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Research Advocacy Taskforce Regulatory Support Workgroup April 28, 2008, Chicago, Illinois Rhonda G. Kost, MD The Rockefeller University. Taskforce Members. Susan Anderson, Yale School of Medicine Wajeeh Bajwa (Chair), Duke University Medical Center Rhonda G. Kost, The Rockefeller University

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Research Advocacy TaskforceRegulatory Support WorkgroupApril 28, 2008, Chicago, IllinoisRhonda G. Kost, MDThe Rockefeller University

taskforce members
Taskforce Members
  • Susan Anderson, Yale School of Medicine
  • Wajeeh Bajwa (Chair), Duke University Medical Center
  • Rhonda G. Kost, The Rockefeller University
  • Liz Martinez, Johns Hopkins School of Medicine
  • Eric P. Rubenstein, University of Rochester
  • Kathryn Schuff, Oregon Health and Sciences University
  • Laurel Yasko, University of Pittsburgh
  • Ted Wun, University of California – UC Davis Cancer Center
research advocacy
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
research advocacy1
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
research advocacy2
Research Advocacy
  • Ambiguity in the RFA – research advocacy – described in less than precise language
    • A position?
    • A program?
    • A group of functions?
the ctsa rfa
The CTSA RFA

“Regulatory Knowledge and Support

…..Regulatory support should include an individualindependent 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.”

ctsa rfa review criteria
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?”

ctsa regulatory workgroup research subject advocacy taskforce
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.”

recommendation of the taskforce and working group
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:

recommendations
Recommendations:

1. The research subject advocacy functionsshould include a reporting pathway to institutional officials of appropriate authority and free of conflict of interest.

  • The research subject advocacyfunctions should be complementary to and integrative with existing entities at the institution to promote and facilitate safe and ethical conduct of human research.
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Recommendations:

3. The research subject advocacy functionsshould 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.

recommendations1
Recommendations:

4. The research subject advocacy functionsshould 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.

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