Institutional review boards (IRBs) are the linchpins of the protection systems that govern human participation in research. In recent years, high-profile cases have focused attention on the weaknesses of the procedures for protecting participants in medical research. The issues surrounding participants protection in the social, behavioral, and economic sciences may be less visible to the public eye, but they are no less important in ensuring ethical and responsible research.
This report examines three key issues related to human participation in social, behavioral, and economic sciences research: (1) obtaining informed, voluntary consent from prospective participants: (2) guaranteeing the confidentiality of information collected from participants, which is a particularly challenging problem in social sciences research; and (3) using appropriate review procedures for “minimal-risk” research.
Protecting Participants and Facilitating Social and Behavioral Sciences Research will be important to policy makers, research administrators, research sponsors, IRB members, and investigators. More generally, it contains important information for all who want to ensure the best protection—for participants and researchers alike—in the social, behavioral, and economic sciences.
Table of Contents |
skim chapter | |
|---|---|---|
| Front Matter | i-xviii | |
| 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 | |
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