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）主要通过以州为基础的公共卫生计划对美国出生的几乎每个孩子进行。在测试之后，每个孩子身上都有剩余的血液，这些血液被许多州卫生部门保留下来。残留样本已用于各种目的，包括国家统计局计划的质量保证，法医测试和研究。我们的项目将侧重于剩余样本在生物医学研究中的潜在用途。许多州正在经历来自学术界和工业界调查人员的请求，要求获得国家统计局的剩余样本。对各州计划的调查显示，各州在保留剩余样本的时间长短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和对其管理最佳做法的不确定性，对政策问题的指导有很大的需求。由于在几乎所有的州计划中缺乏新生儿筛查的知情许可，国家统计局剩余样本的管理变得复杂。缺乏有效的保留和使用标本的知情许可，特别是与国家统计局无关的研究项目，引发了严重的伦理挑战。出于实际和伦理考虑，在可预见的未来，在大多数计划下，对剩余国家统计局样本的存储和使用的知情许可是不可行的。有了这个假设，我们项目更广泛的目标是评估几种方法的可行性，以获得关于研究中样本使用的知情公众意见。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国家统计局问题的方法，将有助于解决这些迅速扩大的项目的一系列重要问题。我们提议的项目将对山地国家地区关于残余样本管理的政策进行全面评估。其次，我们将通过三种方法比较公众对剩余样本保留和研究使用的态度：电话/纸质调查、焦点小组、基于互联网的调查和使用知识网络(r)小组的焦点小组。第三，我们将组织一个由地区和国家专家和非专业人士组成的工作组，以解决保留和使用剩余样本的模范政策要素，并评估获得知情公众意见的方法。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，我们的项目将主要关注该地区（UT， CO， MT， WY， TX， NM， AZ， NV）的国家计划和人口。然而，该项目的组成部分将评估山区地区是否与其他州的项目和全国受访者在关键问题上有所不同。我们预计我们的研究结果将与全国的国家统计局项目相关。公共卫生相关性：国家卫生部门保留和使用剩余的新生儿筛查样本是一个重要的和潜在的争议话题。该项目将对卫生部门工作人员和公众就剩余样本的保留和研究用途进行访谈和调查。该项目还将比较在这一系列重要问题上获得公众意见的三种方法。该项目与影响到该国几乎每一个新生儿的公共卫生部门的政策直接相关。

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.