Hepatitis

Subjects are commonly tested for hepatitis B and/or C in HIV clinical trials. If your protocol includes hepatitis testing it is HIGHLY recommended that you include information in the Risks section of your protocol and consent that positive test results - which will include personally identifying information - will be reported to the State Health Department.

Additionally, it seems the IRB is frequently asking for information about counseling if subjects test positive for hepatitis. We do not provide counseling in our trials however, we note that subjects who test positive will be referred to their primary care provider for treatment.

This has, to date, been acceptable language.

Use of Rituximab and risk of PML

This is the MIRB 2 Committee's suggested language for use of Rituximab. It can go in the "Potential Risks and Discomforts section of the consent form:

PML is one of the viral infections that may develop several months after treatment with Rituxan. PML is a rare and usually fatal disease that is characterized by brain damage that worsens over time. There are no known effective treatments for PML.