It does so because wide dissemination may drive innovation, job creation, technology development, and the advance of science. They assert that broad dissemination of such research results increases the likelihood that a highly contagious form of the virus will be introduced, either accidently or deliberately, into the human population. Because of the complexity of these issues, analysis according to one set of policy priorities may adversely affect other policy priorities. In addition, the controversy surrounding the decision to publish these experiments has demonstrated flaws in the existing mechanisms to identify and balance the potential public benefits and security trade-offs. This report describes the underlying controversy, the potential benefits and harms of publishing these manuscripts, the actions taken by domestic and international stakeholders, and options to improve the way research is handled to minimize security concerns. Case Study: H5N1 Influenza Research

The ongoing controversy regarding the appropriateness of funding research on (and publishing the results of) H5N1 influenza transmissibility serves as a case study for the broader challenges of balancing the potential benefits and potential harms from such research. The two groups submitted manuscripts to different scholarly journals. Balancing Potential Benefits and Harms

Policymakers and stakeholders face difficult calculations when trying to balance the potential benefits of this research against potential harms. The U.K. magazine Nature agreed to consider other stakeholder recommendations prior to publication. Department of Health and Human Services

The HHS charters and oversees the NSABB and adopted both sets of NSABB recommendations. However, the current controversy highlights the flaws in the current processes to identify and mitigate potential security risks associated with performing some research. However, some of the risk mitigation steps in this policy, including the use of prepublication manuscript review and the possibility of limiting distribution of research results, raise additional issues, such as compliance with export control regulations, that likely complicate implementation of this policy. Publishing Dual-Use Research Results

The federal government generally supports the open publication of unclassified, federally funded research results. Limited Access to Research Results

In order to address the security challenges presented by the H5N1 influenza manuscripts, the NSABB recommended that the government develop a mechanism to provide controlled access to sensitive scientific information:
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. Once fully implemented, the new policies may not identify all government-sponsored life science research with potentially significant national security concerns. The "United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern" would establish institutional review and oversight requirements for certain categories of federally funded life sciences research. Congress could decide to wait to act until agencies complete implementation before determining whether the new policies adequately address the challenges highlighted by the recent H5N1 influenza manuscripts. Dual-use issues cut across traditional policy areas, involving simultaneous consideration of security, scientific, health, export, and international policy. For example, maximizing security may lead to detriments in public health and scientific advancement, while maximizing scientific advancement may lead to security risks. Accounting for such trade-offs may allow policymakers to establish regulatory frameworks that more effectively maximize the benefits from dual-use research while mitigating its potential risks.
The federal government generally supports the publication of federally funded research results because wide dissemination may drive innovation, job creation, technology development, and the advance of science. However, some research results could also be used for malicious purposes. Congress, the Administration, and other stakeholders are considering whether current policies concerning publishing such research results sufficiently balances the potential benefits with the potential harms. The current issues under debate cut across traditional policy areas, involving simultaneous consideration of security, science, health, export, and international policy. Because of the complexity of these issues, analysis according to one set of policy priorities may adversely affect other policy priorities. For example, maximizing security may lead to detriments in public health and scientific advancement, while maximizing scientific advancement may lead to security risks. Accounting for such trade-offs may allow policymakers to establish regulatory frameworks that more effectively maximize the benefits from such "dual-use," i.e., potentially beneficial and also potentially harmful, research while mitigating its potential risks.
The issue of balancing scientific publication with security concerns has a long historical context, but the current consideration began in late 2011, when two groups of U.S. government-funded scientists submitted papers to academic journals detailing genetic modifications that increase the transmissibility of a deadly influenza strain. Although these research results may improve pandemic influenza preparedness and response, they may also increase the probability that a highly contagious and deadly influenza strain will be introduced, either accidently or deliberately, into the human population. Stakeholders, including the Department of Health and Human Services, the World Health Organization, journal publishers, and scientists, debated whether the possible benefits of publication outweighed the potential harms. The editors of the scientific journals decided to publish modified versions of both papers.
The controversy surrounding the publication of these influenza experiments revealed weaknesses in the existing federal mechanisms to identify and balance potential benefits of life science research and security trade-offs. Responding to these cases, the Administration released new government-wide policies to address some of these flaws. These new policies establish roles for federal funding agencies, institutions, and scientists to regularly review life science research portfolios and develop methods to mitigate security risks.
It is not clear whether the 113th Congress will agree with the Administration that the new policies sufficiently address all of the dual-use issues brought to light by this recent controversy. Congress could decide to allow the new policies to be fully implemented before evaluating them. Alternatively, Congress could require agencies to implement new, different processes to identify potential research of concern prior to funding; require federal prepublication review of all potential research of concern to establish appropriate limits on the distribution of the research results; require federal licensing of researchers permitted to conduct such experiments and access results; and limit such research to the most safe and secure laboratories. All of these options might, however, reduce the number and quality of research studies undertaken.
This report describes the underlying controversy, the potential benefits and harms of publishing these manuscripts, the actions taken by domestic and international stakeholders, and options that may improve the way research is handled to minimize security concerns.