Astral Codex Ten

IRB

21 min read

IRB

Article

IRB is a recurring organization in the Astral Codex Ten archive, appearing 4 times across 4 issues between June 28, 2021 and April 17, 2023. The archive places it in contexts such as “some people might need to run questions by an IRB first”; “because an IRB placed so many obstacles in my way”; “including one where the IRB demanded patients sign consent forms”. It most often appears alongside FDA, Hans Jonas, Harvard.

Metadata

  • Category: Organizations
  • Mention count: 4
  • Issue count: 4
  • First seen: June 28, 2021
  • Last seen: April 17, 2023

Appears In

Source Context

Recovered passages from the original issue text. When the raw archive preserved outbound links inside the source passage, they are listed directly under the quote.

Open Thread 178
June 28, 2021 · Original source
2. In case you missed it, I'm planning on letting people survey the ACX readership, especially researchers doing some kind of psychology/social sciences project. Somebody mentioned that my previous timeline might have been overly ambitious because some people might need to run questions by an IRB first. If that's you, please send me an email saying so, so that I can consider whether to lengthen my timeline.
Inline links: letting people survey the ACX readership
Details Of The Infant Fish Oil Story
August 06, 2021 · Original source
(it’s easy to say that since lives were on the line, you should fill in the paperwork regardless of how onerous it might be. I agree this is what a good person might do, but I myself am not that good a person - I gave up on what I thought was an important study because an IRB placed so many obstacles in my way that it would have driven me crazy to continue. I take some slight comfort in knowing that even Dr. Gura, part of the tiny pantheon of people who successfully advocated for new drugs, seems to have gotten close to this - in her acceptance speech, she thanks “Eileen Sporing, the VP of patient services at BCH, who successfully advocated for me when the IRB would not let me consent patients for my own drug study.” Maybe if I’d had an Eileen Sporing, I would have continued my project - but Eileen is another one of the heroes who we can best honor by making their sacrifices less necessary in the future.)
Inline links: gave up on
Book Review: From Oversight To Overkill
April 12, 2023 · Original source
His IRB - ie Institutional Review Board, the committee charged with keeping experiments ethical - disagreed. They worried the study would give patients AIDS. Dr. Knight tried to explain that you can’t get AIDS from skin contact. The IRB refused to listen. Finally Dr. Knight found some kind of diversity coordinator person who offered to explain that claiming you can get AIDS from skin contact is offensive. The IRB backed down, and Dr. Knight completed his study successfully.
The eminent doctors and clergymen - the actual board part of the Institutional Review Board - were reduced to rubber stamps. The age of the administrator had begun. These were the sorts of people who might not know that AIDS is sexually transmitted or that smallpox is gone. Their job began and ended with forcing word-for-word compliance with increasingly byzantine regulations.
Most IRB experiences aren’t this bad, right? Mine was worse. When I worked in a psych ward, we used to use a short questionnaire to screen for bipolar disorder. I suspected the questionnaire didn’t work, and wanted to record how often the questionnaire’s opinion matched that of expert doctors. This didn’t require doing anything different - it just required keeping records of what we were already doing. “Of people who the questionnaire said had bipolar, 25%/50%/whatever later got full bipolar diagnoses” - that kind of thing. But because we were recording data, it qualified as a study; because it qualified as a study, we needed to go through the IRB. After about fifty hours of training, paperwork, and back and forth arguments - including one where the IRB demanded patients sign consent forms in pen (not pencil) but the psychiatric ward would only allow patients to have pencils (not pens) - what had originally been intended as a quick note-taking exercise had expanded into an additional part-time job for a team of ~4 doctors. We made a tiny bit of progress over a few months before the IRB decided to re-evaluate all projects including ours and told us to change twenty-seven things, including re-litigating the pen vs. pencil issue (they also told us that our project was unusually good; most got >27 demands). Our team of four doctors considered the hundreds of hours it would take to document compliance and agreed to give up. As far as I know that hospital is still using the same bipolar questionnaire. They still don’t know if it works.
Inline links: Mine was worse.
Highlights From The Comments On IRBs
April 17, 2023 · Original source
Finally, most of the surveys in question are just a series of basic psychology scales or tasks both the worker and average SSC reader are very familiar with. I suspect many of them are administered by students as practice rather than 'serious' research. As the other poster said, rejected HITs are just any task the requestor declines for any reason. A worker's acceptance rate is extremely important - one of the few pieces of advice Amazon seems to give requestors is to filter for 98% or 99% acceptance rate. It's probably pretty reasonable for surveys - if you can't get 99 out of 100 of those filled out acceptably (assuming good faith by the requestors), maybe you should be filtered. It's also worth noting that Amazon makes communication difficult, and that rejected HITs can only be reversed for like a month - after that, they're permanently on your record. It's also probably worth restating: if a worker goes below the high 90s, they'll have access to fewer tasks, likely from less reputable requestors, and they'll need to do 100 of these to offset every rejection. And the worker is at much greater risk of being dug deeper into that hole by requestors rejecting their work in bad faith with no recourse - part of why surveys are popular is because the IRB can bludgeon requestors into accountability. Most of the surveys in question are also are the crumbs that filter through the grasping pedipalps of the hordes of workers (and their scripts). If people are seriously using MTurk to monetize their time, they're likely looking for 'batch HITs' - the sort of thing where there's hundreds or thousands of tasks that can be quickly repeated (moderating images, 3 cents for a sentiment analysis, a couple quarters to outline a car in an image, etc.) Of course, this mana from heaven rarely lasts long, and the worker always takes a risk - 'if I do 100 of these, and this is an unscrupulous requestor, well - I better have ten thousand accepted HITs under my belt.' That's why workers are so protective of their acceptance rate. Back to surveys - again as the other poster replied, most of what the average MTurk worker will see is probably a psychology study questionnaire with a series of whatever common scales, attention checks, and other tricks the worker has probably seen at least dozens if not hundreds of times by now. They often pay Amazon's princely sum of about 10 cents per (expected) minute - based on the minimum wage in whatever benighted 00s year Amazon Mechanical Turk launched. Anecdotally, it also seems like a lot of these are from students - probably just practice research by someone who likely has less experience with the platform than the worker themselves. The problem the requestor has - at least as of ~2018 - is that there is a lot of fraud with foreign workers getting access to MTurk accounts and submitting totally garbo data, often very quickly. Based purely on a 'time to complete' metric, this is hard to distinguish from a legit worker who has filled out hundreds of these and is looking to maximize how many pennies they get for their minutes. It also wasn't uncommon for workers to 'cook' such a survey - letting it sit at the end screen before submitting - just to avoid getting pinged for finishing it quickly. As for how this all ties back into Institutional Review Boards - well, yeah, griping to the IRB is often the MTurk worker's only recourse. Amazon just doesn't care, and as I recall a lot of requestors don't even know workers can contact them - and as mentioned there's a narrow time window to discuss rejected HITs before they become permanent. On the other hand, in a lot of cases this is basically a reddit mob complaining that a student doling out dimes screwed up their understanding of MTurk's arcane inner workings, and that's in the case that the workers aren't actually trying to defraud them for said dimes. 5. Comments About Regulation, Liability, and Vetocracy CatCube writes: I think the fundamental problem is that you cannot separate the ability to make a decision from the ability to make a *wrong* decision. However, our society--pushed by the regulator/lawyer/journalist/administrator axis you discuss--tries to use detailed written rules to prevent wrong decisions from being made. But, because of the decision/wrong decision inseparability thing, the consequences are that nobody has the ability to make a decision. This is ultimately a political question. It's not wrong, precisely, or right either. It's a question of value tradeoffs. Any constraint you put on a course of action is necessarily something that you value more than the action, but this isn't something people like to admit or hear voiced aloud. If you say, "We want to make sure that no infrastructure project will drive a species to extinction", then you are saying that's more important than building infrastructure. Which can be a defensible decision! But if you keep adding stuff--we need to make sure we're not burdening certain races, we need to make sure we're getting input from each neighborhood nearby, etc.--you can eventually end up overconstraining the problem, where there turns out to be no viable path forward for a project. This is often a consequence of the detailed rules to prevent wrong decisions. But because we can't admit that we're valuing things more than building stuff (or doing medical research, I guess?), we as a society just end up sitting and stewing about how we seemingly can't do anything anymore. We need to either: 1) admit we're fine with crumbling infrastructure, so long as we don't have any environmental, social, etc., impacts; or 2) decide which of those are less important and streamline the rules, admitting that sometimes the people who are thus able to make a decision are going to screw it up and do stuff we ultimately won't like. Darwin on why safetyism expanded just as the neoliberals were trying to decrease government regulation: Without the excuse of 'we were following all of the very strict and explicit regulations, so the bad thing that happened was a freak accident and not our fault' to rely on, companies had to take safety and caution and liability limitation and PR management into their own hands in a much more serious way. And without the confidence in very strict and explicit regulations to limit the bad things companies might do, and without democratically-elected regulators as a means to bring complaint and affect change, we became much more focused on seeking remedy for corporate malfeasance by suing companies into oblivion and destroying them in the court of public opinion. Basically, government actually *can* do useful things, as it turns out. One of the useful things it can do is be a third party to a dispute between two people or entities, such as 'corporations' and 'citizens', and use it's power to legibly and credibly ensure cooperation by explicitly specifying what will be considered defection and then punishing it harshly. This actually allows the two parties, which might otherwise be in conflict, to trust each other much more and cooperate much better, because their incentives have been shifted by a third party to make defection more costly. Without government playing that role, you can fall back into bad equilibrium of distrust and warring, which in this case might look like a wary populace ready to sue and decry at the slightest excuse, and paranoid corporations going overboard on caution and PR to shield from that. Meadow Freckle writes: Why can’t you sue an IRB for killing people for blocking research? You can clearly at least sometimes activist them into changing course. But their behavior seems sue-worthy in these examples, and completely irresponsible. We have negligence laws in other areas. Is there an airtight legal case that they’re beyond suing, or is it just that nobody’s tried? I don’t know, and this seems like an important question. And Donald writes: Why do we need special rules for medicine? The law has rules about what dangerous activities people are allowed to consent to, for example in the context of dangerous sports or dangerous jobs. Criminal and civil trials in this context seem to be a fairly functional system. If Doctors do bad things, they can stand in the accused box in court and get charged with assault or murder, with the same standards applied as are applied to everyone else. If there need to be exceptions, they should be exceptions of the form "doctors have special permission to do X". I do want to slightly defend something IRB-like here. When a doctor asks you to be part of a study, they’re implicitly promising that they did their homework, this is a valuable thing to study, and that there’s no obvious reason it should be extremely unsafe. As a patient (who may be uneducated) you have no way of knowing whether or not this promise is true. Every so often, someone does everything right, and something goes wrong anyway. A drug that everyone reasonably thought would be safe and effective turns out to have unpredictable side effects - this is part of why we have to do studies in the first place. If every time this happened, a doctor had to stand trial for assault/murder, nobody would ever study new drugs. Trials are a crapshoot, and juries tend to rule against doctors on the grounds that the disabled/dead patient is very sympathetic and everyone knows doctors/hospitals are rich and can give them infinite money as damages. There is no way for an average uneducated jury to distinguish between “doctor did their homework and got unlucky” and “doctor did an idiotic thing”. Either way, the prosecution can find “expert witnesses” to testify, for money, that you were an idiot and should have known the study would fail. In order to remove this risk, you need some standards for when a study is safe, so that if people sue you, you can say “I was following the standards and everyone else agreed with me that this was good” and then the lawsuit will fail. Right now those standards are “complied with an IRB”. This book is arguing that the IRB’s standards are too high, but we can’t cut the IRB out entirely without some kind of profound reform of the very concept of lawsuits, and I don’t know what that reform would look like. 6. Comments About The Act/Omission Distinction jumpingjacksplash writes: I think you've unintentionally elided two distinct points: first, that IRBs are wildly inefficient and often pointless within the prevailing legal-moral normative system (PLMNS); second, that IRBs are at odds with utilitarianism. Law in Anglo-Saxon countries, and most people's opinions, draw a huge distinction between harming someone and not helping them. If I cut you with a knife causing a small amount of blood loss and maybe a small scar, that's a serious crime because I have an obligation not to harm you. If I see a car hurtling towards you that you've got time to escape from if you notice it, but don't shout to warn you (even if I do this because I don't like you), then that's completely fine because I have no obligation to help you. This is the answer you'd get from both Christianity and Liberalism (in the old-fashioned/European sense of the term, cf. American Right-Libertarianism). Notably, in most Anglo-Saxon legal systems, you can't consent to be caused physical injury. Under PLMNS, researchers should always ask people if they consent to using their personal data in studies which are purely comparing data and don't change how someone will be treated. For anything that affects what medical treatment someone will or won't receive, you'd at least have to give them a full account of how their treatment would be different and what the risks of that are. If there's a real risk of killing someone, or permanently disabling them, you probably shouldn't be allowed to do the study even if all the participants give their informed consent. This isn't quite Hans Jonas' position, but it cashes out pretty similarly. That isn't to say the current IRB system works fine for PLMNS purposes; obviously there's a focus on matters that are simply irrelevant to anything anyone could be rationally concerned with. But if, for example, they were putting people on a different ventilator setting than they otherwise would, and that risked killing the patient, then that probably shouldn't be allowed; the fact that it might lead to the future survival of other, unconnected people isn't a relevant consideration, and nor is "the same number of people end up on each ventilator setting, who cares which ones it is" because under PLMNS individuals aren't fungible. Under utilitarianism, you'd probably still want some sort of oversight to eliminate pointless yet harmful experiments or reduce unnecessary harm, but it's not clear why subjects' consent would ever be a relevant concern; you might not want to tell them about the worst risks of a study, as this would upset them. The threshold would be really low, because any advance in medical science could potentially last for centuries and save vastly more people than the study would ever involve. The problem is, as is always the case for utilitarianism, this binds you to some pretty nasty stuff; I can't work out whether the Tuskegee experiment's findings have saved any lives, but Mengele's research has definitely saved more people than he killed, and I'd be surprised if that didn't apply to Unit 731 as well. The utilitarian IRB would presumably sign off on those. More interestingly, it might have to object to a study where everyone gives informed consent but the risk of serious harm to subjects is pretty high, and insist that it be done on people whose quality of life will be less affected if it goes wrong (or whose lower expected utility in the longer term makes their deaths less bad) such as prisoners or the disabled. The starting point to any ideal system has to be setting out what it's trying to achieve. Granted, if you wanted reform in the utilitarian direction, you probably wouldn't advocate a fully utilitarian system due to the tendency of the general public to recoil in horror. I want to stress how far we are away from “do experiments without patient’s consent” here - a much more common problem is that patients really want to be in experiments, and the system won’t allow it. This is most classic in studies on cancer, where patients really want access to experimental drugs and IRBs are constantly coming up with reasons not to give it to them. Jonas argued that all cancer studies should be banned because it’s impossible to consent when you’re desperate to survive, which isn’t the direction I would have taken that particular example in. But there are other examples - during COVID, lots of effective altruists stepped up to be in human challenge trials that would have gotten the vaccines tested faster, but the government wouldn’t allow them to participate. I would honestly be happy with a system that counts the harm of denying a patient’s ability to consent to an experiment they really want to be in as a negative, forget about any lives saved. And JDK writes: I haven't finished reading by felt compelled to comment on this: "the stricter IRB system in place since the '90s probably only prevents a single-digit number of deaths per decade, but causes tens of thousands more by preventing lifesaving studies." No. It does NOT "cause" deaths. We can't go down this weird path of imprecision about what "causing" means. I've been examining Ivan Illich, "Medical Nemesis" recently. By claiming IRBs which stop research ostensibly CAUSE death strikes me as cultural iatrogenesis masquerading as a cure for clinical iatrogenesis. […] "Might have been saved if" is not the same as "death was caused by". This seems to me to be a weird and overly metaphysical nitpick. Suppose a surgeon is operating on someone. In the process, they must clamp a blood vessel - this is completely safe for one minute, but if they leave it clamped more than one minute, the patient dies. They clamp it as usual, but I rush into the operating room and forceably restrain the surgeon and all the staff. The surgeon is unable to remove the clamp and the patient dies. I (and probably the legal system) would like to be able to say I caused the patient’s death in this scenario. But it sounds like JDK is saying I have to say the surgeon caused the patient's death and I was only tangentially involved. Here’s another example; suppose the US government bans all food production - farmers, hunters, fishermen, etc are forbidden from doing their jobs. After a few months, everyone starves to death. I might want to say something like “the US government’s ban on food production killed people”. But by JDK’s reasoning, this is wrong - the government merely prevented farmers and fishermen from saving people (by giving them food so they didn’t starve). I might want to say something like “Mao’s collective farming policy killed lots of people”. But since this is just a weaker version of hypothetical-Biden’s ban on food, by JDK’s reasoning I can’t do this. This seems contrary to common usage, common sense, and communicating information clearly. I have never heard any philosopher or dictionary suggest this, so what exactly is the argument? (JDK has a response here, but I didn’t find it especially enlightening) 7. Comments About The Applications For AI Metaphysiocrat writes: People have joked about applying NEPA review to AI capabilities research, but I wonder if some kind of IRB model might have legs (as part of a larger package of capabilities-slowing policy.) It’s embedded in research bureaucracies, we sort of know how to subject institutions to it, and so on. I can think of seven obvious reasons this wouldn’t work, but at this point I’m getting doomery enough that I feel like we may just have to throw every snowball we have at the train on the off chance one has stopping power. Zach Stein-Perlman writes: A colleague of mine is interested in 'IRBs for AI'-- he hasn't investigated it but has thought about IRB-y stuff in the context of takeaways for AI (https://wiki.aiimpacts.org/doku.php?id=responses_to_ai:technological_inevitability:incentivized_technologies_not_pursued:vaccine_challenge_trials). He's interested in people's takes on the topic. My take: my understanding is that the US can’t technically demand all doctors use IRBs. (Almost) al doctors use IRBs for a combination of a few reasons : The US government demands that everyone who receives federal funding use an IRB, and most doctors get some federal funding.
Inline links: writes, Darwin, writes, writes, writes, writes, has a response here, writes, writes, https://wiki.aiimpacts.org/doku.php?id=responses_to_ai:technological_inevitability:incentivized_technologies_not_pursued:vaccine_challenge_trials