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提交给当地伦理委员会的申请的设计与方法评估

Evaluation of the Design and Methodology of Applications to the Local Ethics Committee.

作者信息

Altuntas Yuksel, Yildiz Yildirmak Zeynep, Erdogan Sarper, Seckin Deniz, Aksu Cerman Asli, Yapislar Hande, Onal Gulsum, Elcioglu Kubra, Eren Nezaket, Necioglu Orken Dilek

机构信息

Department of Endocrinology Metabolism, University of Health Sciences Turkey, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.

Department of Pediatric Hematology and Oncology, University of Health Sciences Turkey, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.

出版信息

Sisli Etfal Hastan Tip Bul. 2021 Dec 29;55(4):450-456. doi: 10.14744/SEMB.2021.47542. eCollection 2021.

DOI:10.14744/SEMB.2021.47542
PMID:35317372
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8907687/
Abstract

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.

摘要

目的

科学研究提案必须有一个原创假设以及用于检验该前提的适当设计和方法。

方法

本研究是对提交给当地伦理委员会(EC)的申请的适宜性及其研究发表率的评估。

结果

对总共899份提交给伦理委员会批准的文件进行了回顾性评估。伦理委员会发现,44%的申请中方法描述不准确,这类错误最常出现在外科分支的提交材料中。总体而言,我们得知其最终状态的申请中有52%未发表。

结论

结果表明,需要加强流行病学培训以减少申请错误数量,新规定可能有助于激励医护人员开展科学研究并发表其研究结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a4a6/8907687/a602d79815c7/SEMB-55-450-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a4a6/8907687/a602d79815c7/SEMB-55-450-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a4a6/8907687/a602d79815c7/SEMB-55-450-g001.jpg

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本文引用的文献

1
How to get ethics committee approval for clinical trials in Turkey?如何在土耳其获得临床试验的伦理委员会批准?
North Clin Istanb. 2018 Dec 11;5(4):379-386. doi: 10.14744/nci.2018.68815. eCollection 2018.
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Basics of study design: Practical considerations (From the "Biostatistics and Epidemiology Lecture Series, Part 1").研究设计基础:实际考量(源自《生物统计学与流行病学系列讲座,第1部分》)
Cleve Clin J Med. 2017 Sep;84(9 Suppl 2):e10-e19. doi: 10.3949/ccjm.84.s2.03.
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Description and Evaluation of the Research Ethics Review Process in Japan: Proposed Measures for Improvement.
日本研究伦理审查过程的描述与评估:改进建议措施
J Empir Res Hum Res Ethics. 2016 Jul;11(3):256-66. doi: 10.1177/1556264616660644.
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Study design in evidence-based surgery: What is the role of case-control studies?循证外科中的研究设计:病例对照研究的作用是什么?
World J Methodol. 2016 Mar 26;6(1):101-4. doi: 10.5662/wjm.v6.i1.101.
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A study to assess completeness of project application forms submitted to Institutional Ethics Committees (IEC) of a tertiary care hospital.一项评估提交给三级医院机构伦理委员会(IEC)的项目申请表完整性的研究。
Perspect Clin Res. 2012 Oct;3(4):133-8. doi: 10.4103/2229-3485.103594.
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Epidemiology teaching: student and tutor perceptions.流行病学教学:学生与导师的看法
Med Teach. 2004 Dec;26(8):691-5. doi: 10.1080/01421590400013537.