A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital
Introduction: Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). Aim: To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital....
Main Authors: | , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
JCDR Research and Publications Private Limited
2016-09-01
|
Series: | Journal of Clinical and Diagnostic Research |
Subjects: | |
Online Access: | https://jcdr.net/articles/PDF/8488/18393_CE(RA1)_F(T)_PF1(VasuGH)_PFA(AK)_PF2(PAG).pdf |
id |
doaj-d41237f14d5b46239105d0c55fc16d9a |
---|---|
record_format |
Article |
spelling |
doaj-d41237f14d5b46239105d0c55fc16d9a2020-11-25T03:20:05ZengJCDR Research and Publications Private LimitedJournal of Clinical and Diagnostic Research2249-782X0973-709X2016-09-01109FC10FC1210.7860/JCDR/2016/18393.8488A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care HospitalPruthak C. Shah0Ashwin K Panchasara1Manish J. Barvaliya2C.B Tripathi3Student, Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat, India.Assistant Professor, Department of Pharmacology, GMERS Medical College, Sola, Ahmedabad, Gujarat, India.Assistant Professor, Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat, India.Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat, India.Introduction: Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). Aim: To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. Materials and Methods: The 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. Results: Total 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. Conclusion: Our 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. https://jcdr.net/articles/PDF/8488/18393_CE(RA1)_F(T)_PF1(VasuGH)_PFA(AK)_PF2(PAG).pdfacademicclinical trialindustrial |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Pruthak C. Shah Ashwin K Panchasara Manish J. Barvaliya C.B Tripathi |
spellingShingle |
Pruthak C. Shah Ashwin K Panchasara Manish J. Barvaliya C.B Tripathi A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital Journal of Clinical and Diagnostic Research academic clinical trial industrial |
author_facet |
Pruthak C. Shah Ashwin K Panchasara Manish J. Barvaliya C.B Tripathi |
author_sort |
Pruthak C. Shah |
title |
A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital |
title_short |
A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital |
title_full |
A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital |
title_fullStr |
A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital |
title_full_unstemmed |
A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital |
title_sort |
study of assessing errors and completeness of research application forms submitted to instituitional ethics committee (iec) of a tertiary care hospital |
publisher |
JCDR Research and Publications Private Limited |
series |
Journal of Clinical and Diagnostic Research |
issn |
2249-782X 0973-709X |
publishDate |
2016-09-01 |
description |
Introduction: Application form of research work is an essential
requirement which is required to be submitted along with the
research proposal to the Ethics Committee (EC).
Aim: To check the completeness and to find the errors in
application forms submitted to the EC of a tertiary care hospital.
Materials and Methods: The 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.
Results: Total 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.
Conclusion: Our 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. |
topic |
academic clinical trial industrial |
url |
https://jcdr.net/articles/PDF/8488/18393_CE(RA1)_F(T)_PF1(VasuGH)_PFA(AK)_PF2(PAG).pdf |
work_keys_str_mv |
AT pruthakcshah astudyofassessingerrorsandcompletenessofresearchapplicationformssubmittedtoinstituitionalethicscommitteeiecofatertiarycarehospital AT ashwinkpanchasara astudyofassessingerrorsandcompletenessofresearchapplicationformssubmittedtoinstituitionalethicscommitteeiecofatertiarycarehospital AT manishjbarvaliya astudyofassessingerrorsandcompletenessofresearchapplicationformssubmittedtoinstituitionalethicscommitteeiecofatertiarycarehospital AT cbtripathi astudyofassessingerrorsandcompletenessofresearchapplicationformssubmittedtoinstituitionalethicscommitteeiecofatertiarycarehospital AT pruthakcshah studyofassessingerrorsandcompletenessofresearchapplicationformssubmittedtoinstituitionalethicscommitteeiecofatertiarycarehospital AT ashwinkpanchasara studyofassessingerrorsandcompletenessofresearchapplicationformssubmittedtoinstituitionalethicscommitteeiecofatertiarycarehospital AT manishjbarvaliya studyofassessingerrorsandcompletenessofresearchapplicationformssubmittedtoinstituitionalethicscommitteeiecofatertiarycarehospital AT cbtripathi studyofassessingerrorsandcompletenessofresearchapplicationformssubmittedtoinstituitionalethicscommitteeiecofatertiarycarehospital |
_version_ |
1724619368378138624 |