Perspectives on Research with H5N1 Avian Influenza Scientific Inquiry, Communication, Controversy: Summary of a Workshop (2013) / Chapter Skim
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Appendix B: Official Statements
Appendix B: Official Statements
Pages 55-80
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From page 55... ...
Reprinted with permis sion from AAAS. • February 2012, WHO "Report on Technical Consultation on H5N1 Research Issues." • March 29, 2012, NIH, "United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern." • March 30, 2012, NSABB, "Findings and Recommendations, March 29-30, 2012." • April 14, 2012, NIH, "Statement on NSABB's March 30, 2012 Recommendations to NIH on H5N1 Research." • April 20, 2012, NIH, "Statement by NIH Director Francis Collins, M.D., Ph.D.
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From page 60... ...
We continue to urge the international scientific community to work toward a consensus on the future directions of such research to improve public health in light of international security implications, while ensuring the global influenza surveillance and research communities can share through appropriate means critical information about the potential transmissibility of H5N1 influenza in humans. Understanding how influenza viruses become human pandemic threats is vitally important to global health preparedness.
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From page 61... ...
communication of experimental work on H5N1 influenza. Highly pathogenic avian influenza A/H5N1 infection of humans has been a serious public health concern since its We are in the midst of a revolutionary period in the life identification in 1997 in Asia.
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From page 62... ...
governments, allow construction of a genetically altered At the same time, we acknowledge that there are clear influenza virus capable of causing a pandemic with mortality benefits to be realized for the public good in alerting exceeding that of the "Spanish flu" epidemic of 1918? The humanity of this potential threat and in pursuing those aspects research teams that performed this work did so in a well- of this work that will allow greater preparedness and the intended effort to discover evolutionary routes by which potential development of novel strategies leading to future avian influenza A/H5N1 viruses might adapt to humans.
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From page 63... ...
In that case, the research community voluntarily imposed a temporary moratorium on the conduct of recombinant DNA research until they could develop guidance for the safe and responsible Downloaded from www.sciencemag.org on January 31, 2012 conduct of such research. We believe that this is another Asilomar-type moment for public health and infectiousdisease research that urgently needs our attention.
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From page 64... ...
Participants reviewed the chronology of the transfer of the H5N1 viruses used in the research studies, from country of origin to the research laboratories; the associated agreements regarding use of the samples; how the research proposals were reviewed; and the oversight of the work. Under conditions of stringent security, they read the full and redacted versions of both unpublished research reports, and also heard brief presentations by the researchers, summarizing their work.
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From page 65... ...
It was noted that the research methods used in these studies are not novel and are widely used in biomedical research. Participants agreed on the public health value of the data on genetic modifications for improving the existing surveillance performed by both the human public health and animal health sectors, so as to monitor for variants that may be indicative of important changes among circulating H5N1 viruses.
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From page 66... ...
to hold a further discussion on the scientific and societal issues raised by this kind of research. Specific topics to be addressed include how to strengthen public safety and security while ensuring that critical scientific research continues, as well as mechanisms to assess and manage sensitive research.
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From page 67... ...
Future research projects should involve countries from which source material were obtained. • The two studies that were conducted to better understand the transmissibility of H5N1 influenza viruses have shown that these viruses have the potential to become more transmissible among mammals.
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From page 68... ...
68 PERSPECTIVES ON RESEARCH WITH H5N1 AVIAN INFLUENZA • Apart from consideration of these two manuscripts, participants acknowledged the existence of broader issues requiring more detailed exploration and advised that these be considered in subsequent consultations involving other stakeholders.
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From page 69... ...
have helped inform United States Government policies for identifying and managing DURC. This Policy will be updated, as needed, following domestic dialogue, engagement with our international partners, and input from interested communities including scientists, national security officials, and global health specialists.
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From page 70... ...
Avian influenza virus (highly pathogenic)
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From page 71... ...
d) Based on the risk assessment, in collaboration with the institution or researcher, develop a risk mitigation plan to apply any necessary and appropriate risk mitigation measures.
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From page 72... ...
1.c) , departments and agencies may refer to the "Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information," which identifies useful assessment tools and is available at: http://oba.od.nih.gov/biosecurity/biosecurity_documents.html .
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From page 73... ...
In light of this, the United States Department of Health and Human Services convened the NSABB in a closed session March 29‐30, 2012, to review the newly revised manuscripts and to recommend whether and/or how the information 1 In the Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research information, the NSABB defined "dual use research" as "[r] esearch yielding new technologies or information with the potential for both benevolent and malevolent applications." 2 WHO Report on Technical Consultation on H5N1 Research Issues http://www.who.int/influenza/human_animal_interface/mtg_report_h5n1.pdf 1
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From page 74... ...
4 In the Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information, the NSABB defined "dual use research of concern" as "research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or materiel." 2
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From page 75... ...
. The revised manuscripts provided a greater appreciation of the direct applicability of the information to ongoing and future influenza surveillance efforts.
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From page 76... ...
There is a critical need for a mechanism for disseminating sensitive scientific information. There remains a pressing need for an effective and feasible mechanism to provide controlled access to scientific information that has potential public health benefits but poses a significant risk for misuse if broadly disseminated.
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From page 77... ...
The newly released United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern is an important first step in ensuring that dual use concerns associated with federally funded life sciences research will be addressed and managed early in and continuously during the research process. This policy will apply to H5N1 research as well as other agents and toxins that pose the greatest risk of misuse.
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From page 78... ...
The majority of the NSABB recommends that the information contained in these revised H5N1 manuscripts should be communicated in full, but the Board also recognizes that research findings will likely emerge in the very near future that should not be widely disseminated because of a high risk of misuse but that nevertheless should be made available to certain researchers and public health officials around the world who have a legitimate need to know. The need for an effective, practical, and feasible mechanism for selectively sharing sensitive scientific information has never been more apparent.
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From page 79... ...
Ron Fouchier be communicated after appropriate further scientific review and revision. A final recommendation of these two revised manuscripts regarding the transmissibility of the H5N1 avian flu virus in ferrets will be made by the HHS Secretary and brought to the broader U.S.
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From page 80... ...
and other Federal departments and agencies on matters of biosecurity, convened to review unpublished revised manuscripts describing NIH-funded research on the transmissibility of H5N1 influenza virus -- the strain Press Statement: Mee commonly referred to as "bird flu." One manuscript, "Aerosol transmission of avian influenza A/H5N1 virus," to Review Manuscript Transmissibility Rese contained research findings by Dr. Ron Fouchier.
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