ArticlePerspectives in clinical research2012
A study to assess completeness of project application forms submitted to Institutional Ethics Committees (IEC) of a tertiary care hospital.
Article in Perspectives in clinical research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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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.
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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.
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Who cites it
7 citing papers in PubMed.
- What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis.BMJ global health · 2021Article
- Evaluation of the Design and Methodology of Applications to the Local Ethics Committee.Sisli Etfal Hastanesi tip bulteni · 2021Article
- Ethics committees for clinical experimentation at international level with a focus on Italy.Acta bio-medica : Atenei Parmensis · 2020Review
- 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 : JCDR · 2016Article
- Research ethics committees: Need for harmonization at the national level, the global and Indian perspective.Perspectives in clinical research · 2014Article
- Role of accreditation in quality improvement of institutional Review Board.Perspectives in clinical researchArticle
- Analysis of clinical trial agreement and insurance policy submitted to the ethics committee of a tertiary care teaching institute in central India.Perspectives in clinical researchArticle
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo review Ethics Committee (EC) application forms and to find out similarities and differences in content of five ECs forms in India. MATERIALS AND
methodsTHE COMPLETENESS OF EC APPLICATION FORMS WAS ASSESSED ON THE FOLLOWING THEMES: title, study team, sponsor responsibility, scientific aspects, patient safety, regulatory permissions, Informed consent process from 2008-2009. Application forms (available online) of 5 ECs were studied and compared.
resultsA total of 445 application forms were analyzed, 382 were academic, 63 were sponsored. The common deficiencies in academic studies were inappropriate titles (25.13%), lack of budget details (90%). More than 95% studies had not mentioned the method of recruitment. The issue of vulnerability was not marked in more than 50% of studies. Compensation for participation/injury was poorly stated in academic (99%) studies. Among industry sponsored studies, 98% were compliant with regulatory permissions and 41% were CTRI registered. The information pertaining to Informed Consent was mentioned in all forms. Comparative analysis of application forms of 5 ECs showed that the requirements for submission were similar except 1-2 ECs asked for additional information like percentage of time allotted by investigator for studies, GCP training of study team, certification by investigator regarding accuracy of local versions of Informed consent.
conclusionOur study recommends that increased awareness and vigilance by investigators of academic studies regarding submission of applications to EC will increase efficiency and speed of review process. A common application form for all ECs across India would be an important step to achieve uniformity in functioning of ethics committees.
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