Evidence map›Paper›PMID 37430255›Full record

ArticleBMC medical ethics2023

Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations.

Areej AlFattani, Norah AlBedah, Asma AlShahrani, Ammar Alkawi, Amani AlMeharish, Yasmin Altwaijri, Abeer Omar, M Zuheir AlKawi, Asim Khogeer

Abstract read
In one paragraph

Article in BMC medical ethics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
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

9 authors.

Areej AlFattaniBiostatistics, Epidemiology and Scientific computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. aralfattani@kfshrc.edu.sa.
Norah AlBedahBiostatistics, Epidemiology and Scientific computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Asma AlShahraniBiostatistics, Epidemiology and Scientific computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Ammar AlkawiNeuroscience center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Amani AlMeharishBiostatistics, Epidemiology and Scientific computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Yasmin AltwaijriBiostatistics, Epidemiology and Scientific computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Abeer OmarOffice of Research Affairs, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
M Zuheir AlKawiResearch ethics monitoring office, King Abdulaziz City for Science and Technology, Riyadh, Saudi Arabia.
Asim KhogeerResearch Department, The Strategic Planning Administration, General Directorate of Health Affairs Of Makkah Region, Ministry of Health, Makkah, 24382, Saudi Arabia.ORCID 0000-0002-6508-7747

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInstitutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia.

methodThis was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions.

resultsTwenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review.

conclusionSaudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies.

Indexed as

Biomedical ResearchEthics Committees, ResearchCross-Sectional StudiesHumansSaudi ArabiaSelf ReportApprovalFunctionsInstitutional review boardProtocolResearch ethics committeeReviewRoles

Identifiers

PMID37430255
PMCPMC10334562

What OpenQuestion holds

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LicenceCC BY
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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.