Implementing a Novel Consent Process for Biospecimen Research after Newborn Screening in Michigan Hospitals

Utah State Higher Education System--University Of Utah, Salt Lake City UT

Investigators

Linked publications & trials

Abstract

Biobanks are an enormously valuable resource for genomic research. However, incomplete collection from all populations limits their generalization for translational research. Not including biosamples from the entire population has the potential to limit the application of precision medicine. Biobanks created using stored newborn screening bloodspots can be particularly valuable resources in efforts aimed at addressing the need for samples from the entire population: 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. The implementation of consent processes at the state level may become necessary for the continued utilization of this important resource As such, new tools are needed to help individuals make informed decisions about the use of biosamples in research. The proposed renewal of our R01 will address these concerns by: identifying strategies, mechanisms, barriers, and facilitators of consenting quality across hospitals for the retention and research use of residual dried bloodspots for the Michigan BioTrust for Health (Aim 1); engaging members of multiple communities in Michigan to support implementation of a multimedia informed consent intervention (MICI) in hospital settings (Aim 2); and implementing and evaluating the EICI consent approach within four major hospitals across the state of Michigan serving unique geographical areas (Aim 3).