Evidence map›Paper›PMID 34182962›Full record

SynthesisBMC medical ethics2021

Adherence with reporting of ethical standards in COVID-19 human studies: a rapid review.

Lydia O'Sullivan, Ronan P Killeen, Peter Doran, Rachel K Crowley

Open access · goldAbstract readSystematic Review
In one paragraph

Synthesis in BMC medical ethics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 29% of its field
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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. 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 at 2 institutions in 1 country.

Lydia O'SullivanSchool of Medicine, University College Dublin, Dublin 4, D04 V1W8, Ireland. lydia.osullivan@ucd.ie.
Ronan P KilleenEthics and Medical Research Committee, Saint Vincent's University Hospital, Dublin 4, D04 T6F4, Ireland.
Peter DoranSchool of Medicine, University College Dublin, Dublin 4, D04 V1W8, Ireland.
Rachel K CrowleySchool of Medicine, University College Dublin, Dublin 4, D04 V1W8, Ireland.
St. Vincent's University Hospital · IEUniversity College Dublin · IE

Funding

Health Research Board HRB-TMRN-2017-1 grant
6 · The paper itself

Abstract

backgroundPatients with COVID-19 may feel under pressure to participate in research during the pandemic. Safeguards to protect research participants include ethical guidelines [e.g. Declaration of Helsinki and good clinical practice (GCP)], legislation to protect participants' privacy, research ethics committees (RECs) and informed consent. The International Committee of Medical Journal Editors (ICMJE) advises researchers to document compliance with these safeguards. Adherence to publication guidelines has been suboptimal in other specialty fields. The aim of this rapid review was to determine whether COVID-19 human research publications report compliance with these ethical safeguards.

methodsA rapid systematic literature review was conducted in MEDLINE using the search term 'COVID-19'. The search was performed in April 2020 with no start date and repeated to include articles published in November 2020. Filters were 'Full free text available' and 'English Language'. Two reviewers assessed article title, abstracts and full texts. Non-COVID-19 articles and non-clinical studies were excluded. Independent reviewers conducted a second assessment of a random 20% of articles. The outcomes included reporting of compliance with the Declaration of Helsinki and GCP, REC approval, informed consent and participant privacy.

resultsThe searches yielded 1275 and 1942 articles of which 247 and 717 were deemed eligible, from the April  search and November respectively. The majority of journals had editorial policies which purported to comply with ICMJE ethical standards. Reporting of compliance with ethical guidelines was low across all study types but was higher in the November search for case series and observational studies. Reporting of informed consent for case studies and observational studies was higher in the November search, but similar for case series. Overall, participant confidentiality was maintained but some case studies included a combination of details which would have enabled participant identification. Reporting of REC approval was higher in the November search for observational studies.

conclusionsWhile the majority of journal's editorial policies purported to support the ethical safeguards, many COVID-19 clinical research publications identified in this rapid review lacked documentation of these important safeguards for research participants. In order to promote public trust, ethical declarations should be included consistently.

Indexed as

COVID-19Editorial PoliciesEthics Committees, ResearchHumansInformed ConsentSARS-CoV-2Clinical researchClinical trialsCOVID-19Declaration of HelsinkiGood Clinical PracticeInformed ConsentPandemicPatient and Public InvolvementResearch ethicsResearch Ethics Committee

Identifiers

PMID34182962
PMCPMC8237766
OpenAlexW3173826417

What OpenQuestion holds

Textmetadata
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.