The US Department of Health and Human Services, National Institutes of Health has a continuing requirement for the Recipient Epidemiology and Donor Evaluation Study Regional Hub.

The goal of the Recipient Epidemiology and Donor Evaluation Study is to evaluate and improve the safety and availability of the blood supply as well as the safety and effectiveness of transfusion therapies with attention to not only adults, but also neonates and children who need transfusion. This will be accomplished by the establishment of a seven-year multicenter program in the US and in Brazil, charged with conducting epidemiologic and laboratory studies in blood donors and transfusion recipients. This cohesive and comprehensive multicenter program will use a multi-targeted strategy to proactively address potential threats to the nation’s blood supply; evaluate how to enhance the effectiveness and safety of transfusions; and serve as a resource for ongoing work in transfusion research. The program infrastructure will allow for evaluation of key research questions in transfusion medicine that are best studied through the analysis of a comprehensive set of epidemiological data on donors, donations, components, and transfused recipients as well as through the conduct of stand-alone multi-site clinical laboratory and observational studies. The program will include a rapid research response capability to address emerging threats to the blood supply and will be poised to evaluate a new infectious agent quickly for its prevalence and incidence among blood donors, transfusion transmission potential, risk factors, and clinical relevance to the blood recipient population and provide these data to inform the implementation of enhanced blood safety measures and policies.

NHLBI plans to support one Data Coordinating Center (DCC), one Center for Transfusion Laboratory Studies (CTLS), up to four regional hubs, and one international collaborative program in Brazil. THIS NOTICE ADDRESSES THE REGIONAL HUBS ONLY.

Each Regional Hub shall be responsible for the following requirements:

• Manage the REDS program scope of work and ensure transmission of complete and accurate scientific data from the regional hub to the REDS DCC, in accordance with the REDS Operating Procedures, protocols, and Manuals of Operations. All scientific data transmitted to the DCC shall be considered a deliverable for this contract.
• Actively participate in the REDS Steering Committee.
• Ensure access to demographically diverse adult and neonatal/pediatric patient populations and to services that perform most of the blood transfusions.
• As the hub’s blood center, collect a minimum of 75,000 allogeneic blood donations per year and be (directly or through subcontracts) the major supplier of blood to the participating hospitals within the hub, meet the FDA requirements for blood collection, and be in good standing.
• Manage the Centralized Data Collection Center (CCC).
• As a member of the Steering Committee, develop and finalize new stand-alone study protocols, as directed by the COR.
• Develop and conduct new database projects in collaboration with the REDS DCC.
• Complete all approved REDS research protocols.
• Participate in review of study proposals from non-REDS investigators.
• Collect, process, store, and ship biospecimens if required by the COR for stand-alone study protocols.
• Serve as a resource and collaborate with non-REDS funded investigators as directed by the COR.
• Help the DCC modify as appropriate and implement the Resource Dissemination Plan.
• Collaborate with other governmental agencies, non-REDS investigators, and/or existing research networks, to develop and conduct stand-alone studies and/or database projects.
• The hub shall participate in all committee and subcommittee meetings, conference calls, and other organizational training sessions of which the Principal Investigator, Co- Principal Investigator, Co-Investigators, Project Director, and hub center staff are members.
• Obtain all necessary governmental, administrative, and regulatory approvals to ensure participation in and successful completion of all studies included in the REDS research portfolio.
• Participate in the development of data analyses and disseminate research results by preparing scientific reports for publication and presentation.
• Mentor a minimum of one junior investigator in the areas of blood banking and/or transfusion medicine research and prepare the investigator to apply for grants.
• Interact with the NHLBI COR on programmatic research activity issues.
• The Contractor shall deliver to the Government, upon the expiration date of the contract, all government equipment and materials, and inventory database obtained, produced, or developed under the performance of this contract
• At the close out of the REDS program, provide any missing deliverables such as reports, a close out report detailing the completion of all project deliverables, and any unresolved issues, and ensure all government data is properly stored or transferred per the direction of the COR, and all biospecimens are stored, transferred, or destroyed per the direction of the COR.