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.
This exploratory study will assess the attitudes and beliefs of expectant and new parents about the storage and use of biological samples and health information collected around the time of birth for future research purposes. We will also analyze the policies, educational materials, and consent forms, of clinical and public health programs that collect samples for research to see how well they address parental concerns. Our broad objective is to improve how parents are asked to participate in studies using newborn samples in order to promote valuable research while protecting children and families.