IRB approvals? Don't hold your breath.

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

IRB approvals? Don't hold your breath.

Postby bretzke » Fri Apr 23, 2010 6:57 am

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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Postby Lyon » Fri Apr 23, 2010 7:26 am

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Postby mshusband » Fri Apr 23, 2010 8:27 am

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.
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Postby patientx » Fri Apr 23, 2010 8:39 am

Why are careful reviews by an IRB necessary? One example:

http://jme.bmj.com/content/28/1/3.full.html
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Postby Lyon » Fri Apr 23, 2010 1:15 pm

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Postby NZer1 » Fri Apr 23, 2010 1:34 pm

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
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Postby Lyon » Fri Apr 23, 2010 2:33 pm

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Postby mshusband » Tue Jun 08, 2010 6:50 pm

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
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Postby sbr487 » Wed Jun 09, 2010 12:24 am

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.
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