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IRB approvals? Don't hold your breath.

Posted: Fri Apr 23, 2010 5:57 am
by bretzke
Many medical folks have been stopped from pursuing CCSVI testing and treatment pending IRB approvals.

With neuro resistance to CCSVI theory, what are the chances ANY irb's will be approved? Have any been approved yet?

Why wouldn't IRB boards just tell everyone to wait until more formal blind studies are completed before treating/testing CCSVI?

I'll take my aluminum foil hat off now.

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Posted: Fri Apr 23, 2010 6:26 am
by Lyon
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Posted: Fri Apr 23, 2010 7:27 am
by mshusband
IRB does not serve to dictate treatment or not.

It's purpose is to protect patients during RESEARCH. If the doctor isn't doing research ... then you don't even need an IRB approval.

At this point though, they all want to do research to spread this (can't blame them).

But if you find a doctor willing, he doesn't have to go through an IRB first to treat you.

Posted: Fri Apr 23, 2010 7:39 am
by patientx
Why are careful reviews by an IRB necessary? One example:

http://jme.bmj.com/content/28/1/3.full.html

Posted: Fri Apr 23, 2010 12:15 pm
by Lyon
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Posted: Fri Apr 23, 2010 12:34 pm
by NZer1
Dr Freedman may have some input on this regarding his experiences with the death in his trail (on stem cells) where a patient died with <20 participants

Posted: Fri Apr 23, 2010 1:33 pm
by Lyon
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Posted: Tue Jun 08, 2010 5:50 pm
by mshusband
COMPLETELY off topic ... but I read this and couldn't believe it.

University of Pittsburgh Medical Center's IRB approved a "face transplant" treatment.

I'd say that's a lot more risky (or at least experimental) than CCSVI procedure ... considering only 2 have been done in the US ever.

I find this odd ... but I'm not quite sure I can articulate why ...


http://www.post-gazette.com/pg/10159/1064080-100.stm

Posted: Tue Jun 08, 2010 11:24 pm
by sbr487
As more and more people end up going abroad and have the treatment. As more and more people come back with "anecdotal" +ve outcome, it will become compelling for IRB to approve (with whatever safety protocols necessary).

They are definitely walking a thin line in this case. If CCSVI turns out to be a success, they will have a lot of explaining to do if they turn down proposals now.

Reminds me of stem cell treatment status when Bush was at helm. Lot of top notch researchers resented that they cannot carry out this research in US while its done in Korea etc. Some of them even contemplated moving to these foreign universities then. The govt later approved. Bush later said that people will wonder what this issue was all about when they look back at this years later.