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

描述（由申请人提供）：利用出生时收集的生物标本进行研究的能力，整合了遗传变异，社会和环境暴露以及健康结果，这可能是促进疾病预防和健康促进的表观遗传方法的宝贵资源。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、特定儿童疾病或出生缺陷的生物库。此外，一些收集来自现有的大规模临床和公共卫生计划，重点是新生儿及其家庭。然而，这些样本和数据的收集和使用引起了一些关于捐赠者及其家人的伦理、法律的和社会（ELSI）问题。这些问题包括传统的研究伦理问题，如知情同意，捐赠者隐私和研究结果的回报，以及研究人员，IRB和生物库希望从“捐赠者”那里收集样本的新挑战，这些捐赠者的权利和控制他们的健康信息将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储存和使用出生前后收集的生物标本用于研究目的的态度和信念; 2）分析政策、教育材料，和同意文件，从计划收集生物标本在围产期内，以评估他们如何解决的关注和愿望的父母有关使用这些样品。这项研究的参与者将从俄亥俄州克利夫兰的一个学术医学中心的产前课程中招募。该项目将特别关注在出生时收集的三种类型的生物标本：1）作为大型纵向研究计划的一部分收集的生物标本，如国家儿童研究; 2）捐赠的脐带血储存在公共银行，用于潜在的移植; 3）使用新生儿筛查计划中储存的残留血斑。这项探索性研究的长期目标是利用父母的观点来探讨越来越多地使用从新生儿及其家庭收集的样本和健康数据所带来的ELSI挑战是否表明需要采取新的方法来进行生物库管理和人类受试者保护。

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.