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Recombinant DNA News |
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Mark Your Calendars for These Upcoming Educational Opportunities from OBA |
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OBA will be participating in several key meetings in the next few months, sponsoring exhibits and training sessions that will offer information about the oversight of recombinant DNA research, as well as promote awareness about dual use life sciences research. Please take note of the following events: |
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University of Minnesota - OBA will be conducting a full-day IBC training workshop on September 20, 2012, at the University of Minnesota. Further information can be found here. |
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USDA - OBA will be participating in an IBC training event that will take place September 25-26, 2012, at the USDA/ARS National Animal Disease Center in Ames, IA. For further information contact Vicki Jones or call 515-337-7285 for registration information. |
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Massachusetts Society for Medical Research - OBA staff will be presenting at the conference "IACUCs, IBCs & IRBs: Harmonization, Integration & Implementation", which will be held October 1-2, 2012, in Wellesley, MA. OBA staff will also be available during the conference to answer questions on the revised NIH Guidelines and dual use life science research oversight. Further information can be found at: Massachusetts Society for Medical Research. |
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American Biological Safety Association - OBA will be conducting a half day pre-conference class, "Case Studies in Recombinant DNA and Dual Use Research of Concern" at the Annual ABSA Conference in Orlando, FL on October 20, 2012, from 8:00 am - 12:00 pm. OBA staff will also be available to answer questions at an exhibit booth during the conference. The exhibit will display educational material relating to the oversight of research involving recombinant DNA, as well as information on the oversight of dual use life science research. For more information about this event, visit: American Biological Association.
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Questions about OBA activities at any of the above events may be directed to Dr. Kathryn Harris, Senior Outreach and Education Specialist (Contractor), NIH OBA, or 301-435-2195 . |
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(Posted August 29, 2012)
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NIH Certifies Kluyveromyces lactis as a Host-Vector 1 System Under the NIH Guidelines for Research Involving Recombinant DNA Molecules |
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A proposal to certify
K. lactis
as a host-vector 1 system has been reviewed by the NIH Recombinant DNA Advisory Committee and approved by the NIH Director.
This proposal was approved based upon the determination that the
K. lactis
host-vector 1 system affords a degree of biological containment equal to other
certified host-vector 1 systems presently listed in the
NIH Guidelines
for Research Involving Recombinant DNA Molecules (NIH Guidelines).
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Additionally, it has been determined that certain research with the
K. lactis
host-vector 1 system does not present a significant risk to health or the environment
and will be exempt from the
NIH Guidelines
under Section III-F-6 and Appendix C.
Appendix C will be modified to indicate the nature of the research considered exempt when performed in a
K. lactis
certified host-vector 1 system.
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The full version of the Federal Register notice that describes this addition to the NIH Guidelines may be found in the May 12, 2011 Federal Register,
Volume 76, Number 92.
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NIH Guidelines
Revised to Exempt Most Experiments Involving the Breeding of Transgenic Rodents Housed Under BL1 Conditions
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Under the revisions to the
NIH Guidelines for Research Involving Recombinant DNA Molecules
effective January 19,
the breeding of transgenic rodents that may be housed under BL1 containment conditions is exempt from the NIH Guidelines with the exception of:
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Breeding experiments involving transgenic rodents that contain more than 50 percent of the genome of an exogenous eukaryotic virus from a single family,
in order to prevent inadvertent reconstitution of an exogenous virus in the resultant transgenic rodent; and |
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Breeding experiments in which the transgenic rodent's transgene is under the control of a gammaretroviral long terminal repeat (LTR),
in order to address the small risk of recombination with endogenous retroviruses which could potentially result in mobilization of the transgene
via a replication-competent mouse retrovirus. |
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The above two types of experiments must still be registered with, and eventually approved by, an IBC under Section III-E of the
NIH Guidelines.
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A full description of these changes can be found in the January 19 Federal Register (76 FR 3150). Questions about this policy change can be addressed to
OBA staff by email.
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(posted January 19,2011)
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Archived RAC News
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Genetics, Health, Society News |
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Meeting Information |
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Archived SACGHS News |
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Dual Use Research News |
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Department of Health and Human Services (HHS) to Hold International Workshop on Research into Highly Pathogenic H5N1 |
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HHS is sponsoring an international consultative workshop on December 17-18 at the Natcher Auditorium on the NIH Campus on
Gain-of-Function Research on Highly Pathogenic Avian Influenza H5N1 Viruses.
The purpose of this workshop is to provide a forum for sharing multidisciplinary international perspectives on research that aims to increase transmissibility, increase pathogenicity, and/or alter host range of highly pathogenic avian influenza (HPAI) H5N1 viruses. Specific issues for discussion will include the implications of such research for global public health; risks and concerns associated with this research; the risks of not conducting such research; fundamental principles regarding the conduct and oversight of such research; and conditions under which such research might be conducted.
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Perspectives will be presented by individuals from around the globe who collectively have a broad range of expertise in such areas as influenza, other infectious diseases, dual use research, bioethics, national and global public health, biosecurity, epidemiology, national security, public health surveillance, biosafety, biosecurity agriculture/veterinary sciences, the WHO International Health Regulations and the Pandemic Influenza Preparedness Framework, global public health law, and medical countermeasure development. In addition, participants will have the opportunity to exercise a proposed HHS funding framework through discussion of a series of case studies. These presentations and discussions will be an important contribution to the ongoing global dialogue on this issue.
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Because these issues are of great importance to the scientific and public health communities, as well as the public at large, the meeting will be open to all those interested in attending. Registration for this event is highly encouraged. This event will not be webcast.
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To see a preliminary agenda and to register for the event, go to the International Meetings page of the OBA Web site.
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(November 19, 2012)
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Now Available: NIH Statement Conveying the Concurrence of the HHS Secretary with the Recommendations of the National Science Advisory Board for Biosecurity Regarding Revised Manuscripts on Transmissibility of A/H5N1 Influenza Virus |
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(April 20, 2012)
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NIH Statement Regarding the Full Recommendations of the National Science Advisory Board for Biosecurity Regarding its March 29-30, 2012 Meeting to Review Revised Manuscripts on Transmissibility of A/H5N1 Influenza Virus |
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(April 14, 2012)
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Statement of the National Science Advisory Board for Biosecurity Regarding its March 29-30, 2012 Meeting to Review Revised Manuscripts on Transmissibility of A/H5N1 Influenza Virus |
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(March 30, 2012)
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US Government Issues Policy on Oversight of Life Science Dual Use Resarch of Concern: |
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The purpose of this Policy is to establish regular review of United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC) in order to: (a) mitigate risks where appropriate; and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
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(March 29, 2012)
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Archived Workshop Video of THE INTERSECTION OF SCIENCE AND SECURITY: A CASE STUDY APPROACH, CONTINUING THE GLOBAL DIALOGUE WITH THE SCIENTIFIC AND SCIENCE POLICY COMMUNITY: FOCUS ON ASIA AND THE WESTERN PACIFIC |
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On December 9, 2011 the National Science Advisory Board for Biosecurity (NSABB) sponsored a workshop, The Intersection of Science and Security: a Case Study Approach, Continuing the global dialogue with the scientific and science policy community: focus on Asia and the Western Pacific. The purpose of this workshop was to give attendees a greater understanding of dual use research, including an awareness of strategies for managing dual use research of concern and an appreciation of how these issues are being addressed around the globe. The workshop utilized published articles as case studies, involving Mousepox and a SARS-like virus, as examples of dual use research of concern that highlight issues which investigators, institutions, journal editors, governments, and the scientific and security policy communities need to consider. In addition to presentations of the case studies, there were discussions among all panelists and attendees on global science and security issues as well as those of special interest within Asia and the Western Pacific, including information on training and education resources currently available.
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(Posted March 14, 2012)
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Summary of International Video Teleconference on Responsible Conduct of Research |
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On March 16, 2011 NIH, NSABB, the American Association for the Advancement of Sciences (AAAS) and the Kuwait Institute for Scientific Research conducted a bilateral video-teleconference (VTC) on the topic of Responsible Conduct of Research (RCR). This two-hour plenary RCR session was part of the AAAS International Engagement Meeting: Responsible Bioscience for a Safe and Secure Society. The purpose of the session was to engage life scientists and policy makers from the Broader Middle East and North Africa region (BMENA) on the issue of RCR. For this conference, RCR included three sub-topics: biosafety, bioethics, and biosecurity/DUR. Three panelists, including Dr. Michael Imperiale (NSABB), gave presentations on the sub-topics. The session continued with a general discussion on the three RCR sub-topics among participants in Kuwait and a Washington-based panel, which included Drs. Paul Keim (NSABB), Stuart Levy (NSABB), and Kavita Berger (AAAS). |
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(Posted November 29, 2011)
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Report from the National Science Advisory Board on Biosecurity (NSABB) on "Guidance for Enhancing Personnel Reliability and Strengthening the Culture of Responsibility" |
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This report, which is a follow-up to the Board's May 2009 report on personnel reliability, was undertaken in response to the U.S. government's request for specific strategies and guidance on practices that promote a culture of responsibility with respect to biosecurity. The Board's recommendations address good management practices, the role of strong institutional and laboratory leadership and oversight, responsible hiring and employee management practices, and the need to assess that the effectiveness, potential impact, and unintended consequences of any measures being implemented. The report also discusses two potentially useful practices for enhancing personnel reliability and a culture of responsibility at the local level-video monitoring and the "two person rule"-that, while not recommended for broad implementation, should be considered by local institutions only after conducting an assessment of these practices' risks and impacts. The report also notes practices that the NSABB does not recommend for widespread implementation by institutions, particularly academic institutions. This report is now available to the public on the "NSABB Documents" page of the OBA Web site.
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(Posted September 23, 2011)
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Report from the National Science Advisory Board on Biosecurity (NSABB)
on "Strategies To Educate Amateur Biologists and Scientists in Non-life Science Disciplines About Dual Use Research in the Life Sciences" |
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In addition to its standing charge to advise on strategies and tools to promote awareness of the dual use issue in the life sciences community generally, the U.S. government charged the Board with
developing recommendations for promoting awareness of the dual use issue among two non-traditional audiences for these efforts: (1) scientists trained in non-life science fields who collaborate in
the life sciences on such endeavors and synthetic biology, and (2) amateur biologists who pursue life science research as an avocation and whose activities are becoming increasingly sophisticated.
Toward that end, the NSABB has developed a report that presents a series of observations about the special characteristics of these communities and pairs them with recommendations for specially
tailored strategies for awareness building. This report is now available to the public on the "NSABB Documents" page of the OBA Web site.
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(Posted June 21, 2011)
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Strengthening the Culture of Responsibility with Respect to Dual Use Research and Biosecurity |
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On November 1, 2010 the National Institutes of Health (NIH) National Science Advisory Board for Biosecurity (NSABB) and the Chinese Academy
of Sciences organized a bilateral video-teleconference (VTC) as a satellite session of the international workshop
Trends in Science
and Technology Relevant to the Biological and Toxin Weapons Convention
in Beijing, China. The VTC was held in cooperation with the
InterAcademy Panel: The Global Network of Science Academies, the International Union of Microbiological Societies, the International Union of
Biochemistry and Molecular Biology, and the National Research Council of the U.S. National Academy of Sciences. The aim of the
VTC was to raise awareness of the dual use issue among workshop participants, to engage participants in a discussion on fostering a culture of responsibility,
and to inform the NSABB on the views of these international scientists and policy experts from over 30 countries.
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The one-hour VTC linked participants at the workshop site in Beijing with key experts in Bethesda, MD. Issues discussed included
the principal features or attributes of a culture of responsibility and strategies for promoting, creating, and sustaining a culture
of responsibility. The agenda and panelists/moderators biographies from the video-teleconference are available separately at this site.
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To go directly to the archived version of the video: Videocast
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(posted February 7, 2011)
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International Discussion of Dual Use Research Available on OBA Web Site |
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On September 22, 2010, the U.S. government hosted the second in a series of Internet-based meetings aimed at engaging the international
community by region. The focus of this event was Europe. It was hosted by the National Science Advisory Board for Biosecurity (NSABB) in
partnership with the European Molecular Biology Organization, the European Science Foundation, the European Society of Clinical Microbiology
and Infectious Diseases, and Institut Pasteur. This webcast, entitled "Does Your Research Raise Security Concerns: Strategies for Promoting
Responsible Research in the Life Sciences," included both presentations and discussions by European and U.S. scientists on dual use research
with a special focus on antimicrobial resistance and synthetic biology. Participants also examined various approaches to promoting the responsible
conduct of research with dual use potential. The event was interactive, with panelists responding to questions submitted by viewers. The
archived version of the webcast is available at:
International Webcast
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The agenda and slides from the webcast are available separately at this site. Additional information on dual use research, NSABB, and other
NIH DUR-related meetings and educational resources is available at:
Dual Use Research
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(posted January 11, 2011)
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NSABB Public Consultation on Guidance for Enhancing Personnel Reliability and Strengthening the Culture of Responsibility at the Local Level (January 5, 2011) |
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On January 5, 2011, The National Science Advisory Board for Biosecurity (NSABB) is hosting a public consultation to obtain input from the scientific community regarding strategies for enhancing personnel reliability and strengthening the culture of responsibility at research facilities that conduct research with dangerous pathogens. The discussion will inform NSABB deliberations and ultimately the development of an NSABB report on the topic.
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The meeting will be held on January 5, 2011 from 8:30 a.m. - 6:00 p.m. at the Bethesda Hyatt Regency, 7400 Wisconsin Avenue (One Bethesda Metro Center), Bethesda, MD.
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The meeting will focus on five topics: 1) Engaged institutional leadership for promoting biosecurity, personnel reliability, and a culture of responsibility; 2) Encouraging biosecurity awareness and promoting responsible conduct in the laboratory through communication, lab rapport, and a strong sense of team; 3) Peer reporting of concerning behaviors; 4) Addressing impediments to disclosure of negative information about job candidates; and 5) Assessment of effectiveness and impact of practices for strengthening personnel reliability and culture of responsibility. Each session will include remarks from panelists as well as ample time for input from meeting attendees. Specific discussion questions are noted on the meeting agenda.
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The meeting is open to the public and is free of charge. Please note that this meeting will not be webcast.
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(posted December 6, 2010)
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NIH offers DVD on dual use research free of charge |
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We are pleased to announce the availability on DVD of the educational video on the topic of "dual use research" in the life sciences (see June 30, 2010 item below). The DVD is playable on DVD readers and most computers with the commonly used video player software. The DVD may be more convenient for those who wish to view the video in settings without Internet access or where download speeds make viewing the video on line problematic.
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The video aims to promote awareness and understanding about the dual use research issue by offering a conceptual overview through interviews with nationally respected scientists, institutional leaders, journal editors, and a member of the public. Discussants describe the need to ensure scientific progress while attending to scientific responsibility and important oversight and security concerns. The video will be of interest to all segments of the life science research community, from trainees to principal investigators, as well as those responsible for the review and oversight of research. It can also serve as a useful adjunct to training materials and courses designed to educate staff about biosecurity and the responsible conduct of research.
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The video is also still available on the Dual Use Program page of the Web site of the NIH Office of Biotechnology Activities, as well as YouTube.
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Up to five copies of the DVD are available free-of-charge. You may request them by writing to OBA and providing your full mailing address.
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(posted November 18, 2010)
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Archived NSABB News |
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Clinical Research Policy News |
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