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Recombinant DNA News |
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Clonal Population of Cells Detected in a Clinical Human Gene Transfer Trial Using Lentiviral Vector |
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The National Institutes of Health Office of Biotechnology Activities (OBA) has been informed that a "relative clonal dominance" was detected during follow-up of a subject who is participating in a French human gene transfer trial being conducted for individuals with β-Thalassemia Major and Sickle Cell Anemia. The clinical trial, sponsored by Genetix France, used hematopoietic stem cells transduced by a self inactivating (SIN) HIV-1 lentiviral vector containing the gene for β-globin under the control of the β-globin promoter. The subject received the gene modified cells in June 2007. |
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This clonal dominance appears to result from the integration of the vector in the gene encoding for the HMGA2 protein, which is associated with both benign and malignant tumors. The clone however has been stable for five months and the subject remains in good health. In fact, although the subject required almost monthly blood transfusions during the 11 months prior to the gene transfer intervention, the subject has not since required a blood transfusion. |
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The investigators involved in this trial will be performing further studies to evaluate the consequences of this integration and its capacity to proliferate. Until these studies are completed and another review is performed by the French Medicine Agency, AFSSAPS, no other subjects in this study will receive the gene modified cells. |
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OBA has sent a memorandum to inform OBA-registered investigators who are using or propose to use lentiviral or retroviral vectors in hematopoietic or other stem cells. OBA is currently seeking additional information regarding this event such as the specifics of the vector used, the dose of the cells, transduction conditions, and the clinical course of the first subject treated in this trial. OBA will organize a discussion at a meeting of the NIH Recombinant DNA Advisory Committee (RAC) when this information is available. |
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(Posted June 15, 2009)
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NIH Extends Public Comment Period for the Proposed Revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). |
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The NIH has extended the public comment period regarding the proposed revisions to the
NIH Guidelines
. Comments may be submitted to OBA via email at oba@od.nih.gov or mailed to: 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892. All comments regarding the proposed revisions must be submitted by
June 1, 2009. |
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The proposed revisions to the NIH Guidelines include: |
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Broadening the scope of the NIH Guidelines, which currently cover laboratory and clinical research involving DNA molecules created via recombinant techniques (i.e., joining of DNA molecules). NIH proposes to encompass nucleic acids that are synthesized chemically or by other means without the use of recombinant technology. |
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Revising the criteria for determining when introduction of a drug resistance trait into a microorganism must be reviewed and approved by the NIH Director. NIH proposes to remove the current language regarding a microorganism's ability to acquire the trait naturally, since this criterion may not be determinative of the safety and public health implications of the research. As proposed, this portion of the NIH Guidelines would state, "the deliberate transfer of a drug resistance trait to microorganisms, if such acquisition could compromise the ability to treat or manage disease caused by that microorganism in human and veterinary medicine, or agriculture." The proposed amendment also contains additional language requiring consideration of the utility of the drug in certain subpopulations. |
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Changing the 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, as described in Section III-E-1 of the NIH Guidelines. |
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The full version of the proposed changes may be found in the March 4, 2009 Federal Register, Volume 74, Number 41. |
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If you have questions or require additional information about these proposed revisions, please feel free to contact OBA at 301-496-9838 or oba@od.nih.gov |
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(Posted May 21, 2009)
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NIH Proposes Revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) |
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For the purposes of clarification and in acknowledgement of the rapidly developing field of synthetic biology, the NIH is proposing a number of amendments to the current NIH Guidelines. |
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The proposed revisions to the NIH Guidelines include: |
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Broadening the scope of the NIH Guidelines, which currently cover laboratory and clinical research involving DNA molecules created via recombinant techniques (i.e., joining of DNA molecules). NIH proposes to encompass nucleic acids that are synthesized chemically or by other means without the use of recombinant technology. |
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Revising the criteria for determining when introduction of a drug resistance trait into a microorganism must be reviewed and approved by the NIH Director. NIH proposes to remove the current language regarding a microorganism's ability to acquire the trait naturally, since this criterion may not be determinative of the safety and public health implications of the research. As proposed, this portion of the NIH Guidelines would state, "the deliberate transfer of a drug resistance trait to microorganisms, if such acquisition could compromise the ability to treat or manage disease caused by that microorganism in human and veterinary medicine, or agriculture." The proposed amendment also contains additional language requiring consideration of the utility of the drug in certain subpopulations. |
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Changing the 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, as described in Section III-E-1 of the NIH Guidelines. |
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The full version of the proposed changes may be found in the March 4, 2009 Federal Register, Volume 74, Number 41. |
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The public is encouraged to submit comments on the proposed revisions. Comments may be submitted to OBA via email at oba@od.nih.gov or mailed to: 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892. All comments on the proposed revisions must be submitted by May 4, 2009. |
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If you have questions or require additional information about these proposed revisions, please feel free to contact OBA at 301-496-9838 or oba@od.nih.gov |
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(Posted March 26, 2009)
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OBA to Sponsor IBC Professional Development Conference |
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The NIH Office of Biotechnology Activities and the Eagleson Institute, with the participation of the American Association for Laboratory Animal Science, American Biological Safety Association, American Society for Microbiology, and Public Responsibility in Medicine and Research, are planning a professional development conference for Institutional Biosafety Committee members and staff. The conference, titled "Institutional Biosafety Committees: Promoting Optimal Practice Now and in the Future," will takeplace June 24-26 at the Hyatt Regency in Crystal City, Virginia. This event will also be of interest to biosafety professionals, research administrators, scientists, and others involved with recombinant DNA research. Go to the Eagleson Institute Web site to see the agenda or to register. |
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(Posted January 30, 2009)
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OBA Posts Frequently Asked Questions about Research Constituting a "Major Action" |
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Under Section III-A of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), experiments involving the transfer of a drug resistance trait are considered "Major Actions" if the acquisition of the trait could potentially compromise the use of the drug in question to control disease agents 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. If the NIH approves the experiment, the agency will specify appropriate biosafety containment. |
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OBA frequently receives questions about this provision of the NIH Guidelines, and has thus prepared a set of answers, now available on its Web site, to respond to the most frequently asked questions (FAQs). The aim of the FAQs is to provide readily accessible information on the matters most commonly in need of clarification. Institutional staff and investigators may also contact OBA directly by email or telephone with any additional questions they may have. These questions may be directed to Gene Rosenthal, Ph.D., Biotechnology Program Advisor, NIH OBA, at 301-496-9838 or rosenthg@od.nih.gov. Written queries may also be sent to oba@od.nih.gov. |
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(Posted March 21, 2008)
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Archived RAC News
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Genetics, Health, Society News |
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Archived SACGHS News |
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Dual Use Research News |
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Public Consultation Meeting to Seek Input on Personnel Reliability Program Attributes Being Considered by the National Science Advisory Board for Biosecurity |
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Given heightened concerns about insider threats at organizations that work with highly pathogenic agents, the Federal government has charged the National Science Advisory Board for Biosecurity (NSABB) with recommending a personnel reliability program for individuals with access to Select Agents. A portion of their recommendations will address the measures that institutions should undertake to assess whether individuals are trustworthy and reliable to work with these agents.
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The Board appreciates the potential impact that any future requirements for personnel reliability programs would have on institutions and investigators, and thus is sponsoring a public consultation meeting on
April 3, 2009 to engage the scientific community, research organizations, and other stakeholders in a discussion of the various aspects and aims of these programs.
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The public consultation meeting will take place from
8:00 am - 5:15 pm at the Bethesda Marriott, 5151 Pooks Hill Rd, Bethesda, MD. The meeting will be conducted as a series of panels where participants will be asked to discuss particular topics relevant to personnel reliability. In addition to presentations on extant personnel reliability programs and aspects of the current Select Agent Programs that address personnel reliability, panels will explore measures and approaches for assessing (1) scientific and professional integrity and compliance with biosafety and biosecurity standards, and (2) emotional stability, sound judgment, and freedom from vulnerability to coercion. Each panel will include ample time for in-depth discussion of the issues surrounding each topic. The meeting agenda will include specific discussion questions and will be posted prior to the meeting.
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The Board is interested in hearing perspectives from such individuals as investigators who work with Select Agents, senior research officials at institutions registered for Select Agent work, security think tank analysts, responsible officials under the Select Agent program, and individuals who promote the responsible conduct of research and have studied issues of research integrity. Others are equally welcomed and encouraged to participate.
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The meeting is open to the public and free of charge. Due to limited space, pre-registration is encouraged. To register, please connect to http://www.biosecurityboard.gov and go to "NSABB Meetings" where there is a registration link for the April 3 public consultation. Notice of this meeting will also be published in the Federal Register. Any groups or individuals who cannot attend the meeting are encouraged to submit in advance of the meeting written comments to: nsabb@od.nih.gov . Please note that this meeting will not be Web cast.
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Questions about this meeting can be addressed to Allan C. Shipp, Director of Outreach, NIH Office of Biotechnology Activities, 301-435-2152 or shippa@od.nih.gov.
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(Posted March 6, 2009)
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NSABB Issues New Report on Outreach and Education |
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The National Science Advisory Board for Biosecurity (NSABB) has issued a new report titled, "Strategic Plan for Outreach and Education on Dual Use Research Issues." The report describes strategies to enhance awareness and understanding of dual use research issues. The report is the third issued by the NSABB in fulfillment of its charge from the U.S. government. The NSABB was established by the government to advise Federal departments and agencies on ways to minimize the possibility that knowledge and technologies emanating from life sciences research will be misused to threaten public health or other aspects of national security. Among other aspects of its charge, the NSABB was asked to provide recommendations on developing programs of outreach and education on dual use research issues for all scientists and laboratory workers at federally-funded institutions. |
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(Posted January 30, 2009)
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Archived NSABB News |
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Clinical Research Policy News |
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On April 7, 2009, HHS released OHRP Guidance on GINA: Implications for Investigators and IRBs at http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html and a fact sheet for researchers and health care professionals at http://www.genome.gov/Pages/PolicyEthics/GeneticDiscrimination/GINAInfoDoc.pdf
(published April 7, 2009)
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Archived CRpac News
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