3 ms·

(A) The rules are not arbitrary. They are the product of much careful deliberation. https://en.wikipedia.org/wiki/Belmont_Report https://en.wikipedia.org/wiki

by xr4ti 9y ago

(A) The rules are not arbitrary. They are the product of much careful deliberation. https://en.wikipedia.org/wiki/Belmont_Report 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.

harryh 9y ago
(A) They were arbitrarily imposed in this case. Just because a rule is a good idea doesn't mean it is a good idea all the time. (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.
- xr4ti 9y ago
  (A) This is kind of a red herring though. The rules are not uniform. Sick patients require more protections than healthy adults. Placing an implant in someone's leg requires a more comprehensive risk minimization plan than asking someone to look at the ground for 5 seconds and then read a flash card. (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?
  - harryh 9y ago
    I think perhaps we are talking past each other. I certainly agree that there should be rules for conducting research on human subjects and that there should be a process for independent review of said research. 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.
  - jerf 9y ago
    As for your B point, if we're going to play "but what if" I demand we play it consistently. What is the risk of this study not being performed? Is it self-evident that we are better off in a world where those concrete procedures killed this study? 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?
    - occultist_throw 9y ago
      "But we cannot be blamed for a different eventuality, like saving lives. It didn't happen, and its our job to make sure that it doesn't, unless policy is adhered to the letter."
- jancsika 9y ago
  > 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.
  - hawkice 9y ago
    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.
    - throwawayjava 9y ago
      > 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.

by xr4ti 9y ago

harryh 9y ago

(A) They were arbitrarily imposed in this case. Just because a rule is a good idea doesn't mean it is a good idea all the time. (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.

xr4ti 9y ago
(A) This is kind of a red herring though. The rules are not uniform. Sick patients require more protections than healthy adults. Placing an implant in someone's leg requires a more comprehensive risk minimization plan than asking someone to look at the ground for 5 seconds and then read a flash card. (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?
- harryh 9y ago
  I think perhaps we are talking past each other. I certainly agree that there should be rules for conducting research on human subjects and that there should be a process for independent review of said research. 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.
- jerf 9y ago
  As for your B point, if we're going to play "but what if" I demand we play it consistently. What is the risk of this study not being performed? Is it self-evident that we are better off in a world where those concrete procedures killed this study? 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?
  - occultist_throw 9y ago
    "But we cannot be blamed for a different eventuality, like saving lives. It didn't happen, and its our job to make sure that it doesn't, unless policy is adhered to the letter."
jancsika 9y ago
> 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.
- hawkice 9y ago
  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.
  - throwawayjava 9y ago
    > 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.