Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Purpose
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
- Blood Donors
- Research Subjects
- Apheresis
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Criteria
- 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| research donors | healthy volunteers (age 18 years or greater) who donate blood for in vitro research purposes |
Recruiting Locations
Bethesda, Maryland 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
800-411-1222
ccopr@nih.gov
More Details
- Status
- Recruiting
- Sponsor
- National Institutes of Health Clinical Center (CC)
Detailed Description
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.