Evidence map›Paper›PMID 29862323›Full record

ArticleTrauma surgery & acute care open2018

Variations in institutional review board processes and consent requirements for trauma research: an EAST multicenter survey.

Jeffry Nahmias, Areg Grigorian, Scott Brakenridge, Randeep S Jawa, Daniel N Holena, John Varujan Agapian, Brandon Bruns, Paul J Chestovich, Bruce Chung, Jonathan Nguyen and 6 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trauma surgery & acute care open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.Journal of empirical research on human research ethics : JERHRE · 2020
    Article
  4. 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

16 authors.

Jeffry NahmiasDepartment of Surgery, University of California, Irvine, California, USA.
Areg GrigorianDepartment of Surgery, University of California, Irvine, California, USA.ORCID 0000-0002-0998-796X
Scott BrakenridgeDepartment of Surgery, University of Florida Health Science Center, Gainesville, Florida, USA.
Randeep S JawaDepartment of Surgery, Stony Brook University Health Sciences Center School of Medicine, Stony Brook, New York, USA.
Daniel N HolenaDepartment of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
John Varujan AgapianDepartment of Surgery, University of California, Riverside, Rancho Cucamonga, California, USA.
Brandon BrunsDepartment of Surgery, University of Maryland, Baltimore, Maryland, USA.
Paul J ChestovichDepartment of Surgery, University of Nevada, Las Vegas, Nevada, USA.
Bruce ChungDepartment of Surgery, Maine Medical Center, Portland, Maine, USA.
Jonathan NguyenDepartment of Surgery, Morehouse School of Medicine, Atlanta, Georgia, USA.
Carl I SchulmanDepartment of Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Kristan StaudenmayerDepartment of Surgery, Stanford University, Stanford, California, USA.
Rachel DixonEastern Association for the Surgery of Trauma, Chicago, Illinois, USA.
Jason W SmithDepartment of Surgery, University of Louisville, Louisville, Kentucky, USA.
Andrew C BernardDepartment of Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA.
Jose L PascualDepartment of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Oversight of human subject research has evolved considerably since its inception. However, previous studies identified a lack of consistency of institutional review board (IRB) determination for the type of review required and whether informed consent is necessary, especially for prospective observational studies, which pose minimal risk of harm. We hypothesized that there is significant inter-institution variation in IRB requirements for the type of review and necessity of informed consent, especially for prospective observational trials without blood/tissue utilization. We also sought to describe investigators' and IRB members' attitudes toward the type of review and need for consent. Eastern Association for the Surgery of Trauma (EAST) and IRB members were sent an electronic survey on IRB review and informed consent requirement. We performed descriptive analyses as well as Fisher's exact test to determine differences between EAST and IRB members' responses. The response rate for EAST members from 113 institutions was 13.5%, whereas a convenience sample of IRB members from 14 institutions had a response rate of 64.4%. Requirement for full IRB review for retrospective studies using patient identifiers was reported by zero IRB member compared with 13.1% of EAST members (p=0.05). Regarding prospective observational trials without blood/tissue collection, 48.1% of EAST members reported their institutions required a full IRB review compared with 9.5% of IRB members (p=0.01). For prospective observational trials with blood/tissue collection, 80% of EAST members indicated requirement to submit a full IRB review compared with only 13.6% of IRB members (p<0.001). Most EAST members (78.6%) stated that informed consent is not ethically necessary in prospective observational trials without blood/tissue collection, whereas most IRB members thought that informed consent was ethically necessary (63.6%, p<0.001). There is significant variation in perception and practice regarding the level of review for prospective observational studies and whether informed consent is necessary. We recommend future interdisciplinary efforts between researchers and IRBs should occur to better standardize local IRB efforts. LEVEL OF EVIDENCE: IV.

Indexed as

informed consentmedical ethicsobservational study

Identifiers

PMID29862323
PMCPMC5976138

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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.