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Human subjects research regulation : perspectives on the future

Author: I Glenn Cohen; Holly Fernandez Lynch
Publisher: Cambridge, Massachusetts : The MIT Press, [2014] ©2014
Series: Basic bioethics.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Human subjects research regulation
(DLC) 2013047483
(OCoLC)864808785
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: I Glenn Cohen; Holly Fernandez Lynch
ISBN: 9780262320825 0262320827
OCLC Number: 888177930
Language Note: English.
Description: 1 online resource (ix, 373 pages)
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.
Series Title: Basic bioethics.
Responsibility: edited by I. Glenn Cohen and Holly Fernandez Lynch.

Abstract:

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.  Read more...

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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.<\/span>\"@en<\/a> ;\u00A0\u00A0\u00A0\nschema:description<\/a> \"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. 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