HTORR/ NIMH ASD and Control Brain Recovery Project

项目主任/首席调查员(最后、第一、中间)：Bell，Thomas，J. 项目名称：HTORR/NIMH ASD和控制性脑康复项目 项目总结(PY7)： 人体组织器官研究资源(HTORR)是一项国家疾病研究计划 Research Interchange(NDRI)，是使用定制系统以满足以下要求的基本资源 个别研究人员要求回收和分发广泛的高质量正常和 从不同的捐赠者库中恢复患病的人体组织，以满足他们的研究需求。2015年， NDRI建立了自闭症谱系疾病(ASD)HTORR计划，以恢复ASD和控制ASD 大脑支持自闭症研究的进步。这项计划已经连续资助了五年 国家精神卫生研究所(NIMH)通过行政补充(赠款)提供的方案年 编号5U42OD011158)。补充赠款使得能够建立一个 组织源站点网络(TSS)，用于筛选符合条件的ASD的急性死亡转介 并控制捐赠者。在方案的第1至第5年，NDRI开发和维护了TSS网络 在为大约6000万人口提供服务的14个组织源站点中， 为该计划合格的捐赠者候选人提供500,000例急性死亡转介。ASD HTORR计划 已经成功地制定和实施了一项标准做法，以确定 ASD和控制性脑捐赠者为这一重要的研究资源。在第七财年，该计划预测 总共将进行15次大脑恢复。除了PY7，HTORR还提出了以下关键 保持和加强计划努力的目标HTORR将：1)提供监督和 通过定期外展、电话会议对ASD HTORR脑康复网络进行项目管理 和现场访问，2)维护筛选、授权、回收、包装和运输要求 对于ASD HTORR脑康复网络，3)通过以下方式维护项目的所有IRB要求 NDRI与宾夕法尼亚大学的IRB协议，包括ASD HTORR项目特定 捐赠者授权和捐赠者筛选工作表，4)开展脑康复再培训活动，如 需要，以保留ASD HTORR脑康复网络的技术专业知识，5)协调 捐赠者筛选、脑恢复，并与ASD HTORR脑恢复网络和 运往马里兰大学国家健康研究所神经生物库(NIH NBB-马里兰)， 6)提供8个ASD和7个对照大脑和匹配的来自捐赠者的颞肌样本 年龄范围从2到30岁到NIH NBB-马里兰，以及7)促进ASD HTORR计划和 NIH NBB-马里兰州在两次或两次以上的全国会议上。 相关性： 建议继续对自闭症谱系疾病人体组织和器官进行研究 进入PY7的资源(ASD HTORR)计划将有助于满足后 有和没有自闭症病史的尸检捐赠者。ASD HTORR计划的建立 最大限度地确定符合条件的捐赠者并回收支助所需的适当生物检疫制剂 ASD病因学基础研究和翻译研究评估的进展 有效的诊断、治疗和治疗。ASD HTORR脑恢复的增强能力 网络还提供了未来从患有其他神经疾病的捐赠者那里恢复大脑的机会 也有精神障碍。 OMB编号0925-0001/0002(批准的第03/2020版至2023年2月28日)续页格式页

Program Director/Principal Investigator (Last, First, Middle): Bell, Thomas, J. PROJECT TITLE: HTORR/ NIMH ASD and Control Brain Recovery Project PROJECT SUMMARY (PY7): The Human Tissue and Organ Research Resource (HTORR) is a program of the National Disease Research Interchange (NDRI) and is an essential resource that uses systems customized to meet individual researcher requests to recover and distribute a broad range of high quality normal and diseased human tissues recovered from a diverse donor pool to facilitate their research needs. In 2015, NDRI established the Autism Spectrum Disease (ASD) HTORR program to recover ASD and control brains to support the advancement of ASD research. This program has been continuously funded for five program years by the National Institute for Mental Health (NIMH) via an administrative supplement (grant number 5U42OD011158) to the parent HTORR. The supplemental grant enabled the establishment of a network of tissue source sites (TSS) for the purpose of screening acute death referrals for eligible ASD and control donors. In years 1 through 5 of the program, NDRI developed and maintained a TSS network of 14 tissue source sites that serve a population of approximately 60 million and screen approximately 500,000 acute death referrals for eligible donor candidates for this program. The ASD HTORR program has been successful with the development and implementation of a standard practice to identify both ASD and control brain donors for this important research resource. In PY7, the program predicts that a total of 15 brain recoveries will occur. In addition for PY7, HTORR is proposing the following key objectives to maintain and enhance the efforts of the program HTORR will: 1) provide oversight and project management for the ASD HTORR brain recovery network via regular outreach, conference calls and site-visits, 2) maintain the screening, authorization, recovery, packaging and shipping requirements for the ASD HTORR brain recovery network, 3) uphold all IRB requirements for the project through NDRI’s IRB protocol with the University of Pennsylvania, including the ASD HTORR project-specific donor authorization and donor screening worksheet, 4) conduct brain recovery retraining events, as needed, to preserve the technical expertise of the ASD HTORR brain recovery network, 5) coordinate donor screening, brain recovery, and packaging with the ASD HTORR brain recovery network and shipping to the National Institute of Health NeuroBioBank at the University of Maryland (NIH NBB-Maryland), 6) provide eight ASD and seven control brains and matched temporal muscle samples from donors within the age range of 2 to 30 years to the NIH NBB-Maryland, and 7) promote the ASD HTORR program and NIH NBB-Maryland at two or more national meetings. RELEVANCE: The proposed continuation of the Autism Spectrum Disease Human Tissue and Organ Research Resource (ASD HTORR) program into PY7 will help to meet the unmet demand for brains from post - mortem donors with and without a history of ASD. The establishment of the ASD HTORR program maximizes the identification of eligible donors and recovery of the appropriate biospecimens needed to support the advancement of basic research evaluating the etiology of ASD, as well as translational research assessing effective diagnostics, therapies, and cures. The enhanced capabilities of the ASD HTORR brain recovery network also provide for future opportunities to recover brains from donors with other neurological diseases and disorders as well. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page Continuation Format Page