Ethical Issues in Clinical Research A

This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major NIH grants in academic health centers.

Preface	p. ix
Ethical and Regulatory Background
Historical Perspective	p. 3
An Ethical Framework for Research	p. 7
Federal Regulations on Human Participants Research	p. 18
IRB Review of Human Participants Research	p. 28
Assessment of Risks and Benefits	p. 33
Informed Consent	p. 46
Confidentiality	p. 67
The Researcher-Participant Relationship
Identification and Recruitment of Participants	p. 81
Payment to Research Participants	p. 86
Responsibility for Incidental Risks	p. 93
Offering Results of Research Tests to Participants	p. 97
Responsible Conduct of Research
Research Misconduct	p. 109
Authorship and Its Responsibilities	p. 117
Patenting and Commercialization of Discoveries	p. 125
Conflicts of Interest	p. 132
Vulnerable Participants
Persons With Impaired Decision-Making Capacity	p. 145
Research With Children	p. 156
Research With Adolescents	p. 168
Emergency and Intensive Care Research	p. 172
Research With Ethnic and Minority Populations	p. 178
Research With Prisoners	p. 188
Clinical Research in Resource-Poor Countries	p. 194
Ethical Issues in Specific Types of Research
Research With Existing Data and Biological Materials	p. 213
Observational Studies	p. 225
Translational Research	p. 232
Clinical Trials	p. 241
Genetics, Genomics, and Gene Transfer Research	p. 256
Stem Cell Research	p. 270
Index	p. 277
Table of Contents provided by Ingram. All Rights Reserved.

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Ethical Issues in Clinical Research A Practical Guide

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