Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
National Institute for Health Research Biomedical Research Centre, Manchester University Hospital NHS Trust, Manchester, UK.
Sociol Health Illn. 2022 Jan;44(1):211-217. doi: 10.1111/1467-9566.13408. Epub 2021 Nov 23.
With the most recent developments to the European General Data Protection Regulations (GDPR) introduced in May 2018, the resulting legislation meant a new set of considerations for study approvers and health-care researchers. Compared with previous legislation in the UK (The Data Protection Act, 1998), it introduced more extensive and directive principles, requiring anybody 'processing' personal data to specifically define how this data will be obtained, stored, used and destroyed. Importantly, it also emphasised the principle of accountability, which meant that data controllers and processors could no longer just state that they planned to adhere to lawful data protection principles, they also had to demonstrate compliance. New questions and concerns around accountability now appear to have increased levels of scrutiny in all areas of information governance (IG), especially with regards to processing confidential patient information. This article explores our experiences of gaining required ethical and regulatory approvals for an ethnographic study in a UK health-care setting, the implications that the common law duty of confidentiality had for this research, and the ways in which IG challenges were overcome. The purpose of this article was to equip researchers embarking on similar projects to be able to navigate the potentially problematic and complex journey to approval.
随着 2018 年 5 月欧洲《通用数据保护条例》(GDPR)的最新发展,由此产生的立法为研究批准者和医疗保健研究人员带来了一系列新的考虑因素。与英国以前的立法(1998 年的数据保护法)相比,它引入了更广泛和指令性的原则,要求任何“处理”个人数据的人都要明确规定如何获取、存储、使用和销毁这些数据。重要的是,它还强调了问责制原则,这意味着数据控制者和处理者不能再仅仅声明他们计划遵守合法的数据保护原则,他们还必须证明合规性。现在,围绕问责制的新问题和担忧似乎增加了信息治理(IG)的所有领域的审查水平,尤其是在处理机密患者信息方面。本文探讨了我们在英国医疗保健环境中进行民族志研究时获得所需伦理和法规批准的经验,以及普通法保密义务对这项研究的影响,以及克服 IG 挑战的方法。本文的目的是为从事类似项目的研究人员提供装备,使他们能够在可能存在问题和复杂的审批过程中进行导航。