Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance-Reference-Cited by-同舟云学术

Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance

Published:2021-05 Issue:3 Volume:43 Page:26-36
ISSN:2578-2355
Container-title:Ethics & Human Research
language:en
Short-container-title:Ethics & Human Research

Author:

Corneli Amy¹,Dombeck Carrie B.²,McKenna Kevin²,Calvert Sara B.³

Affiliation:

1. Associate professor in the Department of Population Health Sciences at Duke University School of Medicine, a lead social scientist for the Clinical Trials Transformation Initiative, and a faculty member of the Duke Clinical Research Institute

2. Research program leader in the Department of Population Health Sciences at Duke University School of Medicine and a research associate of the Clinical Trials Transformation Initiative

3. Clinical trials project leader III at Duke Clinical Research Institute and a senior project manager of the Clinical Trials Transformation Initiative

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Health (social science)

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/eahr.500092

Reference42 articles.

1. National Institutes of Health “Final NIH Policy on the Use of a Single Institutional Review Board for Multi‐Site Research ” notice number NOT‐OD‐16‐094 June 21 2016 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html.

2. Electronic Code of Federal Regulations accessed July 1 2020 https://www.ecfr.gov/cgi-bin/text-idx?m=01&d=20&y=2020&cd=20200629&submit=GO&SID=83cd09e1c0f5c6937cd9d7513160fc3f&node=pt45.1.46&pd=20180719.

3. Single-Minded Research Review: The Common Rule and Single IRB Policy

4. Final NIH Policy”; Menikoff, J., J. Kaneshiro, and I. Pritchard, “The Common Rule, Updated;National Institutes of Health;New England Journal of Medicine,2017

5. U.S. Food and Drug Administration Impact of Certain Provisions of the Revised Common Rule on FDA‐Regulated Clinical Investigations: Guidance for Sponsors Investigators and Institutional Review Boards October2018 https://www.fdanews.com/ext/resources/files/2018/2/10-12-18-CommonRule.pdf

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