Human Subjects Research Regulation: Perspectives on the Future
Human Subjects Research Regulation: Perspectives on the Future
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Abstract
The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. 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 U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in 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 U.S. 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.
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Front Matter
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Introduction
I. Glenn Cohen andHolly Fernandez Lynch
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1
Setting the Stage: The Past and Present of Human Subjects Research Regulations
Amy L. Davis andElisa A. Hurley
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I Regulation of Risk
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II Protection of Vulnerable Populations
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Introduction to Part II—Protection of Vulnerable Populations
Patrick Taylor
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4
Classifying Military Personnel as a Vulnerable Population
Efthimios Parasidis
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Children as Research Partners in Community Pediatrics
Adam Braddock
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Back to the Future? Examining the Institute of Medicine's Recommendations to Loosen Restrictions on Using Prisoners as Human Subjects1
Osagie K. Obasogie
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Introduction to Part II—Protection of Vulnerable Populations
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III Redefining the Participant–Researcher Relationship and the Role of IRBs
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7
Toward Human Research Protection That Is Evidence Based and Participant Centered
Michael McDonald and others
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8
Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?
Seema K. Shah
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9
Subjects, Participants, and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves?
Alexander Morgan Capron
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10
Democratic Deliberation and the Ethical Review of Human Subjects Research
Govind Persad
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IRBs and the Problem of “Local Precedents”
Laura Stark
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Toward Human Research Protection That Is Evidence Based and Participant Centered
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IV Specimens, Data, and Privacy
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12
Biospecimen Exceptionalism in the ANPRM
Ellen Wright Clayton
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13
Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?
Brett A. Williams andLeslie E. Wolf
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14
Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement
Carol Weil and others
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15
Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens
Gail H. Javitt
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16
Considering Privacy Protections for Human Research
Suzanne M. Rivera
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In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data
Barbara J. Evans
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Biospecimen Exceptionalism in the ANPRM
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V aradigm Shifts in Research Ethics
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18
What Is This Thing Called Research?
Zachary M. Schrag
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What's Right about the “Medical Model” in Human Subjects Research Regulation
Heidi Li Feldman
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Three Challenges for Risk-Based (Research) Regulation: Heterogeneity among Regulated Activities, Regulator Bias, and Stakeholder Heterogeneity
Michelle N. Meyer
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Protecting Human Research Subjects as Human Research Workers
Holly Fernandez Lynch
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Getting Past Protectionism: Is It Time to Take off the Training Wheels?
Greg Koski
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What Is This Thing Called Research?
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End Matter
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