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

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 NIH Investigators
located at NCI-Frederick and Ft. Detrick.

Objectives:

Research uses of normal donor samples will include but not be limited to genotype analysis,
immune function studies, drug screening, vaccine development, method development, quality
control testing of reagents, and 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 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 NCI-Frederick employees and other NIH staff located at Ft. Detrick 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.

- INCLUSION CRITERIA:

Individuals must meet the following eligibility criteria to be entered into the RDP donor
pool:

1. Age 18 or older.

2. Weight of 110 lb or greater.

3. Registration for participation in semen donation is limited to males currently
enrolled in the donor pool.

EXCLUSION CRITERIA:

Individuals with any of the following will be excluded from the donor pool:

1. History of chronic illness which might increase the risk 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 CBC or hemotacrit:

Hemotacrit acceptable range for males: 40-51 percent.

Hemotacrit acceptable range for females: 34-46 percent.

Hemoglobin acceptable range for males: 12.5-17.0 g/dl

Hemoglobin acceptable range for females: 11.5-15.2 g/dl

7. Positive blood test for exposure to HIV-1, HIV-2, HTLV-1, HTLV-2, or HCV or positive
test for HBV surface antigens.

8. Individuals will be shown a list of activities and conditions which place them at high
risk of HIV infection and asked not to donate if any apply.

9. 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.