9 ms·

The IRB is more onerous for the type of studies I do (I generally only work with simulated human subjects) and yet I manage to soldier on. And yes, they do have

by Fomite 9y ago

The IRB is more onerous for the type of studies I do (I generally only work with simulated human subjects) and yet I manage to soldier on. And yes, they do have to try to understand studies, but they also have to balance that with federal law, and the fact that they're going to get applications from all over the place, and aren't subject matter experts in literally everything. A bunch of the things he complains about? - Patients not knowing what they're being studied for - Patients signing their consent forms using an alterable substance - Study discontinuation criteria that aren't well defined Are genuine problems with his protocol. They might be valid (though the last one really needs to be more specific), they might not be, but the process of asking questions is how the IRB comes to understand how a study is supposed to work, and what ethical issues are involved. I've worked with IRBs in one form or another at a dozen different institutions now. Sometimes they're annoying, to be sure, but to be frank, reading his account, I doubt I would have approved his study. And frankly, a lot of what he's put down suggests a really dangerous lack of understanding of medical ethics. He clearly didn't pay much attention during his mandatory training. Hell, a lot of it suggests a really poor understanding of study design.

mindslight 9y ago
First, I presume your studies have more substantiative work, such that the ratio of IRB overhead is lower. A large part of his problem stemmed from basically just trying to formalize things that were already being done anyway. This certainly doesn't mean he should be exempt from any additional overhead, but it does set the priors for the "smell test" when the answers to various questions are rejected outright rather than iteratively clarified. There does seem to be a few points where ethics do directly conflict with his desires (eg getting explicit consent to be "part of a study" versus priming the patient), but reasonable stakeholders should be able to mutually work out their real concerns, rather than go off the rails with arbitrary bureaucracy - say, ask the question first for the clinical purpose, and then obtain consent to incorporate that data in the study itself. > - Patients signing their consent forms using an alterable substance You're really referencing the signatures being in pencil?! I don't see how this could possibly be construed as a strict ethical requirement. Please do enlighten.
- jaggederest 9y ago
  They can be erased or tampered with. Try signing a mortgage, or other notarized or apostille document with a pencil sometime - they won't accept it.
  - mindslight 9y ago
    Yeah that's the obvious point, but any written signature can be similarly tampered with. Which is why the notaries etc get involved for major transactions. Furthermore, it doesn't rise to being an ethical problem unless fraud actually occurs. And I'd be more concerned about the possibility of signatures being straightforwardly forged by a researcher ("here, let me help you write your name") regardless of a pen being used.
    - Fomite 9y ago
      If I were the IRB, I'd be more concerned about altering any check boxes on the form and the date.
- Fomite 9y ago
  "First, I presume your studies have more substantiative work, such that the ratio of IRB overhead is lower. A large part of his problem stemmed from basically just trying to formalize things that were already being done anyway. This certainly doesn't mean he should be exempt from any additional overhead, but it does set the priors for the "smell test" when the answers to various questions are rejected outright rather than iteratively clarified." There's a huge difference between research and routine practice, as well there should be. Note that things that are actually done for quality improvement and routine care are exempt from IRB regulations. Even at the most onerous institution I was at, that was a one page form. At the most lenient, it was a online "Choose your Own Adventure" flow chart. He'd know that if he had paid attention at the training past "Don't be a Nazi". Because IRB training is pretty much universally run by CITI, and I've done that training more times than I care to think about. "There does seem to be a few points where ethics do directly conflict with his desires (eg getting explicit consent to be "part of a study" versus priming the patient), but reasonable stakeholders should be able to mutually work out their real concerns, rather than go off the rails with arbitrary bureaucracy - say, ask the question first for the clinical purpose, and then obtain consent to incorporate that data in the study itself." One of the things that he ignores is you have to justify these things, rather than just going "I want to do it". I've been part of studies that do not even ask for informed consent due to the study design, but that's a point of negotiation and discussion with the IRB. And I absolutely think their default stance should be "No". "You're really referencing the signatures being in pencil?! I don't see how this could possibly be construed as a strict ethical requirement. Please do enlighten." I am. Pencil is really, really easy to alter. Having a requirement like the form must be signed in ink is a reasonable compromise between something like pencil and, as you allude to, notarized and witnessed, etc. And his excuse, that his patients can stab themselves with pens, seems untrue for a subset of pens (felt tips) and still true for pencils. Basically, he cast himself in the best, most put upon light as possible. I am already pre-disposed to muttering about the IRB, because it does add time to things, and sometimes is silly. That I came off reading that going "Noooope!" is a really bad sign.
reality_czech 9y ago
Scott's complaint is basically that the IRB regulations don't match the regulations that apply to standard psychiatric treatment. For example, the department had a huge amount of patient information stored in their regular computer system. But the IRB demands an archaic pen and paper system for storing patient records, rather than using the computer system that exists. You could argue that maybe the department computer system was bad, but in that case it should be fixed, rather than creating a parallel system. Similarly with the issue of consent. The doctors were already giving questionnaires to the patients and already using them to determine what the treatment should be (counselling, medication, etc.) Why do the consent requirements suddenly become completely different when it's part of a study? Should the doctors be asking patients to fill out a consent form each time they give a questionnaire? Should the forms be in pen, even though mental patients can use pends to hurt themselves? I don't know, but I do know that having bizarrely different criteria for a study versus normal medical practice seems unwise. I agree that it would be good to have better-defined criteria for stopping the study. It sounds like Scott had an informal goal of 100 data points, but didn't manage to hit this goal. I'm sure IRBs do some good. But it's really hard to take the IRB's side in this particular case. They weren't even following their own rules (the person asking him to take ethics training hadn't taken the training herself-- which would have probably torpedoed his study even if he had done everything else right.)
- Fomite 9y ago
  "For example, the department had a huge amount of patient information stored in their regular computer system. But the IRB demands an archaic pen and paper system for storing patient records, rather than using the computer system that exists. You could argue that maybe the department computer system was bad, but in that case it should be fixed, rather than creating a parallel system." The department's clinical activities and research activities are subject to different Federal regulations, and the IRB doesn't have any authority over standard clinical care. "Similarly with the issue of consent. The doctors were already giving questionnaires to the patients and already using them to determine what the treatment should be (counselling, medication, etc.) Why do the consent requirements suddenly become completely different when it's part of a study?" Because it's part of a study. An entirely different ethical framework applies when you are trying to treat someone vs. when you're trying to learn how to treat them. Sometimes those criteria are laxer (for example, you can use investigational protocols and things that aren't yet standard of care). Sometimes they're not. "Should the doctors be asking patients to fill out a consent form each time they give a questionnaire? Should the forms be in pen, even though mental patients can use pends to hurt themselves?" Again, different contexts. They happen to be in the same locations, but very different contexts. For example, your doctor can access your entire medical record vs. a hospital's EHR system for your care. That does not mean that the doctor should be able to access all your information, for all time, for any reason. "I don't know, but I do know that having bizarrely different criteria for a study versus normal medical practice seems unwise." Most IRB regulations exist for a reason, and no, study vs. normal medical practice are different, because while the risks may be the same, who bears the benefits are not. The entire purpose of the IRB is to ensure the risks to the study subjects are kept to a minimum because they are also unlikely to bear most of the benefits. Medical ethics works on the ethics of a single patient. They are different by design, and through long experience. "I agree that it would be good to have better-defined criteria for stopping the study. It sounds like Scott had an informal goal of 100 data points, but didn't manage to hit this goal." I meant that it would be halted if the patients become "Violent". Violent is not a clear definition. Though he also probably should have had power calculations in his protocol. IRBs really don't like studies that don't have a chance of producing information. "I'm sure IRBs do some good. But it's really hard to take the IRB's side in this particular case. They weren't even following their own rules (the person asking him to take ethics training hadn't taken the training herself-- which would have probably torpedoed his study even if he had done everything else right.)" The person asking the questions are not necessarily the people who make the decisions. For example, most of the questions at an IRB I worked with were asked by admins, because they've got dedicated time to do it, and can go through a checklist for things like "Is violence well defined?" or "You seem to have deviated from the normal way this goes..." After that, it goes to a formal committee who take a lot of training, who either approve, disapprove, or ask other questions.

by Fomite 9y ago

mindslight 9y ago

First, I presume your studies have more substantiative work, such that the ratio of IRB overhead is lower. A large part of his problem stemmed from basically just trying to formalize things that were already being done anyway. This certainly doesn't mean he should be exempt from any additional overhead, but it does set the priors for the "smell test" when the answers to various questions are rejected outright rather than iteratively clarified. There does seem to be a few points where ethics do directly conflict with his desires (eg getting explicit consent to be "part of a study" versus priming the patient), but reasonable stakeholders should be able to mutually work out their real concerns, rather than go off the rails with arbitrary bureaucracy - say, ask the question first for the clinical purpose, and then obtain consent to incorporate that data in the study itself. > - Patients signing their consent forms using an alterable substance You're really referencing the signatures being in pencil?! I don't see how this could possibly be construed as a strict ethical requirement. Please do enlighten.

jaggederest 9y ago
They can be erased or tampered with. Try signing a mortgage, or other notarized or apostille document with a pencil sometime - they won't accept it.
- mindslight 9y ago
  Yeah that's the obvious point, but any written signature can be similarly tampered with. Which is why the notaries etc get involved for major transactions. Furthermore, it doesn't rise to being an ethical problem unless fraud actually occurs. And I'd be more concerned about the possibility of signatures being straightforwardly forged by a researcher ("here, let me help you write your name") regardless of a pen being used.
  - Fomite 9y ago
    If I were the IRB, I'd be more concerned about altering any check boxes on the form and the date.
Fomite 9y ago
"First, I presume your studies have more substantiative work, such that the ratio of IRB overhead is lower. A large part of his problem stemmed from basically just trying to formalize things that were already being done anyway. This certainly doesn't mean he should be exempt from any additional overhead, but it does set the priors for the "smell test" when the answers to various questions are rejected outright rather than iteratively clarified." There's a huge difference between research and routine practice, as well there should be. Note that things that are actually done for quality improvement and routine care are exempt from IRB regulations. Even at the most onerous institution I was at, that was a one page form. At the most lenient, it was a online "Choose your Own Adventure" flow chart. He'd know that if he had paid attention at the training past "Don't be a Nazi". Because IRB training is pretty much universally run by CITI, and I've done that training more times than I care to think about. "There does seem to be a few points where ethics do directly conflict with his desires (eg getting explicit consent to be "part of a study" versus priming the patient), but reasonable stakeholders should be able to mutually work out their real concerns, rather than go off the rails with arbitrary bureaucracy - say, ask the question first for the clinical purpose, and then obtain consent to incorporate that data in the study itself." One of the things that he ignores is you have to justify these things, rather than just going "I want to do it". I've been part of studies that do not even ask for informed consent due to the study design, but that's a point of negotiation and discussion with the IRB. And I absolutely think their default stance should be "No". "You're really referencing the signatures being in pencil?! I don't see how this could possibly be construed as a strict ethical requirement. Please do enlighten." I am. Pencil is really, really easy to alter. Having a requirement like the form must be signed in ink is a reasonable compromise between something like pencil and, as you allude to, notarized and witnessed, etc. And his excuse, that his patients can stab themselves with pens, seems untrue for a subset of pens (felt tips) and still true for pencils. Basically, he cast himself in the best, most put upon light as possible. I am already pre-disposed to muttering about the IRB, because it does add time to things, and sometimes is silly. That I came off reading that going "Noooope!" is a really bad sign.

reality_czech 9y ago

Scott's complaint is basically that the IRB regulations don't match the regulations that apply to standard psychiatric treatment. For example, the department had a huge amount of patient information stored in their regular computer system. But the IRB demands an archaic pen and paper system for storing patient records, rather than using the computer system that exists. You could argue that maybe the department computer system was bad, but in that case it should be fixed, rather than creating a parallel system. Similarly with the issue of consent. The doctors were already giving questionnaires to the patients and already using them to determine what the treatment should be (counselling, medication, etc.) Why do the consent requirements suddenly become completely different when it's part of a study? Should the doctors be asking patients to fill out a consent form each time they give a questionnaire? Should the forms be in pen, even though mental patients can use pends to hurt themselves? I don't know, but I do know that having bizarrely different criteria for a study versus normal medical practice seems unwise. I agree that it would be good to have better-defined criteria for stopping the study. It sounds like Scott had an informal goal of 100 data points, but didn't manage to hit this goal. I'm sure IRBs do some good. But it's really hard to take the IRB's side in this particular case. They weren't even following their own rules (the person asking him to take ethics training hadn't taken the training herself-- which would have probably torpedoed his study even if he had done everything else right.)

Fomite 9y ago
"For example, the department had a huge amount of patient information stored in their regular computer system. But the IRB demands an archaic pen and paper system for storing patient records, rather than using the computer system that exists. You could argue that maybe the department computer system was bad, but in that case it should be fixed, rather than creating a parallel system." The department's clinical activities and research activities are subject to different Federal regulations, and the IRB doesn't have any authority over standard clinical care. "Similarly with the issue of consent. The doctors were already giving questionnaires to the patients and already using them to determine what the treatment should be (counselling, medication, etc.) Why do the consent requirements suddenly become completely different when it's part of a study?" Because it's part of a study. An entirely different ethical framework applies when you are trying to treat someone vs. when you're trying to learn how to treat them. Sometimes those criteria are laxer (for example, you can use investigational protocols and things that aren't yet standard of care). Sometimes they're not. "Should the doctors be asking patients to fill out a consent form each time they give a questionnaire? Should the forms be in pen, even though mental patients can use pends to hurt themselves?" Again, different contexts. They happen to be in the same locations, but very different contexts. For example, your doctor can access your entire medical record vs. a hospital's EHR system for your care. That does not mean that the doctor should be able to access all your information, for all time, for any reason. "I don't know, but I do know that having bizarrely different criteria for a study versus normal medical practice seems unwise." Most IRB regulations exist for a reason, and no, study vs. normal medical practice are different, because while the risks may be the same, who bears the benefits are not. The entire purpose of the IRB is to ensure the risks to the study subjects are kept to a minimum because they are also unlikely to bear most of the benefits. Medical ethics works on the ethics of a single patient. They are different by design, and through long experience. "I agree that it would be good to have better-defined criteria for stopping the study. It sounds like Scott had an informal goal of 100 data points, but didn't manage to hit this goal." I meant that it would be halted if the patients become "Violent". Violent is not a clear definition. Though he also probably should have had power calculations in his protocol. IRBs really don't like studies that don't have a chance of producing information. "I'm sure IRBs do some good. But it's really hard to take the IRB's side in this particular case. They weren't even following their own rules (the person asking him to take ethics training hadn't taken the training herself-- which would have probably torpedoed his study even if he had done everything else right.)" The person asking the questions are not necessarily the people who make the decisions. For example, most of the questions at an IRB I worked with were asked by admins, because they've got dedicated time to do it, and can go through a checklist for things like "Is violence well defined?" or "You seem to have deviated from the normal way this goes..." After that, it goes to a formal committee who take a lot of training, who either approve, disapprove, or ask other questions.