Oversight and Review of Clinical Gene Transfer Protocols Assessing the Role of the Recombinant DNA Advisory Committee (2014) / Chapter Skim
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1 Introduction
1 Introduction
Pages 9-20
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, in collaboration with the National Research Council, convened an ad hoc committee to provide an independent review and assessment of the role of the Recombinant DNA Advisory Committee (RAC) in advising on clinical gene transfer protocols at the request of the Office of the Director of the National Institutes of Health (NIH)
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currently defines clinical gene transfer research as the deliberate transfer into human research participants of either 1) re combinant nucleic acid molecules, or deoxyribonucleic acid (DNA)
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This expanded definition of gene transfer accommodates newly emerging technologies that would test the limits of the standard used by OBA, such as mitochondrial DNA transfer or the techniques of gene transfer using pluripotent stem cells. OVERSIGHT OF CLINICAL GENE TRANSFER TRIALS Some observers argue that human gene transfer research2 is the most heavily regulated type of biomedical research (Kahn, 2009)
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. A key product of this evolution was the creation, under federal guidelines, of IRBs to review and approve federally funded biomedical and social-behavioral research involving human subjects, including gene transfer research.
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establish a committee to examine safety concerns and create guidelines for rDNA research. The NAS responded positively by creating the Committee on Recombinant DNA Molecules, which met once, in April 1974.
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2593) In addition, the committee recommended caution in the undertaking of certain other research, and it proposed another international conference to consider scientific developments and discuss strategies for dealing with safety concerns.
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as public concerns about the technology have periodically intensified and ebbed. Today, rDNA and human gene transfer research has progressed as a function of both scientific advancement and the changing regulatory context, with the RAC providing an avenue for broad public participation and mechanisms for accountability as a key feature of oversight.
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However, at the time that the RAC approved the OTD protocol, the RAC was unaware of study aspects that were not in compliance with the rules and regulations imposed on clinical gene transfer trials; therefore, these violations occurred despite RAC review. A general assessment of the state of gene transfer research in the aftermath of the death of this research subject was that this was a technology in which investigators were overestimating potential benefits, the media was hyping its curative potential, and oversight mechanisms were struggling to stay ahead of the technology (Kahn, 2009)
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. The committee understood that an essential element of the RAC review is the balancing of two critical values -- the protection of human participants in research and the advancement of medical science to the benefit of society -- and it recognized that inherent tensions exist between advancing science and ensuring the adequate protection of research participants.
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From page 18... ...
Chapter 3, "Oversight of Gene Transfer Research," provides policy and historical context regarding regulation and oversight of gene transfer research and describes the complex oversight mechanisms that exist today for human gene transfer trials. Chapter 4, "Evolution of Oversight of Emerging Clinical Research," offers the committee's findings, conclusions, and recommendations.
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From page 19... ...
1993. Recombinant DNA Advisory Committee minutes of meeting -- January 14, 1993.
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Key Terms
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