GCRC Core Resources

Research Subject Advocate (RSA) Program

In 2001 the National Institutes of Health (NIH) and the National Center for Research Resources (NCRR) approved support for a Research Subject Advocate (RSA) program at all GCRCs, providing a funded mandate for the development of a model program representing the optimal standard of patient safety and research compliance. Northwestern University received funding for its RSA program in early September of 2001.

NCRR has issued GCRC Patient Safety Recommendations that can be found at

http://www.ncrr.nih.gov/clinical/gcrcpatientsafety20010622.asp.

Northwestern's RSA program aims to protect the rights, welfare, and safety of participants in GCRC human subject research. The goals of the RSA program are carried out through a continuous review of the informed consent process, patients' comprehension of their role in the clinical study, and other study-related activities.

Initial goals

• continual review and education of the informed consent process with the principal investigator (PI) and research staff
• definition of risk categories: low, medium, high
• development of GCRC human subjects protection training program for investigators
• development of Data Safety Monitoring Plan guidelines and templates for Northwestern University's GCRC

Data and Safety Monitoring Overview

In June 1998, the NIH issued a policy on data and safety monitoring (http://grants.nih.gov/grants/guide/notice-files/not98-084.html) that requires oversight and monitoring of all intervention studies to ensure the safety of participants and the validity and integrity of the data. The policy further elaborates that monitoring should be commensurate with risks and the size and complexity of the trials.

Northwestern's GCRC is committed to protecting the rights and welfare of participants in GCRC human subject research. In accordance with NIH and NCRR requirements in ensuring the safety of all participants, all PIs must submit a Data Safety and Monitoring Plan (DSMP) as part of the initial GCRC research application packet. The DSMP is the responsibility of the PI and is subject to review and approval by the GCRC Scientific Advisory Committee (SAC) prior to start of patient accrual. The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). The research subject advocate will review all newly submitted protocols and will issue a recommendation to the SAC as to the adequacy of the DSMP.

For more information, contact

Lewis J. Smith, MD
Medical Director, GCRC RSA Program
Associate Vice President for Biomedical Research
Abbott Hall, 5th Floor
Telephone 312/503-0501
Fax 312/503-0555
ljsmith@northwestern.edu

Kelly A. Carroll, PhD
GCRC Research Subject Advocate
Abbott Hall, 10th Floor
Telephone 312/503-2093
Fax 312/503-1505
k-carroll@northwestern.edu