tag:blogger.com,1999:blog-44342582887831250342024-03-12T17:02:18.741-07:00UCLA HIV Research Facilitation CoreFaith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.comBlogger11125tag:blogger.com,1999:blog-4434258288783125034.post-12590009548717989732009-01-16T10:54:00.000-08:002009-01-16T11:01:32.034-08:00California HIV ReportingDid you know?<br /><br />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.<br /><br /></p><p>Health care providers are responsible for providing the client's <span class="contTitle">full name</span>, 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.</p>via <a href="http://lapublichealth.org/hiv/hivreporting.htm">L.A. County Department of Public Health Epidemiology Program</a><br /><br />You must add this information into consents as it also applies to research. The language we have decided on is as follows:<br /><blockquote><br />Your viral load and CD4 cell counts including your personal identifying information will be reported to the State Health Department as required by law. </blockquote>Faith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com2tag:blogger.com,1999:blog-4434258288783125034.post-43102207424963511862008-08-06T11:11:00.001-07:002008-08-06T11:17:13.855-07:00Massive IRB violations at the Arkansas VAThe most damning allegations follow (<a href="http://www.washingtontimes.com/news/2008/aug/05/violations-rife-in-hospitals-studies-on-veterans/">from the Washington Times</a>)<br /><br /><ul><li>In one test the researcher did not sign nearly 200 forms until two months later. </li><li>In four studies reviewed by the Inspector General (IG), times, dates and witness signatures differed on 103 consent forms.</li><li>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.</li><li>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.</li><li>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."</li><li>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. </li></ul>Faith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com1tag:blogger.com,1999:blog-4434258288783125034.post-66318920506691992062008-03-03T08:52:00.000-08:002008-03-03T08:56:49.727-08:00Update on Web IRBThe UCLA Web IRB process is moving along. There was a setback due to the recalculation of dates for the AAHRPP accreditation.<br /><br />The task force last met on February 29th and is now reviewing the forms for continuations and amendments.<br /><br />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.<br /><br />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.<br /><br />Check back for more updates.<br /><br />FaithFaith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com1tag:blogger.com,1999:blog-4434258288783125034.post-29355197518994538122008-01-14T07:56:00.000-08:002008-01-14T08:01:08.626-08:00Recalculation of Expiration DatesIf 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.<br /><br />Thanks.Faith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com3tag:blogger.com,1999:blog-4434258288783125034.post-9007005023264434302007-11-20T13:59:00.000-08:002007-11-20T14:03:03.731-08:00HepatitisSubjects 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.<br /><br />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.<br /><br />This has, to date, been acceptable language.Faith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com302tag:blogger.com,1999:blog-4434258288783125034.post-49315934179790907122007-11-08T13:30:00.000-08:002007-11-20T14:03:57.322-08:00WEB 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!Faith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com2tag:blogger.com,1999:blog-4434258288783125034.post-11306009480708295312007-02-28T08:27:00.000-08:002007-02-28T08:28:36.576-08:00New York Times article on IRB demandsAn <a href="http://www.nytimes.com/2007/02/28/arts/28board.html?_r=1&hp&oref=slogin">article </a>today on the ever increasing demands of Institutional Review boards in the NY TimesFaith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com5tag:blogger.com,1999:blog-4434258288783125034.post-88400438037811292932007-01-26T10:18:00.000-08:002007-01-26T10:39:07.317-08:00Financial Obligations in Research Sponsored by Private SponsorsThis is the UC policy for financial obligations in research with private sponsors (e.g. pharmaceutical companies).<br /><br />Policy #32 - Date of last revision: July 6, 2006<br /><br />A. The cost of clinical trials of drugs or devices conducted according to the sponsor's protocols should always be fully funded by the sponsor and not supported in whole or in part with other funds, including gift or foundation funds.<br /><br />B. All costs associated with the conduct of the clinical trial must be charged to the clinical trial fund and should not be charged to other University funds or be billed to third party medical insurance, unless FDA approval for such charge is documented.<br /><br />C. The Chancellor may approve exceptions to the above requirements in individual cases in areas within his/her jurisdiction when it is in the best interest of the University.<br /><br />D. Approval by the Regents is required in all cases where the University assumes liability for a third party's actions.<br /><br />E. The sponsor must assume responsibility for reimbursing the University for reasonable cost of medical treatment for injuries directly resulting from participation in the study.<br /><br />F. It is not acceptable for such agreements to require billing of third party insurance companies in lieu of recovery of such costs from the sponsor, nor is it appropriate to accept provisions restricting participation of human subjects on the basis of medical insurance coverage status or on the subject's ability to pay.<br /><br />G. Applicable University of California policies are appended to this policy.Faith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com2tag:blogger.com,1999:blog-4434258288783125034.post-8907417376261823452007-01-23T11:29:00.000-08:002007-01-23T11:31:10.518-08:00Growth factor lay languageLay language definition courtesy of <a href="http://www.cancerhelp.org.uk/help/default.asp?page=4622">Cancerhelp.org.uk</a><br /><br />Growth factors are natural substances that stimulate the bone marrow to make blood cells. Some of these substances can now be made artificially and given as treatments to increase the number of white blood cells and stem cells in the blood.Faith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com1tag:blogger.com,1999:blog-4434258288783125034.post-6986892055827612702007-01-19T11:48:00.000-08:002007-01-19T13:13:37.649-08:00Use of Rituximab and risk of PMLThis 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:<br /><br /><strong>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.</strong>Faith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com0tag:blogger.com,1999:blog-4434258288783125034.post-60186610293974210512007-01-19T11:18:00.000-08:002007-01-19T11:34:45.138-08:00UCLA HIV Research CoreWelcome to my new blog for the <span style="color:#663366;"><strong>UCLA HIV Research Core</strong></span>. On this blog I plan on weekly updates regarding regulatory issues. These will include:<br /><br /><ul><li>Where to find forms, etc.</li><li>Standard language</li><li>New Policies</li><li>New Committees</li><li>NEWS</li><li>Breaking news </li></ul><br />And all sorts of other IRB/ISPRC/GCRC/MRSC/RDRC and other regulatory committee concerns.<br /><br />You can access all of these pages 24 hrs. a day and they will never be erased so hopefully if you're looking for standard language regarding progressive multifocal leukoencephalopathy, you will be able to find it here.<br /><br />If you have something you would like me to address, please let me know and I'll work on it.<br /><br /><br /><strong>I hope this will be a resource where we can all help each other.</strong><br /><br />Thanks!<br /><br />Faith Landsman<br />Research Administrator, UCLA HIV Research Facilitation Core<br />email: <a href="mailto:flandsman@mednet.ucla.edu">flandsman@mednet.ucla.edu</a><br /><a href="http://www.uclacarecenter.org">UCLA CARE Center Website</a><br />310-557-3675Faith Landsmanhttp://www.blogger.com/profile/09380178589987063327noreply@blogger.com2