Evidence map›Paper›PMID 19417052›Full record

ArticleJournal of the Royal Society of Medicine2009

Research governance delays for a multicentre non-interventional study.

Andrew A Mallick, Finbar J K O'Callaghan

Abstract read
In one paragraph

Article in Journal of the Royal Society of Medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

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  9. Research governance approval delays studies.Journal of the Royal Society of Medicine · 2009
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors.

Andrew A MallickBristol Institute of Child Life and Health, Academic Unit of Child Health, Level 6, UBHT Education Centre Upper Maudlin Street, Bristol BS2 8AE, UK.
Finbar J K O'Callaghan

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the delay in research governance approval for a non-interventional, multicentre study in the United Kingdom.

designThe times taken from application to the granting of research governance approval for an observational study of childhood stroke with ethical approval were prospectively recorded.

settingNinety-two acute NHS Trusts in the United Kingdom. Main outcome measures Median delay (in working days) between application and research governance approval.

resultsThe median delay between application and research governance approval was 43 working days (interquartile range 27-62, range 0-147). The reason for delay beyond 43 working days was inexplicable in 30 (70%) of 44 trusts.

conclusionsThere is considerable variation in the processes undertaken by research and development departments that can lead to significant delays in commencing an ethically approved study. Any improvements to the systems for gaining approval are welcome.

Indexed as

Biomedical ResearchEthics, ResearchGovernment AgenciesMulticenter Studies as TopicState MedicineTime FactorsUnited Kingdom

Identifiers

PMID19417052
PMCPMC2677429

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.