Institutional Review Board Use of Outside Experts: What Do We Know?

Author:

Serpico Kimberley1,Rahimzadeh Vasiliki2,Anderson Emily E.3,Gelinas Luke4,Lynch Holly Fernandez5

Affiliation:

1. Associate director of IRB operations in the Office of Regulatory Affairs and Research Compliance at the Harvard T. H. Chan School of Public Health and an EdD candidate at Vanderbilt University

2. Postdoctoral fellow and scholar at the Stanford Center for Biomedical Ethics at Stanford University

3. Associate professor at the Neiswanger Institute for Bioethics in the Stritch School of Medicine at Loyola University Chicago

4. Chairperson at Advarra IRB and a senior advisor at The Multi‐Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

5. John Russell Dickson, MD, Presidential Assistant Professor of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania

Publisher

Wiley

Subject

Health (social science)

Reference18 articles.

1. Strategies for Achieving High-Quality IRB Review

2. Protection of Human Subjects 45 C.F.R. 46(2018).

3. Institutional Review Boards 21 C.F.R. 56(2019) (italics added).

4. “Approval of Research with Conditions: OHRP Guidance ” U.S. Department of Health & Human Services Office for Human Research Protections November 10 2010 https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-irb-approval-of-research-with-conditions-2010/index.html.

5. “Attachment B: Recommendation on IRB Membership and Definition of Non‐scientist under 45 CFR 46 and 21 CFR 56 ” U.S. Department of Health & Human Services Office for Human Research Protections January 24 2011 https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2011-january-24-letter-attachment-b/index.html.

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