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Research Advocacy Taskforce Regulatory Support Workgroup April 28, 2008, Chicago, Illinois Rhonda G. Kost, MD The R

Taskforce Members. Susan Anderson, Yale School of MedicineWajeeh Bajwa (Chair), Duke University Medical CenterRhonda G. Kost, The Rockefeller UniversityLiz Martinez, Johns Hopkins School of MedicineEric P. Rubenstein, University of Rochester Kathryn Schuff, Oregon Health and Sciences UniversityLaurel Yasko, University of PittsburghTed Wun, University of California

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Research Advocacy Taskforce Regulatory Support Workgroup April 28, 2008, Chicago, Illinois Rhonda G. Kost, MD The R

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    1. Research Advocacy Taskforce Regulatory Support Workgroup April 28, 2008, Chicago, Illinois Rhonda G. Kost, MD The Rockefeller University

    3. Research Advocacy RSA program was created under the GCRC, (based on NCRR assessment at the time) in response to strong feeling of need for expertise and education on the front lines in the areas of protection of human subjects and participant advocacy In transition to the CTSA, broad uncertainty about the precise role for research participant advocacy

    4. Research Advocacy The title “RSA” from GCRC is very charged, for some, but the issues that led to the creation of such a program are still present in CTSAs Re-focus on the value of a broadly defined program to include any methods to ensure A responsive program to intervene on behalf of participants regarding their protections, rights and welfare in the conduct of clinical research

    5. Research Advocacy Ambiguity in the RFA – research advocacy – described in less than precise language A position? A program? A group of functions?

    6. The CTSA RFA “Regulatory Knowledge and Support …..Regulatory support should include an individual independent of the IRB or compliance office 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 research involving human subjects accords the highest priority to human subject protections.”

    7. CTSA RFA Review Criteria “Regulatory Knowledge and Support: Will this resource provide “researcher-focused” support for regulatory compliance and management?........ ………………………………………………………… ……………. Are criteria for identifying a research participant advocate sound?”

    8. CTSA Regulatory Workgroup: Research Subject Advocacy Taskforce “The purpose of this group is to define and develop the mission, scope and model for the Research Subject Advocacy (RSA) role in the CTSA.”

    9. Iterative process with the larger workgroup Included RSAs and a majority of NON-RSAs Considerable discussion, led to agreement that the four elements of the recommendations are the integral and most valuable elements of research participant advocacy Iterative process with the larger workgroup Included RSAs and a majority of NON-RSAs Considerable discussion, led to agreement that the four elements of the recommendations are the integral and most valuable elements of research participant advocacy

    10. Recommendation of the Taskforce and Working Group The functions of an RSA…….should be fulfilled at every CTSA funded center. The implementation of the functions of the RSA program can be tailored to the strengths, needs, and resources of the individual institution; however, in fulfilling this charge consideration should be given to inclusion of the following core characteristics and functions:

    11. Recommendations: 1. The research subject advocacy functions should include a reporting pathway to institutional officials of appropriate authority and free of conflict of interest. The research subject advocacy functions should be complementary to and integrative with existing entities at the institution to promote and facilitate safe and ethical conduct of human research.

    12. 3. The research subject advocacy functions should have, or have direct access to, an authority that can temporarily suspend a research activity based on ethical and safety concerns so that problem can be explored or resolved through proper procedures. This capacity enables preliminary intervention in problems that might not necessarily invoke an IRB suspension.

    13. Recommendations: 4. The research subject advocacy functions should be a resource to the research community and to participants, have a voice in policy regarding research ethics, participants' rights and research safety, and play a role in the protection of human subjects and responsible conduct of research educational programs of the institution.

    14. Outcome Measures What may be transformative, going forward, is the development of outcome measures in the protection of Human Subjects and participant advocacy.

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