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Recombinant DNA News |
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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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International Workshop on the Intersection of Science and Security December 9, 2011 |
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The United States Government and the NSABB are hosting a workshop entitled
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,
on December 9, 2011, 1-4:30 pm in Masur Auditorium on the NIH Campus.
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What is the purpose? 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. |
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What is the scope? The case studies, involving Mousepox and a SARS-like virus, are examples of dual use research of concern that highlight issues needing to be considered by investigators, institutions, journal editors, governments, and the scientific and security policy communities. |
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What will be covered? In addition to presentations of two case studies, there will be discussions among all panelists on global science and security issues as well as those of special interest to those in Asia and the Western Pacific. These discussions will include information on training and education resources currently available and any gaps. |
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What is the format? A workshop with brief presentations and guided discussions using case studies of published scientific research that raise security concerns relevant to Asia and the Western Pacific region and globally. |
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Who is speaking? The presenters and panelists are from Asia, the Western Pacific, and the United States. They represent the perspectives of academia, government, non-governmental organizations, and the National Science Advisory Board for Biosecurity and have expertise in biosafety, biosecurity, bioethics, biodefense, the responsible conduct of research, and scientific publishing. |
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Who should attend? Scientists and others with an interest in science policy, scientific publishing, dual use research, biosafety, biosecurity, bioethics, biodefense, and responsible conduct of research. Those with an interest in how these issues are viewed and affect Asia and the Western Pacific will find this event of particular value. |
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Will this be an interactive event? Attendees will have the opportunity to ask questions of the presenters and panel members. |
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Where can more information about the workshop be found? Information |
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(Posted October 21, 2011)
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Now Available: Archived 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 and included brief presentations by three panelists; each addressing one of the three RCR 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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Now Available: 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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Now Available: 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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HHS Seeking Comment on Possible Changes to the Human Subjects Regulations |
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The U.S. Department of Health and Human Services has announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects.
Before making changes to the regulations - which have been in place since 1991 and are often referred to as the Common Rule - the government is seeking the public's input on an array of
issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM),
Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,
published in the July 25 Federal Register.
The proposed changes are designed to strengthen protections for human research subjects. For more information, go to: ANPRM for Revision to Common Rule.
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(July 26, 2011)
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On April 7, 2009, HHS released OHRP Guidance on GINA: Implications for Investigators and IRBs and a fact sheet for researchers and health care professionals.
(published April 7, 2009)
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Archived CRpac News
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