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| Archived News and Events - RAC |
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Past Recombinant DNA News |
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Major Action Approved by the NIH Director |
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After a review of public comments and pursuant to the open deliberations of the NIH Recombinant DNA Advisory Committee ( RAC ), the NIH Director has approved two specific research proposals involving the deliberate transfer of a drug resistance trait to a microorganism. NIH approval was required, because these experiments were considered �Major Actions� under Section III-A of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). Major Actions include experiments involving the transfer of a drug resistance trait, the acquisition of which could potentially compromise the use of the drug in question to control disease agents in humans, veterinary medicine, or agriculture. The NIH Director�s approval allows Dr. Dan Rockey and Dr. Walter Stamm (at Oregon State University and the University of Washington , respectively) to transfer from Chlamydia suis (a swine pathogen) a gene encoding tetracycline resistance into C. trachomatis (a human pathogen). This approval is specific to Drs. Rockey and Stamm and the particular research proposals in question, which may proceed only under the conditions outlined in NIH�s approval, as published in the October 31 Federal Register . Other investigators intending to transfer tetracycline resistance to Chlamydia or to engage in other types of experiments fitting the characteristics of those described in Section III-A-1-a of the NIH Guidelines, must submit their proposals to NIH OBA for review and approval before these experiments can be initiated. |
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(Posted November 1, 2007)
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NIH Recombinant DNA Advisory Committee to Discuss Proposals to Transfer Chloramphenicol Resistance to Rickettsia typhi and Rickettsia conorii |
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At its September 17-19, 2007 meeting, the NIH Recombinant DNA Advisory Committee (RAC) will be discussing proposed experiments to transfer chloramphenicol resistance to Rickettsia typhi and Rickettsia conorii. Initiation of these experiments would constitute a Major Action under the NIH Guidelines for Research Involving Recombinant DNA Molecules because they involve the transfer of a drug resistance trait to microorganisms, where the acquisition of that trait could possibly compromise the use of the drug to control disease caused by that microorganism in humans, veterinary medicine, or agriculture. Notice of such experiments must be published in the Federal Register. In order to proceed, the experiments must be reviewed by the RAC and specifically approved by the NIH Director. Appropriate biosafety containment will be specified if the proposals are approved by the NIH. A notice has been published in the Federal Register regarding these experiments, proposed by Dr. David Walker, University of Texas Medical Branch, Galveston, and Dr. Abdu Azad, University of Maryland at Baltimore (copies of each proposal may be downloaded by clicking on the name of the respective investigator). The public is encouraged to comment in writing and/or in person at the September RAC meeting. Written comments can be sent to OBA's email inbox or to Dr. Eugene Rosenthal, Biotechnology Program Advisor, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892-7985. Written comments received by September 6, 2007 will be reproduced and distributed at the September RAC meeting.
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(Posted July 25, 2007)
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NIH OBA Conducting a Series of Training Sessions and Workshops |
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Staff from NIH OBA have been presenting on the NIH system of oversight of recombinant DNA research at a series of meetings sponsored by various professional associations.
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An investigator training session was offered as a preconference educational event during the annual meeting of the American Society for Gene Therapy in Seattle, Washington on May 30, 2007.
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OBA staff presented on Institutional Biosafety Committees at a June 14-15, 2007 meeting of the Massachusetts Society for Medical Research.
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On September 17, 2007, OBA staff will conduct an "IBC Basics" course at a meeting sponsored by Public Responsibility in Medicine and Research. More information about these events can be obtained by clicking on the name of the sponsoring organizations.
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(Posted July 10, 2007)
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