Core-001 - COPE Core B

Core-001 - COPE 核心 B

• 批准号: 10602740
• 负责人: SUSAN JANET LITTLE
• 金额: $ 46.87万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10602740
• 关键词: Acquired Immunodeficiency Syndrome; Adipose tissue; Adult; Altruism; Autopsy; Bar Codes; Behavioral Sciences; Biological; Biopsy; Body Fluids; Cardiovascular Diseases; Cerebrospinal Fluid; Cessation of life; Clinic; Clinical; Clinical Data; Collection; Communities; Community Outreach; Complex; Data; Data Collection; Decision Making; Degenerative Disorder; Documentation; Empirical Research; Enrollment; Ensure; Ethics; Gifts; Goals; HIV; Human; Interview; Investigation; Label; Learning; Life; Malignant Neoplasms; Mission; Modeling; Motivation; Organ; Palliative Care; Participant; Pathology; Patients; Persons; Phase; Process; Protocols documentation; Rectum; Research; Research Ethics; Research Personnel; Safety; Sampling; Schedule; Services; Social Behavior; Solid; Source; Specimen; Terminal Disease; Terminally Ill; Tissues; Translational Research; Underrepresented Populations; United States; Viral; Work; biobank; cohort; community engagement; community involvement; community organizations; end of life; end of life care; experience; genital secretion; health equity; improved; innovation; insight; loved ones; lymph nodes; meetings; member; outreach; programs; recruit; rectal; sample collection; success; tissue processing; volunteer; willingness

Core B: Clinical, Outreach, Pathology and Ethics (COPE) Core - ABSTRACT The Clinical, Outreach, Pathology and Ethics (COPE) Core’s mission is to ethically collect, store and provide the biological specimens needed for the scientific aims of the HIV Obligate MicroEnvironment (HOME) program. A highly innovative component of our program and the COPE Core is the peri-mortem translational research model, ‘Last Gift’ cohort. The cohort is comprised of persons with HIV (PWH) who have a terminal illness, usually from a non-AIDS related condition who wish to participate in HIV cure-related research before they die and donate their entire bodies after death for rapid research autopsy. These participants will be recruited from palliative care programs and clinics in San Diego that provide services to PWH. The COPE Core will fulfill four specific aims: Aim 1. Community Outreach: A critical and consistent component of the HOME project will be the involvement of community partners in all phases of the program. We will continue robust community and stakeholder engagement efforts to ensure acceptance and sustainability of the Last Gift cohort. This will consist of scheduled activities with community advisory groups. We will also actively engage with local residential palliative care programs that provide end-of-life care for PWH. We will also continue to engage with clinical and research partners who are critical to the success of the program. Aim 2. Support of the Last Gift cohort: This will include study recruitment, data collection, collection of pre- mortem samples (e.g., genital secretions, cerebrospinal fluid, lymph node, adipose tissues and rectal biopsies), body transport, rapid autopsy protocol and tissue processing for the HOME program. Aim 3. Support of the Last Gift biorepository: External investigators will be able to access the Last Gift biorepository through a concept sheet review process. The COPE Core will review and organize the collection and processing of all specimens, as well as labeling, bar coding, transporting and cryostoring of specimens. Aim 4: Ethics of end-of-life research: The COPE Core will engage an Ethics Oversight Committee (EOC) in the review of all Last Gift protocols and community engagement activities. The EOC will evaluate ethical and safety issues related to the program. The COPE Core will also conduct qualitative socio-behavioral and empirical ethics research with Last Gift participants next-of-kin/loved ones, and clinical and rapid research autopsy staff to ensure ethical conduct of research and patient/participant-centered approaches.

核心 B：临床、外展、病理学和伦理 (COPE) 核心 - 摘要 临床、外展、病理学和伦理 (COPE) 核心的使命是以合乎道德的方式收集、存储和提供 HIV 义务微环境 (HOME) 计划的科学目标所需的生物标本。 我们项目和 COPE 核心的一个高度创新的组成部分是围死期转化研究 模型，“最后的礼物”队列该队列由患有绝症的艾滋病毒感染者（PWH）组成。 来自非艾滋病相关疾病，希望在死前参与艾滋病毒治疗相关研究，并且 这些参与者将在死后捐献整个尸体以进行快速研究尸检。 圣地亚哥的姑息治疗项目和诊所为 PWH 提供服务。 COPE 核心将实现四个具体目标： 目标 1. 社区外展：HOME 项目的一个关键且一致的组成部分将是参与 我们将在该计划的各个阶段继续保持社区和利益相关者的强大。 确保“最后的礼物”群体的接受和可持续性的参与努力这将包括预定的内容。 我们还将积极参与当地的住院姑息治疗。 我们还将继续参与临床和研究。 对项目成功至关重要的合作伙伴。 目标 2. 支持最后的礼物队列：这将包括研究招募、数据收集、预 尸检样本（例如生殖器分泌物、脑脊液、淋巴结、脂肪组织和直肠活检）， HOME 程序的尸体运输、快速尸检协议和组织处理。 目标 3. 支持“最后的礼物”生物存储库：外部研究人员将能够访问“最后的礼物” COPE 核心将通过概念表审查流程审查和组织收集品。 所有样本的处理和处理，以及样本的标签、条形码、运输和冷冻保存。 目标 4：临终研究的伦理：COPE 核心将聘请伦理监督委员会 (EOC) 对所有《最后的礼物》协议和社区参与活动的审查将评估道德和道德。 COPE 核心还将进行定性社会行为和实证研究。 与“最后的礼物”参与者的近亲/亲人以及临床和快速研究尸检人员进行伦理研究 确保研究的道德行为和以患者/参与者为中心的方法。