BioLINCC

自20世纪70年代中期以来，国家心肺血液研究所（NHLBI）的血液疾病和资源部（DBDR）管理着该研究所的生物标本库（NHLBI库）。存储在NHLBI存储库中的生物标本历史上来自DBDR支持的输血和血液安全性研究，涉及肝炎和HIV/AIDS。目前，来自研究所50多个研究项目的近400万份血浆、血清、细胞或组织生物标本存放在位于Sera-Care BioServices（盖瑟斯堡，马里兰州）的NHLBI储存库中。NHLBI资料库中可用的样本包括逆转录病毒流行病学供体研究（REDS）计划、檀香山心脏计划（HHP）、淋巴管平滑肌瘤病（LAM）登记、心肌梗死溶栓（TIMI）研究和镰状细胞病合作研究（CSSCD）。有关NHLBI存储库的信息可通过NHLBI公共网站http://www.nhlbi.nih.gov/resources/medres/reposit/contents.htm访问。 2000年，NHLBI从研究所支持的临床试验和观察性研究中建立了一个有限访问数据集（LADS）计划，以促进对具有良好特征的人群编制的数据的最佳使用。LADS计划目前包括来自NHLBI支持的研究的60多个数据集，由预防和人口科学司（DPPS）管理。LADS程序中的一些数据集具有NHLBI储存库中生物标本的表型/基因型信息，而其他数据集则没有。LADS计划中的数据集示例包括檀香山心脏计划（HHP）、结节病病例对照病因学研究（ACCESS）、镰状细胞病合作研究（CSSCD）和冠状动脉手术研究（卡斯）。有关LADS方案的信息可在http://www.nhlbi.nih.gov/resources/deca/default.htm上查阅。 有兴趣存储或访问NHLBI储存库生物标本和有限访问数据集的研究者适用于NHLBI。由NHLBI储存库分配委员会或收集的研究指导委员会（对于仍在进行的研究，即，在根据LADS政策获得研究数据集之前）。该委员会评估拟定研究的重要性和适当性、拟定研究的设计、研究者的资格、资金可用性以及伦理和法律的考虑因素，包括与知情同意书条款的一致性以及对人类受试者和HIPAA法规的遵守情况。对LADS数据获取请求的评价包括审查数据分发声明的完整性和适当签名，评价项目描述的适当性和与数据分发协议意图的一致性，以及当前IRB批准。 目前，两个NHLBI计划之间没有中央基础设施，以促进和最大限度地利用这两个重要资源。生物储存库和有限访问数据集信息协调中心（BioLINCC）将负责建立和维护必要的基础设施，以促进和最大限度地利用科学界的NHLBI储存库和LADS计划。获得这些资源将有助于研究人员实现NHLBI战略计划（塑造研究的未来：2007年国家心脏，肺和血液研究所的战略计划）中规定的三个研究目标。有关战略计划的信息可在http://apps.nhlbi.nih.gov/strategicplan/Default.aspx上查阅。

Since the mid-1970s, the Division of Blood Diseases and Resources (DBDR), National Heart, Lung, and Blood Institute (NHLBI) has managed the Institute's Biologic Specimen Repository (NHLBI Repository). Biospecimens stored in the NHLBI Repository have historically been de-rived from DBDR-supported transfusion and blood safety studies involving hepatitis and HIV/AIDS. Currently, almost 4 million plasma, serum, cellular or tissue biospecimens from over 50 research programs across the Institute are housed in the NHLBI Repository located at Sera-Care BioServices (Gaithersburg, Maryland). Examples of collections available at the NHLBI Repository are the Retrovirus Epidemiology Donor Study (REDS) program, the Honolulu Heart Program (HHP), the Lymphangioleiomyomatosis (LAM) Registry, the Thrombolysis in Myocar-dial Infarction (TIMI) studies and the Cooperative Study of Sickle Cell Disease (CSSCD). Infor-mation on the NHLBI Repository can be accessed through the NHLBI public website at http://www.nhlbi.nih.gov/resources/medres/reposit/contents.htm. In 2000, NHLBI established a Limited Access Data Set (LADS) program from Institute-supported clinical trials and observational studies to promote optimal use of data compiled on well charac-terized populations. The LADS program currently includes over 60 data sets from NHLBI sup-ported research studies and is managed by the Division of Prevention and Population Sciences (DPPS). Some of the data sets represented in the LADS program have phenotypic/genotypic information on biospecimens housed at the NHLBI Repository while other data sets do not. Ex-amples of data sets represented in the LADS program include the Honolulu Heart Program (HHP), A Case-Control Etiologic Study of Sarcoidosis (ACCESS), Cooperative Study of Sickle Cell Disease (CSSCD), and the Coronary Artery Surgery Study (CASS). Information on the LADS program is available at http://www.nhlbi.nih.gov/resources/deca/default.htm. Investigators interested in storing or accessing NHLBI Repository biospecimens and limited ac-cess data sets apply to the NHLBI. Evaluation of requests to access biospecimens is per-formed by the NHLBI Repository Allocation Committee or by the collection's Study Steering Committee (for studies that are still active i.e., prior to the availability of the study data set fol-lowing the LADS policy). The committee evaluates the significance and appropriateness of the proposed research, the design of the proposed research, the qualifications of the investiga-tor(s), funding availability, and ethical and legal considerations including consistency with the terms of the informed consent and compliance with human subjects and HIPAA regulations. Evaluation of requests to obtain LADS data involves a review of the Data Distribution Agree-ment for completeness and appropriate signatures, an evaluation of the project description for appropriateness and consistency with the intent of the Data Distribution Agreement, and a cur-rent IRB approval. Currently, no central infrastructure exists between the two NHLBI programs to facilitate and maximize access to these two important resources. The Biorepository and Limited Access Data Set Information Coordinating Center (BioLINCC) will be responsible for establishing and main-taining the infrastructure that is necessary to facilitate and maximize access to the NHLBI Re-pository and LADS programs by the scientific community. Access to these resources will help investigators meet the three research goals delineated in the NHLBI Strategic Plan (Shaping the Future of Research: A Strategic Plan for the National Heart, Lung and Blood Institute 2007). Information on the strategic plan is available at http://apps.nhlbi.nih.gov/strategicplan/Default.aspx .