IRB Decision‐Making about Minimal Risk Research with Pregnant Participants-Reference-Cited by-同舟云学术

IRB Decision‐Making about Minimal Risk Research with Pregnant Participants

Published:2021-09 Issue:5 Volume:43 Page:2-17
ISSN:2578-2355
Container-title:Ethics & Human Research
language:en
Short-container-title:Ethics & Human Research

Author:

White Amina¹,Grady Christine²,Little Margaret³,Sullivan Kristen⁴,Clark Katie⁵,Ngwu Monalisa⁶,Lyerly Anne Drapkin⁷

Affiliation:

1. Clinical associate professor in the Department of Obstetrics & Gynecology at the University of North Carolina at Chapel Hill

2. Head of the Clinical Center Department of Bioethics at the National Institutes of Health

3. Professor of philosophy at The Kennedy Institute of Ethics

4. Research scientist at the Center for Bioethics in the Department of Social Medicine at the School of Medicine at the University of North Carolina at Chapel Hill

5. Research associate at Yale University and research consultant at CHER Solutions

6. Independent research assistant

7. Professor in the Department of Social Medicine at the Center for Bioethics at the University of North Carolina at Chapel Hill

Funder

National Institute of Allergy and Infectious Diseases

Publisher

Wiley

Subject

Health (social science)

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/eahr.500100

Reference30 articles.

1. The Second Wave: Toward Responsible Inclusion of Pregnant Women in Research;Lyerly A. D.;International Journal of Feminist Approaches to Bioethics,2008

2. We recognize that pregnant individuals may have diverse gender identities. Please note that in this article we will refer to pregnant “women” to reflect the language of our survey instrument.

3. Exclusion of Pregnant Women from Industry-Sponsored Clinical Trials;Shields K. E.;Obstetrics & Gynecology,2013

4. 45 C.F.R. 46.102(j).

5. How Do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research?;Shah S.;Journal of the American Medical Association,2004

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