Trial Information

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

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 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 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.