Research Subject Advocate's Office

The Research Subject Advocate’s (RSA) Office is staffed by professionals who have specialized knowledge in bioethics, human-based research, and research subject safety. Accordingly, the RSA plays a lead role in the protection of human subjects at the University of New Mexico Health Sciences Center (UNMHSC) General Clinical Research Center (GCRC). The RSA Office works closely with the Human Research Review Committee (HRRC) to establish common rules that protect the safety of subjects participating in research at UNMHSC. The Research Subject Advocate, Cheryl Reich, is responsible for working with investigators and their staff on data safety monitoring plans (DSMP’s), subject safety, and adverse-event reporting issues.

The RSA office has the responsibilities of:

• Reviewing all GCRC protocols prior to approval
• Guiding and advising investigators in the development of the Human Studies and Data Safety Monitoring Plans (DSMP) elements of their protocol
• Making recommendations to the GCRC advisory committee (GAC) regarding participant safety, compliance with all federal and other applicable regulations, and ethical considerations.
• Review DSMP for each protocol to ensure accuracy and completeness, and advises the GAC on the appropriateness of each DSMP to the protocol under discussion
• Review the informed consent form(s) to verify that the risks and benefits of the research are appropriately addressed.
• Scheduled and unscheduled audits and external reviews of active research are performed to ensure that the DSMP is fully implemented, to ensure compliance, and to identify any unexpected safety or data concerns.
• Works closely with the GAC, GCRC Administrators, and protocol investigators to examine and resolve questions and problems as they arise during the conduct of the research.
• Maintains an up-to-date list of forms and links related to data safety monitoring.
• Educate and train investigators and their staff members in human subject research and good clinical practice.

For more information, please contact

Cheryl Reich, RN, MSN, AOCN
Research Subject Advocate
Phone: 272-6817
Email:creich@salud.unm.edu