Contents
Preface
Figure and Tables
Summary
Acknowledgments
Glossary
Chapter One:Introduction
Purpose and Organization
Background
The Issues
The Text of the Interim Rule
Chapter Two: The History of the Interim Rule
The Memorandum of Understanding Between DoD and FDA
Careful Deliberations: 1990
Litigation: 1991
Actual Gulf War Experience with PB, BT and AX
The Presidential Advisory Committee
Chapter Three: What Uses of Drugs Are Investigational?
The Experiment-Therapy Continuum
The Belmont Report
Ethical Considerations
FDA's Approach to the Definitional Task
Chapter Four: The Interim Rule and Its Alternatives
Issues Associated with the Interim Rule
Alternatives to the Interim Rule
Revocation
Anticipatory Consent
Other Possible Arrangements
Chapter Five: Broader Issues
Internal DoD Issues
The Question of Authority
Interactions Between DoD and FDA
Chapter Six: Conclusions and Recommendations
Chapter Seven: Postscript
References