Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use

This protocol is designed to provide a mechanism for the Department of Transfusion Medicine (DTM), Clinical Center (CC) 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 their 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 the donor s identity. The nature of the in vitro studies in which the blood and components collected on 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 multiple 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) are performed in accordance with the Institutional Review Board (IRB), the Office of Human Subjects Research Protection (OHSRP), and other applicable Federal regulatory standards.

• ELIGIBILITY CRITERIA:

Donors must meet the eligibility criteria for volunteer blood donation, defined in the Code of Federal Regulations 21 CFR 640, and AABB Standards as modified in the 2007 FDA/CBER Guidance Document: Eligibility Criteria for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, with the exception of foreign travel history and other conditions, as noted below:

• Ability of subject to understand, ask questions, and the willingness to provide written informed consent
• Age greater than or equal to 18 years
• Weight greater than 110 pounds
• Female subjects should not be pregnant
• No known heart, lung, kidney disease, or bleeding disorders
• No history of sickle cell disease
• No history of engaging in high-risk activities for exposure to the AIDS virus, as defined in the AABB Donor Education Materials distributed to all donors. Deferral periods for high-risk activities (MSM, IV drug use or receipt of money or drugs in exchange for sex) will not exceed the corresponding deferral period as defined for allogeneic blood donors.
• No history of malaria in the past 12 months
• Donors who have a family history of CJD, donors who have undergone tattooing or body piercing, donors who have received a graft such as bone, skin or dura mater, donors who are taking finasteride or retinoids, and donors who have had sexual contact within the past 12 months with a person who has symptomatic hepatitis C infection or donors who have lived with a person who has hepatitis in the last 12 months, are similarly eligible for research-use only donations on this protocol.
• Donors who have traveled to Europe, Africa, Asia, and areas of South America, who are rendered ineligible for allogeneic donation due to malarial risk, Zika risk and vCJD risk, are eligible for research donations
• Donors with a history of repeat false positive HTLV I/II, who are rendered ineligible for allogeneic donation, are eligible for research donations.
• Donors with a positive antibody to hepatitis B core antigen (anti-HBc) only, without other positive infectious disease markers,are eligible for research donations.
• Donors with HLA antibodies are eligible for research donations
• Donors who have received an experimental drug, agent, or vaccine, and who are referred for a research blood, plasma or leukocyte collection, specifically because they were given this drug, agent, or vaccine, are acceptable only if their research product is collected for use by the PI who administered the experimental drug, agent, or vaccine. Otherwise, they are deferred for one year after receiving an experimental drug, agent, or vaccine.
• Donors who have received a xenotransplant are eligible for research donations.
• Granulocyte donors may not receive dexamethasone if they have poorly controlled hypertension or diabetes, or if they have a history of cataracts. Hetastarch (also known as hydroxyethyl starch or "HES") and dexamethasone may elevate blood pressure and raise blood glucose levels, and repetitive steroid administration may increase the risk of posterior subcapsular cataract formation or progression.
• Granulocyte donors must have an estimated glomerular filtration (eGFR) rate of > 45ml/min/1.73m^2.
• Granulocyte donors may not receive filgrastim if they have a history or symptoms of coronary heart disease.

Investigators are informed that eligibility standards for research donors differ from those for transfusion donors through an electronic "User Agreement" which they electronically sign when they register to receive blood components on this protocol.