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

Format:

Book

Contributor:

Cohen, I. Glenn.

Lynch, Holly Fernandez

ebrary, Inc.

Samuel Bellet Book Fund.

Series:

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.

Research Subjects.

Medical Subjects:

Research Subjects.

Physical Description:

1 online resource (pages cm.)

Place of Publication:

Cambridge, Massachusetts : The MIT Press, [2014]

System Details:

text file

Summary:

The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experiment, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by US government researchers from 1932 to 1972. 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-including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the US government's first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas-some incremental, some radical - for the future of research oversight and human subject protection. After reviewing the history of US research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy; especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts. Book jacket.

Contents:

1 Setting the Stage: The Past and Present of Human Subjects Research Regulations / Amy L. Davis Davis, Amy L., Elisa A. Hurley Hurley, Elisa A. 9

I Regulation of Risk

Introduction / Nir Eyal Eyal, Nir 27

2 De minimis Risk: A Suggestion for a New Category of Research Risk / Rosamond Rhodes Rhodes, Rosamond 31

3 Risk Level, Research Oversight, and Decrements in Participant Protections / Ana S. Iltis Iltis, Ana S. 45

II Protection of Vulnerable Populations

Introduction / Patrick Taylor Taylor, Patrick 61

4 Classifying Military Personnel as a Vulnerable Population / Efthimios Parasidis Parasidis, Efthimios 65

5 Children as Research Partners in Community Pediatrics / Adam Braddock Braddock, Adam 79

6 Back to the Future? Examining the Institute of Medicine's Recommendations to Loosen Restrictions on Using Prisoners as Human Subjects / Osagie K. Obasogie Obasogie, Osagie K. 93

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

Introduction / I. Glenn Cohen Cohen, I. Glenn 109

7 Toward Human Research Protection That Is Evidence Based and Participant Centered / Michael McDonald McDonald, Michael, Susan Cox Cox, Susan, Anne Townsend Townsend, Anne 113

8 Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors? / Seema K. Shah Shah, Seema K. 127

9 Subjects, Participants, and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves? / Alexander Morgan Capron Capron, Alexander Morgan 143

10 Democratic Deliberation and the Ethical Review of Human Subjects Research / Govind Persad Persad, Govind 157

11 IRBs and the Problem of "Local Precedents" / Laura Stark Stark, Laura 173

IV Specimens, Data, and Privacy

Introduction / Jeffrey Skopek Skopek, Jeffrey 189

12 Biospecimen Exceptionalism in the ANPRM / Ellen Wright Clayton Clayton, Ellen Wright 193

13 Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water? / Brett A. Williams Williams, Brett A., Leslie E. Wolf Wolf, Leslie E. 207

14 Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement / Carol Weil Weil, Carol, Hilary Shutak Shutak, Hilary, Benjamin Fombonne Fombonne, Benjamin, Nicole Lockhart Lockhart, Nicole 221

15 Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens / Gail H. Javitt Javitt, Gail H. 237

16 Reconsidering Privacy Protections for Human Research / Suzanne M. Rivera Rivera, Suzanne M. 251

17 In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data / Barbara J. Evans Evans, Barbara J. 265

V Paradigm Shifts in Research Ethics Introduction / I. Glenn Cohen Cohen, I. Glenn 281

18 What Is This Thing Called Research? / Zachary M. Schrag Schrag, Zachary M. 285

19 What's Right about the "Medical Model" in Human Subjects Research Regulation / Heidi Li Feldman Feldman, Heidi Li 299

20 Three Challenges for Risk-Based (Research) Regulation: Heterogeneity among Regulated Activities, Regulator Bias, and Stakeholder Heterogeneity / Michelle N. Meyer Meyer, Michelle N. 313

21 Protecting Human Research Subjects as Human Research Workers / Holly Fernandez Lynch Lynch, Holly Fernandez 327

22 Getting Past Protectionism: Is It Time to Take off the Training Wheels? / Greg Koski Koski, Greg 341.

Notes:

Includes bibliographical references and index.

Electronic reproduction. Palo Alto, Calif. Available via World Wide Web.

Description based on print version record.

Local Notes:

Acquired for the Penn Libraries with assistance from the Samuel Bellet Book Fund.

ISBN:

0262320827

9780262320825

Publisher Number:

99960568968

Access Restriction:

Restricted for use by site license.