Enhancing the Diversity of Participants in the WISDOM Clinical Trial: Practical Challenges and Ethical Implications

标题：增强WISTH临床试验参与者的多样性：实践挑战和伦理 这意味着什么。 摘要 这项生命伦理学补充要求扩大了我们NCI资助的R01的工作，扩大了智慧研究的 多样性、覆盖面和概括性。智慧(根据风险衡量标准被告知进行筛查的妇女) 是一项务实的试验，比较了一种基于风险的乳腺癌筛查方法-在这种方法中，频率和 筛查的方式依赖于个性化的风险计算-对照年度黄金标准 放映。目标是确定个性化的方法是否同样安全、不那么病态、更容易被接受 对妇女来说，鼓励采取预防性干预措施，并具有更高的保健价值(更好的结果 在心理上、身体上和经济上花费更少)。家长资助的目的(赞助 补充)是增加入学人数，增强智慧学习人群的多样性，以便 提高对美国人口的普适性。拟议的补编建立在一种独特的跨学科基础上 WISTH临床试验团队和ELSI研究人员团队之间的伙伴关系，该团队由一个单独的 NCI R01研究智慧的社会和伦理含义，题为：智慧中的精确基因组学 实用临床试验：基于风险的乳腺癌筛查的“嵌入式”ELSI研究。 确定和分析ELSI(伦理、法律和社会)的经验和规范生命伦理学方法 影响)基于风险的筛选的挑战。嵌入的伦理项目是由一个总体的 目的：了解精确基因组学筛查与已知癌症健康差异之间的交集。 拟议的生物伦理学补编将促进和扩大对ELSI问题的研究，因为 智慧审判不断创新和发展，以满足其招聘和留住目标以及其 承诺加强对不同人群的包容。为补编提出的新目标将 扩大这一独特的机会，并将解决我们的原始研究中未包括的关键新问题 设计。我们的具体目标是：(1)扩大道德操守工作组，以包括来自以下方面的代表 智慧四个新的增强多样性的招聘地点，并通过以下方式扩大道德操守工作组 2022年，允许集团继续实时向智慧利益相关者提供建议；以及(2)阐明 通过访谈研究招募不同种族和民族的参与者参加WISTH试验的挑战 原有临床研究站点的下降率以及新添加的临床站点被选择为增强 多样性。拟议的补编意义重大，因为人们对多样化的招聘知之甚少 完全在线研究中的人口。智慧在增强多样性的同时保持基本在线的努力 招聘的方法需要研究。这项关于下降者的研究不仅填补了文献中的空白，而且 还将用于增强智能招聘流程，改善参与者体验，并帮助 完成招聘目标。

Title: Enhancing the Diversity of Participants in the WISDOM Clinical Trial: Practical Challenges and Ethical Implications. Abstract This bioethics supplement request expands the work of our NCI-funded R01 Expanding the WISDOM Study’s Diversity, Reach, and Generalizability. WISDOM (Women Informed to Screen Depending on Measures of Risk) is a pragmatic trial comparing a risk-based approach to breast cancer screening—in which the frequency and modality of screening is dependent on a personalized risk calculation—against the gold standard of annual screening. The goal is to determine whether a personalized approach is as safe, less morbid, better accepted by women, encourages uptake of preventive interventions, and is of higher health care value (better outcomes at less cost psychologically, physically, and financially). The purpose of the parent grant (which sponsors the supplement) is to increase enrollment and enhance the diversity of the WISDOM study population in order to increase generalizability to the US population. The proposed supplement builds upon a unique interdisciplinary partnership between the WISDOM clinical trial team and a team of ELSI investigators funded by a separate NCI R01 to study the social and ethical implications of WISDOM, titled: Precision Genomics in the WISDOM Pragmatic Clinical Trial: An “Embedded" ELSI Study of Risk-based Breast Cancer Screening. This project uses empirical and normative bioethics methods to identify and analyze the ELSI (ethical, legal, and social implications) challenges of risk-based screening. The embedded ethics project is guided by an overarching objective: to understand the intersection of precision genomics screening with known cancer health disparities. The proposed bioethics supplement will facilitate and expand research on the ELSI issues that arise as the WISDOM trial continues to innovate and evolve in order to meet its recruitment and retention goals and its commitment to enhance inclusion of diverse populations. The new aims proposed for the supplement will expand upon this unique opportunity and will address critical emerging issues not included in our original study design. Our Specific Aims are: (1) To expand the Ethics Working Group to include representatives from WISDOM’s four new enhanced-diversity recruitment sites and to extend the Ethics Working Group through 2022, allowing the group to continue to offer advice to WISDOM stakeholders in real time; and (2) To elucidate the challenges of enrolling racially and ethnically diverse participants in the WISDOM trial by interviewing study decliners across the original clinical study sites along with newly added clinical sites selected to enhance diversity. The proposed supplement is significant because little is known about recruitment of diverse populations in fully online studies. WISDOM’s efforts to enhance diversity while maintaining a largely online approach to recruitment requires study. This research with decliners will not only fill a gap in the literature but also will be used to enhance WISDOM recruitment processes, improve participant experiences, and help achieve recruitment goals.