How to get Ethics Committee Approval for Clinical Trials in Turkey?

Ilbars, Hilal

doi:10.14744/nci.2018.68815

Cited by 4 publications

(8 citation statements)

References 4 publications

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“…In the study conducted by Jones et al, [20] in parallel with this study, it was determined that 56% of the applications made to a hospital ethics committee operating in England between 2008 and 2009 were requested for correction. These data show that researchers need to be informed about the preparation of ethics committee application files [9] . In addition, not allocating enough time for the preparation of application files or being careless can be considered as another reason.…”

Section: Discussionmentioning

confidence: 96%

“…Ethics committees carry out these examinations through the project file prepared by the responsible researchers. The sections that should be included in the relevant file are: project summary, general information, justification for the study, literature review, aim and purpose of the study, methodology, data acquisition and analysis, expected outputs in the study, duration of the project, project management, informed consent form, budget and financing institutions, responsibility sharing and resumes of researchers [9] . A well-designed and fully completed application file provides an overview of the entire proposed work and assists in the review of the work objectively [10,11] , while the review process of incompletely filled application files is timeconsuming and difficult [12,13] .…”

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confidence: 99%

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Common Errors in Clinical Research Ethics Committee Applications: The Experience of A Training and Research Hospital

Mercanoğlu¹

2022

Haydarpasa Numune Med J

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Introduction: It is the responsibility of the ethical committees to ensure that the studies carried out on volunteers are carried out in accordance with ethical rules. In this study, it is aimed to analyze the deficiencies in the 2018-2021 application forms of the Istanbul Haydarpaşa Numune Training and Research Hospital Clinical Research Ethics Committee.Methods: The number of applications and revisions, the quality and type of research, area of application and acceptance rate were analyzed retrospectively in the archives of the ethics committee, in 598 files that were finalized between January 2018 and December 2020. Results: In the examined period, the total number of applications has doubled as of the end of 2020 compared to January 2018 (131, 194 and 273 for the years 2018, 2019 and 2020, respectively), and almost all of the applications are non-pharmacologic clinical trials. Among these studies, the highest number of applications are individual research projects, and more than half of them are prospective (63.06%, 66.46% and 58.30%, respectively). The number of applications for which corrections were requested is 77 (58.77%), 107 (55.15%) and 107 (39.19%) according to years. Most of the corrections requested

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Section: Discussionmentioning

confidence: 96%

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confidence: 99%

Common Errors in Clinical Research Ethics Committee Applications: The Experience of A Training and Research Hospital

Mercanoğlu¹

2022

Haydarpasa Numune Med J

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“…A study related to EC applications for non-invasive studies submitted by a private foundation university found that the percentage of individual study and residency thesis applications was 36.5–45.5% and 5.3–6.9%, respectively. [ 3 ] However, Şişli Hamidiye Etfal is a training and research hospital, and hospitals of this category generally graduate many specialists each year, unlike foundation universities. This could explain the large representation (40.4%) of thesis studies among our applications.…”

Section: Discussionmentioning

confidence: 99%

“…These constitute essential minimum requirements for the evaluation of a research application. [ 3 ] Following this preliminary assessment, the applicants are sent a form advising them of any issues to be revised or corrected. Files resubmitted with the required amendments are re-evaluated by the EC.…”

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confidence: 99%

Evaluation of the design and methodology of applications to the local ethics committee

Altuntas

2021

Sisli Etfal

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Objectives: Proposals for scientific studies must have an original hypothesis and the appropriate design and methodology to test the premise. Methods: This study is an evaluation of the suitability of applications submitted to a local ethics committee (EC) and the rate of publication of that research. Results: A total of 899 files submitted for EC approval were retrospectively assessed. The EC found that the description of the methods in 44% of the applications was inaccurate, and that this type of error was most often seen in submissions from the surgical branch. In all, 52% of the applications for which we were informed about their final status were not published. Conclusion: The results suggest that improved training in epidemiology is required to reduce the number of application errors and that new regulations could help to motivate healthcare personnel to conduct scientific research and publish their findings.

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“…A study conducted in Germany and Turkey also examined major design issues such as the issue of consent and the problems of complementary medicine research [24,25].…”

Section: Research Design and Questionmentioning

confidence: 99%

Ethical Considerations in Conducting Clinical Trials

Mousavinejad

Bazmi

Rezaei‐Tavirani

et al. 2022

IJMTFM

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Background: Clinical trials are the golden key in medical science research with human participants. They have always been considered interesting topics by researchers and scientists working in this field. However, the samples are “human participants,” so the research should be carefully conducted. Methods: In the present study, the published articles on the ethical challenges of conducting clinical trials were evaluated between 2010 and 2019 in Google Scholar, PubMed, and Scopus. The English search keywords were “clinical trial,” with at least one of the phrases of “ethical consideration” or “standard”. Results: In this article, we examined the ethical requirements and considerations in these research studies in four stages: research design and question, proposal review and approval, supervision and implementation, and publication of the results. We have examined them using relevant articles published between 2010 and 2019 and identified important and prominent issues or neglected ones. Conclusion: During this study, it was found that the “research design and question” stage was the most discussed and challenging stage, and the authors’ sensitivity about it has been more than the other three stages. On the other hand, the “results publishing” stage has been considered less sensitive with the least number of references in articles.

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How to get Ethics Committee Approval for Clinical Trials in Turkey?

Cited by 4 publications

References 4 publications

Common Errors in Clinical Research Ethics Committee Applications: The Experience of A Training and Research Hospital

Common Errors in Clinical Research Ethics Committee Applications: The Experience of A Training and Research Hospital

Evaluation of the design and methodology of applications to the local ethics committee

Ethical Considerations in Conducting Clinical Trials

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