Research Subject Advocate (RSA)

The primary responsibility for the Research Subject Advocate (RSA) at Yale is to ensure that 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 ensure the safety and comfort of research study participants and the confidentiality of their Protected Health Information (PHI). The RSA achieves this goal by:

• Ensuring all active protocols and consents are updated and approved by the HIC
• Ensuring 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
• Ensuring 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
• The YCCI RSAs work collaboratively with the IRB to assure protocol compliance with all human subject safety issues. They can be reached at the following numbers:

Research Subject Advocate (RSA) Contact

• Thomas Carpenter, M.D.
  Phone: (203) 785-6526
  thomas.carpenter@yale.edu
• Rosa Hendler, M.D.
  Phone: (203) 785-5448
  rosa.hendler@yale.edu