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

描述（由申请人提供）：新生儿筛查（NBS）是对几乎每一个在美国出生的孩子进行的。经过测试，每个孩子身上都有血液残留，被许多州的卫生部门保留。残留样品已被用于各种目的，包括国家统计局项目的质量保证，法医测试和研究。我们的项目将集中在生物医学研究的残留样品的潜在用途。许多州都遇到了学术界和工业界调查人员要求获得NBS残留样本的请求。对各州方案的调查显示，各州在保留剩余样本的时间以及样本管理政策的其他方面存在很大差异。由于获取这些样本的压力以及在管理这些样本的最佳做法方面的不确定性，对政策问题指导的需求很大。由于几乎所有的州项目都缺乏新生儿筛查的知情许可，剩余NBS样本的管理变得复杂。缺乏有效的知情许可保留和使用标本，特别是与国家统计局无关的研究项目，提出了严重的伦理挑战。出于实际和伦理方面的考虑，在可预见的未来，在大多数项目中，知情同意储存和使用残留NBS样本是不可行的。有了这个假设，我们的项目更广泛的目标是评估几种方法的可行性，以获得知情的公众投入有关的样本使用的研究。虽然解决剩余样本的使用本身就很重要，但更好地理解让公众参与NBS问题的方法将有助于解决这些迅速扩大的项目的一系列重要问题。我们拟议的项目将对山区各州关于残留样品管理的政策进行全面评估。其次，我们将使用3种方法比较公众对保留和研究使用剩余样本的态度：电话/纸张调查，焦点小组，基于互联网的调查和焦点小组使用知识网络（r）面板。第三，我们将组织一个由区域和国家专家及非专业人士组成的工作组，讨论保留和使用剩余样本的示范政策要素，并评估获取知情公众投入的方法。鉴于主要研究人员与山区国家区域遗传学合作的密切工作关系，我们的项目将主要集中在该地区（UT，CO，MT，WY，TX，NM，AZ，NV）的州计划和人口。然而，该项目的组成部分将评估山区国家地区是否与其他国家的方案和受访者在关键问题上不同。我们预计，我们的研究结果将与全国各地的国家统计局计划有关。公共卫生相关性：州卫生部门保留和使用剩余新生儿筛查样本是一个重要且可能引起争议的话题。该项目将对卫生部工作人员和公众进行关于残留样本的保留和研究使用的访谈和调查。该项目还将比较在这一重要问题上获得公众意见的3种方法。该项目与公共卫生部门的政策直接相关，这些政策几乎影响到该国的每一个新生儿。

DESCRIPTION (provided by applicant): 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.