GDPR: an impediment to research?
GDPR: an impediment to research?
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DOI：
10.1007/s11845-019-01980-2
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发表时间：
2019-11-01
影响因子：
2.1
通讯作者：
McElvaney, Noel G.
中科院分区：
文献类型：
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作者：
Clarke, Niamh;Vale, Gillian;McElvaney, Noel G.
背景最近出台的《一般数据保护条例》和《健康研究条例》一直是从事临床研究的人非常关注的一个领域。经过爱尔兰卫生部随后的解释，这些欧洲法规现在将爱尔兰置于与其他欧洲国家有很大不同的独特地位，可能被证明是爱尔兰临床研究的重大障碍，剥夺了爱尔兰患者及时获得潜在挽救生命的治疗的机会，并降低了爱尔兰对从事这一领域的制药公司的吸引力。至少，在爱尔兰实施的这些规定将给爱尔兰的临床研究人员带来巨大的额外工作负担，在最糟糕的情况下，将迫使个人和机构退出临床研究领域，这将导致爱尔兰知识经济的重大损失，并导致患者护理的不利。目的在这篇文章中，我们探讨欧洲的GDPR和爱尔兰的卫生研究条例到底提出了什么。我们研究了临床研究人员面临的挑战，并强调了那些需要卫生部和数据保护专员澄清的领域。结论我们提出了五项建议，这些建议将改善这些法规中一些更具限制性的强加。这项研究是由爱尔兰医学科学院委托进行的。
Background The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland's Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland's clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care. Aim In this article, we explore what exactly is proposed by Europe's GDPR and by Ireland's Health Research Regulations. We look at the challenges presented to clinical researchers, and we highlight those areas, which need clarification by the Department of Health and by the Data Protection Commissioner. Conclusions We propose five recommendations, which would ameliorate some of the more restrictive impositions of these regulations. This review was commissioned by the Irish Academy of Medical Science.