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中文摘要
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描述(由申请人提供):国家疾病研究交流(NDRI)是美国国立卫生研究院支持的唯一一个非营利性组织,向学术界、政府和工业界的生物医学研究人员提供各种正常和患病的人类生物谱系。NDRI的人类组织和器官研究资源(HTOR)是生物医学研究界的重要资源,因为它以负担得起的成本提供了根据研究人员的要求定制的高质量生物标本。至关重要的是,HTOR扩大其生物标本获取地点网络,以满足研究人员对人类生物标本日益增长的需求,以研究正常的人体生理和疾病的病理基础。这将通过以下方式实现:1)向生物医学研究界宣传HTOR的任务和计划,并改进研究人员的应用、方案制定和服务交付程序(目标1);2)提高HTOR全国组织获取网络的能力和能力,以采购和分发更多数量高质量、更多样化的正常和疾病人体生物标本(目标2);3)保持HTOR遵守现行HHS、HIPAA和NIH关于捐赠者同意、捐赠者保密、个人信息安全以及HTOR人员和研究人员遵守生物危害的准则和规定(目标3);4)扩大国家罕见病生物标本资源,开发国家艾滋病毒生物标本资源,分别为罕见病和艾滋病毒研究界提供更多服务(目标4);5)向政府和科学界/公众通报HTOR支持的研究项目对生物医学研究界的影响以及由此带来的医学研究进展,并提高对人体组织捐赠用于研究的价值的认识(目标5)。这项研究计划的实施将支持目前生物医学研究的趋势,这些趋势更加重视“床到床”的翻译研究、生物标记物开发和临床前药物开发。
英文摘要
DESCRIPTION (provided by applicant): The National Disease Research Interchange (NDRI) is the only not-for-profit organization supported by the NIH that provides a diverse collection of normal and diseased human biospecimens to biomedical researchers in academia, government and industry. The Human Tissue and Organ Research Resource (HTOR) of NDRI is an important resource to the biomedical research community because it provides high quality biospecimens, customized to researcher's requests, at an affordable cost. It is critical that HTOR expands its network of biospecimen acquisition sites to meet the increasing demands of researchers for human biospecimens for studies of both normal human physiology and the pathological basis of disease. This will be accomplished by, 1) communicating the HTOR mission and programs to the biomedical research community, as well as improving researcher application, protocol development and service delivery processes (Aim 1); 2) increasing the capacity and capability of the HTOR nationwide tissue acquisition network to procure and distribute greater quantities of high quality normal and disease human biospecimens of greater diversity (Aim 2); 3) maintaining HTOR compliance with current HHS, HIPAA and NIH guidelines and regulations governing donor consent, donor confidentiality, security of personal information, as well as HTOR personnel and researcher biohazard compliance (Aim 3); 4) expanding the National Rare Disease Biospecimen Resource and developing the National HIV Biospecimen Resource to provide greater service to the rare disease and HIV research communities, respectively (Aim 4), and 5) informing the government and scientific/lay public of the impact of HTOR-supported research projects on the biomedical research community and the resultant advances in medical research, as well as raising awareness of the value of human tissue donations for research (Aim 5). Implementation of this research plan will support the current trends in biomedical research that are placing greater emphasis on "bench-to-bedside" translational research, biomarker development and pre-clinical drug development.
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LYMPHANGIOLEIOMYOMATOSIS (LAM) REGISTRY
HUMAN TISSUE AND ORGAN RESOURCE FOR RESEARCH
OBTAIN TISSUES AND ORGANS FOR HIV RESEARCH
TISSUE DISTRIBUTION FOR RARE DISEASE RESEARCH
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