Ethical review committees in Sri Lanka: a national framework is required

J. Perera, Dp Galaboda, D. Gunawardena
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引用次数: 1

Abstract

A questionnaire based study to review the status of the Ethical Review Committee (ERCs) was conducted in universities and research institutes involved in bio-medical and psycho-social research. Questionnaires were sent to 37 faculties of 11 universities. Thirty faculties responded. The 6 medical faculties were among the 8 faculties that had ERCs. Questionnaires were sent to 10 research institutes and 3 associations. Among 8 institutes and 2 associations that responded, only the Medical Research Institute and the Sri Lanka Medical Association (SLMA) had ERCs. Fifty percent of the ERCs had a specific application form and there was no uniformity in the information obtained from the researchers. Some application forms lacked essential information relevant to ethical review. Information on availability of consent forms, source of funding, investigations, control selection, review of literature, co-investigators' information, educational qualifications of the investigators are some of them. Sixty percent of ERCs had only academic staff or doctors as committee members. The recruitment of members to the committee did not follow a formal process and no institutional guidelines were available for ERC committee members. In the current context there is a need to establish a national framework for ethical review in Sri Lanka for educating resear­ chers and to regularize ethical review of research.
斯里兰卡伦理审查委员会:需要一个国家框架
以问卷调查为基础,对高校和从事生物医学和心理社会研究的研究机构的伦理审查委员会(ERCs)现状进行了调查。调查问卷被发送到11所大学的37个学院。30个学院回应了。这6所医学院是拥有ERCs的8个学院之一。向10个研究机构和3个协会发放了调查问卷。在作出答复的8个研究所和2个协会中,只有医学研究所和斯里兰卡医学协会有伦理委员会。50%的erc有特定的申请表格,并且从研究人员那里获得的信息没有一致性。一些申请表缺少与伦理审查相关的重要信息。其中包括同意书的可得性、资金来源、调查、对照选择、文献审查、共同研究者的信息、研究者的教育资格等信息。60%的伦理委员会只有学术人员或医生作为委员会成员。委员会成员的招募没有遵循正式程序,也没有针对伦理委员会成员的机构指导方针。在目前的情况下,有必要在斯里兰卡建立一个伦理审查的国家框架,以教育研究人员,并使研究的伦理审查规范化。
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