Evidence map›Paper›PMID 30866722›Full record

ArticleJournal of empirical research on human research ethics : JERHRE2019

Measuring IRB Regulatory Compliance: Development, Testing, and Use of the National Cancer Institute StART Tool.

Lisa Rooney, Laura Covington, Andrea Dedier, Birdena Samuel

Abstract read
In one paragraph

Article in Journal of empirical research on human research ethics : JERHRE, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. A Rare Opportunity: Examining the Experience of a New Institutional Review Board.Journal of empirical research on human research ethics : JERHRE · 2019
    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

4 authors.

Lisa Rooney1 National Cancer Institute, Rockville, MD, USA.ORCID 0000-0002-7310-6303
Laura Covington2 The Emmes Corporation, Rockville, MD, USA.
Andrea Dedier2 The Emmes Corporation, Rockville, MD, USA.
Birdena Samuel2 The Emmes Corporation, Rockville, MD, USA.

Funding

CCR NIH HHS HHSN261200800001CIntramural NIH HHS Z99 CA999999NCI NIH HHS HHSN261200800001ENCI NIH HHS HHSN261201400023C
6 · The paper itself

Abstract

Institutional review boards (IRBs) have been criticized for overstepping their authority by requiring research protocols to meet requirements that go beyond regulatory approval criteria. The youngest National Cancer Institute (NCI) central IRB (CIRB), the Cancer Prevention and Control (CPC) CIRB, was studied with the NCI Stipulation Analysis Review Tool (StART), which categorized 1,049 stipulations in 51 determination letters covering 30 approved protocols. NCI StART reduced the potential for subjective uncertainty in assessing the wide range of content in the stipulations. The tool determined the board functioned in accordance with federal mandates, with 80% of rendered stipulations aligning with IRB approval criteria. A complementary article provides background data and findings from the first 3 years' experience of the CPC CIRB.

Indexed as

Ethics Committees, ResearchBiomedical ResearchHumansNational Cancer Institute (U.S.)United Statesclinical trialscomplianceIRBregulatorystipulationstool

Identifiers

PMID30866722
PMCPMC6448580

What OpenQuestion holds

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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.