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Who exactly needs to get approval from an institutional review board (IRB)?

dynomight.net

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Re: Who exactly needs to get approval from an institutional review board (IRB)?

#2
The article is about medical research on human subjects. And quickly concedes that a great many technically-need-permission things which you might do are of no actual interest to the gov't.

EDIT: The second sentence of the article is -

> Like, let’s eat potatoes and see if we lose weight.

- which, in the minds of 95% of likely jury members, is not "medical research". Nor, at small scale, of plausible interest to the gov't.

If the US Gov't is looking for excuses to crush me, or I've got enough money to be worth a lawsuit, then nothing resembling medical research is needed for them to go ahead with those. Doubtless, I evilly conspired to not pay $0.06 of Use Tax in 2003. And some poor innocent was traumatized for life by my cat looking at them cross-eyed, in a photo I put on the web.

And, notice my phrasing - "of no actual interest to the gov't". Not "IAAL, and you're 100.00% okay to run with this".

Re: Who exactly needs to get approval from an institutional review board (IRB)?

#4
post #2

The article is about medical research on human subjects. And quickly concedes that a great many technically -need-permission things which you might do are of no actual interest to the gov't. EDIT: The second sentence of the article is - > Like, let’s eat potatoes and see if we lose weight. - which, in the minds of 95% of likely jury members , is not "medical research". Nor, at small scale, of plausible interest to th…

People might still sue you.

I had a stressful event and had a psychogenic fever and lost 15 pounds in two weeks and kept it off for more than six months. There is some research on this [1] [2] in particularly that author wrote a case study about a Japanese girl who was bullied at school who developed a stress fever.

Given there is an obesity crisis and everything this might be an effective diet plan, but to do it, you have to induce severe stress. A protocol might be "get 30 people to show up for a weekend encounter group, pick out the 1 person who seems the most susceptible, have the other 29 bully that person." Cal Lightman might get away with something like that in Lie to Me but no way you can get away with that in real life.

[1] https://pubmed.ncbi.nlm.nih.gov/27227051/

[2] https://pubmed.ncbi.nlm.nih.gov/30459027/

Re: Who exactly needs to get approval from an institutional review board (IRB)?

#5
post #2

The article is about medical research on human subjects. And quickly concedes that a great many technically -need-permission things which you might do are of no actual interest to the gov't. EDIT: The second sentence of the article is - > Like, let’s eat potatoes and see if we lose weight. - which, in the minds of 95% of likely jury members , is not "medical research". Nor, at small scale, of plausible interest to th…

That's playing with fire.

You could find yourself standing in front of a courtroom if something goes wrong, or God Forbid, if someone dies, trying to convince a judge and jury with nothing but, "I didn't need government permission".

That's not a good place to be.

Re: Who exactly needs to get approval from an institutional review board (IRB)?

#6
post #2

The article is about medical research on human subjects. And quickly concedes that a great many technically -need-permission things which you might do are of no actual interest to the gov't. EDIT: The second sentence of the article is - > Like, let’s eat potatoes and see if we lose weight. - which, in the minds of 95% of likely jury members , is not "medical research". Nor, at small scale, of plausible interest to th…

People might still sue you. I had a stressful event and had a psychogenic fever and lost 15 pounds in two weeks and kept it off for more than six months. There is some research on this [1] [2] in particularly that author wrote a case study about a Japanese girl who was bullied at school who developed a stress fever. Given there is an obesity crisis and everything this might be an effective diet plan, but to do it, yo…

You can only get away with weird social bullying experiments if you're doing it for Youtube.

Don't try crashing a plane for Youtube though, that went down badly with the FAA.

Re: Who exactly needs to get approval from an institutional review board (IRB)?

#7
post #2

The article is about medical research on human subjects. And quickly concedes that a great many technically -need-permission things which you might do are of no actual interest to the gov't. EDIT: The second sentence of the article is - > Like, let’s eat potatoes and see if we lose weight. - which, in the minds of 95% of likely jury members , is not "medical research". Nor, at small scale, of plausible interest to th…

Of no actual interest to the government, unless you are someone that someone in the government wishes to crush. ‘Gosh, Opponent of the Regime, when you wrote your blog entry in 2019 about cutting eggs out of your kids’ diets, that was un-reviewed human research. To jail with you!’

Re: Who exactly needs to get approval from an institutional review board (IRB)?

#8
post #6

Earlier quoted context omitted.

People might still sue you. I had a stressful event and had a psychogenic fever and lost 15 pounds in two weeks and kept it off for more than six months. There is some research on this [1] [2] in particularly that author wrote a case study about a Japanese girl who was bullied at school who developed a stress fever. Given there is an obesity crisis and everything this might be an effective diet plan, but to do it, yo…

You can only get away with weird social bullying experiments if you're doing it for Youtube. Don't try crashing a plane for Youtube though, that went down badly with the FAA.

There was a driver in California who would provoke people on the road and then capture their unhinged reactions on YouTube, editing out the provocation.

Eventually he got in a car crash and got in a lot of trouble.

Re: Who exactly needs to get approval from an institutional review board (IRB)?

#9
post #5
post #2

The article is about medical research on human subjects. And quickly concedes that a great many technically -need-permission things which you might do are of no actual interest to the gov't. EDIT: The second sentence of the article is - > Like, let’s eat potatoes and see if we lose weight. - which, in the minds of 95% of likely jury members , is not "medical research". Nor, at small scale, of plausible interest to th…

That's playing with fire. You could find yourself standing in front of a courtroom if something goes wrong, or God Forbid, if someone dies, trying to convince a judge and jury with nothing but, "I didn't need government permission". That's not a good place to be.

I used to facilitate the use of an alternative medicine (kambo), which could be dangerous if used incorrectly or given to someone with a contraindicated condition. (It has been linked to a few deaths and has recently been banned in Australia). It occurred to me that even a great signed waiver wouldn't save me if something went sideways and decided to stop. I honestly don't think a waiver wouldn't matter in cases like this too.

Re: Who exactly needs to get approval from an institutional review board (IRB)?

#10
I mean tons of retrospective studies are literally "IRB exempt" (and highlighted as such in their methods) where no explicit consent is required or needed. Physicians doing case reviews don't need consent of the patient this work. Doing retrospective analyses for defining clinical phenotypes on patient data that has been aggregated isn't needed either. Collecting clinical MRIs to do deep learning doesn't require an IRB.

IRBs are only REALLY required when you are intervening in patient care or pose some theoretical risk to a human.

Some institutions still want you to submit approval for institutional data, but as a non-lawyer it seems that's much more of a CYA policy.

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