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

What this Trial Is About

Researchers are collecting and processing blood components from healthy, paid volunteer donors to provide samples for laboratory research at NIH and FDA. The study ensures that donors meet specific eligibility criteria and receive detailed explanations about the investigational use of their blood, including risks and discomforts. Donors give informed consent and receive compensation based on the donation's duration and discomfort. The collected blood is used only for in vitro research, not in living subjects, and is distributed with unique product codes while maintaining donor confidentiality. Donors provide blood and blood components through standard phlebotomy and apheresis methods. Requests for these components come from NIH and FDA investigators who submit electronic memos describing their research and confirming the in vitro use of the samples. The study includes careful and frequent laboratory safety monitoring for donors who repeatedly undergo apheresis. The investigators responsible for the study manage the linking code that maintains donor privacy. Participants will be involved in blood donation procedures and safety monitoring throughout the study. Researchers track the provision of samples to research teams quarterly as the primary outcome. The study follows strict federal regulations and ethical standards, ensuring donor education, counseling, and protection. Participation involves regular assessments to maintain donor safety and data accuracy, with no in vivo use of the donated materials.

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