Biobanking at Birth: Parental Attitudes towards the Use of Perinatal Samples

出生时生物样本库：父母对使用围产期样本的态度

• 批准号: 8488457
• 负责人: Aaron J Goldenberg
• 金额: $ 19.63万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-15 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8488457
• 关键词: Academic Medical Centers; Address; Affect; Attitude; Authorization documentation; Belief; Biocompatible Materials; Biological; Birth; Blood Banks; Child; Childhood; Clinical; Cohort Studies; Collection; Communication Research; Confidentiality; Congenital Abnormality; Consent; Consent Forms; Data; Decision Making; Education; Educational Materials; Environmental Exposure; Epigenetic Process; Family; Gene Expression; Genetic; Genetic Variation; Goals; Health; Health Promotion; Hospitals; Informed Consent; Institutional Review Boards; Interview; National Children' s Study; Neonatal Screening; Newborn Infant; Ohio; Outcome; Parents; Participant; Pathway interactions; Perinatal; Perinatal Exposure; Phase; Physical environment; Policies; Policy Analysis; Privacy; Process; Public Health; Recruitment Activity; Research; Research Ethics; Research Personnel; Residual state; Resources; Rights; Sampling; Social Environment; Specimen; Time; Transplantation; Umbilical Cord Blood; biobank; disorder prevention; ethical legal social implication; expectation; human subject protection; improved; longitudinal design; novel strategies; premature; prenatal; prevent; programs; repository; sample collection; social

DESCRIPTION (provided by applicant): The ability to utilize biospecimens collected at the time of birth for research that integrates genetic variation, social and environmental exposures, and health outcomes may be an invaluable resource in promoting epigenetic approaches to disease prevention and health promotion. There are a growing number of perinatal biobanks in the US and globally, including many focused on preventing prematurity, specific childhood conditions, or birth defects. Additionally, a number collections are derived from existing large- scale clinical and public health programs focused on newborns and their families. However, the collection and use of these samples and data raise a number of ethical, legal and social (ELSI) concerns regarding the donors and their families. These include traditional research ethics issues, such as informed consent, donor privacy, and the return of research results, as well new challenges for researchers, IRBs, and biobanks wishing to collect samples from "donors" whose rights and control regarding their health information will change as they grow older. This project has two primary aims: 1) To assess the attitudes and beliefs of expectant and new parents about the storage and use of biological specimens collected around the time of birth for research purposes; 2) To analyze policies, educational materials, and consent documents from programs collecting biological specimens within the perinatal period to assess how well they address the concerns and desires of parents regarding the use of these samples. Participants for this study will be recruited from prenatal classes at an academic medical center in Cleveland Ohio. The project will specifically focus on three types of biospecimens collected around the time of birth: 1) biospecimens collected as part of large longitudinal research programs, such as the National Children's Study; 2) umbilical cord blood donated for storage in public banks for potential transplantation; 3) use of stored residual bloodspots from newborn screening programs. The long-term goal of this exploratory study is to utilize parental perspectives to explore whether the ELSI challenges raised by the growing use of samples and health data collected from newborns and their families suggest the need for new approaches to biobanking governance and human subject protections.

描述（由申请人提供）：利用诞生时收集的生物测量的能力来整合遗传变异，社会和环境暴露以及健康结果，可能是促进预防疾病预防和健康促进的表观遗传学方法的宝贵资源。在美国和全球范围内，越来越多的围产期生物库，包括许多专注于预防早产，特定的童年状况或出生缺陷。此外，许多集合来自现有的大规模临床和公共卫生计划，这些计划的重点是新生儿及其家人。但是，这些样本和数据的收集和使用引起了人们对捐助者及其家人的许多道德，法律和社会（ELSI）的关注。其中包括传统的研究道德问题，例如知情同意书，捐助者隐私以及研究结果的回报，以及希望从“捐助者”中收集样本的研究人员，IRB和生物群体的新挑战，他们的健康信息的权利和控制权随着年龄的增长而变化。该项目有两个主要目的：1）评估预期和新父母对出生时在出生时收集的生物标本的态度和信念； 2）分析从围产期内收集生物标本的计划的政策，教育材料和同意文件，以评估他们如何满足父母对使用这些样本的关注和愿望。这项研究的参与者将从俄亥俄州克利夫兰的学术医学中心的产前课程中招募。该项目将特别关注出生时期收集的三种类型的生物测量：1）作为大型纵向研究计划的一部分（例如国家儿童研究）收集的生物测量； 2）在公共银行存储的脐带血，以进行潜在的移植； 3）使用新生儿筛查计划中存储的残留血点。这项探索性研究的长期目标是利用父母的观点来探索越来越多的使用样本和从新生儿及其家人收集的样本和健康数据提出的ELSI挑战，这表明需要采取新方法来实现生物群体治理和人类受试者保护。