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

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 09. Apr. Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Recruitment Status: Recruiting Study Type: Observational

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: November 4, 1999, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024

Study ID:	NCT00001846 990168 99-CC-0168
Veröffentlichungen zur Studie:

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PPN (Katalog-ID):	CTG000015652