The title alone of this new arrival from the American Psychiatric Association carries enough hot-button words to pique wide attention, and the contents end up justifying an attentive read. Although nominally written for specialist audiences in the academic research community, this book is a valuable addition to the growing literature on the ethics of research.

The book is an edited compilation of 10 invited chapters from over two dozen well-known and respected physicians, lawyers, academics, and regulators. The editors’ goals were “to develop a practical manual for investigators that was neither [solely] an esoteric discussion of broad ethical principles nor [solely] a description of specific regulatory guidelines.” Happily, they succeeded in producing a book that is both.

The first chapter, “Ethical Principles and History,” reviews the post-WWII history of human subjects research and the numerous safeguards that have been erected to protect against breaches in the ethical conduct of research. It outlines three ethical principles central to the research enterprise: respect for persons (autonomy and informed consent), beneficence (requiring a risk/benefit assessment for each protocol and doing no harm to subjects), and justice (distributing the rewards and burdens of research across groups). This chapter also references seminal documents in these developments, including the Helsinki Declaration, the Belmont Report, US DHHS Code of Federal Regulations, 45 CFR 46 (and other parts), and the Nuremburg Code, all usefully reprinted in almost 100 pages of appendices.

While these protections were drafted to guide most classes of human subjects research, doing research with the mentally ill, the cognitively impaired, and other vulnerable populations such as children, trauma, and emergently ill patients or nursing home residents is more complicated and additional concerns arise in these research contexts. Many of these difficulties are enumerated and discussed in Ethics of Psychiatric Research.

Chapters cover a wide range of topics: “Issues in Clinical Research Design,” “Providing Quality Care in the Context of Clinical Research,” “Subjects’ Capacity to Consent to Neurobiological Research,” “Surrogate Decision Making and Advance Directives With Cognitively Impaired Research Subjects,” “Informing Subjects of Risks and Benefits,” “Special Issues in Mental Health/Illness Research With Children and Adolescents,” “Clinical Research in Substance Abuse,” “Consumer and Family Concerns About Research Involving Human Subjects,” “Administrative Issues and Informed Consent.”

Four of the authors of this book (Paul Appelbaum, Celia Fisher, Laurie Flynn, and Jonathan Moreno) are either on or have contributed invited papers to The National Bioethics Advisory Commission (NBAC). NBAC’s important report on “Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity” recommends almost two dozen specific measures to increase the oversight and protection of vulnerable subjects. NBAC’s work was released too late for any direct discussion of these recommendations, but there is substantive overlap (e.g., Berg and Appelbaum’s chapter on assessing capacity to consent). The book is referenced in Volume I of NBAC’s report and in Volume II, the compilation of commissioned papers (see the document in Adobe Acrobat PDF format), but nothing in the book will look outdated or undeveloped to readers familiar with this work.

However, for all its strengths as a resource manual, the book’s authors present little that is new in the way that Nancy King, et al. did in Beyond Regulations: Ethics in Human Subjects Research (1999). King, et al. tentatively propose a paradigm shift in our way of conceptualizing human subjects research — away from our existing “balancing principles” framework of autonomy, beneficence, justice, informed consent, ethical universalism, and individualist decision making — to a “relationships” framework based on a “layering of relevant relationships,” culture- and context-bound decision making, narrative foci, and continuities of issues and identities before, during, and after research involvement.

This so-called “interpretive turn” is, paradoxically, now filtering into the socio-medical and clinical research environments at the same time that heavily quantitative health services research, evidence-based medicine, and population-based epidemiological methods are becoming more institutionalized. Again, witness the work and impact of NBAC, itself a harbinger of how bioethics as a discipline is in a period of consolidation, legitimation, and institutionalization.

Even though King, et al.’s paradigm has its appeals, it is hard to imagine how it would supplant the existing principlist regulatory approach of NBAC and most of the authors in Pincus. By my reading, King, et al.’s approach builds on principlist paradigms by assuming mutual trust and good will between researchers and subjects and a humanist ethos of respect for persons, while the principlist approach of Pincus and colleagues spells out how to do this in the real world.

Ethics in Psychiatric Research is a well-written overview of the issues and regulations surrounding the conduct of bio-medical and psychiatric research. A thorough reading will benefit all who are involved in the design and conduct of such research as well as those who review, fund, and publish research findings, communities well advised to become more familiar with the changing landscape of psychiatric research. The book is slightly less accessible to lay readers because of the use of specialized vocabulary, but terms are usually well defined and the excellent introductory chapter and individual chapter summaries make it a handy reference for a wide readership.

Gavin Hougham is a medical sociologist with experience in public health, gerontology, geriatrics, medical ethics, health services research, and cross-cultural (Japanese) research. He is currently Project Director in General Internal Medicine at the University of Chicago Medical Center, where he directs grant-funded socio-medical research. He has published on research ethics, informed consent, physician assisted suicide, and has recently taught Advanced Seminar in Data Analysis, Social Science Research Methods, Survey of Social Science, Medical Sociology, Sociology of Health Organizations, Sociology of Health and Social Behavior.

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Categories: Philosophical, MentalHealth

Keywords: human experimentation