The March 2012 DURC Policy sets forth a process of regular Federal review of USG-funded or USG-conducted research and requires Federal agencies that fund or sponsor life sciences research to identify DURC and evaluate this research for possible risks, as well as benefits, and to ensure that risks are appropriately managed and benefits realized. The Policy for Institutional DURC Oversight complements the March 2012 DURC Policy by establishing review procedures and oversight requirements for the same scope of research at the institutions that receive Federal funds for life sciences research. Together, these two policies work to engage the life sciences research community and the Federal departments and agencies that fund such research in a shared commitment to address the risk that knowledge, information, products, or technologies generated from life sciences research could be used for harm. In addition, the Policy for Institutional DURC Oversight and the March 2012 DURC Policy emphasize a culture of responsibility by reminding all involved parties of the shared duty to uphold the integrity of science and prevent its misuse. This Companion Guide comprises a set of tools designed for institutions, principal investigators (PIs), and institutional review entities (IREs) implementing the Policy for Institutional DURC Oversight. However, it is anticipated that much of the guidance embedded in these tools, such as the identification of DURC, risk-benefit assessments, and developing risk mitigation strategies, may also be helpful for Federal agencies in the implementation of the March 2012 DURC Policy. Such guidance may also be applied more broadly to research that is not within the scope of these policies but that may warrant review for dual use potential and special oversight, and it may be used by others within the scientific community (e.g., journal editors) that are not subject to these policies.

The potential misuse of advances in life sciences research is raising concerns about national security threats. Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies examines the U.S. strategy for reducing biosecurity risks in life sciences research and considers mechanisms that would allow researchers to manage the dissemination of the results of research while mitigating the potential for harm to national security.

The potential misuse of advances in life sciences research is raising concerns about national security threats. Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies examines the U.S. strategy for reducing biosecurity risks in life sciences research and considers mechanisms that would allow researchers to manage the dissemination of the results of research while mitigating the potential for harm to national security.

The framework aims to provide global perspectives on principles, tools and mechanisms to support Member States and relevant stakeholders to mitigate and prevent biorisks and govern dual-use research. The framework adopts the One health approach and focuses on the role that responsible life sciences research can play in preventing and mitigating risks caused by accidents, inadvertent or deliberate misuse with the intention to cause harm to humans, nonhuman animals, plants and agriculture, and the environment. The framework is primarily intended for those who have responsibilities in the governance of biorisks, such as policy makers and regulators in charge of developing national policies to harness the potential benefits of the life sciences while constraining their risks. The framework is also directed towards scientists and research institutions, educators, trainers, project management staff, funding bodies, publishers, editors, the private sector and all relevant stakeholders that are part of the research life cycle. The governance of biorisks is an issue that should engage all countries, although countries will have different contexts, needs and starting points. Mitigating these risks will require individual and collective actions among different stakeholders and disciplines. Mitigating biorisks and governing dual-use research is a shared responsibility.

Continuing advances in science and technology offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances have the potential to challenge the oversight systems for responsible conduct of life sciences research with dual use potential â€" research that may have beneficial applications but that also could be misused to cause harm. Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, to promote global dialogue and increased common understandings of the essential elements of governance for such research. Hosted by the Croatian Academy of Sciences and Arts in Zagreb, Croatia, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop.

Ensuring National Biosecurity: Institutional Biosafety Committees reviews the various responsibilities and associated challenges Institutional Biosafety Committees (IBCs) face and proposes changes that may help improve this system and increase national biosecurity and worker safety. In recent years IBCs in academic and other institutions have been tasked with increasing levels of responsibility, overseeing work with recombinant genetic material and hazardous agents. IBC members often lack the training to effectively ensure that the work performed is truly safe for scientists and the general community, and so increasingly rely upon the expertise of the researchers themselves. With the proposed US dual-use research policies soon to be implemented, this strain may increase. This book provides readers with the necessary information to be able to enhance national biosecurity within the US, EU, Australia, New Zealand, Japan and more. Ensuring National Biosecurity is as an invaluable reference for biosafety professionals or for researchers who need to understand the regulatory landscape that impacts their research. - Examines and assesses the current state of Institutional Biosafety Committees (IBCs) - Collates contributions from world-renowned experts in fields as diverse as research compliance, law and astrobiology - Reflects an international perspective on regulatory biosecurity and biosafety

This electronic version has been made available under a Creative Commons (BY-NC-ND) open access license. Never before have the scope and limits of scientific freedom been more important or more under attack. New science, from artificial intelligence to gene editing, creates unique opportunities for making the world a better place. It also presents unprecedented dangers. This book is about the opportunities and challenges – moral, regulatory and existential – that face both science and society. How are scientific developments impacting on human life and on the structure of societies? How is science regulated and how should it be regulated? Are there ethical boundaries to scientific developments in sensitive areas? Such are the questions that the book seeks to answer. Both the survival of humankind and the continued existence of our planet are at stake.

Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

Based on a series of regional meetings on university campuses with officials from the national security community and academic research institutions, this report identifies specific actions that should be taken to maintain a thriving scientific research environment in an era of heightened security concerns. Actions include maintaining the open exchange of scientific information, fostering a productive environment for international scholars in the U.S., reexamining federal definitions of sensitive but unclassified research, and reviewing policies on deemed export controls. The federal government should establish a standing entity, preferably a Science and Security Commission, that would review policies regarding the exchange of information and the participation of foreign-born scientists and students in research.

In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.