Resources

Registry and Biorepository Working Group for a presentation by Dr. Stephen Rosenfeld on a new model of ethical review

The Registry and Biorepository Working Group hosted a presentation by Dr. Stephen Rosenfeld on a new model of ethical review. The “Research Ethics Review Board” is a system of nonprofit, independent, Institutional Review Boards (IRBs).

Research requires public trust in the scientific enterprise. Such trust is necessary both to support ongoing funding and so individuals are comfortable participating in research as subjects. IRBs were established to restore public trust in the research enterprise after the revelation of the Tuskegee Syphilis Study. Their mission is to ensure that research on people follows the principles of the Belmont Report: Respect for Persons, Beneficence and Justice.

However, the research enterprise is facing unprecedented ethical questions:

  • How should the rights of individuals be balanced with the common good when sharing information, doing genomic research and gene editing, and applying artificial intelligence and machine learning to research and medicine?
  • Is individual consent still appropriate when accumulating data blurs the traditional line between research and care in a learning healthcare system?
  • Should duplicative, poorly designed and uninformative research be allowed to go forward, especially after the pandemic has shown us both the opportunity cost of such research and demonstrated that mistrust of research and science can have material consequences for public health?
  • How can the Belmont principle of Justice be strengthened, when historically disadvantaged groups have been systematically excluded from research participation?

There are no clear answers to any of these questions, but we need to answer them together.

Dr. Rosenfeld facilitated a discussion of this model to provide ethical oversight of research by moving away from reviews that are conducted study-by-study behind institutional and corporate walls, and are instead conducted transparently and in a way that informs a foundation of ethical precedent and decision-making.

About the Speaker: Dr. Rosenfeld is the President of North Star Review Board, the immediate past Chair of the Secretary’s Advisory Board on Human Research Protections (SACHRP) and serves on the boards of Public Responsibility in Medicine and Research (PRIM&R) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP). He was the Chief Information Officer of the NIH Clinical Center, the CEO of Western IRB, and the Executive Review Board Chair at Quorum Review.