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This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.
Research on human subjects has always been a highly controversial topic in the field of bioethics. The book, featuring contributions from a Who's Who of biothics scholars, analyzes the seminal document on the topic in the United States: the 1979 Belmont Report, widely regarded as the single-most influential set of guidelines in the practice of bioethics.The Belmont Report is a 20-page statement that spells out the rationale for ethical research on humans, concluding that three primary principles are at play: respect for persons, beneficence, and justice. Since the publication of Belmont these three principles, spelled out further by philosopher Tom Beauchamp and ethicist James Childress and known as the "Georgetown mantra," have dominated all discussions of research on human subjects--though, as this book will show, not everyone agrees that this is the most helpful way to think about the matter. In fact, this book is both a broad overview of the evolution of the Belmont Report and, more important, 1) an assessment of its shortcomings and 2) a strong call to rethink how hospitals and pharmaceutical companies can conduct research more humanely and more ethically. So while the book looks back to the creation of Belmont, it also looks forward to the future of research. Contributors, in addition to the editors, include Alexander Capron, Ruth Faden, Eric Cassell, Karen Lebacqz, Larry Churchill, Robert Levine, Patricia King (Georgetown), Susan Sherwin, Ezekiel Emanuel, Robert Veach (Georgetown), Henry Richardson (Georgetown), John Evans.
Across a broad range of disciplines_in medicine, social science, and the humanities_researchers, scholars, teachers, and administrators increasingly are looking for new ways to approach ethical issues in research with human subjects. Questions about how r
The research ethics system was created without the help of people who know what it is like to be a research subject. This is a serious omission. Experts have overlooked ethical issues that matter to subjects. Silent Partners moves subjects to the forefront, giving them a voice in research ethics.
Debates on the ethics of human subjects research meet with an increasing interest both within the medical profession and the broader public. Frequently, historical arguments are used to propagate or attack certain positions within these debates. However, there is a tendency to oversimplify the complexities of the past for present day purposes, and at the same time a lack of awareness of the historical dimension implicit in today's value preferences. Twentieth Century Ethics of Human Subjects Research brings together leading historians of medicine to reconstruct and analyse the history of actual experimental practices, the debates on human subjects research, and the attempts to regulate such research during the twentieth century. The volume addresses cases of medical research in France, Britain, Israel, the United States, and Germany, including the Nazi period; the major developments of ethical debates in these and further national contexts, such as the Soviet Union, the Czech Republic, and Japan. It also explores religious views (Catholic, Jewish) on human experimentation, and the origins and contexts of international codes and declarations. "Volker Roelckes Uberblick uber die Geschichte der Menschenversuche im Dritten Reich sei jedem empfohlen, der sich kurz und pragnant uber dieses dustere Kapitel deutscher Geschichte informieren mochte." FAZ.
Media headlines about research misconduct in American Universities have focused public attention on the dramatic ethical problems that can arise during the conductof research. In the current atmosphere of accountability, scientific research on humans is now under increased scrutiny by the media, Congress and the public. Ethics of the Use of Human Subjects in Research fills the need for learning materials and strategies providing support for training programs related to the ethics of the use of human subjects in research. It presents a practical introduction to the ethical issues at stake in the conduct of research with human subjects. Beginning with a chapter on research ethics, a total of 10 chapters range in scope from the deveolopment of a protocol for ethical decision making to how to obtain IRB approval, with an emphasis on ethical factors underpinning the IRB process.