Background:~-NIH and FDA intramural investigators performing in vitro studies involving human blood components have a need for a steady, reliable, consistent source of these blood components, preferably derived from screened donors documented to be free of potential transfusion-transmissible diseases.~Objectives:~To provide a mechanism, that is reviewed and approved by IRB, for the Department of Transfusion Medicine, Clinical Center to collect and process blood and blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA laboratories for in vitro research use.~To provide adequate and complete informed consent to the donors of research blood samples, and to assure that the education, counseling, and protection of the study subjects (research blood donors) from research risks is performed in accordance with IRB, OPRR and other applicable Federal regulatory standards.~Eligibility:~Donors must meet the eligibility criteria for volunteer whole blood donation with the exception of foreign travel history and other requirements, some of which are outlined below:~Age greater than or equal to 18 years~Weight greater than 110 pounds~No known heart, lung, kidney disease, or bleeding disorders~No history of sickle cell disease~Female subjects should not be pregnant~Design:~Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques.~The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained.~Donors will be compensated according to an established schedule based on the duration and discomfort of the donation.~NIH and FDA investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research.~Blood components for research use will be distributed with a unique product number, and the DTM principal and associate investigators will serve as the custodians of the code that links the product with a donor s identity.
This protocol is designed to provide a mechanism for the Department of Transfusion Medicine, Clinical Center to collect and process blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory use. Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques. The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. NIH and FDA investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research. This protocol also provides a detailed schema for careful and frequent laboratory safety monitoring of repeat research apheresis donors.~Blood components for research use will be distributed with a unique product number, and the DTM principal and associate investigators will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood and components collected in this study will be used is not the subject of this protocol, and is not possible to describe, since it involves basic investigative efforts in greater than 170 different NIH and FDA laboratories. The intent of this protocol is not to approve the research itself, but to provide adequate and complete informed consent for the donor, and to assure that the education, counseling, and protection of the study subjects (research blood donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal regulatory standards...