Research Subject Advocate (RSA) Mission Statement

The primary responsibility of the Research Subject Advocate (RSA) is to provide assurance to the Principal Investigator (PI) of the General Clinical Research Center (GCRC) that appropriate efforts are being made throughout any clinical research activity at the GCRC to protect the participating individuals and to ensure that their safety receives the highest priority.

• Ensure that the IRB- and GAC-approved monitoring plan is fully implemented and that the protocol carried out at the GCRC complies with the IRB- and GAC-approved protocol.
• Ensure that GCRC investigators send expedited adverse event (AE) reports in a timely fashion to the IRB, GCRC and appropriate Federal agencies.
• Track and review all AEs with RSA faculty advisors:
  
  James Casella, M.D., Professor of Pediatrics and Oncology
  Wendy Post, M.D., Associate Professor, Cardiology
  
  
• Help investigators come into compliance with the requirements.
• Perform audits as requested.
• Review all new protocols: pediatric, adult and NBRU for human subject safety issues.
• Ensure the GCRC application includes the appropriately completed human subjects section, especially inclusion of women, children and minorities and Data and Safety Monitoring Plans.
• Ensure the GCRC application includes an accurately completed Targeted/Planned Enrollment Table.
• Ensure the GCRC application includes a proposed or approved consent form and that the consent form accurately describes the proposed research.
• IRB approval is obtained before research can be conducted in the GCRC (Adult In-patient - Osler 5, Adult Out-patient - Carnegie 3, PCRU - Blalock 3 and NBRU - Kennedy Krieger).
• Remind Principal Investigators and study coordinators of expiration dates (consent and protocol) in order to ensure that research is conducted in the GCRC only on current, approved protocols.
• Observe the consent process and educate investigators and study coordinators on the requirements for informed consent.
• Assist patients or staff with the resolution of any patient or staff generated questions regarding participation of human subjects in studies.

We welcome investigators to take advantage of the important resource our Research Subject Advocacy program provides.