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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Replying to @HawkguyClint @DrLesterColl and
? I'm part of a project right now to improve informed consent in pediatric surgical populations. Our plan was to use a new video, wrist band, and other procedures to improve communication of a surgery's details to parents.
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Replying to @aribindi @HawkguyClint and
For 6 weeks prior to implementation, we collected data on how much parents understood the surgery. Then we intervened, and tried to collect data for 6 weeks after (COVID made that a problem).
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Replying to @aribindi @HawkguyClint and
The IRB actually ruled at first that despite a clear intervention and data collection, what we were doing is not human subjects research. We later got another approval once we started to write up the results.
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Replying to @aribindi @HawkguyClint and
That’s because it was about improving process based on best practices and evidence-based practice. How can you not see the difference between that and giving patients an unproven drug, some without proper informed consent? SMH.

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I know what I’m talking about, too. I served for three years as associate director of a statewide QI initiative for breast cancer care.
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