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

Location Call No. Status Notes
 Law Library  R 853 .H8 H863 2014    DUE 05-10-24
Description ix, 373 pages ; 23 cm
text rdacontent
unmediated rdamedia
volume rdacarrier
Series Basic bioethics.
Bibliography Includes bibliographical references and index.
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.
Subject Human experimentation in medicine -- Evaluation.
Human experimentation in medicine -- Law and legislation.
Medical ethics.
Clinical trials.
Human Experimentation -- legislation & jurisprudence -- United States.
Ethical Review -- United States.
Human Experimentation -- ethics -- United States.
Research Subjects -- legislation & jurisprudence -- United States.
Added Author Cohen, I. Glenn, editor.
Lynch, Holly Fernandez, editor.
ISBN 9780262027465 (hardcover : alk. paper)
0262027461 (hardcover : alk. paper)
9780262526210 (pbk. : alk. paper)
0262526212 (pbk. : alk. paper)
OCLC # 864808785
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