| Translating genomic research into benefits for human health requires large numbers of population-based biological samples. Residual bloodspots from state newborn screening programs are one potential source of specimens for these studies. However, these samples are collected within the context of a mandatory public health program aimed at benefiting individual newborns. This context raises a number of ethical, legal, and social challenges to the use of this resource for genomic research, including questions regarding consent, access, privacy, and the identifiablity of samples. Addressing these issues, moreover, raises questions about the moral justification for mandatory screening when residual samples are used for research purposes.;This dissertation investigates these ethical questions and asks whether residual bloodspots can be used as a genomic research resource without fundamentally changing newborn screening practices? Utilizing a multi-method qualitative approach, this study combines a critical analysis of policies and educational materials relevant to the research use of newborn screening samples with a case study of the development of a bloodspot biobank in Michigan. In-depth interviews were conducted with stakeholders involved in the development of the "Michigan Neonatal Biotrust" including health department officials, genetic researchers, and other public health scholars.;Results from this study suggest that the utilization of bloodspots for research does require changes to newborn screening. The biobank planners' concerns about the negative impact of research consent on the uptake of screening, and their lack of consensus about how best to involve the public and parents in decisions about the biobank provide evidence that the public health and research purposes of bloodspot collection will be impossible to separate. This underlines the need for improved education about newborn screening and some form of parental permission for the use of samples. Additionally, the research use of bloodspots warrants the expansion of the ethical frameworks used to rationalize screening to include benefits to children and populations. Lastly, this study reveals a lack of guidance for health departments and concludes with a set of recommendations for the storage and use bloodspots to help programs address the rights of families and promote the potential social goods generated through public health research. |
