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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https://irb.research.chop.edu/quality-improvement-vs-research … Other IRBs would seem to disagree with you. Yes, he would need approval for a retrospective review before he published the data. Most IRBs wouldn't require a prospective one.
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Thank you for providing a link which very clearly deliniates the difference between QI and research. Giving a drug to human subjects for the purpose of “knowledge-seeking” intended to “answer a question or test a hypothesis" that "may put subjects at risk” is…research, not QI.pic.twitter.com/ohhv7FTs7D
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If you read one of the articles posted earlier, Dr. Robin Armstrong states he is doing what he would want done "for his mother or father". Which implies rather strongly he is giving the drug for the purpose of treating his patients, with answering a research question secondary.
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It doesn’t matter if answering a research question is ”secondary.” It’s STILL human subjects research. You really don’t understand the rules of clinical research, do you?

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I understand that medical literature is filled with studies where we make a change in technique, track the outcomes, then get an IRB approval for a retrospective study, and publish it. I'm doing such a study right now, looking at surgical timeouts and informed consent for surgery
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I presented another such study on foley catheter usage in pediatric populations at Pacific Coast. Doing something for the purpose of treating a patient and tracking what happens does not require an IRB. If you decide to publish, it requires a retrospective one.
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You are, quite simply, wrong on this score. You're comparing apples and oranges.
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Also, the FDA's EUA for
#hydroxychloroquine only applies to patients hospitalized with COVID-19 who don't have access to a clinical trial; so, again, using a drug off-label in this manner with the intent to publish is human subjects research and requires an IRB.2 replies 0 retweets 4 likes -
A simple question: What if it was a malaria outbreak instead of corona virus?
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