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.
Tuesday, November 20, 2007
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!
Wednesday, February 28, 2007
New York Times article on IRB demands
An article today on the ever increasing demands of Institutional Review boards in the NY Times
Friday, January 26, 2007
Financial Obligations in Research Sponsored by Private Sponsors
This is the UC policy for financial obligations in research with private sponsors (e.g. pharmaceutical companies).
Policy #32 - Date of last revision: July 6, 2006
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.
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.
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.
D. Approval by the Regents is required in all cases where the University assumes liability for a third party's actions.
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.
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.
G. Applicable University of California policies are appended to this policy.
Policy #32 - Date of last revision: July 6, 2006
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.
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.
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.
D. Approval by the Regents is required in all cases where the University assumes liability for a third party's actions.
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.
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.
G. Applicable University of California policies are appended to this policy.
Tuesday, January 23, 2007
Growth factor lay language
Lay language definition courtesy of Cancerhelp.org.uk
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.
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.
Friday, January 19, 2007
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.
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.
UCLA HIV Research Core
Welcome to my new blog for the UCLA HIV Research Core. On this blog I plan on weekly updates regarding regulatory issues. These will include:
And all sorts of other IRB/ISPRC/GCRC/MRSC/RDRC and other regulatory committee concerns.
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.
If you have something you would like me to address, please let me know and I'll work on it.
I hope this will be a resource where we can all help each other.
Thanks!
Faith Landsman
Research Administrator, UCLA HIV Research Facilitation Core
email: flandsman@mednet.ucla.edu
UCLA CARE Center Website
310-557-3675
- Where to find forms, etc.
- Standard language
- New Policies
- New Committees
- NEWS
- Breaking news
And all sorts of other IRB/ISPRC/GCRC/MRSC/RDRC and other regulatory committee concerns.
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.
If you have something you would like me to address, please let me know and I'll work on it.
I hope this will be a resource where we can all help each other.
Thanks!
Faith Landsman
Research Administrator, UCLA HIV Research Facilitation Core
email: flandsman@mednet.ucla.edu
UCLA CARE Center Website
310-557-3675
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