PCRC Research Subject Advocate (RSA)

The NIH National Center for Research Resources recently begun funding the Research Subject Advocate position within the GCRC program to further enhance federal policies and regulations that protect patients participating in clinical research. In 2002 Dr. Tomas Silber was appointed RSA for the Children's Hospital PCRC and is a resource to patients and investigator throughout the clinical research process.
The RSA program is committed to facilitating and assisting investigators with the patient and safety monitoring process. The RSA is committed to facilitating and assisting investigators with the patient safety monitoring process to ensure that each study conducted on the PCRC meet all mandated patient safety requirements.

Specifically, the RSA is responsible for the following:

• To ensure adequacy of the patient safety monitoring plans (PSMPs), which may include data safety monitoring board (DSMB) if required by an NIH Institute or the GCRC Advisory Committee (GAC);
• To facilitate Principal Investigators' reporting of adverse events;
• To serve as a source of information for research subjects, investigators, nurses, study coordinators and other key study personnel.
• To serve as an unbiased observer and counsel potential subjects and research teams on informed consent

This level of oversight is necessary to assess compliance of clinical protocols as they relate to subject safety throughout the conduct of the clinical trail.

Additional Food & Drug Administration (FDA) and National Institutes of Health (NIH) scrutiny applies to any clinical study at CNMC, whether or not the study is performed on the PCRC. All investigators are responsible for meeting safety requirements with or without the help of the RSA. The RSA program is designed to help the investigators and to make it easier for them to be in compliance. This program is a unique opportunity to provide PCRC investigators and personnel with the education and guidance to prepare protocols and consent forms, to prepare investigators for mandatory audits, and to ensure compliance with safety regulations.

Investigators are encouraged to contact Dr. Tomas Silber, RSA of Children's National Medical Center PCRC at tsilber@cnmc.org or 202 884-3066 before submitting a protocol to ensure that they have captured the key elements of the NIH's new safety requirements.