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.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE ON RESEARCH STANDARDS AND PRACTICES TO PREVENT THE DESTRUCTIVE APPLICATION OF BIOTECHNOLOGY
• Preface
• Acknowledgments
• Executive Summary
• 1. Introduction
  • THE LIFE SCIENCES TODAY
  • THE DUAL USE DILEMMA
  • A BRIEF HISTORY OF MODERN BIOLOGICAL WARFARE
  • U.S. POLICY AND THE CREATION OF THE BIOLOGICAL AND TOXIN WEAPONS CONVENTION
  • THE NEW THREAT
  • RECENT EXAMPLES OF “CONTENTIOUS RESEARCH” IN THE LIFE SCIENCES
  • THE RESPONSE OF THE LIFE SCIENCES COMMUNITY TO PREVIOUS CHALLENGES
  • COMMITTEE CHARGE AND PROCESS
  • ANNEX: BIOLOGICAL WARFARE IN HISTORY
• 2. The Evolving Regulatory Environment for Life Sciences Research in the 21st Century
  • INTRODUCTION
  • THE U.S. REGULATORY ENVIRONMENT
  • FRAMEWORK FOR IMPLEMENTATION OF THE NIH GUIDELINES FOR RDNA RESEARCH
  • TYPES OF EXPERIMENTS THAT REQUIRE IBC, RAC, AND NIH DIRECTOR REVIEW
  • PHYSICAL AND BIOLOGICAL CONTAINMENT STRATEGIES FOR NIH-FUNDED rDNA RESEARCH ACTIVITIES
  • COMPLIANCE WITH AND ENFORCEMENT OF THE NIH GUIDELINES
  • REGULATION OF MICROBIAL AGENTS (LISTED AGENTS AND TOXINS)
  • POSSESSION OF SELECT AGENTS
  • IMPORTATION AND INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS
  • OVERSIGHT OF FOREIGN NATIONALS
  • PROFESSIONAL EDUCATION AND RESPONSIBILITIES OF LIFE SCIENTISTS
  • THE INTERNATIONAL SITUATION
  • CONCLUSIONS
  • ANNEX
• 3. Information Restriction and Control Regimes
  • INTRODUCTION
  • PAST AS PROLOGUE?
  • SECRET AND SENSITIVE INFORMATION
  • PUBLICATION OF SENSITIVE INFORMATION IN THE LIFE SCIENCES
  • CONCLUSIONS
• 4. Conclusions and Recommendations
  • INTRODUCTION
  • KEY ASSUMPTIONS
  • RECOMMENDATIONS
  • CONCLUSION
• Appendix A ACRONYMS
• Appendix B Biographical Sketches of Committee Members
• Appendix C Committee Meetings

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the Committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

The development of this report was supported by the Alfred P. Sloan Foundation and the Nuclear Threat Initiative. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.