Research Subject Advocacy Best Practices

In April 2008 the CTSA Consortium Steering Committee approved and endorsed the following best practices recommended by the Research Subject Advocacy Taskforce:

  1. The research subject advocacy functions should include a reporting pathway to institutional officials of appropriate authority and should be 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.
  2. 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 problems can be explored or resolved through proper procedures. This capacity enables preliminary intervention into problems that might not necessarily invoke an institutional review board (IRB) suspension.
  3. 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.
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