Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Research Subject Advocacy (RSA)

Research Subject Advocacy (RSA)

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.

Resources

For Potential Study Participants
  • Research Subject Advocacy Resources: Brochures and videos are available to help prospective study participants understand the risks, benefits, rights, and protections associated with participating in a research study.
For Investigators & Study Staff
  • 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.

  • Prefer to watch with closed captioning (CC)?

  • Research Subject Advocacy Resources: Access brochures and videos to help prospective study participants understand the risks, benefits, rights, and protections associated with participating in a research study.

  • Training, toolkits, and consultation services are available upon request.
For Institutions
  • Research Subject Advocacy Resources:
    • Informational Brochures: may be downloaded for print-on-demand or sent to a professional printer. To request printed copies of any of our brochures please contact us.
    • Educational Videos: freely available for use; may be embedded on your website. For instructions on how to embed these videos please contact us. Closed captioned versions of the videos are also available.
      • What does it mean to participate in research?
        This video series provides prospective research subjects with information to consider and questions to ask when thinking about participating in a research study.
      • Considering the Research Subject's Perspective
        This video series discusses ways researchers and staff can help ensure a positive experience for research participants.
    • Training, toolkits, and consultation services are available upon request.

How We Work

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.

Learn More

Advisory Board

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:

  1. Foster communication and linkages between research participants and researchers
  2. Guide strategic planning, including recommendations for collaborations, educational activities, and dissemination strategies
  3. Evaluate progress in adhering to timelines, achieving measureable outcomes, and conforming to program principles
  4. Ensure adherence to core values of clinical research and participant advocacy including culturally competent approaches to it

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

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:

  • Discussion of issues around research subject advocacy
  • Networking and trust-building among institutions
  • Engagement in inter-institutional and cross-disciplinary opportunities for collaborative action, innovation, community outreach, and research related to RSA efforts.
  • Increased awareness of clinical research and enhancement of its capacity and sustainability in Massachusetts by maintaining established partnerships and networks of community members, leaders, and organizations.
  • Collaborative development of educational materials for diverse, underrepresented populations who are underexposed to clear, high-quality information about clinical research.

For questions or to inquire about services please contact:

Enrico Cagliero, MD
Director of Research Subject Advocacy
Email
617-724-7702

Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
Email
617-432-7811

Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations
Email
617-432-5755

Elizabeth Witte
Senior Regulatory Affairs Officer
Email
617-432-7633

Jacquelyn-My Do
Regulatory Affairs Officer
Email
617-432-2088

A Distributed Model: Redefining a Robust RSA Program

Read more about Harvard Catalyst's RSA model in Clinical and Translational Science.