Evidence map›Paper›PMID 33367154›Full record

ArticleInternational journal of academic medicine

A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months.

Zainab Abedin, Alan Teller, Brenda Ruotolo, Kawthar Muhammad, Deborah F Stiles, Rui Ferreira, Nancy Green

Abstract read
In one paragraph

Article in International journal of academic medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Zainab AbedinEvaluation and Continuous Improvement Resource of the Irving Institute for Clinical and Translation Research, Columbia University, New York, USA.
Alan TellerInstitutional Review Board of the Human Research Protection Office, Columbia University, New York, USA.
Brenda RuotoloInstitutional Review Board of the Human Research Protection Office, Columbia University, New York, USA.
Kawthar MuhammadEvaluation and Continuous Improvement Resource of the Irving Institute for Clinical and Translation Research, Columbia University, New York, USA.
Deborah F StilesOffice of Vice President for Research, Columbia University, New York, USA.
Rui FerreiraInstitutional Review Board of the Human Research Protection Office, Columbia University, New York, USA.
Nancy GreenRegulatory Knowledge and Ethics Support (RKSER) of the Irving Institute for Clinical and Translation Research, Columbia University, New York, USA.

Funding

Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
NCATS NIH HHS UL1 TR001873
6 · The paper itself

Abstract

backgroundThe aim of this study is to evaluate whether a dedicated Institutional Review Board (IRB) Liaison Service situated at our Institute's central location could provide additional useful staff support to the investigator community for interactions with the IRB at various levels of protocol submission and review. MATERIALS AND

methodsOver a period of 2½ years, from January 2015 to June 2017, a total of 501 in-person consultations were performed during office hours, usually 25-30 per month. Most requests concerned new protocol development, IRB policy questions, and strategies for compliance or assistance in addressing IRB comments on returned protocols. We analyzed the results of a user evaluation survey for in-person consults and performed a focused in-depth analysis of the impact of the IRB Liaison Service.

resultsSurvey response rate was 43%. Results of 215 completed satisfaction surveys were 100% positive. Users were primarily study coordinators and investigators. Of a randomly selected sample of consultations analyzed in-depth for 67 unique protocols, 73% were subsequently approved within 14 days.

conclusionNational concerns about IRB-related research delays have led to the re-assessment of IRB review processes at institutional levels. Overall, we have found the Liaison Service to be a popular, useful addition to research support for a meaningful number of researchers, enhancing our already research-friendly environment. We plan to continue the service and the evaluation going forward. We will focus in the next phase on exploring whether the Liaison Service can reduce IRB approval times for protocols using its services and on providing support for the use of single IRBs for multi-site studies. THE FOLLOWING CORE COMPETENCIES ARE ADDRESSED IN THIS ARTICLE: Practice-based learning and improvement.

Indexed as

EthicsInstitutional Review Boardresearch supporttranslational research

Identifiers

PMID33367154
PMCPMC7755161

What OpenQuestion holds

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Registered trials

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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.