Contents
Title Page and Notice
i
National Academies Statement
iv
Committee
v
Preface
vii
Acknowledgments
xi
EXECUTIVE SUMMARY
1
1
INTRODUCTION
20
Privacy and Research
21
Health Services Research
25
Benefits of HSR
27
Risks of Harm from HSR
29
Background and Policy Context
34
Project and Scope
37
Outline of Report
39
2
HUMAN SUBJECTS PROTECTION AND HEALTH SERVICES RESEARCH IN FEDERAL REGULATIONS
40
IRBs and Human Subjects Protection
40
Previous Studies of IRBs
47
Human Subjects Protection in HSR
48
Principles and Practices
49
3
BEST PRACTICES FOR IRB REVIEW OF HEALTH SERVICES RESEARCH SUBJECT TO FEDERAL REGULATIONS
51
4
BEST PRACTICES FOR IRB OR OTHER REVIEW BOARD OVERSIGHT OF HEALTH SERVICES RESEARCH NOT NECESSARILY SUBJECT TO FEDERAL REGULATIONS
71
5
RECOMMENDATIONS FOR NEXT STEPS
78
REFERENCES
93
ACRONYMS AND ABBREVIATIONS
99
APPENDIXES
A
Study Activities
101
B
Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary
106
Executive Summary
106
Introduction
111
Workshop Summary
119
References
151
Addendum A--Workshop Speakers
155
Addendum B--Workshop Participants
157
C
Protecting the Health Services Research Data of Minors
159
Ross A. Thompson
D
Confidentiality of Health Information: International Comparative Approaches
173
Bartha Maria Knoppers
E
Biographical Sketches
187
