McGrath Emer R, Kirby Nigel, Shiely Frances
HRB Clinical Research Facility, University of Galway, Galway, Ireland; School of Medicine, University of Galway, Galway, Ireland.
Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK.
J Clin Epidemiol. 2025 Jan;177:111590. doi: 10.1016/j.jclinepi.2024.111590. Epub 2024 Nov 4.
With greater availability of participant data and biobank repositories following clinical trial completion, adequately describing future data and biological sample reuse plans to trial participants is increasingly important. We evaluated how trial teams currently describe current and future use of participant data and biological samples in participant information leaflets (PILs).
Retrospective qualitative analysis of 240 PILs (182 clinical trials) in Ireland and the UK. Descriptions of data and sample use/reuse were extracted and analyzed using a 4-stage pragmatic content analysis approach. A recommended list of questions to be addressed by trial teams when designing PILs was developed.
Of the 240 included PILs, 85% specifically mentioned, or directly implied, how confidentiality of participant data would be maintained; 38% were considered by the authors to adequately describe how data confidentiality would be maintained (ie, the PIL specifically mentioned data deidentification and compliance with data protection regulations); 47% reported the intended duration of data storage (mean 15; SD ± 9 years); 40% specified if data would be used in future research studies and 28% stated if data would be shared with other researchers. Of the 117 PILs stating biological samples would be collected from participants, 80% provided a reason for requesting the sample, 66% stated whether stored samples would be deidentified, 21% specified if individual-level results would be made available to participants and 70% specified whether samples may be used for future studies. Of the 73 PILs specifying planned future sample storage, 18% stated the intended duration of storage and 48% specified if samples would be shared with other researchers. A list of 8 recommended questions to be addressed by trial teams when designing PILs were identified, for example, 'What is the intended duration of data and sample storage for the current study?'.
PILs often provide insufficient detail regarding plans for current use and future reuse of participants' data and their biological samples. The majority do not adequately describe plans for maintaining data confidentiality. Best practice approaches to describing data use and reuse in PILs are needed. This will require multistakeholder input, including potential trial participants to progress this.
随着临床试验结束后参与者数据和生物样本库的可用性提高，向试验参与者充分描述未来的数据和生物样本再利用计划变得越来越重要。我们评估了试验团队目前如何在参与者信息手册（PIL）中描述参与者数据和生物样本的当前及未来用途。
对爱尔兰和英国的240份PIL（182项临床试验）进行回顾性定性分析。使用四阶段实用内容分析方法提取并分析数据和样本使用/再利用的描述。制定了试验团队在设计PIL时应解决的推荐问题清单。
在纳入的240份PIL中，85%特别提及或直接暗示了将如何维护参与者数据的保密性；作者认为38%充分描述了将如何维护数据保密性（即PIL特别提及数据去识别化以及遵守数据保护法规）；47%报告了数据存储的预期时长（平均15年；标准差±9年）；40%明确了数据是否会用于未来的研究，28%说明了数据是否会与其他研究人员共享。在117份表明将从参与者那里收集生物样本的PIL中，80%给出了索要样本的理由，66%说明了存储的样本是否会去识别化，21%明确了是否会向参与者提供个体层面的结果，70%明确了样本是否可用于未来研究。在73份明确了计划中未来样本存储情况的PIL中，18%说明了预期存储时长，48%明确了样本是否会与其他研究人员共享。确定了试验团队在设计PIL时应解决的8个推荐问题清单，例如，“当前研究中数据和样本存储的预期时长是多久？”
PIL通常在参与者数据及其生物样本的当前使用和未来再利用计划方面提供的细节不足。大多数PIL没有充分描述维护数据保密性的计划。需要在PIL中描述数据使用和再利用的最佳实践方法。这将需要包括潜在试验参与者在内的多方利益相关者的投入，以推动此事的进展。
