Maximizing the Scientific Value of the NHLBI Biologic Biospecimen Repository: Scientific Opportunities for Exploratory Research (R21)

This Funding Opportunity Announcement (FOA) will support meritorious exploratory research relevant to the NHLBI mission (http://www.nhlbi.nih.gov/about/org/mission) using the existing biospecimen collections that are stored in the NHLBI Biologic Specimen Repository (Biorepository), thereby maximizing the scientific value of the stored collections and providing researchers with an opportunity to generate preliminary data for subsequent research proposals.Section I. Funding Opportunity Description Purpose The purpose of this Funding Opportunity Announcement (FOA) is to stimulate exploratory research relevant to heart, lung, and blood diseases and sleep disorders using the existing biospecimen collections that are stored in the NHLBI Biorepository, thereby maximizing the scientific value of the stored collections and providing researchers with an opportunity to generate preliminary data for subsequent research proposals. Descriptions and access to the available biospecimen collections and associated datasets can be found at the NHLBI Biospecimen and Data Repository Information Coordinating Center (BioLINCC) website at www.biolincc.nhlbi.nih.gov. Background and Objectives The NHLBI Biorepository has served as a valuable scientific resource for nearly four decades by acquiring unique biospecimen collections from NHLBI-funded clinical studies and distributing samples to qualified investigators at no fee beyond the cost of shipping. The NHLBI Biorepository was initially established to support the need for archival collections to address emerging blood-safety concerns. The use of these collections led to several seminal contributions to public health such as establishing the viral origin of the agent responsible for non-A, non-B hepatitis (HCV) and transfusion transmissibility of HIV. Towards the end of the 1990s the scientific value, public health value and the cost-effectiveness of centrally maintaining biospecimens from unique populations and making them available to the research community were recognized as a key means to enhancing the scientific return on the Institute’s investment in the collection of these valuable resources. As a result, the NHLBI Biorepository mission was expanded to acquire quality biospecimens with potential scientific utility from NHLBI-funded clinical studies in heart, lung and blood diseases. As of January 2022, over 4 million richly phenotyped biospecimens from 49 NHLBI-funded clinical studies are stored in the NHLBI Biorepository and are open to the scientific community through the NHLBI BioLINCC web portal at www.biolincc.nhlbi.nih.gov. The number of collections available through BioLINCC continues to grow each year. Some examples of the collections currently available are: studies in rare diseases such as A Case Control Etiologic Study of Sarcoidosis (ACCESS), the Multicenter Hemophilia Cohort Study (MHCS), Multicenter Study of Hydroxyurea (MSH) and Hemochromatosis and Iron Overload Screening Study (HEIRS); studies from unique populations such as Honolulu Heart Program (HHP), Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2), and National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC); studies from clinical trial networks such as the Acute Respiratory Distress Syndrome Network (ARDSNet) and the Blood and Marrow Transplantation Network (BMT CTN); and studies with implications for changing clinical practice such as Action to Control Cardiovascular Risk in Diabetes (ACCORD) and the Systolic Blood Pressure Intervention Trial (SPRINT). The Biorepository also includes biospecimens from several studies on people living with HIV that are suited for HIV and HIV-related research. New collections were also acquired recently including biospecimens from the Lung Tissue Research Consortium (LTRC), the NHLBI Asthma Network (AsthmaNet), the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network, and Hydroxyurea to Prevent Organ Damage in Children with Sickle Cell Anemia study (BABY HUG). Biospecimen Availability Biospecimens available online are linked to their clinical study data in the NHLBI Data Repository and each biospecimen collection is accessed online through the parent study's BioLINCC web page. The web page provides detailed information about the parent study, research use restrictions specified by the parent study informed consent document and the number and material type of the biospecimens in the collection. Requests to search for biospecimens with specific characteristics are made using the request button at the end of the web page. The search for biospecimens fit for the proposed research question is performed by a BioLINCC and Biorepository team using the information provided by the requestor. Results are communicated back to the requestor through the BioLINCC web portal for their review and acceptance. If the search does not result in an adequate number of samples, the requestor has the opportunity to revise the criteria and continue the search. The time to complete the initial search for biospecimens varies depending on the complexity of the search parameters. Typically, responses to an initial search are provided within two weeks from submission. Additional searches will extend the search timeline. The biospecimens from successful searches are provided to qualified investigators with a funded research protocol following the procedures described on the BioLINCC website. Biospecimen Availability Requirements The process to determine the availability of biospecimens and obtain a Letter of Availability from BioLINCC is as follows: Step 1. From the BioLINCC Home page at www.biolincc.nhlbi.nih.gov select the "Studies" link from the "Biospecimen and Data Resources" menu. Step 2. Follow the search instructions on the page using specified key words and/ or material types, diseases and study type to locate potential studies with biospecimens Step 3. Select the study(ies) of interest and review the study documents, biospecimen catalogue and the informed consent restrictions provided on the study web page to find out more about the study and resources available. Step 4. Submit a request to BioLINCC using the "Request Specimens and/or Data" button at the foot of the selected study web page and follow the instructions on logging in to the BioLINCC web portal. The BioLINCC and NHLBI Biorepository team will then perform a preliminary search based on the information submitted and provide the search results to the applicant. The search results will include the availability of biospecimens from the select study(ies) and may include suggestions for alternative study collections if no/or limited biospecimens are available. If the search results do not include adequate numbers or types of biospecimens for the proposed research, then the applicant can revise the biospecimen characteristics to initiate a new search. Applicants may request a consultation with the BioLINCC and NHLBI Biorepository team prior to or during the biospecimen search to discuss which biospecimen material types and/or study collections may be considered for their proposed research protocol. Requests for a consultation prior to submitting a search request may be made using the "Contact Us" link on the BioLINCC home page. The request to search for biospecimens from a specific collection(s) available through BioLINCC (see Step 4 above) can be initiated at any time but must be initiated at least 21 days prior to the FOA Application Due Date that the applicant proposes to use. Given that the time to complete a search and provide a Letter of Availability varies due to the complexity of a search and/or the necessity to perform additional searches, applicants should ensure they allow adequate time for a search to be performed and confirmed. Supplemental Biospecimens Supplemental biospecimens from other existing collections may be used if the research question(s) cannot be fully addressed using only biospecimens available through BioLINCC. The application must justify the inclusion of other existing biospecimen collections.