The Ethics and Regulation of Research with Human Subjects - 2nd Edition - Carl Coleman

The Ethics and Regulation of Research with Human Subjects 2nd Edition Carl Coleman ISBN 9780769847320

This book offers a comprehensive collection of teaching materials suitable for academic courses on research involving human subjects across a wide range of professional school settings. In developing these materials, the authors recognized that many readers will become future advisers, administrators, and regulators of researchers and research institutions. To be effective in these roles, students must not only understand the historical development of human subject protections and the ethical and regulatory frameworks governing research, but also learn to critically evaluate the current regulatory system and consider the need for policy reform.

The Ethics and Regulation of Research with Human Subjects is composed primarily of primary source materials, including government regulations, policy guidance, court decisions, and selected excerpts from the extensive body of scholarship produced by academics, advisory commissions, and other experts. These materials are supplemented by detailed notes and discussion questions that explore key issues raised in the readings and encourage readers to reflect on the gaps, ambiguities, and conflicts within existing laws and policies.

The book is organized into three parts. Part I provides an overview of the history of research involving human subjects, the current regulatory framework, and the principal institutions responsible for research oversight. Part II addresses the core ethical and regulatory issues common to all research protocols, such as risk–benefit analysis, informed consent, subject recruitment and compensation, inclusion of women and minorities, confidentiality, ongoing research monitoring, and compensation for research-related injuries. Part III focuses on special research contexts, including studies involving children, adults who lack decision-making capacity, incarcerated individuals, fetuses and embryos, and genetic research.

The appendices include a range of primary source documents referenced throughout the book, including key portions of the federal regulations collectively known as the Common Rule.

The Ethics and Regulation of Research with Human Subjects 2nd Edition Carl Coleman ISBN 9780769847320, 978-0769847320 & 9780327176930

Authors
Carl Coleman
Jerry Menikoff
Jesse Goldner
Efthimios Parasidis