Evidence map›Paper›PMID 30208946›Full record

ArticleBMC research notes2018

Research ethics consultation: an attempt and 5-year experience in a Japanese University Hospital.

Hiroaki Yanagawa, Rumi Katashima, Chiho Sato, Kenshi Takechi, Hiroshi Nokihara, Chikako Kane, Masayuki Chuma, Yuki Aoe

Abstract read
In one paragraph

Article in BMC research notes, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Hiroaki YanagawaClinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima, 770-8503, Japan. niseko@tokushima-u.ac.jp.ORCID http://orcid.org/0000-0002-6734-2262
Rumi KatashimaClinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima, 770-8503, Japan.
Chiho SatoClinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima, 770-8503, Japan.
Kenshi TakechiClinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima, 770-8503, Japan.
Hiroshi NokiharaClinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima, 770-8503, Japan.
Chikako KaneClinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima, 770-8503, Japan.
Masayuki ChumaClinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima, 770-8503, Japan.
Yuki AoeClinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima, 770-8503, Japan.

Funding

Japan Agency for Medical Research and Development, AMED 18oa0110003h0003
6 · The paper itself

Abstract

objectiveResearch ethics consultation is an advisory activity that differs from ethics committees, and its role is not yet widely known in Japan. Research ethics consultations were started in 2012 by members of the Clinical Trial Center of Tokushima University Hospital, a support section for clinical trials. We analyzed the research ethics consultation records from Tokushima University Hospital during the 5-year period of 2012-2016 to examine the Japanese context of research ethics consultation.

resultsDuring the study period, 125 research ethics consultations were carried out, 115 (91%) before starting studies. All but one request were from investigators at Tokushima University. The main issue was compatibility with guidance and regulations (n = 74, 67.2%), such as ethical handling of human biological specimens and information utilized in research; only 6 (4.8%) requests involved research ethics issues that investigators face in their research. Therefore, it is necessary to expand the consultation function, with a nationwide system of consultant education and data sharing. Moreover, standardization of consultation should be considered.

Indexed as

Ethics ConsultationHospitals, UniversityHumansJapanClinical researchJapanRegulation compatibilityResearch ethicsResearch ethics consultation

Identifiers

PMID30208946
PMCPMC6134693

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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.