Evidence map›Paper›PMID 31887158›Full record

ArticlePloS one2019

Clinical ethics consultation among Italian ethics committee: A mixed method study.

Ludovica De Panfilis, Domenico Franco Merlo, Roberto Satolli, Marta Perin, Luca Ghirotto, Massimo Costantini

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
8.9field-weighted citation impact, top 2% 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

13 citing papers in PubMed, 35 citations in OpenAlex.

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  10. Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries.International journal of environmental research and public health · 2022
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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

6 authors at 2 institutions in 1 country.

Ludovica De PanfilisUnit of Bioethics, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.ORCID 0000-0002-5509-7626
Domenico Franco MerloInfrastructure for Research and Statistics, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Roberto SatolliZadig, Agenzia di Editoria Scientifica, Milano, Italy.
Marta PerinUnit of Bioethics, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.ORCID 0000-0003-4631-7380
Luca GhirottoUnit of Qualitative Research, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Massimo CostantiniScientific Directorate, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Azienda Sanitaria Unità Locale di Reggio Emilia · ITZadig (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe general purpose for ethics consultations is to deliberate on issues on medical and scientific research and act towards the safeguard of the patient's rights and dignity. With the implementation of European Union (EU) Regulation 536/2014 on clinical trials and cost and time-optimization, the nature of consultations and the bodies they are carried out might be to some extent affected. Accordingly, we sought to gain an updated perspective on the current role and current practices of ethics consultations nationwide in both clinical and research settings.

methodsThe study was carried forth by a three-step mixed-method approach: i) review of policies/regulations for ethics committee (EC) nationwide; ii) a structured survey on ethics consultation activity completed by each EC during 2016; iii) incorporated into the third part, a qualitative assessment with a selected sample of 8 key-informants for a semi-structured interview, discussing EC history, the ethics consultation function, and the professional experience of consultants.

resultsReview of the policies/regulations promoted by ECs showed that 72,6% (n = 69) of all the ECs (N = 95) being actually capable of providing ethics consultation service by policy. 71 ECs (74.7%) responded to the survey on ethics consultation requests; among them, 48 (67.6%) provided ethics consultations of which 23 (23/48) actually received requests for this service in the year 2016. Many ECs did not have a structured database in place to provide precise figures of requests received in the last year nor of their contents.

conclusionTo date, ethics consultation in clinical and research practice is largely underappreciated and not well understood by users. The consultants themselves lack a comprehensive vision of work carried out in their field, and bioethics training programs to keep them updated. Despite clinical ethics consultation services should not necessarily be mandatory, following the recent EU Regulation on clinical trials, institutional ethics consultation bodies should be re-evaluated.

Indexed as

Ethics ConsultationEthics, MedicalClinical Trials as TopicEthics CommitteesEuropean UnionHumansItalyPolicyReferral and ConsultationSocial Control, Formal

Identifiers

PMID31887158
PMCPMC6936824
OpenAlexW2997182937

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.