FEMALE TISSUE ACQUISITION CORE

这个子项目是利用资源的许多研究子项目之一。 由NIH/NCRR资助的中心拨款提供。对子项目的主要支持 子项目的首席调查员可能是由其他来源提供的， 包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能 表示该子项目使用的中心基础设施的估计数量， 不是由NCRR赠款提供给次级项目或次级项目工作人员的直接资金。 注：表格和图表与计划摘要一起上载 1.具体目标： 梅哈里医学院是美国最大的私立、独立的、历史上一直是黑人的学术卫生中心，专门致力于教育少数民族和其他卫生专业人员。该学院尤其以其独特的、高效的教育项目、在健康差距研究方面的新兴优势、对文化敏感、以证据为基础的卫生服务以及对国家卫生职业劳动力多样性的重大贡献而闻名。梅哈里医学院拥有大量的少数族裔女性患者，特别是非裔美国人和西班牙裔女性，因此是招募这些不同群体进行研究的绝佳环境。Meharry位于田纳西州纳什维尔市中心，毗邻纳什维尔综合医院，有两个非现场卫星诊所。梅哈里妇女健康研究中心(CWHR)致力于妇女健康各个方面的临床研究，特别关注有色人种妇女。CWHR由一支拥有丰富研究和医疗经验的高技能、高经验的医生团队组成。 梅哈里对女性健康的研究一直在稳步推进，调查人员的行动具有明确的愿景和目的。然而，一个不足之处是无法随时获得来自女性生殖组织和相关生物样本的存档良好和具有良好特征的人体样本。许多已经在进行的研究项目不断需要这样的样本来验证它们在细胞系、动物模型中的临床前发现，和/或将它们的研究成果转化为临床有用的诊断或治疗应用。鉴于此，我们建议建立一个基于RCMI的女性组织获取核心(FTAC)，具体目标如下。 1)制定FTAC的标准操作程序，包括以下内容：研究设计概述、人员的关键作用、背景信息和科学原理、对纳入对象的潜在风险和益处、核心目标、基于特定纳入和排除标准的研究人群选择、研究程序的大纲和详细描述、样本收集、准备、处理和运输、意外问题和严重不良事件、统计考虑因素，如样本量考虑、受试者登记和跟进、内部和外部质量控制和质量保证、数据处理和记录保存，包括：通过识别样本保护患者机密性、数据采集方法、数据管理责任、研究记录保留、重复标本采集、协议偏差、请求样本的调查员申请表以及非RCMI调查员的核心费用。SOP中的信息将用于获得IRB的批准。 2)与MMC的组织生物医学信息学合作，建立基于网络的信息学策略，用于输入患者信息和样本数据以及样本请求跟踪。 3)在妇女健康中心发展和维持一个女性组织采集实验室(FTAC)，包括一个用于储存样本的-80℃低温冷冻室、生物安全柜、一个液氮储存箱、一个装有计算机的隔间，用于输入有关匿名受试者及其组织的信息，以及相关的组织加工用品。根据需要，FTAC将与BL3设施密切合作，进行组织处理步骤。 4)以收费方式向MMC研究人员提供不同的服务，包括：基础研究组织学、免疫组织化学、DNA和RNA提取、外周血单个核细胞和免疫学研究用血清的分离。 5)通过教育研讨会和小册子促进地方和国家对核心的利用。核心主任将提供关于核心目标和利用的教育研讨会和小册子，以促进Meharry调查人员使用FTAC，并为IRB批准的妇女健康研究提案招募受试者，包括组织样本请求。这样的核心将是对Meharry妇女健康研究的重大改进。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. NOTE: TABLES AND FIGURES WERE UPLOADED WITH PROGRAM SUMMARY 1. Specific Aims: Meharry Medical College is the nation's largest private, independent, historically black, academic health center dedicated solely to educating minority and other health professionals. The College is particularly well known for its uniquely nurturing, highly effective educational programs; emerging preeminence in health disparities research; culturally sensitive, evidence-based health services; and significant contribution to the diversity of the nation's health professions workforce. Meharry Medical College has a large patient population of minority women, particularly African American and Hispanic women, and thus is an excellent environment for recruiting these diverse groups for research studies. Meharry is located in downtown Nashville, Tennessee adjacent to Nashville General Hospital and has two offsite satellite clinics. Meharry Center for Women's Health Research (CWHR) is dedicated to clinical research studies on various aspects of women's health with a special focus on women of color. CWHR is manned by a team of highly skilled, highly experienced physicians with varied research and medical experience. Research on women's health has progressed steadily at Meharry and investigators have moved with a clear vision and purpose. One shortfall however, has been the lack of ready access to well archived and well characterized human samples from female reproductive tissues and related biological samples. Numerous research projects already underway have a continuous need for such samples to validate their preclinical findings in cell lines, in animal models, and/or to translate their research efforts into clinically useful diagnostic or therapeutic applications. Because of this, we propose to establish an RCMI-based Female Tissue Acquisition Core (FTAC) with the following Specific Aims. 1) To develop standard operating procedures for the FTAC that include the following: study design overview, key role of personnel, background information and scientific rationale, potential risks and benefits to the enrolled subjects, Objectives of the core, selection of the study population based on specific inclusion and exclusion criteria, outline and detailed description of study procedures, specimen collection, preparation, handling and shipping, unanticipated problems and serious adverse events, statistical considerations such as sample size consideration, subject enrollment and follow up, internal and external quality control and quality assurance, data handling and record keeping including: protection of patient confidentiality through deidentification of specimens, data capture method, data management responsibilities, study records retention, repeat specimen collection, and protocol deviation, an investigator application form for requesting samples, and core fees for non-RCMI investigators. The information in the SOP will be used to obtain IRB approval. 2) To work with the Tissue Biomedical Informatics at MMC to establish a web-based informatics strategy for entering patient information and specimen's data as well as specimen request tracking. 3) To develop and maintain a female tissue acquisition laboratory (FTAC) at the CWHR, including a -80C low temp freezer for storage of the samples, biological safety cabinets, a liquid nitrogen tank, a cubicle with a computer for entry of information about anonymous subjects and their tissues, and associated supplies for processing tissues. By necessity, the FTAC will work closely with the BL3 facility to conduct tissue processing steps. 4) To provide different services to MMC investigators on a fee-for-service basis including: basic research histology, immunohistochemistry, DNA and RNA extraction, isolation of peripheral blood mononuclear cells and serum for immunological studies. 5) To promote local and national utilization of the core through educational seminars and brochures. The core Director will provide educational seminars and brochures about the core objectives and utilization that promote the use of the FTAC by Meharry investigators and recruitment of subjects for IRB-approved women's health research proposals including tissue sample requests. Such a core will be a major enhancement for women's health research at Meharry.