Biotechnology Research in an Age of Terrorism: Confronting

1,49
MB the Dual Use Dilemma

122
stron

5726
ID National Research Council

2003
rok

Contents

Executive Summary 1

Chapter 1 Introduction 12

The Life Sciences Today. 13

The “Dual use” Dilemma . 14

A Brief History of Biological Warfare . 15

U.S. Policy and the Creation of the Biological and Toxin Weapons Convention 17

The New Threat 17

Recent Examples of “Contentious Research” in the Life Sciences. 19

The Response of the Life Sciences Community to Previous Challenges . 23

Committee Charge and Process. 24

Annex: Biological Warfare in History. 27

Chapter 2 The Evolving Regulatory Environment for Life Sciences Research in the 21st Century 32



Introduction . 32

The U.S. Regulatory Environment 35

Framework for Implementation of the NIH Guidelines for rDNA Research. 36

Types of Experiments That Require IBC, RAC and NIH Director Review 38

Physical and Biological Containment Strategies for NIH-funded rDNA Research Activities. 38

Compliance with and Enforcement of the NIH Guidelines 39

Regulation of Microbial Agents (Listed Agents and Toxins) 40

Possession of Select Agents. 41

Importation and Interstate Shipment of Etiologic Agents 42

Oversight of Foreign Nationals 42

Professional Education and Responsibilities of Life Scientists . 44

The International Situation 45

Conclusions 48

Annex. 59

Chapter 3 Information Restriction and Control Regimes 62

Introduction . 62

Past as Prologue?. 63

Secret and Sensitive Information 67

Publication of Sensitive Information in the Life Sciences 71

Conclusions 72

Chapter 4 Conclusions and Recommendations 84

Introduction . 84

Key Assumptions 85

Recommendations 86

Conclusion 99

Appendix A 102

Appendix B 107