"Of the three main areas of research in applied ethics medical ethics, business ethics, and environmental ethics medical ethics has received the most sustained philosophical attention. But not all issues in medical ethics have received the same degree of philosophical scrutiny, and while much attention has been paid to ethical issues that concern the provision of medical care, comparatively little attention has been paid to ethical issues that arise in the course of clinical research... There is thus much of value in The Ethical Challenges of Human Research, and it serves as a welcome corrective to the more usual bioethical focus on medical care." James Stacey Taylor, The College of New Jersey, Notre Dame Philosophical Reviews
The Ethical Challenges of Human Research: Selected Essaysby Franklin G. Miller
The use of human beings as research subjects poses distinctive ethical issues. Subjects of medical research are exposed to risks of harm for the sake of generating scientific knowledge that can benefit future patients and society. Ethical analysis of the challenges posed by research involving human subjects requires careful attention to the contextual details of… See more details below
The use of human beings as research subjects poses distinctive ethical issues. Subjects of medical research are exposed to risks of harm for the sake of generating scientific knowledge that can benefit future patients and society. Ethical analysis of the challenges posed by research involving human subjects requires careful attention to the contextual details of scientific experimentation. This book contains 22 essays by Franklin G. Miller on research ethics written over a 15-year period. With the exception of the first essay, all have been previously published in bioethics and medical journals.
The book is arranged into four parts. Part One addresses a general ethical perspective on the protection of human subjects in clinical research, including paternalism in research regulation and acceptable limits to research risks. The essays in Part Two examine ethical issues in study design. It includes ethical analyses of controversial types of medical experimentation-studies that provoke psychiatric symptoms, induce infections, provide patients with placebos that withhold proven effective treatments or administer fake invasive procedures, test experimental treatments in cancer patients who have exhausted all standard treatment options, and employ the use of deception to generate scientifically valid data. Part Three offers a systematic critique of "the therapeutic orientation" to clinical trials and the principle of clinical equipoise, which is widely regarded as a fundamental norm for randomized treatment studies. Part Four takes up a range of ethical issues relating to informed consent for research participation, including examination of "the therapeutic misconception" and presentation of a novel approach to the validity of consent: "the fair transaction model." An abiding theme, developed in many of the essays is that the ethics of clinical research is importantly different from the ethics of medical care.
Description: This is a compilation of unrevised essays on research ethics published by the author and sometimes a coauthor since 1997.
Purpose: The author describes the essays as commentaries and applications inspired by the classic article "What Makes Clinical Research Ethical?" Whether a book providing already accessible published articles is needed depends on whether seeing the articles in one place, structured in a particular way, adds new insight from what one could glean from the articles separately. This compilation could have added that insight, showing progress of thought and ideas of a prominent and influential thinker in research ethics, but, unfortunately it is not structured chronologically, so any progress in thinking is lost. Without revisions or prefaces to the articles, readers are left with several articles on a topic, many that overlap considerably in their arguments, without a means to distinguish or compare them. Further, the main innovative themes in the author's and his collaborators' thought (critiques of clinical equipoise, support of placebo-controlled trials, and innovative ways of examining therapeutic misconception), though mentioned in the preface, do not align with the structural themes of the book and, therefore, their overarching power is lost.
Audience: This book is written for a wide audience of those interested in research ethics, although its heavy use of structured arguments makes it lean towards the more academically trained readers.
Features: While the work does not claim to have a systematic framework, it is intentionally organized into four sections: 1) general human subjects protections, 2) study design, 3) therapeutic orientation and equipoise, and 4) consent. Some of the articles are powerful and useful to have together, such as the discussions of controversial research that has questionable risk/benefit balance, including sham surgeries (Ch.9), symptom-inducing and infection-inducing trials (Ch.4, 5), and trials that undermine clinical equipoise (Ch.6, 8, 15-17). The most useful part of the book, in retrospect, is the list of original sources of the articles. With some work, readers could figure out from this list how the author's thoughts developed.
Assessment: The articles in this book are seminal contributions to research ethics thought, especially since they challenge numerous prevailing assumptions in research ethics scholarship. However, as an unrevised and poorly structured compilation, the book does not add much to the previously published works.
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