3 ms·

This could very well be written by the head of the IRB as "My Scott Alexander Nightmare". These questions all have purposes, and are there for a reason. For ex

by Fomite 9y ago

This could very well be written by the head of the IRB as "My Scott Alexander Nightmare". These questions all have purposes, and are there for a reason. For example: "That was the first ten pages or so of the Application. The rest was increasingly bizarre questions such as “Will any organs be removed from participants during this study?” (Look, I promise, I’m not a Nazi)." There are a number of studies done by Not Nazis that still involve removing organs. "And: “Will prisoners be used in the study?” (COME ON, I ALREADY SAID I WASN’T A NAZI)." I'm not a Nazi, and for one of my studies, the answer was yes - prisoners get treated at the hospital I was using EHR records for, which meant they were in the data set. As prisoners have a very distorted capacity for informed consent, it's an important question to ask. "And: “What will you do if a participant dies during this research?” (If somebody dies while I’m asking them whether they sometimes feel happy and then sad, I really can’t even promise so much as “not freaking out”, let alone any sort of dignified research procedure)." This is a perfectly fair question to be asked during a study - especially as for many trials, determining whether or not the death was due to the study is an important question. As far as I can tell, this essay is "In which Scott Alexander didn't do his basic homework, but still wants to be able to do a biomedical study, and is upset the IRB didn't pre-emptively read his mind and tailor his form for his particular case." He actually made me feel sympathetic toward the IRB...which is an impressive feat in and of itself.

mindslight 9y ago
The point is that the IRB's process was onerous for the type of study he was doing, so much so that it effectively killed it. The status-quo assertion that everyone alike is responsible for fulfilling the IRB's onerous process (ie "get back in line") is not a valid refutation of that indictment. As the purpose of the IRB is to police studies, then it indeed has an inherent responsibility to work at actually understanding those studies - not to simply design one-size-fits-all forms and promulgate top-down rules as its primary requirements. Such behavior reeks of an entrenched institution that does little besides bureaucratically gatekeep to perpetuate its own power (and therefore is actually shirking its intended purpose!), a trend which is eating our society alive.
- 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.

by Fomite 9y ago

mindslight 9y ago

The point is that the IRB's process was onerous for the type of study he was doing, so much so that it effectively killed it. The status-quo assertion that everyone alike is responsible for fulfilling the IRB's onerous process (ie "get back in line") is not a valid refutation of that indictment. As the purpose of the IRB is to police studies, then it indeed has an inherent responsibility to work at actually understanding those studies - not to simply design one-size-fits-all forms and promulgate top-down rules as its primary requirements. Such behavior reeks of an entrenched institution that does little besides bureaucratically gatekeep to perpetuate its own power (and therefore is actually shirking its intended purpose!), a trend which is eating our society alive.

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.