Lexis Nexis The Ethics and Regulation of Research with Human Subjects
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Subscribers are advised of the number of Updates that were made to the particular publication the prior year. The number of Updates may vary due to developments in the law and other publishing issues, but subscribers may use this as a rough estimate of future shipments. Subscribers may call Customer Support at 800-833-9844 for additional information.
Subscribers may cancel this subscription by: calling Customer Support at 800-833-9844; emailing customer.support@lexisnexis.com; or returning the invoice marked 'CANCEL'.
If subscribers cancel within 30 days after the product is ordered or received and return the product at their expense, then they will receive a full credit of the price for the annual subscription.
If subscribers cancel between 31 and 60 days after the invoice date and return the product at their expense, then they will receive a 5/6th credit of the price for the annual subscription. No credit will be given for cancellations more than 60 days after the invoice date. To receive any credit, subscriber must return all product(s) shipped during the year at their expense within the applicable cancellation period listed above.
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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.
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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
