Recently, state-mandated newborn screening (NBS) programs have come under intense public scrutiny due to lack of transparency and privacy concerns. Several NBS programs have faced high- profile lawsuits, resulting in the destruction of millions of blood samples. Changes in genomic technology will further transform NBS practice, dramatically increasing the number of conditions tested and the ethical complexity of screening. Expanding the scope and breadth of NBS raises value-laden concerns about privacy, and governmental intrusion in family medical decisions. To preserve the public health benefits of NBS, increased transparency is critical. Public engagement using deliberative techniques offers one approach to assuring public guidance of this vital public health program. The California Department of Public Health (CDPH) oversees the country's largest NBS program, screening an increasingly diverse population. The CDPH has made community engagement a priority for planning and policy development. Through a unique partnership with CDPH policy-makers, an experienced UCSF team proposes to use innovative and tested public engagement methods to inform policy decisions about California's NBS program. The lack of awareness of NBS necessitates an approach that provides for focused deliberation by an informed group of citizens. Deliberative community engagement (DCE) methods, rooted in deliberative democracy theory, pro- vide a framework for informed decision-making in the face of diverse, and sometimes opposing, viewpoints. The goal of the proposed project is to generate informed, deliberative, community-based recommendations to guide urgent policy decisions. Critical decisions facing the CDPH NBS program are: How should the public be involved in policy making? What policies should govern the use of leftover blood- spots for research? Should CDPH obtain permission from families for research uses of NBS? What conditions should be reported back to families? We will pursue the following specific aims: 1. Conduct a two-phase public engagement with a diverse and representative sample of lay Californians. a. Develop and implement a four-day, intensive, DCE that includes mono-lingual Spanish speakers. b. Develop and implement an online engagement and polling (OEP) tool with a sample of 1000 Californians to assess whether a larger group endorses both the DCE process and its specific recommendations. 2. Evaluate the quality, process, and legitimacy of the DCE and its impact on deliberants. a. Conduct a pre- and post-test survey to examine the impact of the DCE on deliberants. b. Using a post-event survey, assess the quality of deliberation and willingness to endorse recommendations. c. Analyze DCE transcripts to assess the engagement process and the legitimacy of recommendations. 3. Transmit recommendations from the public engagement to CDPH leaders and evaluate, using key informant interviews, the impact of recommendations on California's NBS program.
A team from the California Department of Public Health and the University of California, San Francisco will bring together a group of 30 lay Californians from diverse backgrounds to ask their advice about how the state's newborn screening program should operate, including the public's role in oversight, how many diseases should be tested for, whether blood samples can be used for research, and whether parents should be asked permission for their child to be tested. The Californians will be given detailed background information on newborn screening, the opportunity to ask questions of experts, and the chance to deliberate among themselves like a jury. Their recommendations, along with results from a survey of 1000 Californians to see if they agree or disagree with the suggestions of the original group, will be provided to the Department of Public Health's leadership to use in policy making.
|Lemke, Amy A; Harris-Wai, Julie N (2015) Stakeholder engagement in policy development: challenges and opportunities for human genomics. Genet Med 17:949-57|