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