The Ethics and Regulation of Research with Human Subjects

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ISBN: 9780327176930
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This book provides a set of teaching materials that could be used in an academic course on human subject research in a broad range of professional school settings. In developing these materials, the authors were mindful that their readers would include tomorrow's advisers, managers, and regulators of researchers and research institutions. If students are to be effective in these roles, they must not only understand the history of human subject protection and the relevant ethical and regulatory issues; they must begin to think critically about the existing regulatory system and to consider the desirability of policy reform.

The Ethics and Regulation of Research with Human Subjects is largely comprised of primary source documents, including governmental regulations, guidance statements, and court decisions, and excerpts from the voluminous commentary produced by scholars, advisory commissions, and others. These materials are accompanied by extensive notes and questions, which expand on some of the issues raised in the primary readings and ask the reader to think about the gaps, ambiguities, and conflicts those materials raise. The book is divided into three parts: Part I provides a general overview of the history of research with human subjects, the existing regulatory framework, and the major entities involved in overseeing research. Part II examines the key ethical and regulatory issues that arise in every research protocol, including risk-benefit assessment, informed consent, recruiting and paying subjects, promoting the inclusion of women and minorities, confidentiality, monitoring of ongoing research, and compensation for research injuries. Part III looks at special situations, including pediatric research, research with adults who lack decision-making capacity, prison research, research with fetuses and embryos, and genetics research. The appendices contain a variety of primary source material discussed throughout the book, including those portions of the federal regulations known as the Common Rule.

Table of Contents

Part I BACKGROUND AND REGULATORY CONTEXT 

Chapter 1 HISTORICAL ANTECEDENTS

Chapter 2 THE CHANGING FACE OF RESEARCH: NEW REGULATIONS, NEW PLAYERS,NEW PLACES, NEW AGENDAS

Chapter 3 THE FEDERAL AND STATE REGULATORY STRUCTURE

Chapter 4 INSTITUTIONAL REVIEW BOARDS

Chapter 5 CONFLICTS OF INTEREST


Part II REVIEWING RESEARCH PROPOSAL: GENERAL CONSIDERATIONS

Chapter 6 RISK-BENEFIT ASSESSMENT

Chapter 7 INFORMED CONSENT

Chapter 8 RECRUITING AND PAYING SUBJECTS

Chapter 9 RESEARCH AND JUSTICE: PROMOTING THE INCLUSION OF WOMEN AND MINORITIES
Chapter 10 CONFIDENTIALITY

Chapter 11 MONITORING OF ONGOING RESEARCH

Chapter 12 COMPENSATION FOR RESEARCH INJURIES


Part III REVIEWING RESEARCH PROPOSALS: SPECIAL SITUATIONS

Chapter 13 RESEARCHES WITH CHILDREN

Chapter 14 ADULTS WHO LACK DECISION-MAKING CAPACITY

Chapter 15 PRISONERS

Chapter 16 MEMBERS OF THE ARMED SERVICES

Chapter 17 FETUSES AND EMBRYOS

Chapter 18 RESEARCHES INVOLVING EMERGING TECHNOLOGIES

Chapter 19 INTERNATIONAL RESEARCH


Appendix A U.S. CODE OF FEDERAL REGULATIONS TITLE

45—PUBLIC WELFARE AND HUMAN SERVICES PART
46—PROTECTION OF HUMAN SUBJECTS

Appendix B DEPARTMENT OF HEALTH AND HUMAN SERVICES CATEGORIES OF RESEARCH THAT MAY BE REVIEWED BY THE INSTITUTIONAL REVIEW BOARD (IRB)THROUGH AN EXPEDITED REVIEW PROCEDURE

Appendix C FOOD AND DRUG ADMINISTRATION SIGNIFICANT DIFFERENCES IN FDA AND HHS REGULATIONS FOR PROTECTION OF HUMAN SUBJECTS

Appendix D NUREMBERG CODE Appendix E DECLARATION OF HELSINKI Appendix F THE BELMONT REPORT ETHICAL PRINCIPLES & GUIDELINES FOR RESEARCH INVOLVING HUMAN SUBJECTS Table of Cases Index