Actively Recruiting
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Led by National Institutes of Health Clinical Center (CC) · Updated on 2026-05-07
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers must meet the eligibility criteria for blood donation as defined by federal regulations and AABB standards, except certain exceptions noted.
- Ability to understand, ask questions, and provide written informed consent.
- Age 18 years or older.
- Weight over 110 pounds.
- Female participants must not be pregnant.
- No known heart, lung, kidney disease, or bleeding disorders.
- No history of sickle cell disease.
- No history of high-risk activities for AIDS exposure beyond specified deferral periods.
- No history of malaria in the past 12 months.
- Donors with certain medical histories or exposures are eligible for research-only donations per protocol.
- Granulocyte donors must meet specific health criteria related to blood pressure, diabetes, cataracts, kidney function, and heart disease.
You will not qualify if you...
- Pregnant females.
- Known heart, lung, kidney disease, or bleeding disorders.
- History of sickle cell disease.
- History of engaging in high-risk activities for AIDS virus exposure beyond allowed deferral periods.
- History of malaria within the past 12 months.
- Granulocyte donors with poorly controlled hypertension, diabetes, cataracts, or heart disease.
- Donors who received an experimental drug, agent, or vaccine are deferred for one year unless collected for the administering investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Sandra Z Amamoo-Kakra
CONTACT
L
Leonard N Chen, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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