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).

项目总结