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）：利用出生时收集的生物样本进行整合遗传变异、社会和环境暴露以及健康结果的研究的能力可能是促进表观遗传学方法预防疾病和促进健康的宝贵资源。美国和全球范围内的围产期生物库数量不断增加，其中许多专注于预防早产、特定儿童疾病或出生缺陷。此外，许多收藏来自现有的针对新生儿及其家庭的大规模临床和公共卫生项目。然而，这些样本和数据的收集和使用引起了有关捐赠者及其家人的许多道德、法律和社会 (ELSI) 担忧。其中包括传统的研究伦理问题，例如知情同意、捐赠者隐私和研究结果的返还，以及希望从“捐赠者”那里收集样本的研究人员、IRB和生物样本库面临的新挑战，“捐赠者”对其健康信息的权利和控制将受到影响。随着年龄的增长而改变。该项目有两个主要目标： 1) 评估准父母和新父母对于出于研究目的而存储和使用在出生前后收集的生物样本的态度和信念； 2) 分析围产期生物样本采集项目的政策、教育材料和同意文件，以评估它们如何很好地解决父母对使用这些样本的担忧和愿望。这项研究的参与者将从俄亥俄州克利夫兰的一个学术医疗中心的产前课程中招募。该项目将特别关注在出生前后收集的三类生物样本：1）作为大型纵向研究计划（例如国家儿童研究）的一部分收集的生物样本； 2) 捐献的脐带血储存在公共银行以供移植； 3) 使用新生儿筛查项目中储存的残留血斑。这项探索性研究的长期目标是利用父母的观点来探讨由于越来越多地使用从新生儿及其家人收集的样本和健康数据而带来的 ELSI 挑战是否表明需要采取新的生物样本库治理和人类受试者保护方法。