Microbiome-Based Diagnostics: Stakeholder Perceptions and Implications for the Regulatory Framework

项目摘要 关于人类微生物组的知识状态正在迅速发展，并成为一个新兴的领域 研究和开发是基于微生物组的诊断。有很多事情还不是很清楚 基于微生物组的诊断或筛查测试结果的含义以及现有法律和 没有考虑到这些技术进步的法规不足以解决法律、 它们引发了监管、道德和社会方面的担忧。该项目的总体目标是为政策提供信息和支持 和监管方法，以刺激科学发现，发现和解决监管问题，并 减少差距，鼓励创新，同时确保以微生物为基础的新产品安全有效。 该项目的目标1是审查联邦和州政府管理诊断测试和 结果以确定它们是否适合于基于微生物组的诊断测试。我们将进行一项 对管理诊断测试的法律和法规进行全面的环境分析，以确定如何 基于微生物组的诊断目前受到监管，评估现有监督的适用性 机制(例如CLIA、FDA)，并评估对可能面临以下风险的个人是否存在法律保护 基于他们的微生物组检测结果的歧视或污名。目标2是为了更好地理解 利益相关者对基于微生物组的诊断测试的看法，包括测试效用和对医疗保健的价值 与隐私和数据安全有关的决策和关切。我们将进行深入的采访 以及由三组利益相关者组成的焦点小组-微生物组研究人员、提供者和 消费者/患者。这项研究将通过识别患者和 供应商订购这些测试的动机，评估他们对测试结果的理解，并强调问题 这增加了监管的潜在必要性。目标3是制定和提出适当和全面的 基于微生物组的诊断测试的监管框架。基于AIMS 1和AIMS的分析 2、调查人员将在一个多学科工作组的帮助下，评估目前的监管立场 基于微生物组的诊断，并评估该立场的适当性和有效性 法规在多大程度上解决了与测试相关的风险，考虑了临床有效性和 为了确保测试的实用性，确保消费者/患者收到关于 测试和测试结果的好处和风险，并确保患者适当地访问这些测试，同时还 鼓励科学创新。我们研究的预期结果是一个全面的评估。 关于当前的法律和监管格局，评价利益相关者对基于微生物组的 诊断和了解法律保护，为评估现有的监管方案提供信息 以及确定一种可行的、以患者为中心的方法来调节基于微生物组的 诊断。

Project Summary The state of knowledge regarding the human microbiome is advancing rapidly and a burgeoning new area of research and development is microbiome-based diagnostics. There is much that is not yet known about the implications of microbiome-based diagnostic or screening test results and it is possible that existing laws and regulations that did not contemplate these technological advancements are not adequate to address legal, regulatory, ethical and social concerns they raise. The overall goal of the project is to inform and support policy and regulatory approaches that stimulate scientific discovery, identify and address regulatory problems and gaps, and encourage innovation while ensuring that new microbiome-based products are safe and effective. Aim 1 of this project is to review the federal and state laws and regulations that govern diagnostic testing and results to determine if they are appropriate for microbiome-based diagnostic tests. We will conduct a comprehensive landscape analysis of laws and regulations governing diagnostic tests to determine how microbiome-based diagnostics are currently regulated,, assess the applicability of existing oversight mechanisms (e.g. CLIA, FDA), and evaluate what legal protections, if any, exist for individuals who may face discrimination or stigma based on their microbiome-based test results. Aim 2 is to better understand stakeholder perceptions of microbiome-based diagnostic tests including test utility and value to health care decision-making and concerns with regard to privacy and data security. We will conduct in-depth interviews and focus groups with three groups of stakeholders – microbiome researchers, providers and consumers/patients. This study will help inform clinicians, consumers and regulators by identifying patient and provider motivations to order these tests, assessing their understanding of test results, and highlighting issues raising the potential need for regulation. Aim 3 is to develop and propose an appropriate and comprehensive regulatory framework for microbiome-based diagnostic tests. Based on the analyses conducted in Aims 1 and 2, investigators, with the help of a multidisciplinary working group, will assess the current regulatory stance for microbiome-based diagnostics and evaluate the appropriateness and effectiveness of that stance considering the extent to which the regulations address risks associated with testing, contemplate the clinical validity and utility of the tests, ensure that consumers/patients receive accurate and adequate information about the benefits and risks of the tests and test results, and ensure appropriate patient access to these tests while also encouraging scientific innovation. The anticipated outcomes of our research are a comprehensive assessment of the current legal and regulatory landscape, evaluation of stakeholder perceptions of microbiome-based diagnostics and understanding of legal protections to inform an evaluation of the existing regulatory scheme and identification of a practicable, patient-centered approach to the regulation of microbiome-based diagnostics.