Regulation & Ethics Core

规定

• 批准号: 10673663
• 负责人: JASON H KARLAWISH
• 金额: $ 50.57万
• 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 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673663
• 关键词: Accounting; Address; Adult; Affect; Agitation; Alzheimer' s Disease; Alzheimer' s disease related dementia; American; Authorization documentation; Caregivers; Caring; Collaborations; Communities; Dementia; Dementia caregivers; Disease; Distress; Doctor of Medicine; Eating; Economic Burden; Emotional; Enrollment; Equilibrium; Ethical Issues; Ethics; Familiarity; Family; 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; Physical Sufferings; Pilot Projects; Policies; Positioning Attribute; Pragmatic clinical trial; Process; Regulation; Research; Research Personnel; Resources; Role; Running; Services; Shapes; Structure; Symptoms; System; Training; United States National Institutes of Health; Vulnerable Populations; Work; authority; care outcomes; career development; collaboratory; cost; decision-making capacity; dementia care; efficacy trial; 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.

项目总结 阿尔茨海默病和阿尔茨海默病相关痴呆(AD/ADRD)是一种重要的社会和 患者、家庭和卫生保健系统(HCS)的经济负担。痴呆症患者(PWD) 出现烦躁、疼痛和进食困难等令人痛苦的症状时，照顾者会受到影响。 身体上、情绪上和经济上的压力。目前，支持干预措施的证据基础有限。 以及能够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，这类研究必须解决监管和 涉及弱势群体的研究的伦理挑战，并解决感知到的障碍 在可能不太熟悉研究的HCS的PWD中进行ePCT。因此，总体目标是 国家老龄研究所(NIA)AD/ADRD HCS合作实验室内的法规和伦理核心是 澄清在AD/ADRD中促进ePCT的相互竞争的优先事项之间的适当平衡，保护 保护残疾人士及其照顾者的利益，并向院舍提供保证，确保监管问题得到圆满解决 地址。监管和道德核心将由杰森·卡拉维什医学博士领导，他是一名老年病学家和权威 在涉及残疾人士的研究和护理方面的道德和政策问题，并将聘请一个多学科团队 AD/ADRD、老年医学、ePCTS、卫生法、政策以及研究法规和伦理方面的专家。这个 目标是：(1)作为研究界的国家资源(即调查人员、机构审查 委员会、NIA、人类研究保护办公室)，通过制定和传播指南和 解决特定道德问题和监管结构的最佳做法 EPCT与残疾人照顾者；(2)确定和解决道德和监管方面的关切和障碍 (例如，不熟悉研究、污名和更改命名法)到在PWD和 从不同的卫生保健服务利益攸关方的角度为他们的照顾者提供指导和培训 AD/ADRD合作实验室资助的试点项目领导人、职业发展奖获得者和NIA资助的 调查人员，涉及道德和监管问题。为了实现这些目标，法规和伦理的核心 将与AD/ADRD合作实验室工作组的其他核心和团队密切合作。影响：有 是否迫切需要改善保健中心为残障人士及其照顾者提供的护理；ePCT是一种新的 改变护理的交付、质量和结果的方法，但残障是一个弱势群体， 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 在残疾人及其照顾者中开展ePCT的基金会。我们处于有利地位，能够实现这一目标 我们现有的协作关系、运营中心核心的经验和道德方面的多学科专业知识 以及在研究和护理中遇到的涉及残疾患者及其照顾者的监管问题。