Human subjects research regulation : perspectives on the future / edited by I. Glenn Cohen and Holly Fernandez Lynch.

Format:

Book

Contributor:

Cohen, I. Glenn, editor.

Lynch, Holly Fernandez, editor.

Series:

Basic bioethics.

Basic bioethics

Language:

English

Subjects (All):

Human experimentation in medicine--Evaluation.

Human experimentation in medicine.

Human experimentation in medicine--Law and legislation.

Medical ethics.

Clinical trials.

Physical Description:

1 online resource (393 p.)

Edition:

1st ed.

Place of Publication:

Cambridge, Massachusetts : The MIT Press, [2014]

Summary:

The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation and the Tuskegee syphilis study. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws. Invigorated by the U.S. government's first steps toward change in over 20 years, the book brings together leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better.

Contents:

Intro

Contents

Series Foreword

Acknowledgments

Introduction

1 Setting the Stage: The Past and Present of Human Subjects Research Regulations

I Regulation of Risk

Introduction to Part I - Regulation of Risk

2 De minimis Risk: A Suggestion for a New Category of Research Risk

3 Risk Level, Research Oversight, and Decrements in Participant Protections

II Protection of Vulnerable Populations

Introduction to Part II - Protection of Vulnerable Populations

4 Classifying Military Personnel as a Vulnerable Population

5 Children as Research Partners in Community Pediatrics

6 Back to the Future? Examining the Institute of Medicine's Recommendations to Loosen Restrictions on Using Prisoners as Human Subjects

III Redefining the Participant-Researcher Relationship and the Role of IRBs

Introduction to Part III Redefining the Participant-Researcher Relationship and the Role of IRBs

7 Toward Human Research Protection That Is Evidence Based and Participant Centered

8 Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?

9 Subjects, Participants, and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves?

10 Democratic Deliberation and the Ethical Review of Human Subjects Research

11 IRBs and the Problem of "Local Precedents"

IV Specimens, Data, and Privacy

Introduction to Part IV - Specimens, Data, and Privacy

12 Biospecimen Exceptionalism in the ANPRM

13 Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?

14 Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement

15 Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens.

16 Reconsidering Privacy Protections for Human Research

17 In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data

V Paradigm Shifts in Research Ethics

Introduction to Part V - Paradigm Shifts in Research Ethics

18 What Is This Thing Called Research?

19 What's Right about the "Medical Model" in Human Subjects Research Regulation

20 Three Challenges for Risk-Based (Research)Regulation: Heterogeneity among Regulated Activities, Regulator Bias, and Stakeholder Heterogeneity

21 Protecting Human Research Subjects as Human Research Workers

22 Getting Past Protectionism: Is It Time to Take off the Training Wheels?

Appendix: Regulatory Changes in the ANPRM

Comparison of Existing Rules with Some of the Changes Being Considered

Contributors

Index.

Notes:

Description based upon print version of record.

Includes bibliographical references at the end of each chapters and index.

OCLC-licensed vendor bibliographic record.

ISBN:

0-262-32082-7

OCLC:

888177930