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知情同意模板及人类遗传学与人类基因组研究伦理实践指南;马来西亚理科大学倡议

Informed Consent Template and Guidelines on the Ethical Practice in Human Genetics and Human Genomic Research; Initiatives of the Universiti Sains Malaysia.

作者信息

Sasongko Teguh Haryo, Zabidi-Hussin Zamh, Othman Nor Hayati, Van Rostenberghe Hans

机构信息

Human Genome Center, School of Medical Sciences, Health Campus, Universiti Sains Malaysia,16150 Kubang Kerian, Kelantan, Malaysia; Universiti Sains Malaysia Human Research Ethics Committee, Universiti Sains Malaysia Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia.

Department of Pediatrics, School of Medical Sciences, Health Campus, Universiti Sains Malaysia,16150 Kubang Kerian, Kelantan, Malaysia.

出版信息

Malays J Med Sci. 2015 Nov;22(6):47-53.

Abstract

Malaysia is advancing and nearly on pace with the international scientific community in human genetics and human genomics research. However, this research poses unique challenges. Although Malaysia already regulates medical genetic services, these regulations are insufficient for coping with the ethical issues emerging from recent genomic technologies. The Universiti Sains Malaysia recently created in-house guidelines and an informed consent template for genetic and genomic research. This article presents these guidelines and the informed consent template and discusses the justification and the background of the initiative. We also propose recommendations pertaining to local social studies and regulatory arrangements.

摘要

马来西亚在人类遗传学和人类基因组学研究方面正在取得进展,且几乎与国际科学界保持同步。然而,这项研究带来了独特的挑战。尽管马来西亚已经对医学遗传服务进行监管,但这些规定不足以应对近期基因组技术引发的伦理问题。马来西亚理科大学最近制定了内部指南以及遗传和基因组研究的知情同意模板。本文介绍了这些指南和知情同意模板,并讨论了该举措的理由和背景。我们还提出了有关当地社会研究和监管安排的建议。

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