in accordance with Yale's Human Investigation Committee (HIC), General Advisory Committee (GAC), as well as federal regulations and guidelines. The role of the RSA is to insure the safety and comfort of research study participants and the confidentiality of their Protected Health Information (PHI). The RSA achieves this goal by:

Bullet.

Insuring all active protocols and consents are updated and approved by the HIC

Insuring that GCRC records correlate with HIC records for all active protocols and consents

Assisting investigators in the development of appropriate Data and Safety Monitoring Plans (DSMPs) and reviewing DSMPs with GAC members

Insuring all investigator initiated protocols adhere to Health Insurance Portability and Accountability Act (HIPAA) guidelines

Facilitating the reporting of Serious Adverse Events (SAEs) and Conflict of Interest (COI) to appropriate local committees and federal agencies (also maintaining records of SAE and COI forms)

Monitoring and reviewing all new protocol consents and randomly inspecting protocol files in the GCRC for accurate record keeping

There are two RSAs at the Yale GCRC - Rosa Hendler, M.D., and Thomas Carpenter, M.D. They work collaboratively with the HIC to assure protocol compliance with all human subject safety issues. They can be reached at the following numbers:

Thomas Carpenter, M.D., 785-6526
Rosa Hendler, M.D., 785-5448

 
Top of Page.
Yale School of Medicine.