Information about most of the activities carried out at The National Academies can be found on the Current Projects System (CPS; http://www8.nationalacademies.org/cp/). The CPS provides information about our current committee activities that are subject to the requirements of Section 15 of the Federal Advisory Committee Act Amendments of 1997 (FACA). Information in CPS includes descriptions of project scope, names and affiliations of committee members and statements of their qualifications, notice of data-gathering meetings of committees, summaries of closed committee meetings or sessions, and titles of committee reports at the time that they are publicly released. A Public Access Records Office to provide access to project materials is available to the public.
Not all activities of the National Academies are listed in CPS. Information on these other activities may be found by using the Search feature on the homepage of the National Academies (http://nationalacademies.org/) or at the web sites of our major units such as the Transportation Research Board, which administers major research support programs, or the Institute of Medicine, which carries out a number of Forums on particular topics and issues.
This part of the Biosecurity website provides examples of current projects. It is not intended to be an exhaustive list, but we hope that you will find it a useful way to discover some of the many current activities relevant to biosecurity going on at the Academies.
Biodefense, Bioterrorism, and Bioweapons
Continuing Assistance to the National Institutes of Health on Preparation of Additional Risk Assessments for the Boston University NEIDL
The National Academies will once again reconvene the Committee on Technical Input on the NIH’s Draft Supplementary Risk Assessments and Site Suitability Analyses (DSRASSA) for the Boston University (BU) National Emerging Infectious Diseases Laboratories (NEIDL), a group of 11 experts on risk modeling, pathogen-related research, and operation of high containment biological laboratories. The Committee will (1) Meet with the National Institutes of Health in late Feb or early March to discuss the data on agents, models, scenarios, etc. that NIH has gathered for its revised risk assessment for the NEIDL. Following the meeting, the Committee will prepare a brief letter report giving the highlights of its consensus findings on the adequacy of these data to support a sound risk assessment. (2) Meet with the NIH in July or August to discuss the preliminary results of running the risk assessment models, preparing qualitative assessments where data are insufficient for quantitative models, etc. Following the meeting, the Committee will prepare a brief letter report giving the highlights of its consensus findings on the preliminary results of the risk analyses. (3) Meet with the NIH to discuss the draft Supplementary Risk Assessment Report before it is released to the public for comment. Following the meeting, the Committee will prepare a somewhat longer letter report containing consensus comments on the draft document. (4) Provide comments to the NIH on the draft risk assessment document that is made available for public comment as an element of collecting public comment. For this final task, the Committee will need to prepare a letter report of whatever length is appropriate to provide any further consensus comments on the draft document, assuming that NIH addressed its earlier comments before the public release.
Evaluation of the Updated Site-Specific Risk Assessment for the National Bio and Agro-Defense Facility in Manhattan, Kansas
The National Research Council will convene a committee of experts to review a congressionally-mandated updated site-specific risk assessment (SSRA) conducted by the Department of Homeland Security for the planned National Bio and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The Updated SSRA will be prepared in response to the Department of Defense and Full-Year Continuing Appropriations Act of 2011 (P.L. 112-110, Sec. 1647), which requires that it address concerns previously raised in an NRC review of the initial site-specific risk assessment for the NBAF, and requires that it describe risk reduction and mitigation strategies related to conducting essential research and diagnostic testing at the NBAF. DHS will present the committee with a draft work plan approach for carrying out the Updated SSRA. The committee and other meeting participants will discuss gaps in the draft work plan approach, credible approaches and options to consider for the risk assessment, and areas where further technical input or improvements are needed. Based on those discussions, the committee will organize a workshop to include presentations with invited technical experts, and the workshop will serve as an information-exchange forum to address various issues raised by the draft work plan approach. At a subsequent meeting, DHS will provide draft sections of the Updated SSRA for the committee and other participants to discuss any remaining gaps or additional approaches to consider for the final Updated SSRA. There will be discussion of issues from individual committee members and other participants, but no consensus advice will be provided from these open-session meetings. Following the completion of the final Updated SSRA, the committee will review the document and prepare a report to DHS and Congress containing its findings on the adequacy and validity of the final Updated SSRA. The report will be provided to the sponsor within four months of receiving the final Updated SSRA from DHS. The committee will not perform an independent evaluation of the safety of the NBAF, but will restrict its findings to assessing the adequacy and validity of the final Updated SSRA.
Education and Workforce
Developing a Framework for International Faculty Development Institutes on Dual Use Education
An ad hoc committee appointed by the National Research Council will develop a framework for an international series of faculty development workshops with the goal of promoting and enhancing education about issues related to research in the life sciences with dual use potential in key regions around the world.
The workshops will bring together higher education faculty in the life sciences as well as experts in related areas to teach and learn about methods for effective teaching and learning, develop curricular materials to facilitate education about dual use issues that they will use in their classes, and become prepared to be leaders in their communities on these topics.
Synthetic Biology for the Next Generation
Under the auspices of the National Academy of Sciences (NAS), CSTL and the Board on Life Sciences (BLS) are organizing, in conjunction with the National Academy of Engineering (NAE), Royal Society (RS), Royal Academy of Engineering (RAE), Chinese Academy of Sciences (CAS) and Chinese Academy of Engineering (CAE), three symposia on synthetic biology in 2011-2012. The symposia build on a successful 2009 collaboration between the Royal Society, NAS/NAE, and the Organization for Economic Cooperation and Development (OECD) when these organizations partnered to sponsor an international symposium in Washington, D.C. entitled, Opportunities and Challenges in the Emerging Field of Synthetic Biology (http://sites.nationalacademies.org/PGA/stl/PGA_050738). Following from that meeting, the NAS/NAE and the RS reached an agreement with the RAE and the CAS and CAE to hold three symposia – one in the U.K., one in China, and one in the U.S. – during 2011-2012.
The Science of Science Communication
This colloquium was held in Washington, D.C. May 21-22, 2012. The meeting surveyed the state of the art of empirical social science research in science communication and focused on research in psychology, decision science, mass communication, risk communication, health communication, political science, sociology, and related fields on the communication dynamics surrounding issues in science, engineering, technology, and medicine with five distinct goals:
- To improve understanding of relations between the scientific community and the public
- To assess the scientific basis for effective communication about science
- To strengthen ties among and between communication scientists
- To promote greater integration of the disciplines and approaches pertaining to effective communication
- To foster an institutional commitment to evidence-based communication science
Recording and Publication: The talks were recorded and archives are available online. Click to view archive webcast.
Joint U.S.-Russian Assessment of Bioengagement: Impacts, Lessons Learned, and a Path Toward Future Collaboration
An ad hoc committee will carry out an assessment of U.S.-Russian bio-engagement activities during the past 15 years, with particular attention to the impacts of various types of bio-engagement activities, lessons learned from engagement activities that are relevant for future U.S.-Russian bio-engagement programs, and future approaches to U.S.-Russian bio-engagement, particularly approaches that build on the foundations for cooperation that have been established during recent years.
Under the auspices of the National Academy of Sciences (NAS), CSTL and the Board on Life Sciences (BLS) are organizing, in conjunction with the National Academy of Engineering (NAE), Royal Society (RS), Royal Academy of Engineering (RAE), Chinese Academy of Sciences (CAS) and Chinese Academy of Engineering (CAE), three symposia on synthetic biology in 2011-2012. The symposia build on a successful 2009 collaboration between the Royal Society, NAS/NAE, and the Organization for Economic Cooperation and Development (OECD) when these organizations partnered to sponsor an international symposium in Washington, D.C. entitled, Opportunities and Challenges in the Emerging Field of Synthetic Biology. Following from that meeting, the NAS/NAE and the RS reached an agreement with the RAE and the CAS and CAE to hold three symposia – one in the U.K. in April 2011, one in China in October 2011, and one in the U.S. in June 2012. An individually-authored summary of the three symposia will be published as an NRC report.
Antiviral Distribution During a Pandemic
Currently, state and local public health authorities are responsible for the majority of antiviral distribution and dispensing activities within their jurisdiction during a disease pandemic. However, several related challenges arose during the recent 2009 H1N1 pandemic, which should be considered in future planning. Moreover, the current economic climate and substantial funding cuts mean public health departments are losing staff, and with them, the preparedness and response planning activities required to ensure effective distribution and dispensing mechanisms. The CDC is exploring alternative delivery systems that partner with the private sector to leverage the latter’s expertise in pharmaceutical distribution and dispensing. The prospective public-private dispensing mechanisms would specifically consider the requirements for dispending antiviral medications during a severe pandemic influenza. At the request from the Centers for Disease Control and Prevention, the Preparedness Forum will convene a series of public engagement workshops to gauge the public’s perception of the safety, feasibility, acceptability of alternative strategies for distribution and dispensing of medications to the public during a pandemic. These workshops will take place in Fort Benton, MT, Chattanooga, TN, and Los Angeles, CA.
Forum on Medical and Public Health Preparedness for Catastrophic Events
The Forum serves to foster dialogue among stakeholders and provide ongoing opportunities to discuss and confront issues of mutual interest and concern. The Forum provides a neutral venue for broad ranging policy discussions that serve to facilitate coordination and cooperation among the public and private stakeholders in developing and enhancing the nation’s medical and public health preparedness. More specifically, the Forum: provides a catalyst for voluntary public/private collaboration on topics where there is synergy among potential partners; helps define the scope of the field and thus sets the stage for future policy action; brings ongoing attention and visibility to important preparedness issues; explores new approaches for resolving problem areas; and elevates the general understanding and visibility of medical and public health preparedness in the broader research, public policy, and other appropriate communities.
Forum on Microbial Threats
In its 1992 report, Emerging Infections: Microbial Threats to Health in the United States, the IOM pointed to some major challenges for the public health and medical care communities in detecting and managing infectious disease outbreaks and monitoring the prevalence of endemic diseases. In response, the Centers for Disease Control and Prevention’s National Center for Infectious Diseases developed a national strategy for doing so and, with the National Institutes of Health’s National Institute for Allergy and Infectious Diseases, asked the IOM to convene a Forum on Emerging Infections that would serve as a follow-on activity for these initiatives. In 2003, the Forum changed its name to the Forum on Microbial Threats.
Maximizing the Goals of the Cures Acceleration Network to Accelerate the Development of New Drugs and Diagnostics
Recent years have seen both extraordinary opportunity and complex challenges in pharmaceutical innovation. New biomedical technology platforms are creating novel avenues for research and new opportunities for the discovery and clinical development of innovative diagnostics and therapies. Yet despite these advances, the pathway from basic science to new therapeutics faces challenges on many fronts. The translational divide results in only a small fraction of investigational new drugs reaching FDA approval and the patients who need them. New paradigms for discovering and developing drugs are being sought to bridge the ever-widening gap between scientific discoveries and translation of those discoveries into life-changing medications. New collaborative approaches within the federal agencies, academia, and industry are directing focused attention on the advancement of the drug development enterprise. Among these initiatives is the Cures Acceleration Network (CAN), which was originally authorized in the Patient Protection and Affordable Care Act (P.L. 111-148) and was subsequently amended by the Consolidated Appropriations Act, FY 2012 (P.L. 112-74), which moved CAN to the newly authorized National Center for Advancing Translational Sciences (NCATS).
This 1.5 day public workshop will consider options and opportunities to maximize the usefulness and impact of the CAN program in order to advance translational sciences. In addition to providing suggestions to NCATS, the workshop is, in part, in response to Congressional interest in CAN expressed in the FY 2012 appropriations act conference report. The workshop will inform NIH/NCATS in its efforts to implement CAN and advance translational sciences, and will also inform the public, policy community, and other stakeholders as all of these parties continue to work to enhance the development and testing of therapies and diagnostics to patients. The summary will be provided to NCATS and the newly established CAN Board to help it identify ways to accelerate and expand the number of cures.
Science, Security, and Society
Ethical and Societal Implications of Advances in Militarily Significant Technologies that are Rapidly Changing and Increasingly Globally Accessible
The National Academies will develop a consensus report on the topic of ethical, legal, and societal issues relating to research on, development, and use of increasingly globally accessible and rapidly-changing technologies with potential military application, such as information technologies, synthetic biology, and nanotechnology. This report will articulate a framework for policy makers, institutions, and individual researchers to think about such issues as they relate to these technologies of military relevance and to the extent feasible make recommendations for how each of these groups should approach these considerations in their research activities. A workshop to be held as early as practical in the study would be convened to obtain perspectives and foster discussion on these matters. A final report would be issued within 21 months of the project start providing the National Research Council’s findings and recommendations.
Learning from the H5N1 research controversy
In December 2011 it was announced that two research groups, one in the US and the other in the Netherlands, both supported by NIH funding, had submitted for publication papers describing research whereby variants of H5N1 influenza viruses produced in the laboratory by well-established techniques had become readily transmitted among ferrets. It also was announced that the U.S. National Science Advisory Board for Biosecurity (NSABB), after consideration of the benefits and risks of publishing these papers, had recommended that details of these studies be redacted from the manuscripts prior to publication, and that the U.S. Government had endorsed this recommendation. These announcements precipitated a vigorous and far-reaching international discussion about the appropriateness and the risk assessment of this work and of dual use research, in general. As a result, the two research groups and other influenza researchers called for a temporary moratorium on research involving H5N1 influenza viruses that might lead to the creation of highly pathogenic, highly transmissible strains.
An ad hoc committee will organize a one-day public workshop for the purposes of 1) discussing the H5N1 controversy; 2) considering responses by the NIAID, which had funded this research, the WHO, the U.S. National Science Advisory Board for Biosecurity (NSABB), scientific publishers, and members of the international research community; and 3) providing a forum wherein the concerns and interests of the broader community of stakeholders, including policy makers, biosafety and biosecurity experts, non-governmental organizations, international organizations, and the general public may be articulated.
Ranking Vaccines: A Prioritization Framework – Phase I: Demonstration of Concept and a Software Blueprint
As a number of diseases emerge or reemerge, thus stimulating new vaccine development opportunities to help prevent those diseases, it can be especially difficult for decision makers to know where to invest their limited resources. Therefore, it is increasingly important for decision makers to have the tools that can assist and inform their vaccine prioritization efforts.
In this first phase report, the IOM offers a framework and proof of concept to account for various factors influencing vaccine prioritization—demographic, economic, health, scientific, business, programmatic, social, policy factors and public concerns. Ranking Vaccines: A Prioritization Framework describes a decision-support model and the blueprint of software—called Strategic Multi-Attribute Ranking Tool for Vaccines or SMART Vaccines. SMART Vaccines should be of help to decision makers. SMART Vaccines Beta is not available for public use, but SMART Vaccines 1.0 is expected to be released at the end of the second phase of this study, when it will be fully operational and capable of guiding discussions about prioritizing the development and introduction of new vaccines.