Who exactly needs to get approval from an institutional review board (IRB)?
92 comments
·February 13, 2025web007
jhbadger
>"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 thing is, although you and the linked article seem to be associating IRB approval just with human studies, these days you need it for mouse studies.
billjive
There are different IRBs to review animal research[1]. I believe it created for an ethical framework around the use of animals in science. Same thing: what are "we" accepting of when it comes to research of this nature?
[1] example: https://animalcare.umich.edu/institutional-animal-care-use-c...
scarmig
In this analogy, you're also asking permission from the IRB to ride a bike or skateboard.
nxobject
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.)
null
spondylosaurus
Yeah, odd choice to use cars in that analogy when you very much need advance approval before you're allowed to drive a car.
A driver's license is more like a medical license than IRB approval.
xyzzyz
Indeed, and a person with a medical license is able to do much, much more damage than the people who need to ask IRB for permission to do research.
If your point is that we could replace IRBs with some sort of a researcher license, that you need to obtain before being able to do studies that today require IRB approval, then I support it, because while not ideal, it improves over the status quo.
nxobject
I do think that there’s a debate to be had on how reactive or proactive we should be in ensuring the ethical practice of… well, anything involving significant investment. As a wage case, reactive systems like malpractice suits or board actions against physicians aren’t easy to navigate if you don’t have many resources.
nxobject
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.
xyzzyz
Not sure what your analogy is here; private pilots typically don’t need to file any flight plans except in specific circumstances.
derbOac
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
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.
awo495jwal34i5
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.
cal1co
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.
ahi
Also, a great deal of the research organizations like META "just do" wouldn't pass muster with any IRB worth the name.
Xcelerate
> 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
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.
floxy
>...In the real world, people usually attempt to solve problems by forming hypotheses and then testing them against the facts as they know them. When the facts confirm the hypotheses, they are accepted as true, although subject to re-evaluation as new evidence is discovered. This is a successful method of reasoning about scientific and other empirical matters because the physical world has a definite, unique structure. It works because the laws of nature are consistent. In the real world, it is entirely appropriate to assume that once you have confirmed your hypothesis, all other hypotheses inconsistent with it are incorrect.
> In the legal world, however, this assumption does not hold. This is because unlike the laws of nature, political laws are not consistent. The law human beings create to regulate their conduct is made up of incompatible, contradictory rules and principles; and, as anyone who has studied a little logic can demonstrate, any conclusion can be validly derived from a set of contradictory premises. This means that a logically sound argument can be found for any legal conclusion.
The Myth of the Rule of Law:
https://drive.google.com/file/d/1I-JhqpU3_0r_HL06hP-5DABhEtG...
dekhn
It took me a while to accept that the law is not a consistent system with hierarchical top-down rules that can be used to determine legality in an unambiguous way.
If you're a software engineer and you're knee-deep in analyzing court cases to find out how to file some tax correctly, you're definitely overthinking it. The CPA was exactly correct.
appleorchard46
This is addressed at a few different points in the article, I found this bit particularly insightful:
> So what happens in practice is politicians write a vague law. Bureaucrats turn that law into very detailed (but often still vague) specific rules. Those rules might or might not be “legal”, but nobody want to risk fighting them in court. If the regulations are particularly ridiculous or likely to be overturned if challenged, prosecutors may quietly stop bringing cases. But the regulations still sit there on the books. And people still usually pay attention to them, because why risk it?
billjive
This specific quote from the article made me think of lawmaking - the more detailed the law the harder it is to pass (someone can always fine something to nitpick). Therefore, laws are best at establishing goals, principles, guide rails, etc. Nothing is perfect but the way in which laws are implemented SHOULD remain a separate part of the law passage.
Separate rant: I live on the west coast and am annoyed when I vote because of the number of ballot measures. None of them are sufficiently detailed and fall victim to vague language that's open to interpretation. I'd rather "hire" law makers to do the hard work of details law creation.
cal1co
I think the article did sufficient to talk about 'what would happen if one were prosecuted,' given that it's really hard to predict.
What I thought was missing was an acknowledgement of the circumstances that would cause a _prosecutor_ or _other litigant_ to decide to _bring an action to court._
Prosecutors are political, have limited resources, and are ultimately more or less accountable to electoral forces. Their prerogative is (almost) never going after every single person who does an action that is technically illegal. Factors like harm, the reputation of one's actions in their community, and their alignment with the political establishment are going to be considerations.
As written, I could see the article maybe deterring a particularly rules-abiding individual from running a potato-eating weight loss experiment with their roommates. I've seen friends and relatives get all wound up worrying about whether something is technically illegal in some marginal way.
Understanding the human factors in the pipeline between a potentially unlawful action and a consequence for it is really important. All the institutions that get anything done are keenly aware of them.
appleorchard46
It is briefly mentioned in the notes at the end that nobody has seemingly ever been prosecuted for this, and the laws are primarily aimed at institutions doing shady stuff rather than individuals wanting to feed their friends potatoes. But yes, the focus definitely isn't on that side of things.
I don't think it's fair to call that a deficiency, though; both the letter of the law and the practical applications are complex and interesting topics in their own right(s?), and either could fill a lengthy article as we see here. Both are welcome! One doesn't preclude the other. I would be interested in reading an article covering what you describe too.
nxobject
Conversely, a social and “in practice” reason why government-funded institutions _do_ use IRBs is to allay fiscal hawks and criticism about state funding being misused.
cm2012
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.
tonetegeatinst
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
> 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.)
caycep
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
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
In which case conversations should be had about individual board member behavior. It is not a reason to not to have safety oversight.
asdff
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.
nxobject
Congratulations: you are seeing the effect of decades of philosophical wrangling about the ethics of research.
ikanreed
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
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.
jp57
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.
null
Isamu
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.
> 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.