Methods for Promoting Public Dialogue on the Use of Residual Newborn Screening

Newborn screening (NBS) is conducted on virtually every child born in the U.S. primarily through state-based public health programs. Following testing, there is blood leftover on each child that is retained by many state health departments. Residual samples have been used for a variety of purposes including quality assurance for the NBS programs, forensic testing, and for research. Our project will focus on the potential use of residual samples for biomedical research. Many states are experiencing requests from investigators in academia and industry for access to residual NBS samples. Surveys of state programs reveal that there is wide variability among states in how long residual samples are retained and on a variety of other aspects of policies on sample management. As a result of the pressure for access to these samples and uncertainty over best practices in their management, there is a significant demand for guidance on the policy issues. The management of residual NBS samples is complicated by the lack of informed permission for newborn screening in almost all state programs. The lack of effective informed permission for retention and use of the specimens, particularly for research projects unrelated to NBS, raises serious ethical challenges. For both practical and ethical concerns, informed permission for the storage and use of residual NBS samples is not feasible in the foreseeable future under most programs. With this assumption, the broader goal for our project is to assess the feasibility of several methods for obtaining informed public input about sample use in research. While addressing the uses of residual samples is important in its own right, a better understanding of methods to engage the public on NBS issues will be useful for addressing a range of important questions for these rapidly expanding programs. Our proposed project will conduct a comprehensive assessment of policies in the Mountain States region on the management of residual samples. Second, we will compare public attitudes on the retention and research use of residual samples using 3 methods: telephone/paper surveys, focus groups, and internet-based surveys and focus groups using a Knowledge Networks(r) panel. Third, we will organize a working group of regional and national experts and lay individuals to address model policy elements for the retention and use of residual samples and to evaluate methods to obtain informed public input. Given the close working relationship of the primary investigators with the Mountain States Regional Genetics Collaborative, our project will focus primarily on state programs and populations within this region (UT, CO, MT, WY, TX, NM, AZ, NV). However, components of the project will evaluate whether the Mountain States region differs from other state programs and respondents nationally on key issues. We anticipate that our results will have relevance to NBS programs across the country. PUBLIC HEALTH RELEVANCE: The retention and use of residual newborn screening samples by state health departments is an important and potentially controversial topic. This project will conduct interviews and surveys of health department staff and the general public about the retention and research use of residual samples. The project also will compare 3 methods of obtaining public input on this important set of issues. The project is directly relevant to policies in public health departments that affect virtually every newborn in the country.