An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB-Reference-Cited by-同舟云学术

An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB

Published:2021-11 Issue:6 Volume:43 Page:42-48
ISSN:2578-2355
Container-title:Ethics & Human Research
language:en
Short-container-title:Ethics & Human Research

Author:

Johnson Ann R.¹,Rigtrup Lisa M.²,VanBuren John³,Rothwell Erin⁴,Dean J. Michael⁵

Affiliation:

1. Director of the institutional review board and Human Research Protection Program at the University of Utah

2. Manager of the institutional review board at the University of Utah

3. Associate professor and statistician in the Department of Pediatrics at the University of Utah

4. Professor and social scientist in the Department of Obstetrics and Gynecology at the University of Utah

5. Professor and vice chairman for research in the Department of Pediatrics at the University of Utah

Funder

National Center for Advancing Translational Sciences

National Institutes of Health

Publisher

Wiley

Subject

Health (social science)

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/eahr.500109

Reference12 articles.

1. An Ethical Analysis of Exception from Informed Consent Regulations

2. Protection of Human Subjects 21 C.F.R. 50.24(a)(7)(i–ii); “Guidance for Institutional Review Boards Clinical Investigators and Sponsors—Exception from Informed Consent Requirements for Emergency Research ” U.S. Food and Drug Administration April 2013 https://www.fda.gov/files/about%20fda/published/Exception-from-Informed-Consent-Requirements-for-Emergency-Research.pdf.

3. Public Approval of Exception From Informed Consent in Emergency Clinical Trials

4. Recommendations for Implementation of Community Consultation and Public Disclosure Under the Food and Drug Administration’s “Exception From Informed Consent Requirements for Emergency Research”

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Institutional Review Boards' Assessment of Local Context: A Mixed Methods Study;Ethics & Human Research;2024-01

2. Pediatric specific challenges of the single institutional review board mandate;Trials;2022-03-21