Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

There is widespread agreement that it would be both morally and legally wrong to treat a competent patient, or to carry out research with a competent participant, without the voluntary consent of that patient or research participant. Furthermore, in medical ethics it is generally taken that that consent must be informed. The most widely given reason for this has been that informed consent is needed to respect the patient’s or research participant’s autonomy. In this article I set out to challenge (...) this claim by considering in detail each of the three most prominent ways in which ‘autonomy’ has been conceptualized in the medical ethics literature. I will argue that whilst these accounts support the claim that consent is needed if the treatment of competent patients, or research on competent individuals, is to respect their autonomy, they do not support the claim that informed consent is needed for this purpose. (shrink)

In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.

This book is the result of over 30 years of collaboration among its authors. It uses the systematic account of our common morality developed by one of its authors to provide a useful foundation for dealing with the moral problems and disputes that occur in the practice of medicine. The analyses of impartiality, rationality, and of morality as a public system not only explain why some bioethical questions, such as the moral acceptability of abortion, cannot be resolved, but also provide (...) a method for determining the correct answer for those occasions when a bioethical question has a unique correct answer. This new edition includes an entire chapter that has been added to address the controversial issue of abortion within the authors' distinct framework. This book presents the latest revisions of the authors' orignial analyses of the concepts of death and disease, analyses that have had a significant impact on the field of bioethics. It also includes an added chapter on mental disorders, where the authors' definition influenced what psychiatry classifies as a mental disorder, and so has had an impact that reveals beyond the field of bioethics. In this edition, the authors also offer a new, more developed perspective on the concept of valid or informed consent by considering what information physicians should be required to know before proposing screening, diagnostic testing, prescribing medications, or performing surgery. The book also integrates some of the important insights of the field of clinical epidemiology into its discussion of valid consent. Its account of paternalism and its justification, perhaps the most ubiquitous moral problem in medical ethics, has had considerable influence. Its discussion of euthanasia and physician assisted suicide challenges the standard views that have been put forward by both proponents and opponents of physician assisted suicide and voluntary active euthanasia. (shrink)

Thomas Hobbes took a new look at the ways in which society should function, and he ended up formulating the concept of political science. His crowning achievement, Leviathan, remains among the greatest works in the history of ideas. Written during a moment in English history when the political and social structures as well as methods of science were in flux and open to interpretation, Leviathan played an essential role in the development of the modern world. This edition of Hobbes' landmark (...) work is based on the original text. It incorporates the author's own corrections and retains the period spelling and punctuation, offering both flavorful authenticity and the utmost clarity of expression. (shrink)

The human microbiome is the bacteria, viruses, and fungi that cover our skin, line our intestines, and flourish in our body cavities. Work on the human microbiome is new, but it is quickly becoming a leading area of biomedical research. What scientists are learning about humans and our microbiomes could change medical practice by introducing new treatment modalities. This new knowledge redefines us as superorganisms comprised of the human body and the collection of microbes that inhabit it and reveals how (...) much we are a part of our environment. The understanding that microbes are not only beneficial but sometimes necessary for survival recasts our interaction with microbes from adversarial to neighborly. This volume explores some of the science that makes human microbiome research possible. It then considers ethical, legal, and social concerns raised by microbiome research. Chapters explore issues related to personal identity, property rights, and privacy. The authors reflect on how human microbiome research challenges reigning views on public health and research ethics. They also address the need for thoughtful policies and procedures to guide the use of the biobanked human samples required for advancing this new domain of research. In the course of these explorations, they introduce examples from the history of biomedical science and recent legal cases that shed light on the issues and inform the policy recommendations they offer at the end of each topic's discussion.This volume is the product of an NIH Human Microbiome Project grant. It represents three years of conversations focused on consensus formation by the twenty-seven members of the interdisciplinary Microbiome Working Group. (shrink)