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印度喀拉拉邦牙科教学机构的机构伦理委员会概况

Profile of Institutional Ethics Committees in Dental Teaching Institutions in Kerala, India.

作者信息

Janakiram Chandrashekar, Venkitachalam Ramanarayanan, Joseph Joe

机构信息

a Department of Public Health Dentistry , Amrita School of Dentistry, Amrita Vishwa Vidyapeetham , Edapally , Cochin , India.

出版信息

Account Res. 2016;23(4):219-29. doi: 10.1080/08989621.2015.1114887.

DOI:10.1080/08989621.2015.1114887
PMID:26549796
Abstract

OBJECTIVES

To assess the existence, structure, and functioning of Institutional Ethics Committees (IECs) in dental teaching institutions in Kerala.

METHODOLOGY

A cross-sectional questionnaire-based survey was conducted by personally approaching Heads of Institutions/Ethics Committee (EC) in-charge of all dental colleges (23) in Kerala. The validated questionnaire consisted of two parts. The first part pertained to details of institutions, and the second part assessed the structure and functioning of the IEC. The data obtained was tabulated and analyzed using descriptive statistics.

RESULTS

Of the participating 17 colleges, 13 colleges had a functioning IEC. Only four of these IECs were accredited to a central agency. Only one among the 12 colleges completely adhered to recommended structure. Regarding the functioning of IECs, 69% of the IECs had neither a separate application form for ethical review of proposals nor a proforma for its evaluation. On average, more than ten proposals were reviewed in a single EC meeting in 54% of the colleges. Nearly 40% of the IECs had no representation of a lay person.

CONCLUSION

The absence of IEC in four colleges and non-accreditation to a central agency was a matter of concern. Enforced accreditation is the need of the hour to ensure ethical protection to human participants.

摘要

目的

评估喀拉拉邦牙科教学机构中机构伦理委员会(IECs)的存在情况、结构及运作。

方法

通过亲自拜访喀拉拉邦所有23所牙科学院的机构负责人/伦理委员会(EC)负责人,开展了一项基于问卷调查的横断面研究。经验证的问卷由两部分组成。第一部分涉及机构详情,第二部分评估IEC的结构和运作。对获取的数据进行制表,并使用描述性统计进行分析。

结果

在参与调查的17所学院中,13所学院设有运作中的IEC。其中只有4个IEC获得中央机构的认可。12所学院中只有1所完全符合推荐的结构。关于IEC的运作,69%的IEC既没有单独的提案伦理审查申请表,也没有评估表格。在54%的学院中,单次伦理委员会会议平均审查超过十项提案。近40%的IEC没有外行人代表。

结论

四所学院没有IEC以及未获得中央机构认可令人担忧。当前需要强制认可,以确保对人类受试者的伦理保护。

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