Genome Ethical, Legal, and Social Issues
Section
DOE Human Genome Program Contractor-Grantee Workshop
VII
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178. The Responsibility of Oversight
in Genetics Research: How to Enable Effective Human Subjects Review of
Public and Privately Funded Research Programs
Barbara Handelin and Susan Katz
IRBs are under extreme stress to provide
adequate review of all manner of protocols. A central assumption that underlies
the IRB's charge to protect the rights and welfare of human subjects involved
in research, is that each individual IRB will possess or develop the requisite
expertise to accomplish this mission adequately. The increasingly complex
ethical, regulatory and scientific issues presented to IRBs in reviewing
genetic research protocols challenge the validity of this assumption. Individual
IRBs have inadequate time and resources to develop the necessary genetics
expertise and facility to deal with this new challenge. Thus, our project
has been developed to solicit specific needs from IRBs so that specific
working "tools" can be created to address those needs. We will report on
our progress toward that end. But that is not all....as we are also addressing
the concomitant increased pressure on biotech and genomics companies to
conform to a standard of practice in conducting research studies and in
developing marketing plans for gene based products and services. As such
companies become engaged in clinical studies involving human subjects or
tissues it has become apparent that they may need help in effecting quality,
IRB-like review. In this project we are seeking to exploit the synergistic
needs and expertise found in these two types of organizations: the ethics
oversight capabilities and systems of IRBs and the genome expertise in
industrial R&D shops. We will report on the dynamic interplay and relative
perspectives that IRBs and the biotech communities have of one another
and how we are proposing to weave common solutions to critical issues in
the safe and ethical participation of human subjects in genetic research.
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