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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 B: Historical and Policy Timelines for Recombinant DNA Technology
Pages 103-108

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From page 103...
... 1972–1973 Stanley Cohen and colleagues isolate a new cloning vector, pSC101, and create bacterial intra- and interspecies rDNAs. 1973 John Morrow and colleagues clone and propagate ribosomal DNA genes from a eukaryote in E
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From page 104...
... 1973 Concerned researchers draft a letter requesting that the NAS establish a committee to examine the risks and benefits of rDNA research and propose guidelines for such research. 1974 July: The chair of the seven-member NAS committee pre sents the committee's recommendations, including for the deferral of certain risky types of rDNA research; the estab lishment by NIH of an advisory committee to assess the risks of the research, develop procedures to limit such risks, and develop guidelines for research; and the convening of a conference to further discuss ways to deal with hazards of rDNA research (Berg et al., 1974)
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From page 105...
... 1993 Responding to industry concerns and questions, FDA pub lishes a description of its regulatory authority and approach to regulating gene therapy products. 1995 NIH and FDA outline an agreement for FDA to assume review of gene therapy research protocols, with the RAC and FDA jointly determining which protocols warrant pub lic review by the RAC (Advisory Committee to the Director, 2000)
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From page 106...
... . 2013 NIH proposes to revise the rDNA guidelines to remove the requirement for IBC review of certain low-risk gene transfer clinical trials that follow a dose safety trial previously ap proved by an IBC (Recombinant DNA research: Proposed actions under the NIH Guidelines for research involving recombinant or synthetic nucleic acid [NIH Guidelines]
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From page 107...
... :60328–60332. Recombinant DNA research: Proposed actions under the NIH Guidelines for research involving recombinant or synthetic nucleic acid (NIH Guidelines)
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From page 108...
... 2000. Statement of Amy Patterson, Director of the Office of Biotechnology Activities, NIH.
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Key Terms

  • gene transfer
  • recombinant dna
  • rdna research
  • nih guidelines
  • human gene

  • transfer research
  • therapy products
  • dna research
  • research guidelines
  • cell therapy

  • federal register
  • asilomar conference
  • somatic cell
  • dna molecules
  • involving recombinant

  • research involving
  • dna technology
  • human somatic
  • clinical trials
  • synthetic nucleic

  • nucleic acid
  • fda determines
  • cloning vector
  • temporary moratorium
  • transfer study

  • peter lobban
  • propose guidelines
  • base allowing
  • rac minutes
  • concerned researchers


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