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In 2006, the National Science Advisory Board for Biosecurity, an advisory committee to the Secretary of the Department of Health and Human Services, the NIH Director and all Federal entities that conduct/support life sciences research published a report entitled ‘‘Addressing Biosecurity Concerns Related to the Synthesis of Select Agents.’’ 1 The report included a recommendation that the United States Government (USG) ‘‘examine the language and implementation of current biosafety guidelines to ensure that such guidelines and regulations provide adequate guidance for working with synthetically derived DNA and are understood by all those working in areas addressed by the guidelines.’’ The USG adopted this recommendation and asked NIH to review the NIH Guidelines for Research with Recombinant DNA (NIH Guidelines) to evaluate whether these guidelines need to be revised to address biosafety concerns for research with synthetic DNA. With the advice of the NIH Recombinant DNA Advisory Committee (RAC), which is responsible for advising the NIH Director on all aspects of recombinant DNA technology, including revisions to the NIH Guidelines, the following proposed changes were developed. As outlined in more detail below, the proposed changes will expand the scope of the NIH Guidelines to specifically cover nucleic acid molecules made solely by synthetic means. The changes apply to basic laboratory research and clinical research. In addition, changes were made to clarify the criteria for determining whether an experiment to introduce drug resistance into a microorganism raises important public health issues such that it must be reviewed by the RAC and approved by the NIH Director. Finally, the proposed amendments speak to the appropriate level of review for recombinant or synthetic experiments involving more than half but less than two-thirds of the genome of certain viruses in tissue culture. These changes were prompted by an increased understanding of the biology of certain viruses that demonstrate there may be biosafety risks with certain viruses that contain less than two-thirds of the viral genome.
NIH public consultation on "Synthetic nucleic acids and the NIH guidelines for research involving recombinant DNA molecules" [electronic resource] / National Science Advisory Board for Biosecurity.
Series:
Synthetic nucleic acids and the NIH guidelines for research involving recombinant DNA molecules
Author:
National Science Advisory Board for Biosecurity (U.S.)
Publisher:
[Bethesda, Md. : National Institutes of Health, 2009]
Other Title(s):
Synthetic nucleic acids and the NIH guidelines for research involving recombinant DNA molecules
Abstract:
(CIT): In 2006, the National Science Advisory Board for Biosecurity, an advisory committee to the Secretary of the Department of Health and Human Services, the NIH Director and all Federal entities that conduct/support life sciences research published a report entitled "Addressing Biosecurity Concerns Related to the Synthesis of Select Agents." The report included a recommendation that the United States Government (USG) "examine the language and implementation of current biosafety guidelines to ensure that such guidelines and regulations provide adequate guidance for working with synthetically derived DNA and are understood by all those working in areas addressed by the guidelines." The USG adopted this recommendation and asked NIH to review the NIH Guidelines for Research with Recombinant DNA (NIH Guidelines) to evaluate whether these guidelines need to be revised to address biosafety concerns for research with synthetic DNA.
Subjects:
Containment of Biohazards--standards Genes, Synthetic Laboratories--standards Recombination, Genetic Risk Assessment United States
