The Research Subjects’ Advocate (RSA) is a position established by The National Center for Research Resources (NCRR), the funding organization for General Clinical Research Centers.
The Research Subject Advocate (RSA) is available to help investigators develop Data and Safety Monitoring Plans. Michele Watrin, can be reached at 624-2621 or watri001@umn.edu.
The RSA is also available to assist investigators with the following:
Provide education regarding regulatory processes to investigators and study staff.
Help define the Data and Safety Monitoring Plan requirements for a study.
Facilitate adverse event reporting to the IRB and applicable Federal authorities.
Help determine if a Data and Safety Monitoring Board is needed for a study and help define the type of board that is needed.
Serve as an observer in consent discussions (per request of subject, PI or the IRB).
Other responsibilities of the RSA include monitoring approved GCRC protocols to help ensure that the Data and Safety Monitoring Plan is fully implemented, and that the study performed on the GCRC complies with the protocol approved by the IRB and the GCRC. During the monitoring process, the RSA will specifically review the informed consent process, adverse event reporting, and protocol adherence. The RSA will provide monitoring reports of these findings to the PI of the study, PI of the GCRC, and the GCRC Scientific Advisory Committee.