The Ethics and Regulation of Research with Human Subjects
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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.
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|Author||Coleman, Menikoff, et al|
|Edition||2nd ed., 2015|