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

摘要和摘要 在这个指导研究科学家发展奖(K01)中，申请者要求研究和工资 支持提供受保护的时间和专门的培训，以制定针对以下方面的反歧视战略 阿尔茨海默病的神经病理生物标记物。长期的职业目标是成为一名领导者 研究人员，将法律、伦理和神经科学结合在一起，以解决出现的法律和伦理困境 神经系统疾病。拟议的研究和培训将使应聘者能够进行研究 为生物标志物检测和披露的检测前和检测后咨询制定标准；衡量 法律和政策对神经系统疾病研究和治疗的影响；以及基于证据的翻译 为政策、社会和临床实践提供信息的研究。虽然候选人在她身上取得了显著的成就 要成为一个独立的研究领域，她需要培训来发展(1)研究和生物统计学 方法技能；(2)流利的神经疾病；(3)需要翻译的实施科学技能 研究成果包括政策、社会和实践方面的变化。成功实现培训目标的标准 包括：完成培训活动；提交竞争性R01申请；出版目标 与法律、政策和医学期刊中的项目目标保持一致；以及独立开展工作的能力 定性的、经验性的法律和卫生服务研究。 诊断标准定义阿尔茨海默病，以包括正电子在内的神经病理生物标记物开始 发射断层扫描成像或脑脊液分析以测量淀粉样蛋白或tau。生物标志物, 可在症状出现前20年检测到，对于推进针对干预的研究至关重要 提前出现临床症状。然而，生物标记物使患者和研究参与者面临保险和 基于生物标志物地位的就业歧视风险。迫切需要以证据为基础的 为主动的反歧视保护提供信息的研究。建议的研究使用了经过验证的研究 采用定性研究、实证研究、法律研究和定量研究相结合的方法，具体做到以下几点 目标：目标1：通过与阿尔茨海默病患者家属的访谈，评估与AD诊断有关的歧视风险 初发年龄早的AD患者。目标2：确定和加强现有的反歧视保护 基于已识别的风险和与AD生物标记物相关的患者经验。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的有效性 构造。

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.