A Comparative Analysis of the Governance and Use of Residual Dried Blood Spots from State Newborn Screening Programs and Neonatal Biobanks

Abstract

Newborn screening (NBS) using dried blood spots is a public health testing program for metabolic or genetic disorders that involves approximately four million newborns in the United States each year. Historically, the governance of each state's screening program has been left to individual states. However, in recent years, there have been movements to standardize various aspects of the programs, including collection and storage procedures and the set of disorders on the screening panel. In 2009, two lawsuits brought the uses of residual dried blood spots (rDBS) to public attention; since, a vigorous debate has developed around the use of rDBS in research. The objective of this study was to assess the current procedures for the governance and research use of rDBS from state NBS programs. This mixed-methods social science research study involved five main sources of information from both consumer and regulatory sources. The policies from two neonatal biobanks were included for comparison purposes, and content analysis was used to identify the major themes of research governance that were addressed by each policy. It was found that 38 state newborn screening programs, as well as the two neonatal biobanks, addressed the research use of rDBS in one or more of the data sources analyzed. Discoverable state research policies were outlined in an internal policy and/or a state law in 23 states, but 15 states lacked any written law or policy. Important differences between the NBS programs and biobanks included the type and number of research reviewers, the agreements required of the researcher, and the evaluation criteria used. None of the policies explained how the listed evaluation criteria would be applied during the evaluation process. Overall, this study demonstrates that there are different ways that research policies have been structured, and the highlighted features of these policies could be useful during future policy evolution and creation with respect to the governance and use of rDBS. The creation of a model policy or template, developed with cooperation between the states and input from other experts, might be the next step in addressing this issue.