Belmont Revisited

Research with human subjects has long been controversial because of the conflicts that often arise between promoting scientific knowledge and protecting the rights and welfare of subjects. Twenty-five years ago the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research addressed these conflicts. The result was the Belmont Report: Ethical Principles and Guidance for Research Involving Human Subjects, a report that identified foundational principles for ethical research with human subjects: respect for persons, beneficence, and justice. Since the publication of Belmont, these three principles have greatly influenced discussions of research with human subjects. While they are often regarded as the single-most influential set of guidelines for biomedical research and practice in the United States (and other parts of the world), not everyone agrees that they provide adequate guidance. Belmont Revisited brings together a stellar group of scholars in bioethics to revisit the findings of that original report. Their responses constitute a broad overview of the development of the Belmont Report and the extent of its influence, especially on governmental commissions, as well as an assessment of its virtues and shortcomings. Belmont Revisited looks back to reexamine the creation and influence of the Belmont Report, and also looks forward to the future of research—with a strong call to rethink how institutions and investigators can conduct research more ethically.

Observing Bioethics examines the history of bioethics as a discipline related not only to modern biology, medicine, and biotechnology, but also to the core values and beliefs of American society and its courts, legislatures, and media. The book is written from the perspective of two social scientists--a sociologist of medicine(Renee C. Fox) and a historian of medicine (Judith P. Swazey)--who have participated in bioethics since the emergence of this multidisciplinary field more than 30 years ago. Fox and Swazey draw on first-hand observations and experiences in a variety of American bioethical settings; face-to-face interviews with first- and second-generation figures in the genesis and early unfolding of bioethics; a detailed examination of the theatrical media coverage of what was considered to be a banner event in the annals of bioethics (the creation and birth of the cloned sheep, Dolly); case studies of how bioethics has internationally developed; and a large corpus of primary documents and secondary source materials. While recognizing the intellectual, moral, and sociological importance of American bioethics, Fox and Swazey are critical of its characteristics. Foremost among these are what they identify as the problems of thinking socially, culturally, and internationally in American bioethics; the 'tenuous interdisciplinarity' of the field; and the troubling extent to which the 'culture wars' have penetrated bioethics. This book will appeal to a wide range of doctors, scientists, and academics who are involved in the history and sociology of bioethics.

This book represents the first comprehensive, gold standard reader on research integrity in the biomedical sciences. Now more than ever, the responsible conduct of research (RCR) has become critically important as new technologies affect research practices in both positive and negative ways. Since learning to do science and practicing it brings researchers into contact with a vast array of ethical issues, it is critical to know the standards and how they are evolving. Indeed, research integrity requires scientists at all levels to operate ethically in a system that supports ethical practice. This unique, foundational text covers all the relevant areas -- subject protection, research misconduct and conflict of interest as well as newly quantified concerns about research bias and non-reproducibility, as well as other unique issues. Developed by renowned experts, this compelling title discusses the full range of practices and policies that should support research that is honestly produced and disseminated. It also specifically incorporates topics noted by the National Institutes of Health as essential and required for training in RCR. Getting to Good – Research Integrity in the Biomedical Sciences is a major contribution to the literature on bioethics and will serve as an invaluable resource for all researchers, students, administrators and professionals interested in research ethics and integrity.

This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science. This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. The EU Clinical Trial Directive, the Council of Europe’s Oviedo Convention (and its Additional Protocol), and national regulation in member states are covered. It is a relevant work for lawyers and ethicists, and the practical approach makes a valuable tool for researchers and members of research ethics committees supervising biomedical research.

The factions debating health care reform in the United States have gravitated toward one of two positions: that just health care is an individual responsibility or that it must be regarded as a national concern. Both arguments overlook a third possibility: that justice in health care is multilayered and requires the participation of multiple and diverse communities. Communities of Health Care Justice makes a powerful ethical argument for treating communities as critical moral actors that play key roles in defining and upholding just health policy. Drawing together the key community dimensions of health care, and demonstrating their neglect in most prominent theories of health care justice, Charlene Galarneau postulates the ethical norms of community justice. In the process, she proposes that while the subnational communities of health care justice are defined by shared place, including those bound by culture, religion, gender, and race that together they define justice. As she constructs her innovative theorization of health care justice, Galarneau also reveals its firm grounding in the work of real-world health policy and community advocates. Communities of Health Care Justice not only strives to imagine a new framework of just health care, but also to show how elements of this framework exist in current health policy, and to outline the systemic, conceptual, and structural changes required to put these justice norms into fuller practice.

Ethics and integrity in research are increasingly important for social scientists around the world. We are tackling more complex problems in the face of expanding and not always sympathetic regulation. This book surveys the recent developments and debates around researching ethically and with integrity and complying with ethical requirements. The new edition pushes beyond the work of the first edition through updated and extended coverage of issues relating to international, indigenous, interdisciplinary and internet research. Through case studies and examples drawn from all continents and from across the social science disciplines, the book: demonstrates the practical value of thinking seriously and systematically about ethical conduct in social science research identifies how and why current regulatory regimes have emerged reveals those practices that have contributed to the adversarial relationships between researchers and regulators encourages all parties to develop shared solutions to ethical and regulatory problems.

This work offers a comprehensive understanding rooted in Catholic anthropology and moral theory of the meaning and limits of informed and proxy consent to experimentation on human subjects. In particular, it seeks to articulate the rationale for proxy consent in both therapeutic and nontherapeutic settings. As to the former, the book proposes that the Golden Rule, recognizing the basic inclinations of human nature toward objective goods perfective of human persons, should underpin the notion of proxy consent to experimentation on humans. As to the latter, an additional scrutiny of the amount of risk involved is necessary, since the risk-benefit ratio frequently invoked to justify higher-risk therapeutic research does not exist in its nontherapeutic counterpart. This study discusses a number of possible solutions to this question and develops a position that builds upon the objective notion of the human good.

Highlights the most important topics, issues, questions, and debates in the field of psychology. Provides material of interest for students from all corners of psychological studies, whether their interests be in the biological, cognitive, developmental, social, or clinical arenas.