Implementing a Novel Consent Process for Biospecimen Research after Newborn Screening in Hospitals Serving Diverse Patients

在为不同患者提供服务的医院进行新生儿筛查后，实施新的生物样本研究同意程序

• 批准号: 10704170
• 负责人: Aaron J Goldenberg
• 金额: $ 65.41万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10704170
• 关键词: Address; Adoption; Attitude; Blood; Blood Screening; Characteristics; Child; Clinical; Collection; Communities; Conflict (Psychology); Consent; Control Groups; Data; Decision Making; Dryness; Electronics; Environment; Evidence based practice; Focus Groups; General Population; Goals; Group Processes; Health; Health Benefit; Health system; Hospitals; Individual; Infant; Informed Consent; Institution; Intervention; Interview; Knowledge; Logic; Methods; Michigan; Modeling; Neonatal Screening; Newborn Infant; Outcome; Outcomes Research; Parents; Participant; Patient-Focused Outcomes; Patients; Policies; Population; Population Heterogeneity; Process; Recommendation; Recording of previous events; Regrets; Research; Research Assistant; Research Personnel; Residual state; Resources; Sampling; Services; Specimen; Spottings; Surveys; System; Technology; Testing; Translational Research; Trust; Underrepresented Populations; Underserved Population; biobank; efficacy evaluation; electronic consent; experience; follow-up; genome resource; health assessment; health disparity; implementation evaluation; implementation framework; implementation outcomes; implementation science; improved; member; novel; patient population; population health; postnatal; precision medicine; programs; prospective; repository; routine care; satisfaction; screening program; technology platform; tool; virtual

PROJECT SUMMARY Biobanks are an enormously valuable resource for genomic research. However, inadequate diversity among specimen donors limits their generalization for translational research. The lack of representativeness of biosamples has the potential to limit the application of precision medicine within underrepresented communities and may inadvertently exacerbate health disparities. Biobanks created using stored newborn screening bloodspots can be particularly valuable resources in efforts aimed at addressing the need for samples from diverse populations: they represent virtually the whole population of infants in a given state, and can be accessed by a wider range of researchers and institutions than smaller repositories with narrower research goals. However, the storage and future research use of newborn bloodspots has itself experienced a long history of national controversy given that state newborn screening programs do not obtain informed consent for collection and testing, and only a few states have subsequently added consent for the research use of leftover bloodspots. Ongoing lawsuits among some state programs and policy debates at both the state and federal levels have further mired any progress to promote the use of newborn screening bloodspots for important health research, including studies that assess health disparities. The implementation of consent processes at the state level may become necessary for the continued utilization of this important resource. The proposed renewal of our R01 will address these concerns by: identifying determinants, strategies, mechanisms, barriers, and facilitators of consenting quality across hospitals serving diverse and underserved populations for the retention and research use of residual dried bloodspots for the Michigan Biotrust of Health (Aim 1); engaging members of underrepresented and non-English speaking communities in Michigan to support implementation of an electronic informed consent intervention (EICI) in diverse hospital settings (Aim 2); and implementing and evaluating the EICI consent approach within four major hospitals across the state of Michigan serving underrepresented persons, Spanish and Arabic speaking participants, and the general population (Aim 3).

项目摘要 生物库是基因组研究的一个非常宝贵的资源。然而，多样性不足， 标本捐赠者限制了他们对转化研究的推广。缺乏代表性 生物样品有可能限制精准医学在代表性不足的地区的应用。 社区，并可能无意中加剧健康差距。使用储存的新生儿创建生物库 筛选血斑可以是特别有价值的资源， 来自不同人群的样本：他们实际上代表了给定状态下的整个婴儿人群， 可以被更广泛的研究人员和机构访问，而不是较小的存储库， 研究目标。然而，新生儿血斑的储存和未来的研究使用本身经历了一个 鉴于国家新生儿筛查计划没有获得知情的全国性争议的长期历史， 同意收集和测试，只有少数几个州随后增加了对研究的同意 利用残留的血迹一些州的项目和政策辩论正在进行的诉讼， 联邦一级进一步阻碍了任何促进使用新生儿筛查血斑的进展， 重要的健康研究，包括评估健康差距的研究。同意的执行 为了继续利用这一重要资源，可能需要在州一级开展工作。的 R 01的拟议更新将通过以下方式解决这些问题：确定决定因素、战略， 机制，障碍，并同意跨医院服务质量的促进因素多样化和服务不足 人口的保留和研究使用的残留干血斑的密歇根生物信托基金会的健康 (Aim 1）;让密歇根州代表性不足和非英语社区的成员参与， 支持在不同医院环境中实施电子知情同意干预（EICI）（Aim 2）;在全州四家主要医院内实施和评估EICI同意方法。 密歇根州为任职人数不足的人、讲西班牙语和阿拉伯语的与会者以及一般 人口（目标3）。