• Front Matter R1-R18

• Executive Summary 1-8

• 1 Introduction 9-22

• 2 Basic Concepts 23-58

• 3 Regulatory History 59-80

• 4 Enhancing Informed Consent 81-112

• 5 Enhancing Confidentiality Protection 113-142

• 6 Enhancing the Effectiveness of Review: Minimal-Risk Research 143-164

• 7 System Issues 165-182

• References 183-190

• Appendix A: Tracing Changes in Regulatory Language 191-216

• Appendix B: Organizations and Resources for Human Research Participant Protection 217-220

• Appendix C: Agenda for Panel's First Meeting 221-224

• Appendix D: Selected Studies of IRB Operations: Summary Descriptions 225-234

• Appendix E: Confidentiality and Data Access Issues for Institutional Review Boards 235-252

• Biographical Sketches of Panel Members and Staff 253-258

" Appendix B: Organizations and Resources for Human Research Participant Protection ." Protecting Participants and Facilitating Social and Behavioral Sciences Research . Washington, DC: The National Academies Press, 2003 .

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