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

Language:

English

Subjects (All):

Human experimentation in medicine--Evaluation.

Human experimentation in medicine.

Human experimentation in medicine--Law and legislation.

Medical ethics.

Clinical trials.

Human Experimentation--legislation & jurisprudence.

United States.

Ethical Review.

Human Experimentation--ethics.

Research Subjects--legislation & jurisprudence.

Medical Subjects:

Human Experimentation--legislation & jurisprudence.

United States.

Ethical Review.

Human Experimentation--ethics.

Research Subjects--legislation & jurisprudence.

Physical Description:

ix, 373 pages ; 23 cm.

Place of Publication:

Cambridge, Massachusetts ; London, England : 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 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:

Setting the stage : the past and present of human subjects research regulations / Amy L. Davis and Elisa A. Hurley

De minimis risk : a suggestion for a new category of research risk / Rosamond Rhodes

Risk level, research oversight, and decrements in participant protections / Ana S. Iltis

Classifying military personnel as a vulnerable population / Efthimios Parasidis

Children as research partners in community pediatrics / Adam Braddock

Back to the future? : examining the Institute of Medicine's recommendations to loosen restrictions on using prisoners as human subjects / Osagie K. Obasogie

Toward human research protection that is evidence based and participant centered / Michael McDonald, Susan Cox, and Anne Townsend

Outsourcing ethical obligations : should the revised common rule address the responsibilities of investigators and sponsors? / Seema K. Shah

Subjects, participants, and partners : what are the implications for research as the role of informed consent evolves? / Alexander Morgan Capron

Democratic deliberation and the ethical review of human subjects research / Govind Persad

IRBs and the problem of "local precedents" / Laura Stark

Biospecimen exceptionalism in the ANPRM / Ellen Wright Clayton

Biobanking, consent, and certificates of confidentiality : does the ANPRM muddy the water? / Brett A. Williams and Leslie E. Wolf

Mandating consent for future research with biospecimens : a call for enhanced community engagement / Carol Weil, Hilary Shutak, Benjamin Fombonne, and Nicole Lockhart

Take another little piece of my heart : regulating the research use of human biospecimens / Gail H. Javitt

Reconsidering privacy protections for human research / Suzanne M. Rivera

In search of sound policy on nonconsensual uses of identifiable health data / Barbara J. Evans

What is this thing called research? / Zachary M. Schrag

What's right about the "medical model" in human subjects research regulation / Heidi Li Feldman

Three challenges for risk-based (research) regulation : heterogeneity among regulated activities, regulator bias, and stakeholder heterogeneity / Michelle N. Meyer

Protecting human research subjects as human research workers / holly Fernandez Lynch

Getting past protectionism : is it time to take off the training wheels? / Greg Koski

Appendix. Regulatory changes in the ANPRM : comparison of existing rules with some of the changes being considered.

Notes:

Includes bibliographical references and index.

ISBN:

9780262027465

0262027461

9780262526210

0262526212

OCLC:

864808785