Evidence map›Paper›PMID 31992320›Full record

ArticleHealth research policy and systems2020

Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands.

Anna Mae Scott, Simon Kolstoe, M C Corrette Ploem, Zoë Hammatt, Paul Glasziou

Abstract read
In one paragraph

Article in Health research policy and systems, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing 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

28 citing papers in PubMed.

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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

5 authors.

Anna Mae ScottInstitute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, QLD, 4226, Australia. ascott@bond.edu.au.ORCID http://orcid.org/0000-0002-0109-9001
Simon KolstoeUniversity of Portsmouth, Portsmouth, UK.
M C Corrette PloemAmsterdam University Medical Centre, Amsterdam, The Netherlands.
Zoë HammattZ Consulting LLC, Denver, USA.
Paul GlasziouInstitute for Evidence-Based Healthcare, Bond University, 14 University Drive, Robina, QLD, 4226, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDisproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands.

methodsWe examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together.

resultsNine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories - evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation - were exempted by one country each. The remaining categories were exempted by two or three countries.

conclusionsExamples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

Indexed as

Research DesignAustraliaBiomedical ResearchEfficiencyEthics Committees, ResearchGuidelines as TopicHealth Services ResearchHumansNetherlandsPublic HealthRisk AssessmentUnited KingdomUnited Statesexemptionhealth researchhumaninternational variationlow-risk researchmedical researchresearch committeesResearch ethicswaste in research

Identifiers

PMID31992320
PMCPMC6986069

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.