A Texas doctor used his GOP connections to get hydroxychloroquine to administer to dozens of elderly patients diagnosed with COVID-19 in what he calls an "observational study." In some cases, he didn't discuss with families before prescribing the drug.https://trib.al/9wF549I
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Replying to @NPR
This is, of course, utterly unethical human experimentation.
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Dr. Gorski, I agree with the broader concerns about plaquenil, but this is really not experimentation nor is it unethical. Ironically, if he randomly chose who gets the drug and who doesn't THAT would be unethical human experimentation. But is described is standard off-label rx.
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He plans on publishing his results to add to the research on
#COVID19. That’s experimentation and he should have gotten IRB approval.
pic.twitter.com/B0vI08LTlc
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IMO the line between tracking outcomes/quality improvement and research is not always as distinct as we would like. If a surgeon adopts a ligasure for thyroidectomies, tracks OR times and bleeds, and then decides to publish them, is that research that requires a prospective IRB?
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IRB member here. This is absolutely human subjects research and requires IRB approval.pic.twitter.com/7Izw841Zi0
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Indeed. There is a distinct difference between human subjects research and QI. QI involves evaluating processes and improving adherence to evidence based guidelines. Off-label prescribing of
#Hydroxychloroquine is NOT QI, even by the most tortured definition. It’s just not.1 reply 1 retweet 10 likes -
Replying to @gorskon @DrLesterColl and
Intent is to produce scientific information to share with others = Research
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