Author: Carl Coleman
Date: 11-08-05 22:22
We are pleased to inform you of the publication of our new book, The Ethics and Regulation of Research with Human Subjects.
As you well know, in recent years there has been a sea change in the regulatory climate relating to the protection of human research subjects. As a result of increased vigilance by federal officials, institutional efforts to achieve accreditation, and private lawsuits, there is a growing need to ensure that personnel involved in the human subject protection process — including IRB members and staff, attorneys, other regulatory personnel, and researchers — have received an appropriate level of education regarding this complex regulatory framework. Our book is designed to meet that need.
The book offers a comprehensive overview of the ethical and regulatory structure governing research with human subjects in the United States, as well as an in-depth exploration of a broad range of ethical and policy questions. In addition to including numerous excerpts from articles by leading scholars, advisory commissions and others, it collects original source materials not found elsewhere in a single volume, such as government guidance statements, state statutes, and edited versions of leading court opinions (for example, Grimes v. Kennedy Krieger Institute). These materials are knitted together by more than 700 accompanying notes and questions, which guide the reader in developing an adequate understanding of the subject matter, expand on some of the issues raised in the primary readings, and encourage thinking 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 book is over 800 pages in length (only 60 pages of which are appendices containing reprints of the relevant federal regulations and similar materials), and is competitively priced at $48. Discounts are available for bulk purchases. In addition, purchasers of the book can receive a complimentary copy of a teacher’s manual, which provides an extensive discussion of many of the questions posed in the book, including answers to those questions for which specific “correct” answers exist.
To order a copy of the book, please call Lexis publishing at 800-223-1940, or visit their online bookstore at bookstore.lexis.com.
Please also feel free to contact any of us if you have any questions about the book.
Carl H. Coleman, J.D.
Seton Hall Law School
colemaca@shu.edu
Jerry A. Menikoff, M.D., J.D.
University of Kansas School of Medicine
jmenikof@kumc.edu
Jesse A. Goldner, J.D.
Saint Louis University Schools of Law and Medicine
goldneja@slu.edu
Nancy N. Dubler, LL.B.
Albert Einstein College of Medicine
ndubler@montefiore.org
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