Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001846
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
1999-11-03
Brief Title:
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Status:
RECRUITING
Status Verified Date:
2024-09-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-CC-0168 | None | None | None |