Collection
of Body Fluids
If you are planning to collect body fluids or tissue, a statement that indicates that persons at increased risk for Hepatitis B or C or HIV (AIDS) infections should not donate blood or other body fluids. In order to locate source subjects quickly, the informed consent document should contain the current address and telephone number of the subject. Compulsory screening of source subjects for infections should not be done except where such screening is required to protect the validity of the research data. In those cases where an investigator asserts that screening is necessary, the need for such testing must be justified to the IRB. A sample statement follows:
Persons who have ever had hepatitis B or C, who have tested positive for HIV or any AIDS virus, or persons who have AIDS should not donate body fluids or tissues. Persons at risk for getting and spreading any AIDS virus also should not donate body fluids or tissue and should not participate in this investigation. You are at risk if:
1. You are a man who has had sex with another man since 1977, even one time.
2. You have shared a needle, even one time, to inject drugs or medication.
3. You have taken clotting factor concentrates for a bleeding disorder such as hemophilia.
4. You have ever had a positive test for any AIDS virus or Hepatitis B or C or any AIDS antibody.
5. You have had sex with any person described above.
6. You have had sex with a male or female prostitute since 1977.
The IRB has developed guidelines for preventing the transmission of infection in University research laboratories. The purpose of the guidelines is to establish procedures to protect laboratory workers and source subjects from exposure to infectious or potentially infectious human material in University research laboratories.