Evidence map›Paper›PMID 32036724›Full record

ArticleJournal of empirical research on human research ethics : JERHRE2020

Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee.

Saara Happo, Tapani Keränen, Arja Halkoaho, Soili M Lehto

Abstract read
In one paragraph

Article in Journal of empirical research on human research ethics : JERHRE, 2020. 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. 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.

Saara HappoUniversity of Eastern Finland, Kuopio, Finland.ORCID 0000-0002-7879-2410
Tapani KeränenKanta-Häme Central Hospital, Hämeenlinna, Finland.
Arja HalkoahoTampere University of Applied Sciences, Finland.
Soili M LehtoUniversity of Eastern Finland, Kuopio, Finland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Several frameworks assist research ethics committees (RECs) in risk assessment of medical studies. However, little is known about how researchers describe risks of the procedures in study protocols and participant information sheets. We examined 349 study protocols and participant information sheets submitted to an REC and evaluated the risk assessments performed for 1,510 study procedures. Risks had been assessed for 399 (26%) procedures in study protocols and for 425 (28%) procedures in participant information sheets. Physical risks were assessed six times more frequently than psychological risks. Risks of medical procedures are not always detailed in study protocols or participant information sheets. Risk descriptions of procedures believed to be familiar to potential participants may be omitted.

Indexed as

Ethical ReviewEthics Committees, ResearchHumansRisk Assessmentmedical research ethicsmedical study proceduresmedical study protocolparticipant information sheetrisk assessment

Identifiers

PMID32036724
PMCPMC7604935

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.