Tuesday, November 20, 2007

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.

Thursday, November 8, 2007

WEB IRB!!!!

UCLA is getting ready to upgrade to a web based IRB program. I am sitting on the Advisory Board so check back here for more information as it is available!