Table of Contents
Preface ix
Section I Ethical and Regulatory Background
1 Historical Perspective 3
2 An Ethical Framework for Research 7
3 Federal Regulations on Human Participants Research 18
4 IRB Review of Human Participants Research 28
5 Assessment of Risks and Benefits 33
6 Informed Consent 46
7 Confidentiality 67
Section II The Researcher-Participant Relationship
8 Identification and Recruitment of Participants 81
9 Payment to Research Participants 86
10 Responsibility for Incidental Risks 93
11 Offering Results of Research Tests to Participants 97
Section III Responsible Conduct of Research
12 Research Misconduct 109
13 Authorship and Its Responsibilities 117
14 Patenting and Commercialization of Discoveries 125
15 Conflicts of Interest 132
Section IV Vulnerable Participants
16 Persons With Impaired Decision-Making Capacity 145
17 Research With Children 156
18 Research With Adolescents 168
19 Emergency and Intensive Care Research 172
20 Research With Ethnic and Minority Populations 178
21 Research With Prisoners 188
22 Clinical Research in Resource-Poor Countries 194
Section V Ethical Issues in Specific Types of Research
23 Research With Existing Data and Biological Materials 213
24 Observational Studies 225
25 Translational Research 232
26 Clinical Trials 241
27 Genetics, Genomics, and Gene Transfer Research 256
28 Stem Cell Research 270
Index 277