Resolving Ethical Issues in Clinical Research Book

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