Core-001 - COPE Core B

核心B：临床、外展、病理和伦理(COPE)核心-摘要 临床、外展、病理和伦理(COPE)核心的使命是从伦理上收集、存储和提供 艾滋病毒专属微环境(家庭)计划的科学目标所需的生物标本。 我们的项目和COPE核心的一个高度创新的组成部分是临终翻译研究 模特，《最后的礼物》队列。队列由患有晚期疾病的艾滋病毒(PWH)患者组成，通常 来自非艾滋病相关疾病，他们希望在死前参与艾滋病毒治疗相关研究，并 在他们死后捐献整个身体进行快速研究尸检。这些参与者将从以下地点招募 圣地亚哥为威尔斯亲王医院提供服务的姑息关怀计划和诊所。 COPE核心将实现四个具体目标： 目标1.社区外联：家庭项目的一个关键和一贯的组成部分将是参与 社区合作伙伴参与该计划的所有阶段。我们将继续发展强大的社区和利益相关者 参与努力，以确保最后一份礼物的接受度和可持续性。这将包括计划的 与社区咨询小组的活动。我们还将积极参与当地的住宿姑息关怀 为威斯康星医院提供临终关怀的计划。我们还将继续从事临床和研究工作 对该计划的成功至关重要的合作伙伴。 目标2.对最后一份礼物队列的支持：这将包括招收学生、收集数据、收集 尸检样本(如生殖器分泌物、脑脊液、淋巴结、脂肪组织和直肠活检)， 身体运输，快速尸检协议和家庭计划的组织处理。 目标3.支持最后一份礼物生物储存库：外部调查人员将能够访问最后一份礼物 通过概念表审查过程建立生物信息库。COPE CORE将审查和组织收集 以及所有标本的加工，以及标本的标记、条形码、运输和冷冻储存。 目标4：临终研究的伦理：COPE核心将在#年与伦理监督委员会(EOC)合作 回顾所有最后的赠品协议和社区参与活动。平机会将评估道德和 与该计划相关的安全问题。COPE核心还将进行定性的社会行为和经验研究 最后一份礼物的伦理研究参与者的近亲/亲人，以及临床和快速研究尸检人员 确保研究和以患者/参与者为中心的方法的合乎道德的进行。

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.