Employment and Insurance Discrimination Based on Biomarkers for Alzheimer's disease

内容和摘要 在这个指导研究科学家发展奖（K 01），申请人要求研究和工资 支持提供受保护的时间和专门的培训，以制定针对 阿尔茨海默病的神经病理学生物标志物。长期的职业目标是成为一名领导者 一个研究人员，整合法律，伦理学和神经科学，以解决出现在法律的和伦理困境， 神经系统疾病拟议的研究和培训将使候选人能够执行研究 为生物标志物测试和披露的测试前和测试后咨询制定标准; 法律和政策对神经系统疾病研究和治疗的影响;以及 为政策、社会和临床实践提供信息的研究。虽然候选人在她的成就显着 领域，成为一个独立的研究，她需要培训发展（1）研究和生物统计 方法技能;（2）在神经系统疾病方面的流利程度;（3）翻译的实施科学技能 研究成果转化为政策、社会和实践的变化。成功实现培训目标的标准 包括：完成培训活动;提交竞争性R 01申请;出版目标 与法律的、政策和医学期刊上的项目目标一致;以及独立开展 定性的、实证的法律的和医疗服务研究。 诊断标准定义阿尔茨海默病开始于神经病理学生物标志物，包括正电子 发射断层摄影成像或脑脊液分析以测量淀粉样蛋白或tau蛋白。生物标志物， 在症状发作前20年可检测到，对于推进针对干预的研究至关重要。 在临床症状出现之前。然而，生物标志物使患者和研究参与者获得保险， 基于生物标志物状态的就业歧视风险。迫切需要基于证据的 开展研究，为积极主动的反歧视保护提供信息。拟议的研究使用经过验证的研究 方法从定性，经验法律的，和定量研究得出，以实现以下具体 目的：目的1：通过与患者家属的访谈，评估与AD诊断相关的歧视风险。 早期AD患者。目标2：确定和加强现有的反歧视保护 基于与AD生物标志物相关的已确定风险和患者经历。目标3：研究可行性和 在现行政策和临床范围内实施拟议的反歧视保护措施的有效性 结构。

SUMMARY AND ABSTRACT In this Mentored Research Scientist Development Award (K01), the applicant requests research and salary support to provide protected time and dedicated training to develop anti-discrimination strategies tailored to neuropathological biomarkers in Alzheimer’s disease. The long-term career goal is to become a leading researcher that integrates law, ethics, and neuroscience to resolve legal and ethical dilemmas that arise in neurological diseases. The proposed study and training will enable the candidate to execute research studies that generate standards for pre- and post- test counseling for biomarker testing and disclosure; measure the impact of law and policy on research and treatment of neurological diseases; and translate evidence based research to inform policy, social, and clinical practices. While the candidate has notable achievements in her field, to become an independent research she needs training to develop (1) research and biostatistical methods skills; (2) a fluency in neurological diseases; and (3) an implementation science skillset to translate research results into policy, social and practice changes. Criteria for successful achievement of training goals include: completion of training activities; submission of a competitive R01 application; publication targets consistent with project goals in legal, policy, and medical journals; and capabilities to independently conduct qualitative, empirical legal, and health services research. Diagnostic criteria define Alzheimer’s disease that begins with neuropathological biomarkers including positron emission tomography imaging or cerebrospinal fluid analysis to measure amyloid or tau. Biomarkers, detectable up to 20 years prior to symptom onset, are essential to advancing research that targets intervention in advance of clinical symptoms. Yet, biomarkers expose patients and research participants to insurance and employment discrimination risks based on biomarker status. There is a critical need for evidence-based research to inform proactive anti-discrimination protections. The proposed study uses validated research methods drawn from qualitative, empirical legal, and quantitative research to achieve the following specific aims: Aim 1: Assess discrimination risks related to an AD diagnosis through interviews with family members of patients with early age-of-onset AD. Aim 2: Determine and strengthen existing anti-discrimination protections based on identified risks and patient experiences related to AD biomarkers. Aim 3: Study the feasibility and effectiveness of implementing proposed anti-discrimination protections within current policy and clinical constructs.