The Ethical Challenges of Human Research Selected Essays

by Miller, Franklin G.

• ISBN13: 9780199896202
• ISBN10: 0199896208
• Edition: 1st
• Format: Hardcover
• Copyright: 2012-10-23
• Publisher: Oxford University Press

Summary

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.

Table of Contents

Preface

Acknowledgments

Protecting Human Subjects in Clinical Research: A General Perspective

Situating research ethics: revisiting Beecher and Jonas

Facing up to paternalism in research ethics. Hastings Center Report 2007;37(3):24-34

Limits to research risks. Journal of Medical Ethics 2009;35:445-449

Study Design

Psychiatric symptom-provoking studies: an ethical appraisal. Biological Psychiatry. 1997;42:403-9

The ethical challenge of infection-inducing challenge experiments. Clinical Infectious Diseases. 2001;33:1028-33

Placebo-controlled trials in psychiatric research: an ethical perspective. Biological Psychiatry. 2000;47:707-16

What makes placebo-controlled trials unethical? The American Journal of Bioethics. 2002;2(2):3-8.

Ethical issues concerning research on complementary and alternative medicine. JAMA 2004;291:599-604

Sham surgery: an ethical analysis. American Journal of Bioethics 2003;3(4):41-8

Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option? Clinical Trials 2008;5:617-23

Deception in research on the placebo effect. PLo

S Medicine 2005;2(9):e262

Debriefing and accountability in deceptive research. Kennedy Institute of Ethics Journal 2008;18:235-51

Therapeutic Orientation and Equipoise

Professional integrity in clinical research. Journal of the American Medical Association. 1998;280:1449-54

The therapeutic orientation to clinical trials. New England Journal of Medicine. 2003;348:1383-86

A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials. Hastings Center Report. 2003;33(3):19-28

Clinical equipoise and the incoherence of research ethics. Journal of Medicine and Philosophy 2007;32:151-65

Equipoise and the randomized clinical trial dilemma. New England Journal of Medicine 2011;364:476-80

Consent

Evaluating the therapeutic misconception. Kennedy Institute of Ethics Journal 2006;16:353-66

Is it ethical to keep interim findings of randomized controlled trials confidential? Journal of Medical Ethics 2008;34:198-2

Research on medical records without informed consent, Journal of Law, Medicine and Ethics 2008;36:560-6621. F. G. Miller and S. D. Pearson: Coverage with evidence development: ethical issues and policy implications. Medical Care 2008;46:746-5722. F. G. Miller and A. Wertheimer: The fair transaction model of informed consent: an alternative to autonomous authorization, Kennedy Institute of Ethics Journal 2011;21:201-18

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