NYU, CTSI  Research Subject Advocate Program

The National Center for Research Resources (NCRR), the NIH Center that oversees Clinical Translational Science Institutes (CTSI), established the position of Research Subject Advocate (RSA) in 2001 in response to growing concern over the safety of human research subjects in clinical trials. The RSA ensures the safety of human research subjects participating in research studies conducted on the CTSI by:

• Reviewing newly submitted protocols for evidence of a data and safety monitoring plan.
• Reviewing informed consent forms for newly submitted protocols.
• Reviewing protocol renewal applications for safety issues and compliance with data and safety monitoring plans.
• Reviewing amendments to protocols and informed consents at time of renewal.
• Monitoring research charts to ensure adherence to protocols and safety plans.
• Monitoring the informed consent process.
• Reviewing adverse event and safety monitoring reports. 
• Serving as a resource for study investigators and coordinators regarding data and safety monitoring plan requirements, regulatory issues, or subject safety concerns.
• Serving as a resource and advocate for research subjects.

The NCRR requires that all studies at the CTSI involving human subjects have a data and safety monitoring plan (DSMP). The DSMP must be appropriate to the level of risk to subjects, study design, objectives and procedures. The CTSI requires that a Data and Safety Monitoring Report (DSMR) based on the DSMP be submitted (at a minimum) with annual renewal. More information about DSMPs can be found here: http://www.med.nyu.edu/ctsi/researchers/apply.html
The RSA is available to help investigators create the data and safety monitoring plan or to assist with the content of the informed consent for a specific study. Preparing the safety plan and informed consent prior to submission to the CTSI Advisory Committee may to help streamline the protocol review process. Our contact information is as follows:

Anna Nolan MD, MS
Assistant Professor of Medicine and Environmental Medicine
Research Subject Safety Office, NYU CTSI
New York University, School of Medicine
New Bellevue 16S Room 16
Phone: 212-562-8242
Email: anna.nolan@med.nyu.edu

Halia Melnyk, RN
Research Subject Advocate
Clinical and Translational Science Institute
NYU Langone Medical Center
550 First Ave.
VET# 10th Floor-West Wing
New York, NY  10016
Phone: 212-263-4296
Fax: 212-263-4147
E-mail: halia.melnyk@nyumc.org