HTORR/ NIMH ASD and Control Brain Recovery Project

项目负责人/主要研究者（最后，第一，中间）：Bell，托马斯，J。 项目名称：HTORR/ NIMH ASD和控制脑恢复项目 项目总结（PY 7）： 人体组织和器官研究资源（HTORR）是美国国家疾病控制和预防中心的一个项目。 研究交流（NDRI），是一个重要的资源，使用定制的系统，以满足 个别研究人员要求恢复和分发广泛的高质量正常和 从不同的捐赠者库中回收患病的人体组织，以满足他们的研究需求。在2015年， NDRI建立了自闭症谱系疾病（ASD）HTORR计划，以恢复ASD和控制 大脑来支持ASD研究的进步。该计划已连续资助五年 计划年由国家精神卫生研究所（NIMH）通过行政补充（赠款） 编号5 U42 OD 011158）。这笔补充赠款使得能够建立一个 组织来源研究中心（TSS）网络，用于筛选符合条件的ASD的急性死亡转诊 和对照供体。在项目的第一年到第五年，NDRI开发并维护了一个TSS网络 14个组织来源站点，为大约6000万人口提供服务， 50万急性死亡转诊合格的捐助者候选人为这个计划。ASD HTORR计划 已经成功地制定和实施了一个标准做法， ASD和控制脑捐赠者为这一重要的研究资源。在PY 7中，该程序预测， 总共将进行15次脑复苏。此外，对于PY 7，HTORR还提出了以下关键 为了保持和加强该计划的努力，HTORR将：1）提供监督， 通过定期外展、电话会议， 2）保持筛选、授权、回收、包装和运输要求 对于ASD HTORR脑恢复网络，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）进行大脑恢复再培训活动， 需要，以保持ASD HTORR大脑恢复网络的技术专长，5）协调 供体筛选、脑恢复和ASD HTORR脑恢复网络的包装， 运送到马里兰州大学的国家健康研究所神经生物库（NIH NBB-马里兰州）， 6)提供八个ASD和七个对照大脑和匹配的颞肌样本， 年龄范围为2至30岁的NIH NBB-马里兰州，和7）促进ASD HTORR计划， NIH NBB-Maryland在两次或两次以上的全国会议上。 相关性： 自闭症谱系疾病人体组织和器官研究的建议继续 资源（ASD HTORR）计划将有助于满足未满足的人才需求， 有无自闭症病史的尸体捐献者ASD HTORR计划的建立 最大限度地确定合格的捐赠者和回收支持所需的适当生物标本 评估ASD病因的基础研究的进展，以及评估ASD病因的转化研究的进展， 有效的诊断、治疗和治愈。ASD HTORR脑恢复的增强能力 该网络还为将来从患有其他神经系统疾病的捐赠者那里回收大脑提供了机会 和疾病。 OMB编号0925-0001/0002（修订版03/2020批准至02/28/2023）页码继续格式页码

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