Testing Blood Samples for HIV, HBV, and HCV
Handling of blood samples during the research process exposes research staff to the risk of exposure to bloodborne pathogens, including the Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and the Hepatitis C Virus (HCV).
It is important that researchers understand their role in prospectively informing subjects of testing and reporting responsibilities should a researcher have unprotected contact with a subject's blood sample (i.e., an exposure incident), and understand whom to contact for assistance in the event of an exposure incident.
Testing and Reporting Protocol
The follow steps must be followed to test a subject's blood for the presence of HIV, HBV, and HCV:
- In the event of an exposure incident for which a link of the blood sample can be made back to the subject, prior signed consent must be obtained from the subject to test his/her blood for the presence of HIV, HBV, and HCV. See the below section titled "Obtaining Consent for Testing" for more information.
- The Principal Investigator of the research must report the incident to the IRB by submitting an adverse event report, and the IBC.
- Follow the steps prescribed by EHS's BBP Exposure Reporting Program.
- Note: The sample must be tested by a CLIA-approved laboratory, which requires a physician order prior to testing. The laboratory follows formal procedures for reporting of test results (e.g., informs patient/subject, person exposed and the local health department; ensures appropriate counseling is provided).
The above steps provide a structured process for the proper and legal testing and reporting procedures. Under no circumstance may a researcher test blood samples for the presence of HIV, HBV, and/or HCV, and/or report related findings using procedures other than those prescribed by the university.
Obtaining Consent for Testing
As discussed above, as feasible, a subject must provide consent before his/her blood may be tested for the presence of HIV, HBV, and HCV.
Unless subjects' consent will not be sought for the analysis of his/her blood (e.g., for the analysis of existing, de-identified blood samples received from an external source), the researcher must include the following information within the consent document submitted to the IRB:
- In the event a researcher or other staff person is inadvertently exposed to your blood, your blood will be tested for the presence of HIV, the Hepatitis B Virus, and the Hepatitis C Virus. There will not be any cost to you for this test. The research team will follow proper procedures for testing and reporting as outlined by Virginia State Law, which includes sending the sample to a certified laboratory. Please note that, should your blood require testing, you will be informed of your test results and provided with the opportunity to receive appropriate and timely counseling. In addition, positive test results will be sent to the local health department.
Note: Subjects must be informed (within the consent document) if the collection/analysis of blood samples is required as a condition of participation (i.e., necessary to achieve study results). If, instead, collection/analysis of blood samples is an elective portion of the research project, subjects should be asked to initial or sign a separate section of the consent form that specifically asks whether the subject consents to blood collection and/or analysis.