Evidence map›Paper›PMID 31805918›Full record

ArticleBMC medical ethics2019

Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study.

Yanni Wu, Michelle Howarth, Chunlan Zhou, Mingyu Hu, Weilian Cong

Abstract read
In one paragraph

Article in BMC medical ethics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Compliance with Ethical Clearance Certifications among Medical Journals in Nigeria - A Mixed Method Study.Journal of empirical research on human research ethics : JERHRE · 2025
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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.

Yanni WuNanfang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.
Michelle HowarthThe School of Health & Society, University of Salford, Greater Manchester, UK.
Chunlan ZhouNanfang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China. lanchun200488@126.com.ORCID 0000-0001-8537-2679
Mingyu HuNanfang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.
Weilian CongNanfang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEthical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals.

methodsThis is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review.

resultsA total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that "consent was obtained from participants or participants agreed to join in the research". Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P < 0.05).

conclusionThe reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.

Indexed as

Biomedical ResearchInformed ConsentNursing CarePublishingConfidentialityEditorial PoliciesPeriodicals as TopicRetrospective StudiesClinical researchEthical approvalInformed consentNursing journalResearch ethics

Identifiers

PMID31805918
PMCPMC6896583

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.