The philosopher Henry Richardson's short book is a defense of a position on a neglected topic in medical research ethics. Clinical research ethics has been a longstanding area of study, dating back to the aftermath of the Nazi death-camp doctors and the Tuskegee syphilis study. Most ethical regulations and institutions (such as Institutiional Review Boards) have developed in response to those past abuses, including the stress on obtaining informed consent from the subject. Richardson points out that that these ethical regulations do not address one of the key dilemmas faced by medical researchers -- whether or not they have obligations towards subjects who need care not directly related to the purpose of the study, termed "ancillary care obligations." Does a researcher testing an HIV vaccine in Africa have an obligation to provide anti-retrovirals to those who become HIV positive during the trial? Should a researcher studying a volunteer's brain scan, who sees a possible tumor, do more than simply refer him or her to a specialist? While most would agree that some special obligation does exist in these cases, what is the basis of this obligation, and what are its limits? Richardson's analysis of those key questions and the development of his own position are at the heart of this book, which will appeal to bioethicists studying research ethics, to policy makers, and to political and moral philosophers interested in the obligations of beneficence, one of the key issues in moral theory. " 'Philosophy recovers itself,' wrote John Dewey, 'when it ceases to be a device for dealing with the problems of philosophers and becomes a method, cultivated by philosophers, for dealing with the problems of men.' Henry Richardson confronts a problem in the ethics of medical research that is often (as his many real-life examples show) a matter of life and death. The problem is unexplored and quite difficult: Richardson finds he must craft new theory to deal with it. The theory he creates shows how we become morally entangled with others without intending to, as we enter into intimacies with them. This theory of moral entanglement is a genuine discovery in philosophy, with application across a wide range of human relationships. Since the theory was designed for medical researchers it also provides a bespoke ethical framework, as well as specific guidance, for researchers in the field. This book shows practical philosophy at its best: inspired by real problems, responding with powerful solutions." -- Leif Wenar, Chair of Ethics, King's College London "A medical researcher investigating transmission of malaria may find that a subject has another disease. Does the researcher have an obligation to devote some of the team's resources to treating this disease? The traditional principles of research ethics do not ask much less answer this important question. In this theoretically and practically rich book, Henry Richardson seeks to provide an answer and to identify issues that need further exploration. He argues that "ancillary care obligations" are explained by "moral entanglement" and cannot be justified by traditional principles of justice or the duty to rescue. He is admirably soft-hearted and tough-minded in combining his long demonstrated philosophical acuity with a deep knowledge of the problems on the ground. Richardson's book is characterized by great generosity towards those who need help, towards the problems faced by researchers, and towards the scholarly community - even those with whom he disagrees." - Alan Wertheimer, Senior Research Scholar, Department of Bioethics, National Institutes of Health "In this important book, Henry Richardson sculpts a new path for research ethics, one that focuses on ethical obligations of ancillary-care in clinical trials and medical research, particularly in developing countries, but with relevance throughout the world. In Moral Entanglements, Richardson extends the reach of his analysis both deep within and outside the research itself, recognizing the broader moral backdrop relevant for society-wide judgments of justice, and the special relationships that exist within the medical research context, about what is or is not owed research participants in situations of medical need. Rather than leave such important decisions up to the vagaries of politics or ad hoc assessments, this book sets out a comprehensive theoretical framework with principles to guide such decisions in the everyday lives of both medical researchers and research participants. This book significantly contributes to the ethics of ancillary-care in medical and public health research and judiciously enlightens questions and potential resolutions to these vital global and domestic problems." - Jennifer Prah Ruger, Associate Professor, Yale Schools of Public Health and Medicine

Professor of Philosophy, Georgetown University. Author of DEMOCRATIC AUTONOMY (OUP 2003)

Preface Chapter 1: Medical Researchers' Ancillary-Care Obligations: A Perplexing Issue Ancillary-Care Obligations and the Distinctive Ancillary-Care Obligation Chapter 2: Special Ancillary-Care Obligations: The Partial-Entrustment Model The Existing Lack of Guidance Scope: Partial Entrustment of Aspects of Health The Variable Strength of Ancillary-Care Claims Combining the Tests of Scope and Strength Controversy Surrounding the Scope Requirement Chapter 3: The Moral Basis of the Partial Entrustment A Range of Intimacies The Duty to Warn Autonomy-Centered Reasons for Privacy Rights Ancillary Duties of Care Why Those Accepting Privacy Waivers Take on Special Responsibilities How the Duty to Warn Blocks Maintaining a Tactful Silence How the Duty to Warn Indirectly Supports Tactful Engagement How the Duty of Tactful Engagement Provides a Focus for Beneficence Returning to the Context of Medical Research Potential Rival Accounts: Vulnerability and Threat Avoidance Chapter 4: Justice, Exploitation, and Ancillary Care Why Special Ancillary-Care Obligations Cannot Rest on Justice Will Providing Ancillary Care Conflict with Justice? Justice Reinforcing Ancillary-Care Claims Chapter 5: Limits on the Waiver of Ancillary-Care Obligations The Difficulty of Annulling Ancillary-Care Claims Moral Constraints on Soliciting Waivers of Ancillary-Care Claims Chapter 6: Gradations of Ancillary-Care Responsibility Within the Scope: Minimally, Clearly, or Centrally? Variations in the Expectable Depth of the Researcher-Participant Relationship Variation in Relative Cost Putting These Factors Together Conclusion Chapter 7: Issues for Further Exploration Needed Conceptual Work What Does It Mean To Provide Ancillary Care? Who Are the Researchers? Who Are "Participants"? What are some of the important boundaries of "medical research"? What if ancillary non-medical problems are encountered? Needed Empirical Work Chapter 8: Philosophical Implications and Practical Steps Philosophical Implications Practical Steps References Tables Table 1: General and Special Grounds of Ancillary-Care Obligations Table 2: Functions of Obtaining Informed Consent Figures Figure 1: The Partial-Entrustment Model's Two Tests Figure 2: The Elements Generating Privacy-Based Moral Entanglements Figure 3: Privacy-Based Moral Entanglements: Putting the Pieces Together Figure 4: Four Grades of Ancillary-Care Obligation for ART Provision Cases Advanced Cervical Cancer in a HIV-transmission Study Brain Scans Grimes v. the Kennedy Krieger Institute Juba Malaria Researchers and Schistosomiasis N's Seatmate's Pills Quinodyne The Massage Therapist and the Mole the Nepal Newborn Washing Study The Old Man and the Groceries The Participant's Feverish Child The Reporter and the Peasant The Tax Accountant and the Gambling Addict Transfusion for a Jehovah's Witness Welts