10 ms·

Who exactly needs to get approval from an institutional review board (IRB)?

211 points by gregorymichael 2y ago

bell-cot 2y ago
The article is about medical research on human subjects. And quickly concedes that a great many technically-need-permission things which you might do are of no actual interest to the gov't. EDIT: <sigh/> The second sentence of the article is - > Like, let’s eat potatoes and see if we lose weight. - which, in the minds of 95% of likely jury members, is not "medical research". Nor, at small scale, of plausible interest to the gov't. If the US Gov't is looking for excuses to crush me, or I've got enough money to be worth a lawsuit, then nothing resembling medical research is needed for them to go ahead with those. Doubtless, I evilly conspired to not pay $0.06 of Use Tax in 2003. And some poor innocent was traumatized for life by my cat looking at them cross-eyed, in a photo I put on the web. And, notice my phrasing - "of no actual interest to the gov't". Not "IAAL, and you're 100.00% okay to run with this".
- PaulHoule 2y ago
  People might still sue you. I had a stressful event and had a psychogenic fever and lost 15 pounds in two weeks and kept it off for more than six months. There is some research on this [1] [2] in particularly that author wrote a case study about a Japanese girl who was bullied at school who developed a stress fever. Given there is an obesity crisis and everything this might be an effective diet plan, but to do it, you have to induce severe stress. A protocol might be "get 30 people to show up for a weekend encounter group, pick out the 1 person who seems the most susceptible, have the other 29 bully that person." Cal Lightman might get away with something like that in Lie to Me but no way you can get away with that in real life. [1] https://pubmed.ncbi.nlm.nih.gov/27227051/ https://pubmed.ncbi.nlm.nih.gov/27227051/ [2] https://pubmed.ncbi.nlm.nih.gov/30459027/ https://pubmed.ncbi.nlm.nih.gov/30459027/
  - pjc50 2y ago
    You can only get away with weird social bullying experiments if you're doing it for Youtube. Don't try crashing a plane for Youtube though, that went down badly with the FAA.
    - PaulHoule 2y ago
      There was a driver in California who would provoke people on the road and then capture their unhinged reactions on YouTube, editing out the provocation. Eventually he got in a car crash and got in a lot of trouble.
- bilbo0s 2y ago
  That's playing with fire. You could find yourself standing in front of a courtroom if something goes wrong, or God Forbid, if someone dies, trying to convince a judge and jury with nothing but, "I didn't need government permission". That's not a good place to be.
  - temp0826 2y ago
    I used to facilitate the use of an alternative medicine (kambo), which could be dangerous if used incorrectly or given to someone with a contraindicated condition. (It has been linked to a few deaths and has recently been banned in Australia). It occurred to me that even a great signed waiver wouldn't save me if something went sideways and decided to stop. I honestly don't think a waiver wouldn't matter in cases like this too.
    - selimthegrim 2y ago
      see also certain sweat lodge practitioners
  - handoflixue 2y ago
    > if something goes wrong, or God Forbid, if someone dies Does emacs improve your typing speed? STOP! That's human experimentation!! That's the point of the article. Why would you worry someone is doing to die testing their typing speed, or filling out an online survey? You've probably conducts numerous Experimental Human Trials over your lifetime - anyone who is even slightly curious and empirical has!
    - Xmd5a 2y ago
      He's right you know. I have no opinion on this subject but there has been a crackdown against these kind of activities, especially after covid. https://en.wikipedia.org/wiki/Thierry_Casasnovas https://en.wikipedia.org/wiki/Thierry_Casasnovas
    - apical_dendrite 2y ago
      Not accurate. As the article points out, there's a whole category for "benign behavioral interventions" which are exempt from IRB review.
- eadmund 2y ago
  Of no actual interest to the government, unless you are someone that someone in the government wishes to crush. ‘Gosh, Opponent of the Regime, when you wrote your blog entry in 2019 about cutting eggs out of your kids’ diets, that was un-reviewed human research. To jail with you!’
  - selimthegrim 2y ago
    This is inconsistent with the general line of the Party, comrade. Your train to Vorkuta awaits.
  - nxobject 2y ago
    Perhaps the issue there is in electing a government that wishes to crush critics by creatively interpreting the law, and not the existence of IRBs.
  - ls612 2y ago
    Yeah, this post reads like “socially awkward guy discovered the mechanism by which the rule of law is a sham and always has been” to me.
fsflover 2y ago
https://news.ycombinator.com/item?id=43038288 https://news.ycombinator.com/item?id=43038288
- bell-cot 2y ago
  Is that version of the article meaningfully different?
- dang 2y ago
  (Just so you know: on HN, the convention is to link to other threads only if there are meaningful comments there.) (Reposts aren't considered dupes unless the previous submission got significant attention within the last year or so - see https://news.ycombinator.com/newsfaq.html https://news.ycombinator.com/newsfaq.html) (It's on my list to implement karma sharing so in the future, several submitters can share in the 'win' when a story makes the frontpage)
skwb 2y ago
I mean tons of retrospective studies are literally "IRB exempt" (and highlighted as such in their methods) where no explicit consent is required or needed. Physicians doing case reviews don't need consent of the patient this work. Doing retrospective analyses for defining clinical phenotypes on patient data that has been aggregated isn't needed either. Collecting clinical MRIs to do deep learning doesn't require an IRB. IRBs are only REALLY required when you are intervening in patient care or pose some theoretical risk to a human. Some institutions still want you to submit approval for institutional data, but as a non-lawyer it seems that's much more of a CYA policy.
- potato3732842 2y ago
  >IRBs are only REALLY required when you are intervening in patient care or pose some theoretical risk to a human. In practice, sure, but that's not what the spaghetti of rules that one is compelled by law to follow state. This disconnect is the whole point of the article.
  - skwb 2y ago
    I just pointed out the numerous exemptions to IRBs for research. People can literally make a research career and never touch IRBs. The point I'm trying to make is that the blog is so narrowly defined that it doesn't match the reality of clinical research.
- fluidcruft 2y ago
  > Collecting clinical MRIs to do deep learning doesn't require an IRB Yes it does, but typically the IRB will waive consent and waive notification for those sorts of studies if the images can be de-identified. There's also HIPAA involved which may or may not require establishing a BAA depending on what's being done if the images can't be de-identified. This is particularly an issue with brain MRI because it is usually trivial to generate an image that can be compared to full-face photographs (i.e. can be compared to drivers license/passport type photos to reestablish identify). And longer term you're not getting anything even in the door at the FDA without an IRB and you're not selling anything without FDA approval. Also please note that MRI is a Class II regulated device that deposits energy in subjects/patients so it doesn't qualify for a lot of the exemptions (early last year the FDA granted IRBs the ability to do things like wave full written consent for minimal risk research for FDA-regulated research).
nxobject 2y ago
Congratulations: you are seeing the effect of decades of philosophical wrangling about the ethics of research.
- ikanreed 2y ago
  And it's an interesting time to think about this problem. Because we're about to see how all the structures that were put in place to enforce those ethics react to being told they must instead do keyword searches for forbidden phrases set by fiat. If you're the kind of administrator who does boring work of making sure all professors in your biomedical campus submitted IRB paperwork, are you also going to be the person who makes sure their papers don't contain the word "Woman" or "Historically"?
  - nxobject 2y ago
    It is, and I do think it’s as subtle as the conversation on any other checks-and-balances mechanism in government these days: we can weaponise both painstakingly following the rules, or weaponizing the fact that rule enforcement is a human process that people ignore by convention.
  - mmooss 2y ago
    Has that happened to you?
    - ikanreed 2y ago
      No, this is a very recent development in science policy.
perihelions 2y ago
And yet, FAANG's somehow get way with employing credentialed psychologists and psychiatrists, to experiment on social media users, for maximizing their various engagement and click metrics. For the scale and impact of non-IRB human psychology research, that one has to be at the very top.
- deleted 2y ago
  [deleted]
- dehrmann 2y ago
  I'm not sure how much this actually happens or if product teams and algorithms figure it out just by trying different things and chasing engagement metrics.
- avalys 2y ago
  Cite that this actually happens? Note that “this person is a psychologist and is employed by Meta working on user research” is not evidence that supports the statement you made.
  - mrkeen 2y ago
    This comes to mind https://www.theguardian.com/technology/2014/jun/30/facebook-emotion-study-breached-ethical-guidelines-researchers-say https://www.theguardian.com/technology/2014/jun/30/facebook-...
    - avalys 2y ago
      In what way does this article support the claim that psychologists “experiment on social media users for maximizing their various engagement and click metrics”?
- nxobject 2y ago
  I wouldn’t be surprised that, if Facebook was suddenly subject to extra scrutiny, they would just hire an independent IRB in the way that corporate clinical research does, e.g.: https://www.sterlingirb.com/ https://www.sterlingirb.com/ https://www.pearlirb.com/ https://www.pearlirb.com/
machine_ghost 2y ago
The fact that the very foundation of our legal system is fundamentally undemocratic (in the sense that no regular citizen can be reasonably expected to understand it) is starting to bubble up into societal awareness. With everything Trump is doing to destroy the rule of law, and all the potential for technology to help us simplify it, I can only hope that when Trump burns it all down, the people who rebuild will be wise enough to do better.
- kubb 2y ago
  I think this might be a missed analogy, rule of law isn't like a house that you can burn down and rebuild stronger. The default state without rule of law is rule of the strongest. The law is like pillars that support a tunnel. Once these are weakened, the tunnel goes crashing down, and it has to be dug again. The society backslides to authoritarianism. And the price for digging a new tunnel is often a lot of blood.
- c048 2y ago
  I have little faith that, should it all be burned down, recreating it all from the ground up that it would be better. People need to accept that what Trump is doing is only possible because of what his predecessors put down as law. That means democratic presidents too. I didn't see Trump's detractors call all of this out when the winds were blowing their way. So no, I have no faith that rebuilding it from the ground up would make it one iota better. Not without deep societal changes.
- mmooss 2y ago
  > the people who rebuild That's you and I.
michaelt 2y ago
As a foreigner something I've always found hilarious is that on one hand, Americans in academia act like mailing a survey to adults is Performing Research On Humans and it's wildly unethical to do so without IRB approval, informed consent, data control, the right to withdraw at any time and so on. But at the same time American corporations will gleefully A/B test to determine the most clicked ads, the most profitable search result ordering, and the algorithmic feed parameters that maximise time spent scrolling - all with nary a thought about any ethics whatsoever.
- nickff 2y ago
  There's an unfortunate history of scientists harming study subjects, which caused most institutions to institute these safeguards, so as to avoid reputational harm which would cause the government to cease funding them. Corporations are not subject to political whims, though they often do have lawyers review their study techniques, as they are subject to lawsuits.
- voxic11 2y ago
  That is because most academics work at institutions which receive federal funding and all human research at such institutions requires IRB approval. American corporations in general do not receive federal funding and so IRB approval is only required in limited circumstances such as research on unapproved medical drugs and procedures.
  - cess11 2y ago
    Are you sure it's not common for US corporations to have access to public funds, either through subsidies or public investment of some sort?
    - voxic11 2y ago
      Tax subsidies are received by many corporations but they do not fall under the types of funds covered by the "Common Rule". > Federal funds administered by a Federal department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-...
derbOac 2y ago
The answer is no, you don't need permission, but you do incur a legal and ethical risk whenever you do research, and as such, the more you can do to strengthen the legal and ethical arguments in your defense, the better. IRBs are simply a way to say "I had an independent group of ethical and legal authority review my research and they thought it was ok".
- billjive 2y ago
  That is right, and further - I think about IRBs like I do non-profit boards. One of the key tasks of a board is to determine what risk the organization is willing to bear. I think the IRBs at these institutions are 1) following federal laws but 2) making a judgement on the risk the institution is willing to sign up for. For example, for many clinical trials are distributed to multiple "sites" where the trial is actually administered. Many of these sites are universities. What the University of Iowa is willing to bear is different than the University of Michigan and the IRBs reflect that.
- rights_reminder 2y ago
  It's hard to take the article seriously since 1) It doesn't even reference the relevant law 2) The relevant law is so simple and clear 42 USC 289(a) states: "The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an “Institutional Review Board”) to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research."[1] To put it succinctly this only relates to any entity which applies for a grant, contract, coop. agreement under chapter 6A of 42 USC. This in no way relates to private research. It's easy to get hung up on regulation spaghetti code, but regulations cannot exceed the scope of the statutes, which in turn cannot exceed the authority of Congress. Edit: add source [1] https://www.law.cornell.edu/uscode/text/42/289 https://www.law.cornell.edu/uscode/text/42/289
Isamu 2y ago
This gets my enthusiastic upvote. Reason: author bothered to do work to research his answer. In contrast, a shockingly large amount of content is extremely lazy, gut-feeling reaction. Avoiding the work and disappointment of finding out that your hot take is wrong.
cal1co 2y ago
An article like this is interesting from a research (meta-research?) perspective, but I think the lack of relevant case law (nobody seems to have ever been prosecuted) really undermines the usefulness. It's easy for people (especially the kinds of people who gravitate towards engineering) to get all worked up about the necessary implications of the regulations as-written. But it's also important to remember that being facings consequences would require A) The intentional action of either a state prosecutor or an injured private party B) The involvement of a human being as a judge to interpret the facts and applicable rules When you look at it from that angle, it's obvious why organizations like META just do the research, imho.
- Xcelerate 2y ago
  > It's easy for people (especially the kinds of people who gravitate towards engineering) to get all worked up about the necessary implications of the regulations as-written I was once trying to figure out taxes owed on some RSUs granted in California that vested in North Carolina (and some other edge case that I can’t remember). Hoh boy. What a rabbit hole. I didn’t think the CPA that I hired to do my taxes handled it correctly, so I started digging into the tax laws and regulations. Couldn’t find anything that covered my specific case. So I started digging into court cases involving disputes over RSU taxes owed in North Carolina and found conflicting outcomes. I brought what I had found back to the CPA who basically said something along the lines of: there is no absolute “rule” for what to do in this case like you’re looking for. We make a good faith effort to mirror what was done in similar prior situations, write a number down, and then forget about it unless you hear from the IRS. Did not make me feel very confident about the legal system.
  - noodlesUK 2y ago
    I think this illustrates an issue in common law systems in general. Contrary to what we’re taught in school about how actions are generally legal by default, and only illegal if a law has been passed to prohibit them, in reality, actions exist in a superposition of legal and illegal until someone challenges that position and a court finds out (subject to any appeals). You can only evaluate in practice whether something is legal based on copying others in similar situations. The further you get from the known outcomes the fuzzier this all becomes. This tends to be something people encounter a lot around tax, complex business structures, and various international dealings where you’re more likely to end up in an edge case that hasn’t been well explored.
deleted 2y ago
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kazinator 2y ago
Do you need permission from the government to invite people to your house and let them try food and drinks?
web007 2y ago
> As an analogy, driving a car is dangerous. Whenever I drive, I could easily kill someone. But the government doesn’t force me to submit a driving plan any time I want to go somewhere. Instead, if I misbehave, I am punished in retrospect. Why don’t we apply the same policy to research? "We" decided that Tuskegee was bad enough that it should be stopped before harm is done, and that there is no appropriate or sufficient "punish[ment] in retrospect" for the fallout. The government makes you get a license to drive at all, then "drive a Pinto" versus "drive a Trabant" are similar enough that they don't require more info. They require you to get different licensure to drive a bigger truck where you could potentially cause more harm, or to drive an airplane. In this analogy the IRB is the DMV/FAA/whatever, and you're asking for permission to drive a tank, a motorized unicycle, a helicopter, an 18-wheeler or a stealth fighter. You don't get a Science License rubber stamp because that's like getting a Vehicle License - the variation in "Vehicle" is big enough that each type needs review.
- scarmig 2y ago
  In this analogy, you're also asking permission from the IRB to ride a bike or skateboard.
  - nxobject 2y ago
    In the context of universities, the equivalent of riding a bike or a skateboard here is having people fill out surveys after events, or piloting new services offered by a student health clinic. (I guess the point of analogies like these are to force us to sweat the details and examples.)
- deleted 2y ago
  [deleted]
- nxobject 2y ago
  Another equally good comparison is, say, the existence of flight plans for private pilots, flight logs, etc. There are escape hatches, too: I doubt many rural Alaskan pilots worry (or need to worry) about these things.
jp57 2y ago
I helped my daughter do a human study for her fifth grade science project. There were inevitably jokes among my friends on Facebook about getting approval from her school’s IRB.
- froindt 2y ago
  In my AP Statistics class, we had a few weeks after the test before school was out. We had to do a statistics project, and the teacher didn't particularly care what it was. We were checking which candy was most popular from a giant bowl, and went classroom to classroom just asking a randomly selected student to pick a piece of candy. We got 100% on the report, which included "We didn't inform the participants of and potential harm from participating in the study. We're heartless bastards, oh well." Then I went to college and helped in quite a few study designs with a Professor who had worked with over 30 IRB's across his career. Ours was by far the most strict. We were primarily doing software usability studies, and every single question we would ask a participant needed to be verbatim. Your data anonymization, destruction, and analysis plans had to be fully defined, including storing the participant name to UID key separately from the data. Deviation or asking follow-up questions based on a prior response was either not allowed or a whole additional huge layer of SCRUTINY (I'm not sure). I'm genuinely curious how any sort of therapy focused study could have occurred with that IRB.
  - mmooss 2y ago
    Maybe the professor was training you and didn't care about the value of your undergraduate study, which was almost certainly not worth the professor's time otherwise.
    - CharlieDigital 2y ago
      This is also my take; it's part of the process of practical transfer of knowledge and process. He did extra work, but it was effectively practice.
    - froindt 2y ago
      Late reply, but that experience was actually in grad school. I was involved with research as an undergrad as well, but it was definitely confusing from how I stated things. I was funded through a DARPA grant. It was definitely not a training exercise.
arnonejoe 2y ago
When I was an undergrad I volunteered for a few different studies conducted by Phd candidates. How much independent research is conducted at universities w/o permission?
- asdff 2y ago
  If they took on human subjects it all has to have written approval.
eesmith 2y ago
This topic came up 11 years ago after Facebook did human subjects research by tweaking a ranking algorithm. https://petrieflom.law.harvard.edu/2014/06/29/how-an-irb-could-have-legitimately-approved-the-facebook-experiment-and-why-that-may-be-a-good-thing/ https://petrieflom.law.harvard.edu/2014/06/29/how-an-irb-cou...
photochemsyn 2y ago
The reason nobody is interested in the independent research efforts of little online community groups is that it's almost certain that they didn't put enough thought into the statistical design of their study, and thus the results are meaningless. Generally professional academics have to submit their research proposal to a funding agency and the statistical design is examined at every stage of the process to ensure that results will have some validity - and even then, it's not unusual for preliminary studies that look promising to be overturned by later more comprehensive studies. Even with all this professional double-checking, a non-trivial amount of fraud and data manipulation takes place as academics rush to climb the bureaucratic ladder or get large corporations to buy their government-subsidized startups, often making it difficult even for experts in the field to determine what's reliable and what isn't.
asdff 2y ago
This is basically why some researchers gravitate towards certain model systems in terms of abstracting the problem. It is just easier in terms of approval the simpler things get and you can basically grasp at the same sort of questions since basic cell biology is so conserved. You can do things like grow up a generation of transgenic yeast that glows green under UV light and then pour bleach over it and throw it in a carboy for disposal over the week without anyone needing approve anything but the form for the carboy to get incinerated. You try and write up a proposal for transgenic mice it might take months since the IRB needs planets to align for meetings to be scheduled. And you are paying orders of magnitude more for orders of magnitude fewer individuals in your sample that will take orders of magnitude longer to get data, than an organism that can measure reproduction rates on the log scale over hours and cost pennies on the billions.
tonetegeatinst 2y ago
This is just as confusing and explosives and energetics research. Explosives are regulated by the ATF, but can also fall under regulations of the DOT and the EPA. And if your doing any pulse power z pinch or electronic detanator experiment or research, then that's also regulated. Keep in mind this also has state regulations and ordinance to worry about and its almost like they are trying to get you to accidentally make some mistake that can technically be a felony. And they can visit and do inspections during your hours of operations. Potato cannons, model rockets, and innovation and experiments in your backyard seem to be impossible these days. Do I think safety is important, sure, but I'd argue that the paperwork of regulation has stifled the common man who want to follow the laws. Also see: export control and gpu's
- nxobject 2y ago
  > I'd argue that the paperwork of regulation has stifled the common man who want to follow the laws. I’d argue that it’s not the regulations themselves, but people who want to avoid liability, whether ethical or social. (The existence of institutional review is a good argument against, say, a fiscal hawk looking at a state university’s research output to identify the existence of fraud or abuse.)
- oneplane 2y ago
  You'd think someone would notice how this process is suboptimal and either come up with a way to make the process better, or at least a way to have a single point of contact with knowledge and experience (and reputation) to deal with this for you, i.e. on a more local governmental level. As a random citizen, you'd perhaps get away with an online self-service form, as a small company or startup you might need a form and an interview, but the entire "talk to 4 different agencies at different levels of abstraction" seems like a waste of time for everyone when it can be done in one go (provided the thing you wanted to do is common enough that it doesn't require some extreme documentation and safeguards etc). If 100000 people were to want to try out a potato canon, it should be sufficient to do something at a local level where you select "I wanna play with a potato canon for a bit" in some drop-down, and it might ask you if you intend to shoot at people or not, and if you have enough room to experiment with this without hurting anyone (including yourself). If yes, problem solved, no need to fill out a form, if unsure or no, fill out a form since you probably are doing something novel, or something you might not want to do. If this then means some other agency at some other level needs to get notified, sure, automate that, who cares. If it turns out you filled out your form and specified radio active potatoes, perhaps one of those other agencies might want to have a chat first to see if everything is okay. But the default of "talk to an arbitrary number of agencies in every case" is not great.
sfpotter 2y ago
But sometimes, when everyone is having fun, some very mean very bad people show up and say, “HEY! YOU CAN’T DO THAT! THAT’S HUMAN SUBJECTS RESEARCH! YOU NEED TO GET APPROVAL FROM AN INSTITUTIONAL REVIEW BOARD!” I can't stand this precious style of writing. I wish it were less ubiquitous. I think what upsets me about it is that it's disingenuous. When it registers as "cute and charming", it flies over the reader's head and doesn't encourage them to evaluate for themselves whether something like an IRB (or whatever) should exist. If it comes across as disingenuous---or if the reader doesn't feel like the "very mean very bad people" are "very mean" or "very bad"---then the reader is put in the position of feeling like they're going to rain on someone's parade if they disagree. Basically, it's a rhetorical tactic used to forestall argument or discussion about something the writer finds distasteful. I find myself unwilling to read an article if it opens this way because I don't feel comfortable trusting anything the writer says since they've already opened their piece with a piece of rhetoric which is essentially dishonest.
- appleorchard46 2y ago
  It's intended to be an amusingly simplistic strawman in order to contrast with and highlight the actual (deeply) complex reality described thoroughly through the rest of the article. They don't actually think anyone who suggests IRB approval is very mean and very bad, that line really isn't the thesis statement. If you read a bit further I think you'd be less annoyed by it.
  - sfpotter 2y ago
    Assuming the author isn't being disingenuous, what does this line actually bring to the table? If the article is thoughtful and nuanced, why not write with the maturity that a thoughtful and nuanced topic deserves? You can do it in a way that invites thought and deliberation and isn't stuffy or overly serious. I just don't see what value interjecting this kind of preciousness is supposed to bring. If it's supposed to be funny... I mean... it isn't.
    - JohnMakin 2y ago
      It seems you'd answer your own questions here and maybe some of your frustration if you actually proceeded to read the rest of the article, which explains quite clearly the point being made. You being exasperated by the tone or style isn't really relevant to the substance of what was written about, or to anyone else really.
trhway 2y ago
>"HEY! YOU CAN’T DO THAT! THAT’S HUMAN SUBJECTS RESEARCH! YOU NEED TO GET APPROVAL FROM AN INSTITUTIONAL REVIEW BOARD!” reminded - The EcoHealth Alliance application successfully granted by NIH for those Wuhan coronavirus gain-of-function experiments did have the "Human Subjects Included" and "IRB" checkboxes checked :)
deleted 2y ago
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caycep 2y ago
I feel like the OP is overthinking it. The simple answer is you submit an approval for an IRB waiver, and if your IRB isn't staffed with nitwits, they usually grant it. (i.e. most retrospective studies including w/ chart review, or "minimal harm" studies i.e. w/ asking questions etc, w/o any drugs/surgeries/blood draws etc, or any risk of disseminating private health information usually get the waiver)
- nxobject 2y ago
  And, conversely, when people _do_ weaponize institutional review requirements to police research, you have a much more pressing and bigger problem: the existence of people who would be happy to find any mechanism to police research.
  - caycep 2y ago
    In which case conversations should be had about individual board member behavior. It is not a reason to not to have safety oversight.
  - thereisnospork 2y ago
    I would argue that the weaponization is an intrinsic part of the nature of review boards. Not just for ethics, but accross pretty much all categories. It's been pretty universal in my experience that people will use the power given to them to push their agenda, which is generally only somewhat aligned with the nameplate mission. E.g. a vegan or vegetarian on an ERB has an obvious, if soft, conflict of interests that will come out in how they treat requests involving animals, or whose results might lead to future testing on animals.
    - caycep 2y ago
      But...people and people-communications make it work, i.e "Technical problems are easy, people are hard." This is a truism of life. I think this comment in the marca linux kernel brouhaha thread is relevant. (and most IRB squabbles that involve non-invasion/low risk research never really get as bad as that, at least in my experience, knock on wood) https://news.ycombinator.com/item?id=43037699 https://news.ycombinator.com/item?id=43037699
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motohagiography 2y ago
the challenge with IRB's is that they are para-bureaucratic orgs without the transparency or accountability of an actual public or government review. my limited experience with them was to do with governing access to repositories of personal health information and really, just bet that unethical research that abuses powers is going to happen, and that research product gets fed back to policymakers to increase the unaccountable powers of policymakers. any public benefit is for show.
cm2012 2y ago
IRBs are one of the most wasteful and hurtful institutions in the developing world today. In order to prevent a few possible ethical lapses, they smother hundreds of good potential research. See Scott Alexander's works on IRB review.
- dekhn 2y ago
  IRBs dont prevent ethical lapses; they reduce the liability of the contractee/grantee.
- Viliam1234 2y ago
  > See Scott Alexander's works on IRB review. Links: https://slatestarcodex.com/2017/08/29/my-irb-nightmare/ https://slatestarcodex.com/2017/08/29/my-irb-nightmare/ https://slatestarcodex.com/2017/08/31/highlights-from-the-comments-on-my-irb-nightmare/ https://slatestarcodex.com/2017/08/31/highlights-from-the-co...
- mmooss 2y ago
  > In order to prevent a few possible ethical lapses, they smother hundreds of good potential research. Doesn't that describe all safety and security measures? Airport security wastes millions of hours in order to prevent a few possible problems. > ethical lapses That's quite a euphemism for death and bodily injury. I'm sure you wouldn't mind it yourself. There is plenty of evidence of what happens without IRBs - just look what happened before IRBs.
  - cm2012 2y ago
    Do yourself a favor and read this link: https://slatestarcodex.com/2017/08/29/my-irb-nightmare/ https://slatestarcodex.com/2017/08/29/my-irb-nightmare/ And yes, airport security is also a colossal waste
awo495jwal34i5 2y ago
According to the Office of Compliance at the University of Texas at Austin, my graduate advisor didn't need to get IRB approval to perform experiments on human test subjects that risked severe bodily harm. I reported him, they ignored the complaint, and then gave him tenure. They also didn't care about the part where he falsified his results or lied to his sponsors about how he was spending their money.
asimpleusecase 2y ago
I worked in environmental chemistry - commercial lab. We did not do tests on humans nor animals but we were constrained by federal law and commercial liability . If the test you were doing was covered by federal law appeared in the CFR ( code of federal regulations) you needed to make if you said you were doing a test that was detailed in law that you followed that procedure in a documented way. If you changed it in a significant way you were engaging in a felony. Then you had some Tests that were not covered by federal regulations- so how do you protect yourself from lawsuits ? ( the fact you could do a test that would cost $100 but the client was making a million dollar decision with the results meant there could be a lot of liability risk)so in those cases where there was no clear regulation you would opt for “industry best practice “ using processes, equipment, reagents that were commonly used for that test by others in the Industry. If you did that then your insurance provider would defend yourself. If you had good documentation you could prove you did the right thing the right way and win the lawsuit. Based on that background I suspect the biggest reason for review boards is liability protection.
Kevin_S 2y ago
As an academic researcher, it's most frustrating in that it feels like IRB scrutiny doesn't seem to align with risk. I do accounting research. My human-subjects research involves surveying practitioners about their jobs, interviewing them about their experiences, and conducting very simple experiments online that ask them to make decisions. There is virtually 0 real risk to any participants of my studies. IRB does always give my studies "exempt" status, but it still has to be reviewed. And they will pester me about different things like where will store our data (Onedrive is fine, but dropbox is not for some reason). This process will typically take a couple weeks of back and forth. Yet I have a friend who participated in a Kinesiology dissertation study where they were asked to do extremely strenuous physical activity. He fainted(!) at one point from the activity. And it seemed to them that there were relatively few safeguards from that happening. Now, I'm sure that study did have IRB approval, but it really got me thinking... are we really scrutinizing studies optimally?
- jampekka 2y ago
  We are not. Here's a great essay about the subject: https://journals.sagepub.com/doi/abs/10.1177/174701611100700402 https://journals.sagepub.com/doi/abs/10.1177/174701611100700... The author also has a blog about IRBs: http://www.institutionalreviewblog.com/?m=1 http://www.institutionalreviewblog.com/?m=1
- p_j_w 2y ago
  >Onedrive is fine, but dropbox is not for some reason As far as I know, it's possible to get OneDrive even HIIPA compliant, but I don't think so for Dropbox.
  - eszed 2y ago
    Dropbox claims that it can achieve HIPAA-compliance, and I personally know two (large and serious) organizations who use it as such. https://help.dropbox.com/security/hipaa-hitech-overview https://help.dropbox.com/security/hipaa-hitech-overview In keeping with the theme of the OP, I don't know if that's been tested in court, soooo... Take that all for what you will.
- 2y ago
mannyv 2y ago
This is what good lawyers do: dig in to the sausage factory. What's interesting is how agencies push the limits on what they can do. All agencies do this to one extent or another. And they obviously won't tell you if they're doing that to you or not. Granted authority and actual authority are different. It's worth remembering that when dealing with any bureaucracy.
- mannyv 2y ago
  As a note, the FDA circulars in particular (like the labeling one) aren't technically law, but because they're (1) put out by the FDA and (2) a good summary people treat them as law. The thought is that you can always point to the circular if you need to. You should read the actual regulations as well, but that's work so lots of people don't do it. Here's an example of why you should read the regulations. Technically, supplements can't make structure/function claims. However, you can submit your structure/function claim to the FDA. Once you do that you can make that particular structure/function claim on your labels. Since the FDA has no process in place to actually review those claims your structure/function claim is suddenly valid. It's amusing.
jablongo 2y ago
My understanding is IRB is not a governmental regulation but an institutional regulation. For example if you want to design a study and then have acme medical center take part in conducting it, you would need to pass the Acme IRB. Governmental funding may also have restrictions that require you to have some kind of IRB review.
- pc86 2y ago
  It's quoted in another comment but 42 USC 289(a) requires the establishment of an IRB in any institution applying for federal grants, among other things. So it is a law that there exist some sort of IRB for any "biomedical or behavioral research" and my guess is most institutions see 99% of their research falling under behavioral.
tptacek 2y ago
The article suggests that simply agreeing with friends to experiment with diets would trigger the IRB requirement, and cites a NY state law requiring affiliation with an IRB-enabled institution to do human research. But the "definitions" section of that New York law says: 2. "Human research" means any medical experiments, research, or scientific or psychological investigation, which utilizes human subjects and which involves physical or psychological intervention by the researcher upon the body of the subject and which is not required for the purposes of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of medical condition for the direct benefit of the subject. Human research shall not, however, be construed to mean the conduct of biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice, or to include epidemiological investigations.
- lmm 2y ago
  Are you claiming that agreeing with friends to experiment with diets does not fall under that definition? If so, which part do you think it doesn't meet? If you read "physical or psychological intervention by the researcher upon the body of the subject" in such a way that a friend telling another friend to follow a given diet doesn't qualify then most medical research would be exempt too - researchers generally give subjects medication and tell them to take it rather than physically pushing it down their throat.
mannyv 2y ago
Can someone set up an independent IRB that you can use that is more of a UL-style IRB?
pinoy420 2y ago
Medical device research to reduce risk (liability)
- 63737389 2y ago
  Rico
mounceyboy 2y ago
This is a nice first pass at the common sense problems with interpreting FDA regulations. I imagine that those who have been dealing with this for some time aren't as confused as the author suggests we should be. On the first pass, for example, are human subjects involved? Do you interact with humans? No, then probably not. There are many subtleties after that, but it's not so bad as the poster suggests. I remember a comment one investigator told me about animal research, where he illustrated the problem by saying you can go into a grocery store and buy a leg of lamb and do anything you want with it, but don't call it research!
renewiltord 2y ago
IRBs are like run of the mill CSOs. Ideally, they'd prefer you do zero research since that involves zero risk. Waste of everyone's time. Just like ethicists. Once we clean up funding and reward research we can get rid of all these makework scolds.

The article is about medical research on human subjects. And quickly concedes that a great many technically-need-permission things which you might do are of no actual interest to the gov't. EDIT: <sigh/> The second sentence of the article is - > Like, let’s eat potatoes and see if we lose weight. - which, in the minds of 95% of likely jury members, is not "medical research". Nor, at small scale, of plausible interest to the gov't. If the US Gov't is looking for excuses to crush me, or I've got enough money to be worth a lawsuit, then nothing resembling medical research is needed for them to go ahead with those. Doubtless, I evilly conspired to not pay $0.06 of Use Tax in 2003. And some poor innocent was traumatized for life by my cat looking at them cross-eyed, in a photo I put on the web. And, notice my phrasing - "of no actual interest to the gov't". Not "IAAL, and you're 100.00% okay to run with this".

PaulHoule 2y ago
People might still sue you. I had a stressful event and had a psychogenic fever and lost 15 pounds in two weeks and kept it off for more than six months. There is some research on this [1] [2] in particularly that author wrote a case study about a Japanese girl who was bullied at school who developed a stress fever. Given there is an obesity crisis and everything this might be an effective diet plan, but to do it, you have to induce severe stress. A protocol might be "get 30 people to show up for a weekend encounter group, pick out the 1 person who seems the most susceptible, have the other 29 bully that person." Cal Lightman might get away with something like that in Lie to Me but no way you can get away with that in real life. [1] https://pubmed.ncbi.nlm.nih.gov/27227051/ https://pubmed.ncbi.nlm.nih.gov/27227051/ [2] https://pubmed.ncbi.nlm.nih.gov/30459027/ https://pubmed.ncbi.nlm.nih.gov/30459027/
- pjc50 2y ago
  You can only get away with weird social bullying experiments if you're doing it for Youtube. Don't try crashing a plane for Youtube though, that went down badly with the FAA.
  - PaulHoule 2y ago
    There was a driver in California who would provoke people on the road and then capture their unhinged reactions on YouTube, editing out the provocation. Eventually he got in a car crash and got in a lot of trouble.
bilbo0s 2y ago
That's playing with fire. You could find yourself standing in front of a courtroom if something goes wrong, or God Forbid, if someone dies, trying to convince a judge and jury with nothing but, "I didn't need government permission". That's not a good place to be.
- temp0826 2y ago
  I used to facilitate the use of an alternative medicine (kambo), which could be dangerous if used incorrectly or given to someone with a contraindicated condition. (It has been linked to a few deaths and has recently been banned in Australia). It occurred to me that even a great signed waiver wouldn't save me if something went sideways and decided to stop. I honestly don't think a waiver wouldn't matter in cases like this too.
  - selimthegrim 2y ago
    see also certain sweat lodge practitioners
- handoflixue 2y ago
  > if something goes wrong, or God Forbid, if someone dies Does emacs improve your typing speed? STOP! That's human experimentation!! That's the point of the article. Why would you worry someone is doing to die testing their typing speed, or filling out an online survey? You've probably conducts numerous Experimental Human Trials over your lifetime - anyone who is even slightly curious and empirical has!
  - Xmd5a 2y ago
    He's right you know. I have no opinion on this subject but there has been a crackdown against these kind of activities, especially after covid. https://en.wikipedia.org/wiki/Thierry_Casasnovas https://en.wikipedia.org/wiki/Thierry_Casasnovas
  - apical_dendrite 2y ago
    Not accurate. As the article points out, there's a whole category for "benign behavioral interventions" which are exempt from IRB review.
eadmund 2y ago
Of no actual interest to the government, unless you are someone that someone in the government wishes to crush. ‘Gosh, Opponent of the Regime, when you wrote your blog entry in 2019 about cutting eggs out of your kids’ diets, that was un-reviewed human research. To jail with you!’
- selimthegrim 2y ago
  This is inconsistent with the general line of the Party, comrade. Your train to Vorkuta awaits.
- nxobject 2y ago
  Perhaps the issue there is in electing a government that wishes to crush critics by creatively interpreting the law, and not the existence of IRBs.
- ls612 2y ago
  Yeah, this post reads like “socially awkward guy discovered the mechanism by which the rule of law is a sham and always has been” to me.

fsflover 2y ago

https://news.ycombinator.com/item?id=43038288 https://news.ycombinator.com/item?id=43038288

bell-cot 2y ago
Is that version of the article meaningfully different?
dang 2y ago
(Just so you know: on HN, the convention is to link to other threads only if there are meaningful comments there.) (Reposts aren't considered dupes unless the previous submission got significant attention within the last year or so - see https://news.ycombinator.com/newsfaq.html https://news.ycombinator.com/newsfaq.html) (It's on my list to implement karma sharing so in the future, several submitters can share in the 'win' when a story makes the frontpage)

skwb 2y ago

I mean tons of retrospective studies are literally "IRB exempt" (and highlighted as such in their methods) where no explicit consent is required or needed. Physicians doing case reviews don't need consent of the patient this work. Doing retrospective analyses for defining clinical phenotypes on patient data that has been aggregated isn't needed either. Collecting clinical MRIs to do deep learning doesn't require an IRB. IRBs are only REALLY required when you are intervening in patient care or pose some theoretical risk to a human. Some institutions still want you to submit approval for institutional data, but as a non-lawyer it seems that's much more of a CYA policy.

potato3732842 2y ago
>IRBs are only REALLY required when you are intervening in patient care or pose some theoretical risk to a human. In practice, sure, but that's not what the spaghetti of rules that one is compelled by law to follow state. This disconnect is the whole point of the article.
- skwb 2y ago
  I just pointed out the numerous exemptions to IRBs for research. People can literally make a research career and never touch IRBs. The point I'm trying to make is that the blog is so narrowly defined that it doesn't match the reality of clinical research.
fluidcruft 2y ago
> Collecting clinical MRIs to do deep learning doesn't require an IRB Yes it does, but typically the IRB will waive consent and waive notification for those sorts of studies if the images can be de-identified. There's also HIPAA involved which may or may not require establishing a BAA depending on what's being done if the images can't be de-identified. This is particularly an issue with brain MRI because it is usually trivial to generate an image that can be compared to full-face photographs (i.e. can be compared to drivers license/passport type photos to reestablish identify). And longer term you're not getting anything even in the door at the FDA without an IRB and you're not selling anything without FDA approval. Also please note that MRI is a Class II regulated device that deposits energy in subjects/patients so it doesn't qualify for a lot of the exemptions (early last year the FDA granted IRBs the ability to do things like wave full written consent for minimal risk research for FDA-regulated research).

nxobject 2y ago

Congratulations: you are seeing the effect of decades of philosophical wrangling about the ethics of research.

ikanreed 2y ago
And it's an interesting time to think about this problem. Because we're about to see how all the structures that were put in place to enforce those ethics react to being told they must instead do keyword searches for forbidden phrases set by fiat. If you're the kind of administrator who does boring work of making sure all professors in your biomedical campus submitted IRB paperwork, are you also going to be the person who makes sure their papers don't contain the word "Woman" or "Historically"?
- nxobject 2y ago
  It is, and I do think it’s as subtle as the conversation on any other checks-and-balances mechanism in government these days: we can weaponise both painstakingly following the rules, or weaponizing the fact that rule enforcement is a human process that people ignore by convention.
- mmooss 2y ago
  Has that happened to you?
  - ikanreed 2y ago
    No, this is a very recent development in science policy.

perihelions 2y ago

And yet, FAANG's somehow get way with employing credentialed psychologists and psychiatrists, to experiment on social media users, for maximizing their various engagement and click metrics. For the scale and impact of non-IRB human psychology research, that one has to be at the very top.

deleted 2y ago
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dehrmann 2y ago
I'm not sure how much this actually happens or if product teams and algorithms figure it out just by trying different things and chasing engagement metrics.
avalys 2y ago
Cite that this actually happens? Note that “this person is a psychologist and is employed by Meta working on user research” is not evidence that supports the statement you made.
- mrkeen 2y ago
  This comes to mind https://www.theguardian.com/technology/2014/jun/30/facebook-emotion-study-breached-ethical-guidelines-researchers-say https://www.theguardian.com/technology/2014/jun/30/facebook-...
  - avalys 2y ago
    In what way does this article support the claim that psychologists “experiment on social media users for maximizing their various engagement and click metrics”?
nxobject 2y ago
I wouldn’t be surprised that, if Facebook was suddenly subject to extra scrutiny, they would just hire an independent IRB in the way that corporate clinical research does, e.g.: https://www.sterlingirb.com/ https://www.sterlingirb.com/ https://www.pearlirb.com/ https://www.pearlirb.com/

machine_ghost 2y ago

The fact that the very foundation of our legal system is fundamentally undemocratic (in the sense that no regular citizen can be reasonably expected to understand it) is starting to bubble up into societal awareness. With everything Trump is doing to destroy the rule of law, and all the potential for technology to help us simplify it, I can only hope that when Trump burns it all down, the people who rebuild will be wise enough to do better.

kubb 2y ago
I think this might be a missed analogy, rule of law isn't like a house that you can burn down and rebuild stronger. The default state without rule of law is rule of the strongest. The law is like pillars that support a tunnel. Once these are weakened, the tunnel goes crashing down, and it has to be dug again. The society backslides to authoritarianism. And the price for digging a new tunnel is often a lot of blood.
c048 2y ago
I have little faith that, should it all be burned down, recreating it all from the ground up that it would be better. People need to accept that what Trump is doing is only possible because of what his predecessors put down as law. That means democratic presidents too. I didn't see Trump's detractors call all of this out when the winds were blowing their way. So no, I have no faith that rebuilding it from the ground up would make it one iota better. Not without deep societal changes.
mmooss 2y ago
> the people who rebuild That's you and I.

michaelt 2y ago

As a foreigner something I've always found hilarious is that on one hand, Americans in academia act like mailing a survey to adults is Performing Research On Humans and it's wildly unethical to do so without IRB approval, informed consent, data control, the right to withdraw at any time and so on. But at the same time American corporations will gleefully A/B test to determine the most clicked ads, the most profitable search result ordering, and the algorithmic feed parameters that maximise time spent scrolling - all with nary a thought about any ethics whatsoever.

nickff 2y ago
There's an unfortunate history of scientists harming study subjects, which caused most institutions to institute these safeguards, so as to avoid reputational harm which would cause the government to cease funding them. Corporations are not subject to political whims, though they often do have lawyers review their study techniques, as they are subject to lawsuits.
voxic11 2y ago
That is because most academics work at institutions which receive federal funding and all human research at such institutions requires IRB approval. American corporations in general do not receive federal funding and so IRB approval is only required in limited circumstances such as research on unapproved medical drugs and procedures.
- cess11 2y ago
  Are you sure it's not common for US corporations to have access to public funds, either through subsidies or public investment of some sort?
  - voxic11 2y ago
    Tax subsidies are received by many corporations but they do not fall under the types of funds covered by the "Common Rule". > Federal funds administered by a Federal department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-...

derbOac 2y ago

The answer is no, you don't need permission, but you do incur a legal and ethical risk whenever you do research, and as such, the more you can do to strengthen the legal and ethical arguments in your defense, the better. IRBs are simply a way to say "I had an independent group of ethical and legal authority review my research and they thought it was ok".

billjive 2y ago
That is right, and further - I think about IRBs like I do non-profit boards. One of the key tasks of a board is to determine what risk the organization is willing to bear. I think the IRBs at these institutions are 1) following federal laws but 2) making a judgement on the risk the institution is willing to sign up for. For example, for many clinical trials are distributed to multiple "sites" where the trial is actually administered. Many of these sites are universities. What the University of Iowa is willing to bear is different than the University of Michigan and the IRBs reflect that.
rights_reminder 2y ago
It's hard to take the article seriously since 1) It doesn't even reference the relevant law 2) The relevant law is so simple and clear 42 USC 289(a) states: "The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an “Institutional Review Board”) to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research."[1] To put it succinctly this only relates to any entity which applies for a grant, contract, coop. agreement under chapter 6A of 42 USC. This in no way relates to private research. It's easy to get hung up on regulation spaghetti code, but regulations cannot exceed the scope of the statutes, which in turn cannot exceed the authority of Congress. Edit: add source [1] https://www.law.cornell.edu/uscode/text/42/289 https://www.law.cornell.edu/uscode/text/42/289

Isamu 2y ago

This gets my enthusiastic upvote. Reason: author bothered to do work to research his answer. In contrast, a shockingly large amount of content is extremely lazy, gut-feeling reaction. Avoiding the work and disappointment of finding out that your hot take is wrong.

cal1co 2y ago

An article like this is interesting from a research (meta-research?) perspective, but I think the lack of relevant case law (nobody seems to have ever been prosecuted) really undermines the usefulness. It's easy for people (especially the kinds of people who gravitate towards engineering) to get all worked up about the necessary implications of the regulations as-written. But it's also important to remember that being facings consequences would require A) The intentional action of either a state prosecutor or an injured private party B) The involvement of a human being as a judge to interpret the facts and applicable rules When you look at it from that angle, it's obvious why organizations like META just do the research, imho.

Xcelerate 2y ago
> It's easy for people (especially the kinds of people who gravitate towards engineering) to get all worked up about the necessary implications of the regulations as-written I was once trying to figure out taxes owed on some RSUs granted in California that vested in North Carolina (and some other edge case that I can’t remember). Hoh boy. What a rabbit hole. I didn’t think the CPA that I hired to do my taxes handled it correctly, so I started digging into the tax laws and regulations. Couldn’t find anything that covered my specific case. So I started digging into court cases involving disputes over RSU taxes owed in North Carolina and found conflicting outcomes. I brought what I had found back to the CPA who basically said something along the lines of: there is no absolute “rule” for what to do in this case like you’re looking for. We make a good faith effort to mirror what was done in similar prior situations, write a number down, and then forget about it unless you hear from the IRS. Did not make me feel very confident about the legal system.
- noodlesUK 2y ago
  I think this illustrates an issue in common law systems in general. Contrary to what we’re taught in school about how actions are generally legal by default, and only illegal if a law has been passed to prohibit them, in reality, actions exist in a superposition of legal and illegal until someone challenges that position and a court finds out (subject to any appeals). You can only evaluate in practice whether something is legal based on copying others in similar situations. The further you get from the known outcomes the fuzzier this all becomes. This tends to be something people encounter a lot around tax, complex business structures, and various international dealings where you’re more likely to end up in an edge case that hasn’t been well explored.

deleted 2y ago

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kazinator 2y ago

Do you need permission from the government to invite people to your house and let them try food and drinks?

web007 2y ago

> As an analogy, driving a car is dangerous. Whenever I drive, I could easily kill someone. But the government doesn’t force me to submit a driving plan any time I want to go somewhere. Instead, if I misbehave, I am punished in retrospect. Why don’t we apply the same policy to research? "We" decided that Tuskegee was bad enough that it should be stopped before harm is done, and that there is no appropriate or sufficient "punish[ment] in retrospect" for the fallout. The government makes you get a license to drive at all, then "drive a Pinto" versus "drive a Trabant" are similar enough that they don't require more info. They require you to get different licensure to drive a bigger truck where you could potentially cause more harm, or to drive an airplane. In this analogy the IRB is the DMV/FAA/whatever, and you're asking for permission to drive a tank, a motorized unicycle, a helicopter, an 18-wheeler or a stealth fighter. You don't get a Science License rubber stamp because that's like getting a Vehicle License - the variation in "Vehicle" is big enough that each type needs review.

scarmig 2y ago
In this analogy, you're also asking permission from the IRB to ride a bike or skateboard.
- nxobject 2y ago
  In the context of universities, the equivalent of riding a bike or a skateboard here is having people fill out surveys after events, or piloting new services offered by a student health clinic. (I guess the point of analogies like these are to force us to sweat the details and examples.)
deleted 2y ago
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nxobject 2y ago
Another equally good comparison is, say, the existence of flight plans for private pilots, flight logs, etc. There are escape hatches, too: I doubt many rural Alaskan pilots worry (or need to worry) about these things.

jp57 2y ago

I helped my daughter do a human study for her fifth grade science project. There were inevitably jokes among my friends on Facebook about getting approval from her school’s IRB.

froindt 2y ago
In my AP Statistics class, we had a few weeks after the test before school was out. We had to do a statistics project, and the teacher didn't particularly care what it was. We were checking which candy was most popular from a giant bowl, and went classroom to classroom just asking a randomly selected student to pick a piece of candy. We got 100% on the report, which included "We didn't inform the participants of and potential harm from participating in the study. We're heartless bastards, oh well." Then I went to college and helped in quite a few study designs with a Professor who had worked with over 30 IRB's across his career. Ours was by far the most strict. We were primarily doing software usability studies, and every single question we would ask a participant needed to be verbatim. Your data anonymization, destruction, and analysis plans had to be fully defined, including storing the participant name to UID key separately from the data. Deviation or asking follow-up questions based on a prior response was either not allowed or a whole additional huge layer of SCRUTINY (I'm not sure). I'm genuinely curious how any sort of therapy focused study could have occurred with that IRB.
- mmooss 2y ago
  Maybe the professor was training you and didn't care about the value of your undergraduate study, which was almost certainly not worth the professor's time otherwise.
  - CharlieDigital 2y ago
    This is also my take; it's part of the process of practical transfer of knowledge and process. He did extra work, but it was effectively practice.
  - froindt 2y ago
    Late reply, but that experience was actually in grad school. I was involved with research as an undergrad as well, but it was definitely confusing from how I stated things. I was funded through a DARPA grant. It was definitely not a training exercise.

arnonejoe 2y ago

When I was an undergrad I volunteered for a few different studies conducted by Phd candidates. How much independent research is conducted at universities w/o permission?

asdff 2y ago
If they took on human subjects it all has to have written approval.

eesmith 2y ago

This topic came up 11 years ago after Facebook did human subjects research by tweaking a ranking algorithm. https://petrieflom.law.harvard.edu/2014/06/29/how-an-irb-could-have-legitimately-approved-the-facebook-experiment-and-why-that-may-be-a-good-thing/ https://petrieflom.law.harvard.edu/2014/06/29/how-an-irb-cou...

photochemsyn 2y ago

The reason nobody is interested in the independent research efforts of little online community groups is that it's almost certain that they didn't put enough thought into the statistical design of their study, and thus the results are meaningless. Generally professional academics have to submit their research proposal to a funding agency and the statistical design is examined at every stage of the process to ensure that results will have some validity - and even then, it's not unusual for preliminary studies that look promising to be overturned by later more comprehensive studies. Even with all this professional double-checking, a non-trivial amount of fraud and data manipulation takes place as academics rush to climb the bureaucratic ladder or get large corporations to buy their government-subsidized startups, often making it difficult even for experts in the field to determine what's reliable and what isn't.

asdff 2y ago

This is basically why some researchers gravitate towards certain model systems in terms of abstracting the problem. It is just easier in terms of approval the simpler things get and you can basically grasp at the same sort of questions since basic cell biology is so conserved. You can do things like grow up a generation of transgenic yeast that glows green under UV light and then pour bleach over it and throw it in a carboy for disposal over the week without anyone needing approve anything but the form for the carboy to get incinerated. You try and write up a proposal for transgenic mice it might take months since the IRB needs planets to align for meetings to be scheduled. And you are paying orders of magnitude more for orders of magnitude fewer individuals in your sample that will take orders of magnitude longer to get data, than an organism that can measure reproduction rates on the log scale over hours and cost pennies on the billions.

tonetegeatinst 2y ago

This is just as confusing and explosives and energetics research. Explosives are regulated by the ATF, but can also fall under regulations of the DOT and the EPA. And if your doing any pulse power z pinch or electronic detanator experiment or research, then that's also regulated. Keep in mind this also has state regulations and ordinance to worry about and its almost like they are trying to get you to accidentally make some mistake that can technically be a felony. And they can visit and do inspections during your hours of operations. Potato cannons, model rockets, and innovation and experiments in your backyard seem to be impossible these days. Do I think safety is important, sure, but I'd argue that the paperwork of regulation has stifled the common man who want to follow the laws. Also see: export control and gpu's

nxobject 2y ago
> I'd argue that the paperwork of regulation has stifled the common man who want to follow the laws. I’d argue that it’s not the regulations themselves, but people who want to avoid liability, whether ethical or social. (The existence of institutional review is a good argument against, say, a fiscal hawk looking at a state university’s research output to identify the existence of fraud or abuse.)
oneplane 2y ago
You'd think someone would notice how this process is suboptimal and either come up with a way to make the process better, or at least a way to have a single point of contact with knowledge and experience (and reputation) to deal with this for you, i.e. on a more local governmental level. As a random citizen, you'd perhaps get away with an online self-service form, as a small company or startup you might need a form and an interview, but the entire "talk to 4 different agencies at different levels of abstraction" seems like a waste of time for everyone when it can be done in one go (provided the thing you wanted to do is common enough that it doesn't require some extreme documentation and safeguards etc). If 100000 people were to want to try out a potato canon, it should be sufficient to do something at a local level where you select "I wanna play with a potato canon for a bit" in some drop-down, and it might ask you if you intend to shoot at people or not, and if you have enough room to experiment with this without hurting anyone (including yourself). If yes, problem solved, no need to fill out a form, if unsure or no, fill out a form since you probably are doing something novel, or something you might not want to do. If this then means some other agency at some other level needs to get notified, sure, automate that, who cares. If it turns out you filled out your form and specified radio active potatoes, perhaps one of those other agencies might want to have a chat first to see if everything is okay. But the default of "talk to an arbitrary number of agencies in every case" is not great.

sfpotter 2y ago

But sometimes, when everyone is having fun, some very mean very bad people show up and say, “HEY! YOU CAN’T DO THAT! THAT’S HUMAN SUBJECTS RESEARCH! YOU NEED TO GET APPROVAL FROM AN INSTITUTIONAL REVIEW BOARD!” I can't stand this precious style of writing. I wish it were less ubiquitous. I think what upsets me about it is that it's disingenuous. When it registers as "cute and charming", it flies over the reader's head and doesn't encourage them to evaluate for themselves whether something like an IRB (or whatever) should exist. If it comes across as disingenuous---or if the reader doesn't feel like the "very mean very bad people" are "very mean" or "very bad"---then the reader is put in the position of feeling like they're going to rain on someone's parade if they disagree. Basically, it's a rhetorical tactic used to forestall argument or discussion about something the writer finds distasteful. I find myself unwilling to read an article if it opens this way because I don't feel comfortable trusting anything the writer says since they've already opened their piece with a piece of rhetoric which is essentially dishonest.

appleorchard46 2y ago
It's intended to be an amusingly simplistic strawman in order to contrast with and highlight the actual (deeply) complex reality described thoroughly through the rest of the article. They don't actually think anyone who suggests IRB approval is very mean and very bad, that line really isn't the thesis statement. If you read a bit further I think you'd be less annoyed by it.
- sfpotter 2y ago
  Assuming the author isn't being disingenuous, what does this line actually bring to the table? If the article is thoughtful and nuanced, why not write with the maturity that a thoughtful and nuanced topic deserves? You can do it in a way that invites thought and deliberation and isn't stuffy or overly serious. I just don't see what value interjecting this kind of preciousness is supposed to bring. If it's supposed to be funny... I mean... it isn't.
  - JohnMakin 2y ago
    It seems you'd answer your own questions here and maybe some of your frustration if you actually proceeded to read the rest of the article, which explains quite clearly the point being made. You being exasperated by the tone or style isn't really relevant to the substance of what was written about, or to anyone else really.

trhway 2y ago

>"HEY! YOU CAN’T DO THAT! THAT’S HUMAN SUBJECTS RESEARCH! YOU NEED TO GET APPROVAL FROM AN INSTITUTIONAL REVIEW BOARD!” reminded - The EcoHealth Alliance application successfully granted by NIH for those Wuhan coronavirus gain-of-function experiments did have the "Human Subjects Included" and "IRB" checkboxes checked :)

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caycep 2y ago

I feel like the OP is overthinking it. The simple answer is you submit an approval for an IRB waiver, and if your IRB isn't staffed with nitwits, they usually grant it. (i.e. most retrospective studies including w/ chart review, or "minimal harm" studies i.e. w/ asking questions etc, w/o any drugs/surgeries/blood draws etc, or any risk of disseminating private health information usually get the waiver)

nxobject 2y ago
And, conversely, when people _do_ weaponize institutional review requirements to police research, you have a much more pressing and bigger problem: the existence of people who would be happy to find any mechanism to police research.
- caycep 2y ago
  In which case conversations should be had about individual board member behavior. It is not a reason to not to have safety oversight.
- thereisnospork 2y ago
  I would argue that the weaponization is an intrinsic part of the nature of review boards. Not just for ethics, but accross pretty much all categories. It's been pretty universal in my experience that people will use the power given to them to push their agenda, which is generally only somewhat aligned with the nameplate mission. E.g. a vegan or vegetarian on an ERB has an obvious, if soft, conflict of interests that will come out in how they treat requests involving animals, or whose results might lead to future testing on animals.
  - caycep 2y ago
    But...people and people-communications make it work, i.e "Technical problems are easy, people are hard." This is a truism of life. I think this comment in the marca linux kernel brouhaha thread is relevant. (and most IRB squabbles that involve non-invasion/low risk research never really get as bad as that, at least in my experience, knock on wood) https://news.ycombinator.com/item?id=43037699 https://news.ycombinator.com/item?id=43037699

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motohagiography 2y ago

the challenge with IRB's is that they are para-bureaucratic orgs without the transparency or accountability of an actual public or government review. my limited experience with them was to do with governing access to repositories of personal health information and really, just bet that unethical research that abuses powers is going to happen, and that research product gets fed back to policymakers to increase the unaccountable powers of policymakers. any public benefit is for show.

cm2012 2y ago

IRBs are one of the most wasteful and hurtful institutions in the developing world today. In order to prevent a few possible ethical lapses, they smother hundreds of good potential research. See Scott Alexander's works on IRB review.

dekhn 2y ago
IRBs dont prevent ethical lapses; they reduce the liability of the contractee/grantee.
Viliam1234 2y ago
> See Scott Alexander's works on IRB review. Links: https://slatestarcodex.com/2017/08/29/my-irb-nightmare/ https://slatestarcodex.com/2017/08/29/my-irb-nightmare/ https://slatestarcodex.com/2017/08/31/highlights-from-the-comments-on-my-irb-nightmare/ https://slatestarcodex.com/2017/08/31/highlights-from-the-co...
mmooss 2y ago
> In order to prevent a few possible ethical lapses, they smother hundreds of good potential research. Doesn't that describe all safety and security measures? Airport security wastes millions of hours in order to prevent a few possible problems. > ethical lapses That's quite a euphemism for death and bodily injury. I'm sure you wouldn't mind it yourself. There is plenty of evidence of what happens without IRBs - just look what happened before IRBs.
- cm2012 2y ago
  Do yourself a favor and read this link: https://slatestarcodex.com/2017/08/29/my-irb-nightmare/ https://slatestarcodex.com/2017/08/29/my-irb-nightmare/ And yes, airport security is also a colossal waste

awo495jwal34i5 2y ago

According to the Office of Compliance at the University of Texas at Austin, my graduate advisor didn't need to get IRB approval to perform experiments on human test subjects that risked severe bodily harm. I reported him, they ignored the complaint, and then gave him tenure. They also didn't care about the part where he falsified his results or lied to his sponsors about how he was spending their money.

asimpleusecase 2y ago

I worked in environmental chemistry - commercial lab. We did not do tests on humans nor animals but we were constrained by federal law and commercial liability . If the test you were doing was covered by federal law appeared in the CFR ( code of federal regulations) you needed to make if you said you were doing a test that was detailed in law that you followed that procedure in a documented way. If you changed it in a significant way you were engaging in a felony. Then you had some Tests that were not covered by federal regulations- so how do you protect yourself from lawsuits ? ( the fact you could do a test that would cost $100 but the client was making a million dollar decision with the results meant there could be a lot of liability risk)so in those cases where there was no clear regulation you would opt for “industry best practice “ using processes, equipment, reagents that were commonly used for that test by others in the Industry. If you did that then your insurance provider would defend yourself. If you had good documentation you could prove you did the right thing the right way and win the lawsuit. Based on that background I suspect the biggest reason for review boards is liability protection.

Kevin_S 2y ago

As an academic researcher, it's most frustrating in that it feels like IRB scrutiny doesn't seem to align with risk. I do accounting research. My human-subjects research involves surveying practitioners about their jobs, interviewing them about their experiences, and conducting very simple experiments online that ask them to make decisions. There is virtually 0 real risk to any participants of my studies. IRB does always give my studies "exempt" status, but it still has to be reviewed. And they will pester me about different things like where will store our data (Onedrive is fine, but dropbox is not for some reason). This process will typically take a couple weeks of back and forth. Yet I have a friend who participated in a Kinesiology dissertation study where they were asked to do extremely strenuous physical activity. He fainted(!) at one point from the activity. And it seemed to them that there were relatively few safeguards from that happening. Now, I'm sure that study did have IRB approval, but it really got me thinking... are we really scrutinizing studies optimally?

jampekka 2y ago
We are not. Here's a great essay about the subject: https://journals.sagepub.com/doi/abs/10.1177/174701611100700402 https://journals.sagepub.com/doi/abs/10.1177/174701611100700... The author also has a blog about IRBs: http://www.institutionalreviewblog.com/?m=1 http://www.institutionalreviewblog.com/?m=1
p_j_w 2y ago
>Onedrive is fine, but dropbox is not for some reason As far as I know, it's possible to get OneDrive even HIIPA compliant, but I don't think so for Dropbox.
- eszed 2y ago
  Dropbox claims that it can achieve HIPAA-compliance, and I personally know two (large and serious) organizations who use it as such. https://help.dropbox.com/security/hipaa-hitech-overview https://help.dropbox.com/security/hipaa-hitech-overview In keeping with the theme of the OP, I don't know if that's been tested in court, soooo... Take that all for what you will.
2y ago

mannyv 2y ago

This is what good lawyers do: dig in to the sausage factory. What's interesting is how agencies push the limits on what they can do. All agencies do this to one extent or another. And they obviously won't tell you if they're doing that to you or not. Granted authority and actual authority are different. It's worth remembering that when dealing with any bureaucracy.

mannyv 2y ago
As a note, the FDA circulars in particular (like the labeling one) aren't technically law, but because they're (1) put out by the FDA and (2) a good summary people treat them as law. The thought is that you can always point to the circular if you need to. You should read the actual regulations as well, but that's work so lots of people don't do it. Here's an example of why you should read the regulations. Technically, supplements can't make structure/function claims. However, you can submit your structure/function claim to the FDA. Once you do that you can make that particular structure/function claim on your labels. Since the FDA has no process in place to actually review those claims your structure/function claim is suddenly valid. It's amusing.

jablongo 2y ago

My understanding is IRB is not a governmental regulation but an institutional regulation. For example if you want to design a study and then have acme medical center take part in conducting it, you would need to pass the Acme IRB. Governmental funding may also have restrictions that require you to have some kind of IRB review.

pc86 2y ago
It's quoted in another comment but 42 USC 289(a) requires the establishment of an IRB in any institution applying for federal grants, among other things. So it is a law that there exist some sort of IRB for any "biomedical or behavioral research" and my guess is most institutions see 99% of their research falling under behavioral.

tptacek 2y ago

The article suggests that simply agreeing with friends to experiment with diets would trigger the IRB requirement, and cites a NY state law requiring affiliation with an IRB-enabled institution to do human research. But the "definitions" section of that New York law says: 2. "Human research" means any medical experiments, research, or scientific or psychological investigation, which utilizes human subjects and which involves physical or psychological intervention by the researcher upon the body of the subject and which is not required for the purposes of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of medical condition for the direct benefit of the subject. Human research shall not, however, be construed to mean the conduct of biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice, or to include epidemiological investigations.

lmm 2y ago
Are you claiming that agreeing with friends to experiment with diets does not fall under that definition? If so, which part do you think it doesn't meet? If you read "physical or psychological intervention by the researcher upon the body of the subject" in such a way that a friend telling another friend to follow a given diet doesn't qualify then most medical research would be exempt too - researchers generally give subjects medication and tell them to take it rather than physically pushing it down their throat.

mannyv 2y ago

Can someone set up an independent IRB that you can use that is more of a UL-style IRB?

pinoy420 2y ago

Medical device research to reduce risk (liability)

63737389 2y ago
Rico

mounceyboy 2y ago

This is a nice first pass at the common sense problems with interpreting FDA regulations. I imagine that those who have been dealing with this for some time aren't as confused as the author suggests we should be. On the first pass, for example, are human subjects involved? Do you interact with humans? No, then probably not. There are many subtleties after that, but it's not so bad as the poster suggests. I remember a comment one investigator told me about animal research, where he illustrated the problem by saying you can go into a grocery store and buy a leg of lamb and do anything you want with it, but don't call it research!

renewiltord 2y ago

IRBs are like run of the mill CSOs. Ideally, they'd prefer you do zero research since that involves zero risk. Waste of everyone's time. Just like ethicists. Once we clean up funding and reward research we can get rid of all these makework scolds.