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.
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