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、病理学和伦理学（科普）核心-摘要 临床、外展、病理学和伦理学（科普）核心的使命是道德地收集、储存和提供 艾滋病毒专性微环境（HOME）计划的科学目标所需的生物标本。 我们的计划和科普核心的一个高度创新的组成部分是围尸检翻译研究 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，通常 来自非艾滋病相关疾病，希望在死前参与艾滋病治疗相关研究， 死后捐献整个身体用于快速研究性尸检这些参与者将从 为威尔斯亲王医院提供服务的缓和医疗计划和诊所。 科普核心将实现四个具体目标： 目标1。社区外展：HOME项目的一个关键和一致的组成部分将是参与 社区合作伙伴在项目的各个阶段。我们将继续保持强大的社区和利益相关者 参与努力，以确保接受和可持续性的最后礼物队列。这将包括预定的 社区咨询小组的活动。我们还将积极参与当地的住宅姑息治疗 为威尔斯亲王医院提供临终关怀的计划。我们还将继续参与临床和研究 对于该计划的成功至关重要的合作伙伴。 目标二。最后一次捐赠队列的支持：这将包括研究招募、数据收集、预 尸体样本（例如，生殖器分泌物、脑脊髓液、淋巴结、脂肪组织和直肠活组织检查）， 运送尸体快速尸检协议和HOME项目的组织处理 目标3.支持最后一份礼物生物储存库：外部研究者将能够访问最后一份礼物 通过概念说明书审查过程建立生物储存库。科普核心将审查和组织收集 所有标本的处理，以及标本的标记、条形码、运输和冷冻保存。 目标4：临终研究的伦理：科普核心将与伦理监督委员会（EOC）合作， 审查所有最后的礼物协议和社区参与活动。平机会会评估职业操守及 与项目有关的安全问题。科普核心还将进行定性的社会行为和经验 伦理研究与最后的礼物参与者近亲/亲人，和临床和快速研究尸检人员， 确保研究的道德行为和以患者/参与者为中心的方法。