BioLINCC

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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 .