title: Informed Consent Template and Guidelines on the Ethical Practice in Human Genetics and Human Genomic Research; Initiatives of the Universiti Sains Malaysia.
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.
authors.affiliation: 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.
authors.forename: Teguh Haryo
authors.initials: TH
authors.lastname: Sasongko
authors.affiliation: Department of Pediatrics, School of Medical Sciences, Health Campus, Universiti Sains Malaysia,16150 Kubang Kerian, Kelantan, Malaysia.
authors.forename: Zamh
authors.initials: Z
authors.lastname: Zabidi-Hussin
authors.affiliation: Department of Pathology, 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.
authors.forename: Nor Hayati
authors.initials: NH
authors.lastname: Othman
authors.affiliation: Department of Pediatrics, 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.
authors.forename: Hans
authors.initials: H
authors.lastname: Van Rostenberghe
keywords: Malaysia; ethical; guidelines; human genetics; human genomic; informed consent