Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jun 19, 2006

Keywords

ClinConnect Summary

Background

-NCI-Frederick scientists performing in vitro studies involving human specimens have a need for a reliable and consistent source of samples which protects the donor from research risks.

Objective

-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, feces, nasopharyngeal swabs, or nail clippings) from paid, healthy volunteer donors for in vitro research conducted by NIH investigators located at NCI-Frederick and Ft. Detrick. Research will include, but are not limi...

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• Individuals must meet the following eligibility criteria to be entered into the RDP donor pool, as follows:
• • 1. Age 18 or older.
• • 2. Weight of 110 lb or greater.
• • 3. All subjects must have the ability and agree to participate fully and comply with the procedures of the protocol and provide informed consent.
• • 4. Registration for participation in semen donation is limited to males currently enrolled in the donor pool.
• • 5. Subjects must be NCI Frederick Employees
• EXCLUSION CRITERIA:
• Individuals with any of the following will be excluded from the donor pool:
• • 1. History of chronic illness that might increase the risks associated with phlebotomy, including but not limited to heart, lung, or kidney disease
• • 2. Current acute illness.
• • 3. History of clotting disorders.
• • 4. Current medications which might increase the risk associated with phlebotomy.
• • 5. History of syncope or other difficulty with venipuncture.
• • 6. Anemia, as determined by hematocrit or hemoglobin.
• • Hematocrit acceptable range for males: 40-51 percent.
• • Hematocrit acceptable range for females: 34-46 percent.
• • 7. Hemoglobin acceptable range for males: 12.5-17.0 g/dl
• • Hemoglobin acceptable range for females: 11.5-15.2 g/dl
• • 8. Positive blood test for exposure to HIV-1, HIV-2, HTLV-1, HTLV-2, or HCV or for HBV surface antigens.
• • 9. Individuals whose activities or conditions place them at high risk of HIV infection are asked not to donate.
• • 10. Males who qualify for participation in the donor pool will be excluded from participation in semen donation if they have knowingly had any injury, infection, or treatment performed that renders them incapable of producing sperm.
• • 11. Pregnancy: Pregnant women will not be allowed to enroll in this study because there is no benefit.