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Pages 1-8

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From page 1...
... Since the RAC's creation in the early 1970s, its roles and responsibilities have changed from those of a formal regulatory body to an advisory body that functions within a complex regulatory oversight system that includes FDA and oversight bodies at research institutions -- IRBs and IBCs. The RAC's individual protocol review of proposed clinical gene transfer research was instituted at a time when there was a somewhat unique combination of new technology, limited scientific and public understanding, heightened social concern about genetics, and uncertainty regarding the risks to individuals and the environment (Berg, 2004)
From page 2...
... for an examination of the role of the RAC. Given the involvement of multiple regulatory and oversight bodies in reviewing and approving gene transfer protocols at the present time, and given arguments that gene transfer is no longer itself so novel, NIH commissioned the IOM to review the current state of the science and regulatory process and to assess whether gene transfer research raises issues of concern that warrant continuing extra oversight, specifically with respect to individual clinical trial protocols by the RAC.
From page 3...
... When individual gene transfer protocols are reviewed publicly, the purpose will be to advise prospective research participants, the investigator, and NIH's Office of the Director, as well as to inform the public and other regulatory bodies, such as FDA and IRBs. Emerging technologies in gene transfer science, as presented in new clinical trials protocols (for example, first-in-human trials)
From page 4...
... Office of the Director should continue to register all gene transfer protocols and, in consultation with appropriate regulatory and/or oversight authorities, should identify protocols for additional public review only if both items 1 and 2 below are satisfied 1. Protocol review could not be adequately performed by other regulatory and oversight processes (for example, institutional review boards, institutional biosafety committees, the U.S.
From page 5...
... Therefore, the committee recommends that the RAC's review of gene transfer oversight be narrowed to those areas still in need of special review or expertise. The committee also notes that the experience with gene transfer research may offer valuable lessons for how to proceed with human trials of other medical advances that depend on emerging technologies.
From page 6...
... director should convene an ad hoc working group that will be responsible for considering whether additional oversight and a venue for public deliberation are indicated for other applications of emerging technologies, and if so, to explore procedural options, including the possibility of an integrated oversight body. In this task, the focus should be on those human clinical applications that may be of particular interest to the public, or that feature uncertain risk, may pose harms to individuals or to the public's health, and which could not otherwise be adequately assessed by existing regulatory and oversight processes.
From page 7...
... The committee recommends that any expanded process established to evaluate and advise on new technologies be focused on those that are anticipated to be part of clinical research interventions and that pose uncertain risk and consequences to individual and/or public health. To be clear, the criteria presented in Recommendation 4-1 are meant to be used to select gene transfer protocols that require an exceptional level of review and are not meant to apply in whole or in part to other technologies.
From page 8...
... and gene transfer research. Independent review and assessment of the activi ties of the NIH Recombinant DNA Advisory Committee -- Meeting one.


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