Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions-Reference-Cited by-同舟云学术

Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions

Published:2019-01 Issue:1 Volume:41 Page:22-31
ISSN:2578-2355
Container-title:Ethics & Human Research
language:en
Short-container-title:Ethics & Human Research

Author:

Klitzman Robert¹,Pivovarova Ekaterina²,Murray Alexandra³,Appelbaum Paul S.⁴,Stiles Deborah F.⁵,Lidz Charles W.⁶

Affiliation:

1. Professor of psychiatry and the director of the Master of Science in Bioethics Program at Columbia University

2. Assistant professor of psychiatry at the University of Massachusetts Medical School in Worcester

3. Research coordinator II at the University of Massachusetts Medical School in Worcester

4. Dollard professor of psychiatry, medicine, & law and the director of the Center for Law, Ethics, and Psychiatry at Columbia University

5. Vice president for research operations and policy and the chief operating officer in the Office of the Executive Vice President for Research at Columbia University

6. Professor emeritus of psychiatry at the University of Massachusetts Medical School in Worcester.

Publisher

Wiley

Subject

Health(social science)

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/eahr.500003

Reference21 articles.

1. National Institutes of Health “Single IRB Policy for Multi‐site Research ” inPolicy & Compliance 2017 https://archives.nih.gov/asites/grants/08-22-2017/policy/clinical-trials/single-irb-policy-multi-site-research.htm;Federal Register Federal Policy for the Protection of Human Subjects (January 19 2017) https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects.

2. Centralized Institutional Review Boards: Assessing the Arguments and Evidence;Resnik D. B.;Journal of Clinical Research Best Practices,2012

3. Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators Proposed Rules, Advanced Notice of Proposed Rulemaking (2011);U.S. Department of Health and Human Services;Federal Register,2011

4. Federal Policy for the Protection of Human Subjects; Proposed Rules, Notice of Proposed Rule Making;U.S. Department of Homeland Security;Federal Register,2015

5. Regulations.gov Comments for Docket: HHS‐OPHS-2011-0005. Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden Delay and Ambiguity for Investigators 2011 https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&s=central&dct=PS&D=HHS-OPHS-2011-0005

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