Radboud Biobank, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Health Expect. 2023 Jun;26(3):1308-1317. doi: 10.1111/hex.13746. Epub 2023 Apr 4.
Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk-based MAmmascreening study (PRISMA). The original PRISMA informed consent was project-specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants' needs for broadened consent to preserve informed decision-making while maximising the potential re-use of data.
Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach.
Twenty-three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants' ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de-identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be disclosed.
Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision-making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research.
Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes.
了解参与者对扩大同意的关注和信息需求对于确保透明度和参与者自主权至关重要。我们的研究在参与个性化风险基础的乳腺筛查研究（PRISMA）的女性中定性研究了这些问题。原始的 PRISMA 知情同意书是特定于项目的（即乳腺癌研究），限制了二次研究的范围。我们探讨了参与者对扩大同意的需求，以在最大限度地利用数据的同时保留知情决策。
在半结构化讨论指南之后进行了焦点小组（FG）。两名独立研究人员使用归纳方法对数据进行主题分析。
23 名无症状女性和 13 名被诊断患有乳腺癌的女性被随机分为 6 个 FG。确定了四个上位主题：（1）正常化，（2）对制药行业的态度，（3）隐私和（4）知识。我们的参与者认为数据共享是推进医学科学的重要途径。完整性更多地归因于非商业而非商业方，对制药行业的明显不信任。大多数要求的信息需求与数据保护有关。参与者理想的同意过程将赋予一系列选择；例如，他们将能够选择与谁共享数据，数据是否将被去识别或匿名，同意的截止日期以及如何在要求时公开一般和个人研究结果。
我们的参与者表达了明确的信息需求，并强烈希望积极参与未来的数据共享决策。鉴于许多研究人员与商业方合作，建立公众对这些机构的信任将是有益的。解决隐私问题并澄清困难条款的说明性示例将有助于同意决策。尽管我们的参与者在共享数据方面表现出极大的利他主义，并接受广泛的同意最终将促进未来的研究，但广泛的同意并没有反映他们的理想情况。动态同意可能是一种选择，但需要进一步的可行性研究。
女性是从一般的乳腺癌筛查人群中招募的。他们在本研究中报告的看法和信息需求不仅将为 PRISMA 的扩大同意提供信息，而且理想情况下将指导其他同意模板和关于同意过程的决策。
