Consent to access and use routine health data: appropriate wording for participant-facing materials of randomised clinical trials (CrossWord)

同意访问和使用常规健康数据：面向参与者的随机临床试验材料的适当措辞（CrossWord）

• 批准号: 2869207
• 金额: --
• 依托单位: University College London
• 依托单位国家: 英国
• 项目类别: Studentship
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=studentship-2869207
• 关键词: Consent; access; use; routine; health

Access to routine health data (from healthcare systems) is one of the key steps that will transform the way clinical trials are done. However, successful access is commonly problematic due to inconsistent guidelines across providers and across time, inconsistent interpretations by trialists, and shifting requirements (e.g., legal framework or provider changes). A key challenge to timely data access is interpretation of wording used in participant-facing trial documents to inform participants of the required consent to access their health data. Appropriate wording will meet the needs of participants, enhance transparency and generate trust in clinical trials research. This studentship aims to review existing wording used in consent for randomised clinical trials, assess users views on this wording and develop new guidance on consent through consensus with a variety of stakeholders and in consultation with regulatory agencies.

访问常规健康数据（来自医疗保健系统）是改变临床试验方式的关键步骤之一。然而，由于不同提供者和不同时间的指导方针不一致，试验者的解释不一致，以及不断变化的要求（例如，法律的框架或提供商变更）。及时获取数据的一个关键挑战是解释面向参与者的试验文件中使用的措辞，以告知参与者获取其健康数据所需的同意。适当的措辞将满足参与者的需求，提高透明度，并在临床试验研究中产生信任。该研究旨在审查随机临床试验同意书中使用的现有措辞，评估用户对该措辞的看法，并通过与各种利益相关者达成共识并与监管机构协商，制定新的同意指南。