8 ms·

The author doesn't seem to take the history of medical research ethics (e.g. the Tuskegee syphilis experiments [1]) seriously. Having a sophisticated understand

• harryh 9y ago
  The IRB process he described did not have a sophisticated understanding of the ethical risks of research. It imposed arbitrary and useless rules on an experiment with few if any risks.
  • ak_yo 9y ago
    IRB review procedures are flawed, I agree. But ethical review by a third party is enormously important for research with human subjects. I'm alarmed by the notion of researchers deciding unilaterally that a study has only "nonexistent risks" -- that's a recipe for disastrously unethical scientific conduct.
    • harryh 9y ago
      I don't think the author was proposing getting rid of oversight completely, just that said oversight should, you know, make sense.
    • mannykannot 9y ago
      The point is that the decision should not have been unilateral - the author and his colleague had a very good case for their position, based on the fact that they were not asking anything that was not being asked anyway, and not recording anything that was not being recorded anyway. It was mindless dogma on the part of the IRB that made it unilateral. Meanwhile, a practice with a real potential for risk went unstudied. You might argue that there was risk to the patients in the one part of the procedure that was different than what they would experience anyway - the actual asking for consent - but if so, what would you propose doing about it? You have made a straw man out of this one case, and are defending it with all the dogma displayed by this IRB.
    • JamesBarney 9y ago
      I don't think the author is in any way arguing that research should be completely without oversight. Just that current oversight is uselessly burdensome.
• barry-cotter 9y ago
  Did you read the post? There were multiple ridiculously stupid things the IRB insisted on that had no impact on safety and were pure bureaucratic BS, the insistence on blinding patient's names with the blinding instrument right next to the blinded data, the signing in pen only, the person in the Research office having to do the course when they did not do research. All of this for a study that involved taking notes on things the doctors were going to be doing anyway, which posed no risks to anyone.
  • euyyn 9y ago
    > the insistence on blinding patient's names with the blinding instrument right next to the blinded data The requirement wasn't that the code should be next to the data, if I understood it correctly; rather that it be blinded and stored safely. Storing them together was the least-effort way he found of passing the requirement, partially defeating its purpose. So if anything that's an argument for adding even more requirements to the IRB process in his hospital. Because grad students that feel sufficiently aggravated will do things like that.
• kinkrtyavimoodh 9y ago
  While I agree that the author is being a little facetious (with the constant Nazi references and such), I don't think he is arguing in favor of removing ethical considerations in research, or even arbitrarily weakening the constraints put on scientific studies. But what purpose is having a review board made up of people who can think for themselves if their behavior is going to be indistinguishable from a program running through a checklist without any care whatsoever for whether or not the checklist makes sense in that context? Massive inefficiencies in bureaucracy are always hidden behind the fig leaf of consistency and accountability, but it's worthwhile to consider what aim they serve and at what cost.
  • ak_yo 9y ago
    I agree that IRBs are not great -- the book cited above does a great job of unpacking how IRBs fail to live up to their promises, and this covers some good additional examples. I also agree that the author isn't necessarily advocating against ethical review as such. I'm more concerned with the author's insistence that he knew the right way to conduct his study ethically. Peer review is a core scientific principle-- we don't allow researchers to make autonomous judgments about the quality of their work.
    • justabystander 9y ago
      I don't think he's advocating that he should be setting the rules or self-evaluating. He just wants the rules to be sensible and sensibly enforced. He has justification to complain if the modifications they requested violated safety policies, risked patient well-being or defeated the purpose of the study. Policy that doesn't add any benefit deserves to be questioned. Not to mention that the questions were already being asked. He just wanted to ask them earlier to compare against the eventual diagnosis. It's not the kind of study that should have been abandoned in frustration after two years, as happened here.
      • chris_wot 9y ago
        I think for his next study he should do one into the mental health of those who interact with Institutional Review Boards. If nothing else, it would have a nice recursive effect on the authors.
• apsec112 9y ago
  "The author doesn't seem to take the history of medical research ethics (e.g. the Tuskegee syphilis experiments [1]) seriously." This is the same dynamic that happened in, say, the 1950s with Communism. At that time, the Soviet Union was legitimately scary. They had the world's largest army, an arsenal of nuclear weapons, and were led by a power-mad dictator. It was certainly a wise move to defend against them. But eventually, Communism became a catch-all justification that could be used for any rule or policy, no matter how silly it was. Why, for example, did we need the words "under God" in the Pledge of Allegiance? Because of communism, even though it didn't help the Western military position at all. Likewise, any challenge to these policies could be dismissed as "naive", "uninformed", or "not taking the threat seriously".
  • pg_bot 9y ago
    The best thing about this is that we recreated this mentality when dealing with terrorism. The current brown scare that we are living through is almost exactly the same as the red scare of the 1950s.
• deleted 9y ago
  [deleted]
• Teodolfo 9y ago
  This is more troubling given the author's support for eugenics.
  • archgoon 9y ago
    This is the sort of claim that requires a link.
• pg_is_a_butt 9y ago
  the post communicates a high level of readability and humanity of an individual dealing with "authority" that is ostensibly worse than the nazis. the government and the hospital both need to remove people from the planet. drugging people in psych hospitals was "obviously the right way to do it", so the decision was made a long time ago. you're all idiots.
• Houshalter 9y ago
  I'm deeply disturbed to see comments here defending this. The top comment no less! At every single step the things the author went through were absolutely ludicrous and indefensible. Actual real people are getting hurt by the IRB. This study alone could have saved thousands of people from getting misdiagnosed as bipolar. God knows how many tens of thousands of other similar studies have been stopped by this bureaucracy.
  • euyyn 9y ago
    > At every single step the things the author went through were absolutely ludicrous and indefensible. I disagree. Even the one that he makes sound the most ludicrous ("IRB required pens, be we were only allowed to use pencils") can be rephrased as: "Your hospital had reasons to be concerned that patients might stab themselves or someone else with a pen, yet you don't even think of giving them pencils as any sort of risk".
    • Houshalter 9y ago
      The hospital allowed them to have pencils and apparently had no issue with it. Presumably patients fill out forms with pencils all the time. Even the IRB failed to complain or notice this "danger". They never complained that pencils were too dangerous, just that it didn't meet the arbitrary signature requirement that it be a pen. And you say this is the most ludicrous requirement, but it's actually the least. After all it's not entirely the IRB's fault, they didn't ban pens in the hospital. But it demonstrates exactly what is wrong with bureaucracy. Maybe one bureaucracy with one set of arbitrary rules could be tolerated. But once you have two interacting they can create contradicting and incompatible rules. One bureaucracy bans pens, the other bans pencils, and you end up with a world with no writing implements at all. I'm sure the regulation sounded entirely reasonable at the time. Someone had to put together a set of rules on how to get consent. And they think pens are supposed to be the proper way of writing a signature, because banks require you to sign checks in pen. Because long ago people would erase checks written in pencil and commit check fraud. At no point did they ever consider the history of that rule or that it doesn't make much sense applied to consent forms. At no point did they ever consider that there might be a hospital somewhere that bans pens for whatever reason. And I can't blame them, why would they? You can't anticipate every possible edge case. This is a website made up of programmers, we should know that better than anyone. And yet at no point did anyone with common sense come along and make an exemption for that rule. When rules become fixed and inflexible they do things that weren't intended by the rule writers. And every single thing in the article is like that. Some rule that might not be so bad or make sense in isolation. But combine it with 10,000 other rules, and total weight becomes overwhelming. And as a result you get a bunch of people misdiagnosed with bipolar disorder, and god knows what else since doctors can't do the research necessary to find out.
• DataWorker 9y ago
  He most likely has sufficient training and knowledge about the ethics given his profession. Curious what credentials you have that might make you more qualified to speak on the ethics of medical research, but in any case I think the point he makes is that it's possible to get so caught up in the letter of the law that you run roughshod over the spirit of protecting people that brought about the laws in the first place. This seems to often be the case with concerns about data sharing and personal privacy. If you read his whole piece he discusses this and you can extrapolate that as the result of the irb stonewalling, as well intentioned as it presumably was, many patients are still suffering from not only violations of the privacy that the irb was concerned about, but those same patients may also have erroneous and stigmatizing diagnoses being included in the information that's being freely shared. The IRB in this case is doing damage by preventing research that might address this. Pinker's made some worthwhile comments on this if you're interested in this topic. You probably will get downvoted because you come across as being entirely dismissive of expertise or thinking that is not your own. I think you general point about the importance of oversight isn't lost on anyone.
  • zimpenfish 9y ago
    > He most likely has sufficient training and knowledge about the ethics given his profession. Sure but the mockery in that post suggests he either doesn't care about them or thinks they're stupid. Also do we really have to point out that just because someone is a doctor doesn't mean they have any authority when it comes to medical ethics? I mean, there's hundreds of cases amply demonstrating this even just this decade.
    • DataWorker 9y ago
      If you don't think irb's are fitting targets for such mockery I'm inclined to be strongly suspicious of your claims to have had sufficient dealings with them. They are the DMV and IRS of research rolled into one. I've never met anyone who disagreed with that, even amongst those who served on them, critically important though they may be.
      • 9y ago
• yread 9y ago
  Exactly! As someone working in medical research data sharing I am sometimes stopped from doing things the simple way by our IRB but I much prefer them being there and saying this is ok and this isn't versus just doing it the best way I can only to miss a detail and then be sued/charged with mishandling information. I don't understand how a medical doctor can write such a simplistic post. Of course your consent forms need to mention that you will access medical data if you look at diagnosis even though they are your patients! You have access to all kinds of data for treating the patient (so called primary use), but you should have the absolute minimal set of attributes for research (secondary use). Who judges whether these attributes are really needed? IRB! Of course you need to have you paperwork in order. This is not only your paperwork but also the hospital's! If you fuck up the newspapers are gonna carry headlines: doctors in this hospital leaked patients data. Do you think patients will want to come to that hospital? Of course your investigators need to go through training on research ethics! In fact you should've put them through more training so that they fill in the damn consent forms properly! Of course you need to separate personally identifiable information from the actual research and encode patient identifiers. Ever heard of publishing your data next to your research? When someone asks for the data from your study and you would forget to scrub it you would leak data. Encoding it and having it in two separate folders in one cabinet makes data sharing simpler. It protects you from making a stupid error. Of course they can be next to each other in the cabinet. That cabinet is fucking locked! And it's in a hospital next to other private data. The risk is with publishing it! Of course you need to fill in New Study Application, describe your study design and consent. IRB judges research studies, how would they do it if they didn't have that? You need to describe that stuff when asking for a grant and most studies are funded by grants so for most people it's no extra work. Of course you need a monitoring plan and study meeting monitoring problems. If you had one you would notice that the newbies were doing a shitty job! Them doing a shitty job is not only bad for you but much more importantly it wastes patient's time! Patient's didn't come to hospital to improve your credentials! The fact that there is some less than ideal stuff already used doesn't mean that your new study can be shit. That's like being angry about your pull request not getting accepted cause your indentation is all over the place and saying "but your indentation is already inconsistent". If there are style guidelines that's the way to do it. New code needs to follow them. Old stuff might get fixed or not but new stuff should be done according to guidelines.
• Sniffnoy 9y ago
  I think you're basically making a bucketing error here. As Scott Alexander points out, the exact same things he wanted to do were already being widely done elsewhere to no ill effect with no such worrying about consent. Why then does it make sense to group it under "research" together with the Tuskegee syphilis experiment and conclude things about it from that experiment, when the two have nothing in common except being research? I think that's a mistake of inference. Like, why should we conclude that we need that sort of consent to administer a questionnaire for experimental purposes (i.e.: gaining generally useful knowledge), but that there are no substantial issues of consent when it’s for diagnostic purposes (i.e.: gaining information about that particular patient) instead? Wouldn't it make more sense to group this case with the case with similar risk profile but a different purpose, rather than a related purpose but an entirely different risk profile? Something being research isn't what causes problems.
  • throwawayjava 9y ago
    > Like, why should we conclude that we need that sort of consent to administer a questionnaire for experimental purposes (i.e.: gaining generally useful knowledge), but that there are no substantial issues of consent when it’s for diagnostic purposes (i.e.: gaining information about that particular patient) instead? 1. Researcher incentives. Data => publications => prestige. If the procedure actually contains some inherent risk (e.g., a surgery) then this mismatch between the priorities of the physician and the priorities of the researcher matters. Even (actually, especially!!!) if the physician and the researcher are the same person. 2. Publication. De-anonymization is a real risk even if you're careful to only talk about patient # N in the publication. 3. Patient preference. Just because I allow my hosting provider to access my servers for the purpose of maintenance doesn't mean I'm OK with them accessing my servers for the purpose of surveillance or to read my personal emails. Purpose matters. Some patients won't want data about them used in the context of a scientific study. Patients should and do have the right to insist on that preference. Frankly, the presumption otherwise is exactly why IRBs exist. This story sounds stupid because -- aside from de-anonymization or data leaks -- there are actually no substantive risks associated with this study. Change "questionnaire" to "open heart surgery" and all of this process starts to make a lot more sense. FWIW I'm not saying IRB's aren't completely overbearing when it comes to benign studies. They totally are. But that doesn't mean these processes aren't well-justified in other circumstances. (Also, a lot of this pain is completely avoidable if you learn and follow the rules, which isn't actually nearly as hard as this post makes it out to be IME.)
• appleflaxen 9y ago
  > If the author thinks that ethics review is "Blindly trusting authority to make our ethical decisions for us", then he clearly doesn't understand what ethics review is or how it works. What is the basis for this statement? The author states that there is no oversight or governing body for the IRB. Is this incorrect (and if so, who is it)? If not, then the author's criticism seems apt.
  • euyyn 9y ago
    Not the parent, but I reached that same conclusion. You're not trusting them blindly because any and every ethical protection you decide your procedure needs, will be there. In addition to the ones the IRB thinks need to be there too. When you implement a workplace safety policy in your company, making it comply with OSHA regulations isn't "blindly trusting authority to decide what is safe". If you think a practice is unsafe, yet OSHA thinks it's safe enough, they're not gonna prevent you from taking more precautions. Same deal with code reviews. You aren't blindly trusting your colleague to decide what is bad or good code. You're adding their polish to yours.