California HIV Reporting

Did you know?

Laboratories are responsible for reporting ALL CD4 T-Cell test results (not just those less than 200/ul or less than 14%), as well as any HIV-indicative test – including all viral loads (even if undetectable) and confirmed antibody tests – to the Health Officer of the local health jurisdiction where the health care provider facility is located. The Health Officer’s designee – HIV Epidemiology Program – will follow-up with health care providers for laboratory reports you send to us to complete the HIV/AIDS registry.

Health care providers are responsible for providing the client's full name, date of birth, and gender when submitting laboratory requisitions for any test used to identify HIV, a component of HIV, or antibodies or antigens to HIV.

via L.A. County Department of Public Health Epidemiology Program

You must add this information into consents as it also applies to research. The language we have decided on is as follows:

Your viral load and CD4 cell counts including your personal identifying information will be reported to the State Health Department as required by law.

Massive IRB violations at the Arkansas VA

The most damning allegations follow (from the Washington Times)

• In one test the researcher did not sign nearly 200 forms until two months later.
• In four studies reviewed by the Inspector General (IG), times, dates and witness signatures differed on 103 consent forms.
• In a review of several cancer studies involving 1,400 veterans, investigators randomly sampled the files of 105 patients and could locate only 20 consent forms.
• The VA failed to pass on new drug warnings and risks in a timely manner to more than 200 participants in a smoking-cessation study who were also taking the drug Chantix. The eventual warnings of hallucinations and possible suicidal behavior were issued too late for James Elliott, who was subdued by police with a stun gun during a psychotic breakdown.
• The IG said researchers in the smoking study "did not ensure that patients involved in the smoking cessation study were notified of the risk of suicidal thoughts or behavior in a timely manner."
• The IG also said it could not confirm whether warning letters reached the intended study participants, and more than half have not signed and returned amended consent forms advising that the drug may cause hallucinations or psychotic or suicidal behavior.

Update on Web IRB

The UCLA Web IRB process is moving along. There was a setback due to the recalculation of dates for the AAHRPP accreditation.

The task force last met on February 29th and is now reviewing the forms for continuations and amendments.

It seems, as of now, that there will no longer be a difference between continuations and renewals as all of the questions will be asked in the form for each continuation. This seems to actually be a good thing and will most likely make the process that much easier.

Additionally, it seems as for the Medical Campus, Medical IRB 2 will be the first to roll out, though it hasn't quite been decided which investigators.

Check back for more updates.

Faith

Recalculation of Expiration Dates

If you are engaged in research at UCLA, you have almost certainly been informed about the recalculation of expiration dates. If you have not, if you would like to receive a copy of the memo or the Frequently Asked Questions (FAQ) page or if you have any questions about this issue, please feel free to contact me at flandsman@mednet.ucla.edu or (310) 557-3675.

Thanks.

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.

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!

New York Times article on IRB demands

An article today on the ever increasing demands of Institutional Review boards in the NY Times