| Helping researchers navigate clinical & translational research regulatory processes. | Regulatory Knowledge & Support Program |
Research Subject Advocacy (RSA)
The Research Subject Advocate (RSA) program seeks to engage, educate and advocate on behalf of potential research subjects and the local community by providing education for research participants and research staff. The RSA prepares educational materials for research volunteers and educates research staff about research participant advocacy.
A Research Subject Advocate is:
An individual, independent of the IRB or compliance officer, who acts as a sounding board for potential research participants, serves as an advocate for research participants, and works with investigators, trainees, and research teams to ensure that the highest priority is given for human subject protections. The RSA program serves as a resource to the research community and to participants.
More information regarding RSA functions is available here.
Resources for potential study participants:
- Community Connect to Research is a health information resource for patients and families in Massachusetts. The site is an educational resource that can be effectively used by clinical investigators who need a high quality resource for educating patients and their families about clinical research, including answers to the following questions:
- Available materials
- The RSA program supports efforts at an institutional level with help and protection for research volunteers, by:
- helping with any questions regarding research studies
- serving as a resource for volunteers
- finding information about a study or communicating with the study team
- supporting the needs of people in health research
- Additional Information
- Contact the RSA
Resources for investigators, study staff and institutions:
- As a resource for investigators, study staff and institutions the RSA provides:
- Training
- Tool Kits
- Consultation services
- Community Connect to Research overview brochure (for research staff) [PDF]
- Contact the RSA
Advisory Board
The Harvard Catalyst Research Subject Advocate Advisory Board helps bring to the forefront the vital voice of the research participants and serves as a sounding board to validate the needs of this constituency and focus the RSA activities with the Harvard researchers and the clinical community at large.
The Massachusetts RSA Group
The Massachusetts RSA group is a voluntary forum comprised of representatives from Harvard Catalyst, and the Clinical and Translational Science Centers at Boston University, Tufts University/Baystate Medical Center, and University of Massachusetts.
The goals of the group include:
- Discussion of issues around Research Subject Advocacy
- Networking and trust-building between institutions
- Engagement in inter-institutional and cross-disciplinary opportunities for collaborative action, innovation, community outreach, and research related to RSA efforts.
- Increased clinical research awareness and enhancement of clinical research capacity and sustainability in Massachusetts through established partnerships and networks of community members, leaders, and organizations.
- Collaborative development of educational materials for diverse, underrepresented populations otherwise underexposed to clear, high quality information about clinical research.
Contact
For Questions or Services please contact:
Enrico Cagliero, MD
Director of Research Subject Advocacy
E-mail
617-724-7702
Sabune Winkler, JD
Director, Regulatory Affairs Operations
E-mail
617-432-7884
