1. The Research Subject Advocate (RSA)

2. Pictured, left to right: Andrea Saltzman, RN; Enrico Cagliero, MD; Debi Dunkless.

3. The RSA Program The Research Subject Advocate (RSA) Program was established in 2001 by the National Center for Research Resources with a mandate to ensure that research studies on the GCRC are designed and conducted safely and ethically, with protection of human subjects accorded the highest priority.

4. The RSA Program Our office reports directly to the Principal Investigator of the GCRC grant (MGH President Peter Slavin), and not to the GCRC Program Directors or the GCRC Advisory Committee. This reporting structure ensures that we have the necessary autonomy to provide independent oversight of GCRC protocols and functions.

5. The RSA Program Our responsibilities include: Subject advocacy. Protocol documentation review. Staff education. and safety monitoring. In many ways, these functions are similar to those of the IRB (with whom we work closely), although our program provides on-site monitoring to only those study visits carried out on our unit.

6. RSA Responsibilities Advocate on behalf of your study volunteers to help resolve any individual concerns related to their research participation. Review new protocols and amendments submitted to the GCRC with attention to risk/benefit analysis, consent form completeness and readability, and the adequacy of Data Safety Monitoring Boards (DSMBs).

7. RSA Responsibilities (continued) Available to assist with creation of Data Safety Monitoring Plans (DSMPs) and establishment of Data Safety Monitoring Plans. Review adverse event reports to identify issues or patterns that might require changes to your study.

8. RSA Responsibilities (continued) Perform random and “for cause” protocol audits to assist you in maintaining regulatory compliance, and to promote collaborative efforts aimed at improving overall data integrity and subject safety. Ensure adequate human subject protection staff training.

9. RSA Responsibilities (continued) Consult with the Partners Human Research Committee (IRB) to address areas of mutual safety or ethical concerns. Make recommendations to GCRC leadership and/or Principal Investigators regarding adequacy of monitoring plans, safety mechanisms and potential areas of concern related to subject protections on the GCRC.

10. What The RSA Needs From The Study Staff Maintain open and ongoing communication with the RSA regarding any potential safety issues, or other study-related concerns that you or your research volunteers may have. Submit copies of adverse event reports to our office, at the same time that you submit them to the HRC.

11. What The RSA Needs From The Study Staff (continued) If your study uses a Data and Safety Monitoring Board (DSMB), we need you to give us a copy of the DSMB charter- identifying the board’s: members, responsibilities, planned frequency of meetings, data to be evaluated and report distribution plan.

12. What The RSA Needs From The Study Staff (continued) We also need you to send us copies of DSMB meeting minutes at the time that they are compiled.

13. RSA Forms Data and Safety Monitoring Plan Worksheet: http://www.mgh.harvard.edu/gcrc/MGH %20Worksheet.doc

14. RSA Video The RSA program is developing a series of videos to aid subjects in understanding what to expect when participating in a study. Topics include overview of GCRC inpatient/outpatient areas. Additional titles are under development. To view the video, go to: http://www.mgh.harvard.edu/gcrc/gcrc_advocate.htm

15. Contact Us ! Names: Enrico Cagliero, M.D., Director Andrea Saltzman, R.N., Associate Director Debi Dunkless, Administrative Assistant Location: White 13, Room 1302 Phone:617 726-0541 Fax: 617 724-8090 Office Hours: M-F, 9-5 Email: ecagliero@partners.org asaltzman@partners.org ddunkless@partners.org

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