Introduction

The National Center for Research Resources (NCRR – the NIH Center that oversees CRCs) recently established a new position, Research Subject Advocate (RSA) within the CRC. This position was created as part of the response to the growing concern over the safety of human research subjects in clinical trials. The Office of Research Subject Advocacy was created in 2002 at the University of Rochester.Robert Betts, MD and Nancy Needler, BS, CCRC are the Research Subject Advocates for the CRC.

Who We Are

Roberts Betts is Professor of Medicine in the Department of Infectious Diseases, and has been involved in various clinical research projects including “Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications.”

Nancy Needler has coordinated clinical trials since 1997 for the Endocrine-Metabolism Unit within the Department of Medicine, mostly recently working with Dr. Stephen Welle on his NIH Gene Expression Grant. She is a member of the Study Coordinators' Group Advisory Board here at the University of Rochester and has been involved in the quality assurance process at Monroe Community Hospital.

Nancy_Needler@urmc.rochester.edu
Phone: 585-275-1020

What We Do

The RSAs ensure safety of human research subjects by: 1) reviewing newly submitted protocols for safety issues and making sure there is a data and safety monitoring plan in place - prior to being approved by the CRC Advisory Committee (GAC); 2) monitoring study protocols on a continual basis by reviewing CRC charts to ensure protocol adherence; 3) monitoring the informed consent process through quality assurance surveys or by being an objective observer when requested by an investigator; 4) reviewing adverse event and safety monitoring committee reports for studies conducted on the CRC; and 5) being a resource for study investigators and coordinators regarding data and safety monitoring plan requirements, regulatory issues, etc.

The RSAs are available to help investigators create the data and safety monitoring plan for a specific study.

Preparing the safety plan and consent prior to submission to the CRC and RSRB will help streamline the protocol review process. Please contact one of the RSAs if you would like assistance in writing the DSMP, or if you would like one of us to evaluate your plan prior to review.

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