Evidence map›Paper›PMID 27790458›Full record

ArticleJournal of clinical and diagnostic research : JCDR2016

A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital.

Pruthak C Shah, Ashwin K Panchasara, Manish J Barvaliya, C B Tripathi

Abstract read
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Article in Journal of clinical and diagnostic research : JCDR, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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1citing papers in PubMed
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1 · What the graph read from it

What it found

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2 · The registry

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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.

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4 · The record

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5 · Who and what money

Authors and funding

4 authors.

Pruthak C ShahStudent, Department of Pharmacology, Government Medical College , Bhavnagar, Gujarat, India .
Ashwin K PanchasaraAssistant Professor, Department of Pharmacology, GMERS Medical College , Sola, Ahmedabad, Gujarat, India .
Manish J BarvaliyaAssistant Professor, Department of Pharmacology, Government Medical College , Bhavnagar, Gujarat, India .
C B TripathiProfessor and Head, Department of Pharmacology, Government Medical College , Bhavnagar, Gujarat, India .

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionApplication form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC).

aimTo check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. MATERIALS AND

methodsThe application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents.

resultsTotal 100 application forms were analysed. Among them, 98 were academic and 2 were industrial studies. Majority of academic studies were of basic science type. In 63.26% studies, type of study was not mentioned in title. Age group of subjects was not mentioned in 8.16% application forms. In 34.6% informed consent, benefits of the study were not mentioned. Signature of investigators/co-investigators/Head of the Department was missing in 3.06% cases.

conclusionOur study recommends that the efficiency and speed of review will increase if investigator will increase vigilance regarding filling of application forms. Regular meetings will be helpful to solve the problems related to content of application forms. The uniformity in functioning of EC can be achieved if common application form for all ECs is there.

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AcademicClinical trialIndustrial

Identifiers

PMID27790458
PMCPMC5071958

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