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涉及人类受试者的本科研究,除非其可能具有可发表的质量,否则不应给予伦理批准。

Undergraduate research involving human subjects should not be granted ethical approval unless it is likely to be of publishable quality.

作者信息

Gallagher Cathal T, McDonald Lisa J, McCormack Niamh P

机构信息

Department of Pharmacy, University of Hertfordshire, College Lane, Hatfield, AL10 9AB, UK,

出版信息

HEC Forum. 2014 Jun;26(2):169-80. doi: 10.1007/s10730-013-9232-2.

Abstract

Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, in itself, justify such risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval.

摘要

涉及人类受试者的小规模研究项目已被确定在培养本科生的批判性评估技能方面是有效的。在决定是否批准此类项目的伦理许可时,大学研究伦理委员会必须权衡研究的益处与参与者受到伤害或不适的风险。由于无需人类受试者就能实现与学生研究相关的学习目标,培训新的医疗专业人员本身所带来的益处并不能证明此类风险是合理的。如果研究成果要影响未来的实践,就必须与更广泛的科学界分享。我们对英国19所大学的调查表明,与医学、牙医学和药学学科相关的本科毕业论文通常不会被保留在其图书馆目录中,从而切断了传播其研究结果的一条主要途径。如果此类研究不太可能在同行评审期刊上发表、在会议上展示或以其他方式供其他研究人员使用,那么参与者受到伤害、不适或不便的风险就不太可能被社会效益所抵消。在给予伦理批准之前,伦理委员会应确保本科研究将被引入可能为临床实践提供信息的进一步研究中。

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