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Genetic research and consent: On the crossroads of human and data research

机译:遗传研究与同意:关于人类和数据研究的十字路口

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This paper explores the legal and ethical concept of human subject research in order to determine whether genetic research with already available biosamples and data falls within this concept. Although the ethical concept seems to have evolved to recognize research based on data as human research, from a supranational legal perspective this form of research is not considered human subject research. Thus human subject research regulations do not apply and therefore do not invoke the requirement of obtaining consent prior to using an individual's biosample or genetic data in research. Furthermore, it remains ambiguous in both the legal and ethical realm whether the use of biosamples or genetic data without additional links to the individual would invoke the same safeguards as research involving additional or specific identifiers. Seeing that research based on already available biosamples and genetic data is not governed by rules concerning human subject research, the second part of the paper analyses whether any consent requirements apply for the further use of already available bio-samples or genetic data in research. Whereas further use of biosamples is subject to considerably lax consent requirements under Article 22 of the Oviedo Convention, under the General Data Protection Regulation further use of genetic data might not be subject to a prior consent requirement at all, unless it is stipulated in national laws. When it comes to clinical trials, however, sponsors will have the possibility under Article 28(2) of Regulation 536/2014 to obtain open consent for further use of data in any kind of future research.
机译:本文探讨了人类主题研究的法律和伦理概念,以确定是否有可用的生物素和数据在这一概念中的遗传研究。虽然道德概念似乎已经进化以认识到基于数据作为人类研究的研究,但是这种形式的研究不被认为是人类主题的研究。因此,人类主题研究法规不适用,因此在使用个人生物体或研究中的遗传数据之前,请勿在获取同意的要求。此外,在法律和伦理领域仍然存在暧昧,无论是使用生物素还是遗传数据,无需额外的联系人都会调用与涉及其他或特定标识符的研究相同的保障措施。看到基于已经可用的生物酶和遗传数据的研究不受关于人类主题研究的规则的管辖,该文件的第二部分分析了是否有任何同意要求适用于进一步使用已经可用的生物样本或研究中的遗传数据。虽然在oviedo公约第22条根据“oviedo公约”第22条根据“oviedo公约”第22条根据“一般数据保护规例”,但进一步使用遗传数据可能不会受到事先同意要求,除非其国家法律规定。然而,涉及临床试验时,提案国将有可能根据第536/2014号法规第28(2)条,以获得开放同意,以进一步使用任何类型的未来研究。

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