Regulation & Ethics Core

规定

• 批准号: 10443665
• 负责人: JASON H KARLAWISH
• 金额: $ 38.37万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10443665
• 关键词: Accounting; Address; Adult; Affect; Agitation; Alzheimer' s Disease; Alzheimer' s disease related dementia; American; Caregivers; Caring; Communities; Dementia; Disease; Distress; Doctor of Medicine; Eating; Economic Burden; Emotional; Enrollment; Equilibrium; Ethical Issues; Ethics; Familiarity; Family Caregiver; Family health status; Financial Hardship; Foundations; Funding; Gatekeeping; Geriatrics; Goals; Group Homes; Guidelines; Health; Health Policy; Healthcare Systems; Human Resources; Impairment; Individual; Informed Consent; Institutional Review Boards; Insurance; International; Intervention; K-Series Research Career Programs; Laws; Linguistics; National Institute on Aging; Nomenclature; Nursing Homes; Office for Human Research Protections; Pain; Patients; Persons; Pilot Projects; Policies; Policy Research; Positioning Attribute; Pragmatic clinical trial; Process; Regulation; Research; Research Personnel; Resources; Role; Running; Services; Structure; Symptoms; System; Training; United States National Institutes of Health; Vulnerable Populations; Work; authority; base; care outcomes; career development; collaboratory; cost; decision-making capacity; dementia care; evidence base; experience; improved; interest; investigator training; multidisciplinary; novel; novel strategies; prevent; programs; social; social stigma; systems research; working group

PROJECT SUMMARY Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) place a significant social and economic burden on patients, families, and health care systems (HCS). Persons with dementia (PWD) experience distressing symptoms such as agitation, pain, and difficulty eating, and their caregivers suffer physical, emotional, and financial strain. At present, there is a limited evidence-base to support interventions and services that could address these problems. Embedded pragmatic clinical trials (ePCTs) in HCS offer an opportunity to remedy this. To be successful, however, this type of research must address the regulatory and ethical challenges of research that involves this vulnerable population and also address perceived barriers to conducting ePCTs in PWD in HCS that may be less familiar with research. Thus, the overarching objective of the Regulation and Ethics Core within the National Institute of Aging (NIA) AD/ADRD HCS Collaboratory is to clarify the appropriate balance among the competing priorities of promoting ePCTs in AD/ADRD, protecting the interests of PWD and their caregivers, and providing HCS with assurance that regulatory issues are satisfactorily addressed. The Regulation and Ethics Core will be led by Jason Karlawish M.D., a geriatrician and authority on ethical and policy issues in research and care involving PWD, and will engage a multi-disciplinary team of experts in AD/ADRD, geriatric medicine, ePCTs, health law, policy, and research regulation and ethics. The Aims are: (1) to serve as a national resource for the research community (i.e., investigators, institutional review boards, the NIA, the Office for Human Research Protections) by developing and disseminating guidelines and best practices to address the particular ethical issues and regulatory structures encountered in conducting ePCTs with PWD in their caregivers; (2) to identify and address the ethical and regulatory concerns and barriers (e.g., lack of familiarity with research, stigma and changing nomenclature) to conducting ePCTs in PWD and their caregivers from the perspectives of diverse HCS stakeholders; and (3) to provide guidance and training to AD/ADRD Collaboratory-funded pilot project leaders, career development awardees, and NIA-funded investigators, regarding ethical and regulatory issues. To achieve these aims, the Regulation and Ethics Core will collaborate closely with the other AD/ADRD Collaboratory Working Group Cores and Teams. IMPACT: There is an urgent need to improve the care provided by HCS for PWD and their caregivers; ePCTs are a novel approach to transform the delivery, quality, and outcomes of care, but PWD are a vulnerable population that present particular ethical and regulatory challenges for research. This Core will set the ethical and regulatory foundation for the conduct of ePCTs in PWD and their caregivers. We are well positioned to achieve this given our existing collaborative relationships, experience running center cores and multi-disciplinary expertise in ethical and regulatory issues encountered in research and care that involves PWD and their caregivers.

项目摘要 阿尔茨海默病和阿尔茨海默病相关痴呆（AD/ADRD）是一个重要的社会和 对患者、家庭和卫生保健系统（HCS）造成经济负担。痴呆症患者（PWD） 经历焦虑、疼痛和进食困难等令人痛苦的症状，他们的照顾者也会遭受痛苦。 身体，情绪和经济压力目前，支持干预措施的证据基础有限 以及可以解决这些问题的服务。HCS中的嵌入式实用临床试验（ePCT）提供了 有机会补救这一点。然而，为了取得成功，这种类型的研究必须解决监管和 涉及这一弱势群体的研究的伦理挑战，并解决人们认为的 在HCS的PWD中进行ePCT，可能不太熟悉研究。因此， 国家老龄化研究所（NIA）AD/ADRD HCS合作实验室的监管和伦理核心是 澄清在AD/ADRD中推广ePCT的竞争优先事项之间的适当平衡， 残疾人及其照顾者的利益，并向HCS保证监管问题令人满意， 处理。监管和道德核心将由Jason Karlawish医学博士领导，老年病专家和权威人士 就涉及残疾人士的研究和护理的道德和政策问题，并将聘请一个多学科的团队， AD/ADRD、老年医学、ePCT、卫生法、政策、研究法规和伦理方面的专家。的 目的是：（1）作为研究界的国家资源（即，研究者，机构审查 委员会、NIA、人类研究保护办公室）制定和传播指导方针， 解决在开展工作中遇到的特定道德问题和监管结构的最佳做法 照顾者中患有PWD的ePCT;（2）识别并解决伦理和监管问题和障碍 (e.g.,缺乏对研究的熟悉，耻辱和不断变化的术语）在PWD中进行ePCT， 从不同的HCS利益相关者的角度来看，他们的照顾者;（3）提供指导和培训， AD/ADRD合作资助的试点项目领导人，职业发展获奖者，以及NIA资助的 调查人员，关于道德和监管问题。为了实现这些目标，《法规和道德核心》 将与其他AD/ADRD协作工作组核心和团队密切合作。影响：在 迫切需要改善HCS为PWD及其护理人员提供的护理; ePCT是一种新的 我们需要采取一种方法来改变护理的提供、质量和结果，但残疾人是一个弱势群体， 对研究提出了特殊的伦理和监管挑战。这一核心将设定道德和监管 在PWD及其护理人员中进行ePCT的基础。我们有能力实现这一目标， 我们现有的合作关系，运行中心核心的经验和道德方面的多学科专业知识 在涉及残疾人及其护理人员的研究和护理中遇到的监管问题。