Beyond Consent: Seeking Justice in Research / Edition 1

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Overview

Patients with cancer and AIDS now clamor for access to clinical trials. Federal policies governing research that once emphasized protecting subjects from dangerous research now promote access to clinical research. Have claims about justice and access to the benefits of research eclipsed concerns about consent and protection from risks? How can we make good and fair decisions about the selection of subjects and other questions of justice in research?

Beyond Consent examines the concept of justice and its application to human subject research through the different lenses of important research populations: children, the vulnerable sick, captive populations, women, people of color, and subjects in international settings. To set the stage for this examination, an introductory chapter addresses the evolution of research policies. After a look at specific subject populations, the authors discuss the concept of justice for research with human subjects in the future and analyze justice throughout the research enterprise.

The book contains no figures.

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Editorial Reviews

Doody's Review Service
Reviewer: Leslie Pickering Francis(University of Utah)
Description: The editors of this book argue that the theoretical paradigm for ensuring justice in research with human subjects has shifted from the protection of vulnerable subjects to inequality in access to healthcare. With attention in particular to the vulnerable sick, women, children, people of color, and prisoners, contributors to this edited collection explore how the rules governing participation in research imperfectly accommodate concerns about access to healthcare.
Purpose: The purpose is to reassess what justice is required for clinical research, to develop understanding of the history of principles of justice in clinical research, and to recommend changes in standards for participation. These objectives are of critical importance in contemporary research as well as to the assessment of clinical care in diverse populations. The objectives are fully met; indeed, this book is a model of what a collection of papers ought to be.
Audience: The intended audience includes those with interests in bioethics, ethics in research, public policy, and research, and the design of clinical research with human subjects. In my judgment, it is appropriate for those audiences, but it will also be of interest for use in special topics courses in bioethics and research ethics. The editors are very well-respected in the field of ethics and clinical research; the contributors are uniformly well selected.
Features: The volume consists of contributions on the history of concerns for justice in clinical research; research involving particular populations such as children or prisoners; and several integrative chapters about justice in clinical research. Although it is a collection, a particular strength of the volume is that it is superbly edited. There is limited overlap (with the one exception that the emphasis on history is occasionally repetitive). The editors are well aware that they omit discussion of the elderly and people with disabilities. A concluding piece by Madison Powers is particularly noteworthy for how he links the other pieces together and for his discussion of liberal theory and justice in clinical research. Powers' central point is that a primary emphasis on informed consent and individual decision-making about risk is in tension with a commitment to avoiding disparate impact on the access of diverse groups to healthcare.
Assessment: This volume is an original contribution to the discussion of justice in research. I believe it will compel rethinking of the field. Among collections about justice in healthcare, this book stands out for originality and for the forcefulness of the central thesis, as well as for the care with which that thesis is explored.
Leslie Pickering Francis
The editors of this book argue that the theoretical paradigm for ensuring justice in research with human subjects has shifted from the protection of vulnerable subjects to inequality in access to healthcare. With attention in particular to the vulnerable sick, women, children, people of color, and prisoners, contributors to this edited collection explore how the rules governing participation in research imperfectly accommodate concerns about access to healthcare. The purpose is to reassess what justice is required for clinical research, to develop understanding of the history of principles of justice in clinical research, and to recommend changes in standards for participation. These objectives are of critical importance in contemporary research as well as to the assessment of clinical care in diverse populations. The objectives are fully met; indeed, this book is a model of what a collection of papers ought to be. The intended audience includes those with interests in bioethics, ethics in research, public policy, and research, and the design of clinical research with human subjects. In my judgment, it is appropriate for those audiences, but it will also be of interest for use in special topics courses in bioethics and research ethics. The editors are very well-respected in the field of ethics and clinical research; the contributors are uniformly well selected. The volume consists of contributions on the history of concerns for justice in clinical research; research involving particular populations such as children or prisoners; and several integrative chapters about justice in clinical research. Although it is a collection, a particular strength of the volume is that it is superblyedited. There is limited overlap (with the one exception that the emphasis on history is occasionally repetitive). The editors are well aware that they omit discussion of the elderly and people with disabilities. A concluding piece by Madison Powers is particularly noteworthy for how he links the other pieces together and for his discussion of liberal theory and justice in clinical research. Powers' central point is that a primary emphasis on informed consent and individual decision-making about risk is in tension with a commitment to avoiding disparate impact on the access of diverse groups to healthcare. This volume is an original contribution to the discussion of justice in research. I believe it will compel rethinking of the field. Among collections about justice in healthcare, this book stands out for originality and for the forcefulness of the central thesis, as well as for the care with which that thesis is explored.

5 Stars! from Doody
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Product Details

  • ISBN-13: 9780195113532
  • Publisher: Oxford University Press, USA
  • Publication date: 8/28/1996
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 208
  • Product dimensions: 6.30 (w) x 9.30 (h) x 0.90 (d)

Table of Contents

1. Changing Claims About Justice in Research: An Introduction and Overview, Jeffrey Kahn, Anna Mastroianni (both at the University of Minnesota), Jeremy Sugarman (Duke University)
2. The Evolving Story of Justice in Federal Research Policy, Charles R. McCarthy (Georgetown University)
3. Research on the Vulnerable Sick, Baruch Brody (Baylor College of Medicine)
4. Children as Research Subjects, Robert M. Nelson (Medical College of Wisconsin)
5. Gender and Research, Nancy Kass (Johns Hopkins University)
6. Race, Justice and Research, Patricia A. King (Georgetown University)
7. Convenient and Captive Populations, Jonathan D. Moreno (University of Virginia)
8. Justice in International Research, Ruth Macklin (Albert Einstein College of Medicine)
9. Theories of Justice in the Context of Research, Madison Powers (Georgetown University)
10. Implementing Justice in a Changing Research Environment, Jeffrey Kahn, Anna Mastroianni, Jeremy Sugarman

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