5 ms·

I can't agree. The authors wounds at every stage in the narrative were self inflicted. (1) The study title doesn't work at the top of the form? Change it! Su

by xr4ti 9y ago

I can't agree. The authors wounds at every stage in the narrative were self inflicted. (1) The study title doesn't work at the top of the form? Change it! Surely there is some other arrangement of English words that would satisfy both the author and IRB. (2) They leave the risk section blank because minimal risk, and then complain about the requirement for pens because the patients might stab themselves if given pens. Looks to me like they didn't spend much effort thinking about risks to the patient. If they had just mentioned the pen stabby thing as a risk factor, and given "don't use pens" as a risk minimization plan, they wouldn't have had a problem. (3) They poopoo the training because Hitler, and then get upset when they unknowingly violate a personnel rule that is most definitely covered in any decent IRB/GCP training. I could go on, but every new thing I enumerate makes me angrier. Life is too short. Look. IRB applications suck, but human experimentation is serious business. The rules aren't there to make the study easy, the are there to (a) look out for the patient (respect), (b) evaluate risk and benefits of the study (beneficence), and (c) ensure that the benefits are distributed to the group bearing the risk (justice).

harryh 9y ago
From reading the post it's not at all clear to me that 2 of the 3 goals you list were accomplished by the rules. A) Instead of actually looking out of the patient a list of arbitrary rules were imposed. B) The risk (minimal) was not properly evaluated but instead massively overstated. Given this failure of the process to meet said goals it seems perfectly reasonable to question the process.
- 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?
BurningFrog 9y ago
> human experimentation is serious business. Sometimes. When you just ask a few simple questions, it clearly isn't. Your list of the benefits of IRBs looks valid. But without a corresponding set of costs to weigh them against, it's meaningless.
- xr4ti 9y ago
  Well a few simple questions about deep seated emotional trauma (e.g. molestation), or embarrassing or taboo subjects can present risks to patients. So like you say. Sometimes. The question is who decides and how they make the decision? Surely it should involve someone other than the investigator, and have clearly defined rules so people know what to expect. Hence the IRB.
  - BurningFrog 9y ago
    Yeah, but that kind of system has real problems. The incentive for the IRB is to be as thorough and put up as many obstacles as possible. Both from a blame deflection standpoint and a bureaucratic empire building standpoint. I'm not aware of any force pushing in the other direction to make the scrutiny proportional to the risk. If this is true - and I'm just some programmer reading stuff on the web who knows little of real life IRBs - the end result is a system that overproduces IRB red tape and underproduces science. Of course, complaining about a system is easy. Figuring out a better system is not.
    - euyyn 9y ago
      > I'm not aware of any force pushing in the other direction to make the scrutiny proportional to the risk. Each research institution has its own IRB, which I expect is composed by faculty/researchers. The have an incentive not to block their own institution from producing any research output whatsoever.
  - imgabe 9y ago
    The point reiterated several times is that they were already asking the patients all of those questions as part of their normal procedure, without any of the alleged protections provided by the IRB. Once they wanted to use the data that they were already collecting anyway it suddenly became a huge risk that required all of this bureaucracy to mitigate.
sevenfive 9y ago
Yeah, the author was not quite as bureaucracy-savvy as you, it's clear. You do realize that the whole study was nothing but matching the results of a questionnaire that was already being used against interviews that were already being done?. Literally, all he's doing is observing. And maybe asking a few extra people to complete the questionnaire, the wording isn't clear.
- xr4ti 9y ago
  Said this in another comment, but I'll reiterate here. The big difference is purpose/intent. Looking under the hood of someone's car can be totally fine or a violation depending on whether or not I'm being paid to fix it. Same thing applies here. In one case the questions are being asked to provide treatment the patient is paying for. In the other it's being done to collect data for a publication.
  - aidenn0 9y ago
    Bullshit. If my mechanic wants to publish a paper on wear-and-tear on 4 cylinder engines using just the information he gleaned from doing work on cars that I (and others) paid him for, he has caused zero damage to me versus just doing the work on my car. The same applies here. Patients come in for treatment, and they provide exactly the same questions as if they weren't doing research.
    - euyyn 9y ago
      Private information about my mental health is much more personal and sensitive than the wear of my car's engine. Handling that data to an untrained student intent on publishing a paper can cause plenty of harm. I agree, though, that this study could have been done more easily by accessing the patients' records post-facto. But it's not the IRB's fault that the experiment could have been designed better.
      - aidenn0 9y ago
        Yes, mental health information is personal and sensitive, but it looks like the IRB didn't even address patient privacy, it was instead something that came out of a later audit. [edit] Also it seems that post-facto experiments are being encouraged over controlled trials, which seems the opposite of what you want from an experimenters point of view.
lsiebert 9y ago
Hey did you know that there are pens made specifically not to allow stabbing for prisons? https://smile.amazon.com/Prison-Flexible-Non-Lethal-Ball-Point/dp/B003FJQS4A?sa-no-redirect=1 https://smile.amazon.com/Prison-Flexible-Non-Lethal-Ball-Poi...
- aidenn0 9y ago
  Fill out this 40 page form requesting for an exemption to the no-pen rule. In 3-5 years we will deny the request due to increased risks of patients choking on the more flexible pens.
  - occultist_throw 9y ago
    Did you fill out the 100 page exemption to do the 40 page form? Did you also remember to complete the form completion class and ethics sub-committee on completion? (Yeah, pretty sure is the the deepest pit of hell)
  - lsiebert 9y ago
    There wasn't a no pen rule by the irb, there was a mandatory pen rule.

by xr4ti 9y ago

harryh 9y ago

From reading the post it's not at all clear to me that 2 of the 3 goals you list were accomplished by the rules. A) Instead of actually looking out of the patient a list of arbitrary rules were imposed. B) The risk (minimal) was not properly evaluated but instead massively overstated. Given this failure of the process to meet said goals it seems perfectly reasonable to question the process.

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?

BurningFrog 9y ago

> human experimentation is serious business. Sometimes. When you just ask a few simple questions, it clearly isn't. Your list of the benefits of IRBs looks valid. But without a corresponding set of costs to weigh them against, it's meaningless.

xr4ti 9y ago
Well a few simple questions about deep seated emotional trauma (e.g. molestation), or embarrassing or taboo subjects can present risks to patients. So like you say. Sometimes. The question is who decides and how they make the decision? Surely it should involve someone other than the investigator, and have clearly defined rules so people know what to expect. Hence the IRB.
- BurningFrog 9y ago
  Yeah, but that kind of system has real problems. The incentive for the IRB is to be as thorough and put up as many obstacles as possible. Both from a blame deflection standpoint and a bureaucratic empire building standpoint. I'm not aware of any force pushing in the other direction to make the scrutiny proportional to the risk. If this is true - and I'm just some programmer reading stuff on the web who knows little of real life IRBs - the end result is a system that overproduces IRB red tape and underproduces science. Of course, complaining about a system is easy. Figuring out a better system is not.
  - euyyn 9y ago
    > I'm not aware of any force pushing in the other direction to make the scrutiny proportional to the risk. Each research institution has its own IRB, which I expect is composed by faculty/researchers. The have an incentive not to block their own institution from producing any research output whatsoever.
- imgabe 9y ago
  The point reiterated several times is that they were already asking the patients all of those questions as part of their normal procedure, without any of the alleged protections provided by the IRB. Once they wanted to use the data that they were already collecting anyway it suddenly became a huge risk that required all of this bureaucracy to mitigate.

sevenfive 9y ago

Yeah, the author was not quite as bureaucracy-savvy as you, it's clear. You do realize that the whole study was nothing but matching the results of a questionnaire that was already being used against interviews that were already being done?. Literally, all he's doing is observing. And maybe asking a few extra people to complete the questionnaire, the wording isn't clear.

xr4ti 9y ago
Said this in another comment, but I'll reiterate here. The big difference is purpose/intent. Looking under the hood of someone's car can be totally fine or a violation depending on whether or not I'm being paid to fix it. Same thing applies here. In one case the questions are being asked to provide treatment the patient is paying for. In the other it's being done to collect data for a publication.
- aidenn0 9y ago
  Bullshit. If my mechanic wants to publish a paper on wear-and-tear on 4 cylinder engines using just the information he gleaned from doing work on cars that I (and others) paid him for, he has caused zero damage to me versus just doing the work on my car. The same applies here. Patients come in for treatment, and they provide exactly the same questions as if they weren't doing research.
  - euyyn 9y ago
    Private information about my mental health is much more personal and sensitive than the wear of my car's engine. Handling that data to an untrained student intent on publishing a paper can cause plenty of harm. I agree, though, that this study could have been done more easily by accessing the patients' records post-facto. But it's not the IRB's fault that the experiment could have been designed better.
    - aidenn0 9y ago
      Yes, mental health information is personal and sensitive, but it looks like the IRB didn't even address patient privacy, it was instead something that came out of a later audit. [edit] Also it seems that post-facto experiments are being encouraged over controlled trials, which seems the opposite of what you want from an experimenters point of view.

lsiebert 9y ago

Hey did you know that there are pens made specifically not to allow stabbing for prisons? https://smile.amazon.com/Prison-Flexible-Non-Lethal-Ball-Point/dp/B003FJQS4A?sa-no-redirect=1 https://smile.amazon.com/Prison-Flexible-Non-Lethal-Ball-Poi...

aidenn0 9y ago
Fill out this 40 page form requesting for an exemption to the no-pen rule. In 3-5 years we will deny the request due to increased risks of patients choking on the more flexible pens.
- occultist_throw 9y ago
  Did you fill out the 100 page exemption to do the 40 page form? Did you also remember to complete the form completion class and ethics sub-committee on completion? (Yeah, pretty sure is the the deepest pit of hell)
- lsiebert 9y ago
  There wasn't a no pen rule by the irb, there was a mandatory pen rule.