> The lack of risk is self evident to anyone who considers the question.
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.
I'm concerned you conflate two things. A paranoid psychiatric patient may see a world full of overwhelming risk behind everything. It does not mean that risk exists. It does mean, however, that confirming their paranoia, or seeming to, would cause a panic. We're concerned about the panic because it is unjustified. A good procedure would avoid this unjustified panic. The IRB requires a procedure that doesn't avoid it. In this way, the IRB failed to protect the interest of the patient.
> The IRB requires a procedure that doesn't avoid it
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.
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.