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.

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.

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.

The SAGE Encyclopedia of Research Design maps out how one makes decisions about research design, interprets data, and draws valid inferences, undertakes research projects in an ethical manner, and evaluates experimental design strategies and results. From A-to-Z, this four-volume work covers the spectrum of research design strategies and topics including, among other things: fundamental research design principles, ethics in the research process, quantitative versus qualitative and mixed-method designs, completely randomized designs, multiple comparison tests, diagnosing agreement between data and models, fundamental assumptions in analysis of variance, factorial treatment designs, complete and incomplete block designs, Latin square and related designs, hierarchical designs, response surface designs, split-plot designs, repeated measures designs, crossover designs, analysis of covariance, statistical software packages, and much more. Research design, with its statistical underpinnings, can be especially daunting for students and novice researchers. At its heart, research design might be described simply as a formalized approach toward problem solving, thinking, and acquiring knowledge, the success of which depends upon clearly defined objectives and appropriate choice of statistical design and analysis to meet those objectives. The SAGE Encyclopedia of Research Design will assist students and researchers with their work while providing vital information on research strategies.

Tom L. Beauchamp of Georgetown is one of the founding fathers of contemporary bioethics, and is particularly influential as one of the co-authors (with James Childress) of PRINCIPLES OF BIOMEDICAL ETHICS, first published by OUP over 25 years ago and a true cornerstone of contemporary bioethics. This volume is both an introductory textbook as well as a definitive expression of what is known as the dominant "principlist" approach which views bioethical reasoning developing out of four key principles: respect for autonomy, nonmaleficence, beneficence, and justice. This view has been highly influential over the last two decades and has set the agenda for the field. This volume will collect Tom Beauchamp's 15 most important published articles in bioethics, most of which were published over the last 25 years, and most of which have a strong connection to the principlist approach. Most of the essays included here augment, develop, or defend various themes, positions and arguments in that earlier book, both adding depth as well as taking off in new directions. Among the topic discussed are the historical origins of modern research ethics, to moral principles and methodological concerns. Beauchamp will include a new introduction to explain the history of the essays and their relationship to the principlist theory.

The forty-year Tuskegee Syphilis Study, which took place in and around Tuskegee, Alabama, from the 1930s through the 1970s, has become a profound metaphor for medical racism, government malfeasance, and physician arrogance. Susan M. Reverby's Examining Tuskegee is a comprehensive analysis of the notorious study of untreated syphilis among African American men, who were told by U.S. Public Health Service doctors that they were being treated, not just watched, for their late-stage syphilis. With rigorous clarity, Reverby investigates the study and its aftermath from multiple perspectives and illuminates the reasons for its continued power and resonance in our collective memory.