The Ethics and Regulation of Research with Human Subjects

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.

Carl Coleman is Professor of Law and Associate Dean for Graduate Programs at the Seton Hall University School of Law. In 2024 he was named a fellow by the Hastings Center, the oldest independent, nonpartisan interdisciplinary research institute of its kind in the world.

Jerry Menikoff, M.D., J.D, is the retired Director of the Office for Human Research Protections (OHRP), a component of the U.S. Department of Health and Human Services (HHS).

jesse Goldner is the John D. Valentine Professor of Law Emeritus at St. Louis University School of Law.

Efthimios Parasidis holds the Chief Justice Thomas J. Moyer Professorship for the Administration of Justice and Rule of Law at The Ohio State University Moritz College of Law, maintains a joint appointment with the College of Public Health, and is a faculty affiliate with the College of Medicine's Center for Bioethics.