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Oversight and Review of Clinical Gene Transfer Protocols Assessing the Role of the Recombinant DNA Advisory Committee (2014) / Chapter Skim
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Appendix A: Data Sources and Methods
Pages 95-102

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From page 95...
... The IOM committee was instructed that if it concluded that this particular function of the RAC should remain intact, it should then describe the criteria that the RAC should use to select protocols for public review. The IOM committee reviewed information collected from a variety of sources, including scientific literature, previous evaluations and progress reports, open-session meetings and conference calls, public testimony and input, and other publicly available resources.
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From page 96...
... Experts in the field of financial and scientific investment in gene transfer research presented their perspectives on whether individual protocol review by the RAC brings expertise and transparency to the oversight process and whether additional oversight has a significant impact on financial investment in potential gene transfer products. Investors also compared gene transfer oversight in the United States to that in Europe.
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From page 97...
... The Charge to the Committee: A Discussion with the Sponsor Kathy Hudson, Ph.D. Deputy Director for Science, Outreach, and Policy Office of the Director, National Institutes of Health 2:10 p.m.
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From page 98...
... Closing Remarks Larry Gostin, J.D., Committee Chair MEETING TWO Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee August 6, 2013 Keck Center, Room 100 500 Fifth Street, NW Washington, DC 9:00 a.m. Welcome and Introductory Remarks Larry Gostin, J.D., Committee Chair
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From page 99...
... Director of the University of Florida Powell Gene Therapy Center Professor of Pediatrics, Molecular Genetics, and Microbiology Associate Chair of Pediatrics University of Florida Helen Heslop, M.D. Professor in the Department of Medicine Director of Adult Stem Cell Transplant Program Baylor College of Medicine Elizabeth Hohmann, M.D.
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From page 100...
... SESSION 3: PATIENT ADVOCACY EFFORTS AND PERSPECTIVES 11:15 a.m. Panel Discussion Session Objectives: Discuss the patient, consumer, and public perspective on oversight of clinical gene transfer protocols and how patients who may benefit from future gene therapies view the relevant regulatory landscape.
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From page 101...
... Panel Discussion Session Objectives: Explore the policy implications of emerging sciences and the underlying reasons for establishing layers of oversight. Understand overlapping ethical, legal, and social issues that warrant elevated scrutiny of gene transfer research and other areas of scientific research.
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From page 102...
... Chief of Surgery National Cancer Institute National Institutes of Health 3:00 p.m. Public Comment Period Harry Malech, M.D.
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Key Terms

  • transfer research
  • gene therapy
  • clinical gene
  • transfer protocols
  • transfer oversight

  • patient advocacy
  • protocol review
  • input tool
  • public access
  • public input

  • public comment
  • gene therapies
  • nih recombinant
  • committee meetings
  • recombinant dna

  • oversight process
  • conference calls
  • online input
  • comment period
  • dna advisory

  • individual protocol
  • chief medical
  • medical officer
  • additional oversight
  • transfer compared

  • vidual gene
  • public education
  • individual gene
  • powell gene
  • transfer products


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