Evidence map›Paper›PMID 35218600›Full record

ReviewEthics & human research2022

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

Kimberley Serpico, Vasiliki Rahimzadeh, Emily E Anderson, Luke Gelinas, Holly Fernandez Lynch

Abstract readReview
In one paragraph

Review in Ethics & human research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. A Scoping Review of Empirical Research on Research Ethics Board Membership and Expertise.Journal of empirical research on human research ethics : JERHRE · 2025
    Article
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Kimberley SerpicoAssociate 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.
Vasiliki RahimzadehPostdoctoral fellow and scholar at the Stanford Center for Biomedical Ethics at Stanford University.
Emily E AndersonAssociate professor at the Neiswanger Institute for Bioethics in the Stritch School of Medicine at Loyola University Chicago.
Luke GelinasChairperson at Advarra IRB and a senior advisor at The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard.
Holly Fernandez LynchJohn Russell Dickson, MD, Presidential Assistant Professor of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania.

Funding

The Stanford Training Program in ELSI ResearchT32HG008953 · NHGRI · STANFORD UNIVERSITY · PI Mildred K. Cho, Meghan Halley · 2016 to 2026
$3.1M
NHGRI NIH HHS T32 HG008953
6 · The paper itself

Abstract

Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the primary focus of any published literature or empirical study to date. These issues have important implications for IRB quality. The capacity IRBs have to fulfill their mission of protecting research participants without unduly hindering research is influenced by IRBs' access to and use of the right type of expertise to review challenging research ethics, regulatory, and scientific issues. Through a review of the regulations and standards permitting IRBs to draw on the competencies of outside experts and through examination of the needs, strategies, challenges, and concerns related to doing so, we identify critical gaps in the existing literature and set forth an agenda for future empirical research.

Indexed as

Biomedical ResearchEthics Committees, ResearchEthics, ResearchHumanscompetenciesconsultantHRPPhuman research protection programhuman subjects researchinstitutional review boardIRBoutside expertiseresearch ethics

Identifiers

PMID35218600
PMCPMC10360020

What OpenQuestion holds

Textmetadata
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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.