|Helping researchers navigate clinical & translational research regulatory processes.||Regulatory Foundations, Ethics, and Law Program|
The Research Subject Advocacy (RSA) Program serves as a resource to the research community and to participants. In educating the general public, and specifically, research subjects and potential subjects, the program's goal is to provide support and advocacy throughout the research process.
Many roles in the research process help support, promote, and protect the rights of a research subject. Advocating on behalf of research participants demands a strong and broad foundation, including a robust human subjects protection program, quality assurance and improvement initiatives, and engagement with communities. Training and education initiatives for researchers and staff are of paramount importance to maintaining open and clear communication with research participants and community members.
Considering the Research Subject's Perspective: This video series discusses ways researchers and staff can help ensure a positive experience for research participants. The video series is freely available for use and may be embedded on your website. For instructions on how to embed these videos please contact us.
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The RSA program at Harvard Catalyst works with local communities to advocate on behalf of research participants, disseminate materials, and organize educational events to train research volunteers, investigators, and staff around participant rights and protections. The program supports local advocacy activities at our partner institutions by serving as a central resource to the research community, participants, and the diverse local communities within the metro-Boston area.
The RSA Advisory Board is comprised of leaders from community development organizations, members of a local community ethics committee, partnering hospital research nurses, research coordinators, researcher/staff educators, RSAs, health disparities experts, a community engagement liaison, and an expert in cultural competency in research.
The RSA Advisory Board is tasked to:
The RSA Advisory Board meets quarterly to guide the Regulatory Foundations, Ethics, and Law Program, identify areas for collaboration, and, most importantly, bring to the table relevant and current issues for the program to consider and address as appropriate. In addition to strategic planning, the board has served as a sounding board for tactical guidance in the drafting of surveys, programmatic evaluation, the development of materials and resources, and in identifying potential resources for educational outreach efforts.
The New England RSA group is a voluntary forum comprised of representatives from Harvard Catalyst, and the Clinical and Translational Science Centers at Boston University, Dartmouth College, Tufts University, University of Massachusetts, and Yale University. The group meets quarterly to explore common issues, interests, and concerns related to research participants, and research subject advocacy.
The goals of the group include:
For questions or to inquire about services please contact:
Enrico Cagliero, MD
Director of Research Subject Advocacy
Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations
Senior Regulatory Affairs Officer
Regulatory Affairs Officer
Read more about Harvard Catalyst's RSA model in Clinical and Translational Science.