Data_Sheet_3_Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study.DOCX

BackgroundThe COVID-19 pandemic brought global disruption to health, society and economy, including to the conduct of clinical research. In the European Union (EU), the legal and ethical framework for research is complex and divergent. Many challenges exist in relation to the interplay of the various applicable rules, particularly with respect to compliance with the General Data Protection Regulation (GDPR). This study aimed to gain insights into the experience of key clinical research stakeholders [investigators, ethics committees (ECs), and data protection officers (DPOs)/legal experts working with clinical research sponsors] across the EU and the UK on the main challenges related to data protection in clinical research before and during the pandemic.
Materials and methodsThe study consisted of an online survey and follow-up semi-structured interviews. Data collection occurred between April and December 2021. Survey data was analyzed descriptively, and the interviews underwent a framework analysis.
Results and conclusionIn total, 191 respondents filled in the survey, of whom fourteen participated in the follow-up interviews. Out of the targeted 28 countries (EU and UK), 25 were represented in the survey. The majority of stakeholders were based in Western Europe. This study empirically elucidated numerous key legal and ethical issues related to GDPR compliance in the context of (cross-border) clinical research. It showed that the lack of legal harmonization remains the biggest challenge in the field, and that it is present not only at the level of the interplay of key EU legislative acts and national implementation of the GDPR, but also when it comes to interpretation at local, regional and institutional levels. Moreover, the role of ECs in data protection was further explored and possible ways forward for its normative delineation were discussed. According to the participants, the pandemic did not bring additional legal challenges. Although practical challenges (for instance, mainly related to the provision of information to patients) were high due to the globally enacted crisis measures, the key problematic issues on (cross-border) health research, interpretations of the legal texts and compliance strategies remained largely the same.

背景 新型冠状病毒肺炎（COVID-19）大流行对全球卫生、社会与经济领域造成了广泛冲击，临床研究的开展工作亦受到波及。在欧盟（European Union，EU）范围内，临床研究相关的法律与伦理框架体系复杂且存在区域差异。各类适用规则之间的交互作用带来了诸多挑战，尤其是在符合《通用数据保护条例（General Data Protection Regulation，GDPR）》相关要求方面。本研究旨在深入了解欧盟与英国境内核心临床研究利益相关方——包括研究者、伦理委员会（ethics committees，ECs）以及为临床研究申办方提供服务的数据保护官（data protection officers，DPOs）/法律专家——在疫情前后遭遇的临床研究数据保护相关主要挑战。

材料与方法 本研究采用线上问卷调查与后续半结构化访谈相结合的研究方法。数据采集工作于2021年4月至12月期间开展。问卷数据采用描述性统计分析方法进行处理，访谈数据则采用框架分析法开展编码与分析。

结果与结论 本次调查共回收有效问卷191份，其中14名受访者参与了后续的半结构化访谈。本次调研覆盖了欧盟与英国原定的28个目标国家中的25个，受访利益相关方主要来自西欧地区。本研究实证阐明了（跨境）临床研究场景下与GDPR合规相关的多项核心法律与伦理问题。研究结果显示，法律体系缺乏统一协调仍是该领域面临的最大挑战，这一问题不仅存在于欧盟核心立法文件与GDPR国内实施细则的交互适配层面，也体现在地方、区域及机构层面的法规解读环节。此外，本研究还进一步探讨了伦理委员会在数据保护工作中的角色，并对其规范性界定的可行路径展开了讨论。参与调研的受访者认为，疫情并未带来额外的法律层面挑战。尽管受全球范围内出台的疫情防控应急措施影响，实践层面的挑战（例如主要涉及向研究对象患者提供研究信息相关的问题）显著增加，但跨境健康研究领域的核心症结、法律文本解读以及合规策略等核心问题并未发生实质性变化。