https://en.wikipedia.org/wiki/Belmont_Report
(B) Is experimentation on suicidal patients really minimal risk? Maybe, maybe not. But failure of the investigator to show they have thought about it is a huge red flag.
(B) We're not talking about injecting the patients with some experimental drug here. We're talking about asking them questions that they were already being asked anyways. The lack of risk is self evident to anyone who considers the question.
(B) Is the lack of risk really self-evident? To everyone? Or just to you? Thus the question who should decide? And by what process do they decide?
I'm just saying that in this case the people tasked with doing the reviewing did a really bad job. And it seems like, from other things I've read, this sort of bad job isn't exactly uncommon. It would be great if the people in charge of this stuff could reform the system so that IRBs did a bad job less often.
This is one of the core flaws in bereuacracy, looking at the putative benefits of a policy without considering the costs. No one really denies that some oversight is needed, the question is, is this oversight needed?
Even the author disagrees with you (and, oddly, himself):
From the article:
> Also, psychiatric patients are sometimes…how can I put this nicely?…a little paranoid. Sometimes you can offer them breakfast and they’ll accuse you of trying to poison them. I had no illusions that I would get every single patient to consent to this study, but I felt like I could at least avoid handing them a paper saying “BY THE WAY, THIS STUDY IS FULL OF RISKS”.
If merely offering breakfast has a reasonable chance of getting re-interpreted as offering poison, offering a consent form for a test the purpose of which cannot be revealed before it is given certainly has a nonzero chance of triggering some kind of similar episode. So the risk of having such patients sign a consent form isn't zero, as the author somehow implies everywhere except this paragraph. Thus it should have been written into the risks section.
The IRB requires getting informed consent from the patient. This is not unreasonable. In fact, IMO, experimenting on people and then publishing the results of those experiments without prior informed consent is grossly unreasonable and creepy.
Parent's point is that the author concedes that in a psych ward context, even asking for consent carries serious risks. I'm not sure if this is true because I have no personal experience, but the author seems to believe it is true.
Look, it sucks that doing any research in a psych ward carries substantial risk. But that doesn't mean that you can perform experiments on psych patients without their informed consent. Even if you think that the experiment is NBD. Guess what? You're not the patient and it's not your medical data, so it's not your call. Insisting otherwise is incredibly disrespectful and dehumanizing toward psych ward patients. They are humans, they have rights, and an inconvenienced researcher is not a reasonable justification for nullifying those rights.
Are there aspects of IRBs that are infuriating and unnecessary? Absolutely. But requiring informed consent before medical data is used in a non-treatment context is -- and should be -- a basic right afforded to every patient. Even psych patients.
I hate IRBs, especially for questionnaires, and especially the stupid training. But posts like yours convince me that both are sadly necessary.