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Collection and Distribution of Blood Samples From Healthy Donors for In Vitro Research at the NCI Frederick Cancer Research and Development Center

2014-08-27 03:44:05 | BioPortfolio

Summary

Background:

The purpose of this protocol is to establish a centralized repository for the collection and distribution of samples (either blood, buccal mucosal cells, semen, urine, or nail clippings) from paid, healthy volunteer donors for in vitro research conducted by NCI Frederick Investigators.

Objectives:

Research uses of normal donor samples obtained through this protocol will include but not be limited to genotype analysis, immune function studies, drug screening, vaccine development, method development, quality control testing of reagents, and the propagation of infectious agents, including HIV.

Although samples may be used to screen for genetic polymorphisms, this protocol will not be used to conduct genetic screening, or other types of studies, specifically designed to reveal information of known clinical relevance or implication. Further, Investigators wishing to recontact donor(s) for repeated samples when preliminary work has given rise to a research question of potential clinical relevance will seek IRB guidance on whether a separate, specific protocol should be initiated.

Eligibility:

Healthy FCRDC employees will be recruited. Potential donors will be excluded if screening indicates exposure to HIV, HTLV or Hepatitis C virus or Hepatitis B virus infection.

Study Design:

Samples provided to Investigators will be either anonymous or coded, depending on the specific need.

Codes will be securely maintained and under no circumstances will donor identity be released to Investigators.

The investigational nature of the studies in which their specimens will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and signed informed consent documents covering study participation and HIV testing will be obtained.

Donors will receive financial compensation for their time, discomfort and inconvenience according to an established schedule; compensation for blood donation is based on the volume donated.

Investigators requesting to participate in the Research Donor Program (RDP) by receiving samples for research use will be required to submit a written 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 research.

Whole blood will be collected by the standard phlebotomy technique of venipuncture of forearm veins.

Buccal mucosal cells will be collected by use of a sterile swab or brush or after oral rinse. Semen will be collected by self-masturbation at the donors' homes.

Urine and nail clippings can be collected either in donors' homes or at OHS.

Description

Background:

The purpose of this protocol is to establish a centralized repository for the collection and distribution of samples (either blood, buccal mucosal cells, semen, urine, or nail clippings) from paid, healthy volunteer donors for in vitro research conducted by NCI Frederick Investigators.

Objectives:

Research uses of normal donor samples obtained through this protocol will include but not be limited to genotype analysis, immune function studies, drug screening, vaccine development, method development, quality control testing of reagents, and the propagation of infectious agents, including HIV.

Although samples may be used to screen for genetic polymorphisms, this protocol will not be used to conduct genetic screening, or other types of studies, specifically designed to reveal information of known clinical relevance or implication. Further, Investigators wishing to recontact donor(s) for repeated samples when preliminary work has given rise to a research question of potential clinical relevance will seek IRB guidance on whether a separate, specific protocol should be initiated.

Eligibility:

Healthy FCRDC employees will be recruited. Potential donors will be excluded if screening indicates exposure to HIV, HTLV or Hepatitis C virus or Hepatitis B virus infection.

Study Design:

Samples provided to Investigators will be either anonymous or coded, depending on the specific need.

Codes will be securely maintained and under no circumstances will donor identity be released to Investigators.

The investigational nature of the studies in which their specimens will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and signed informed consent documents covering study participation and HIV testing will be obtained.

Donors will receive financial compensation for their time, discomfort and inconvenience according to an established schedule; compensation for blood donation is based on the volume donated.

Investigators requesting to participate in the Research Donor Program (RDP) by receiving samples for research use will be required to submit a written 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 research.

Whole blood will be collected by the standard phlebotomy technique of venipuncture of forearm veins.

Buccal mucosal cells will be collected by use of a sterile swab or brush or after oral rinse. Semen will be collected by self-masturbation at the donors' homes.

Urine and nail clippings can be collected either in donors' homes or at OHS.

Study Design

N/A

Conditions

Samples

Location

National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda
Maryland
United States
20892

Status

Recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:05-0400

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Testing erythrocytes to determine presence or absence of blood-group antigens, testing of serum to determine the presence or absence of antibodies to these antigens, and selecting biocompatible blood by crossmatching samples from the donor against samples from the recipient. Crossmatching is performed prior to transfusion.

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