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

dynomight.net

81–90 of 165 posts

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

#81
post #74

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)

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.

In which case conversations should be had about individual board member behavior. It is not a reason to not to have safety oversight.

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

#82
post #41

> 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 suffici…

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.

Not sure what your analogy is here; private pilots typically don’t need to file any flight plans except in specific circumstances.

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

#83
post #10

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 I…

> 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 usuall…

I've worked in MRI AI both in academic and non-academic centers, including technology that has received 510K clearance.

I admit it sounds pedantic, but I'm not discussing IRB *exemptions* that are sometimes required by an institution nor am I discussing BAAs. I was specifically talking about the specific IRB applications (which I've submitted and signed before) that the blog author was talking about. Yes, HIPAA and other state and local regulations also govern what you can and cannot do with the data, but that's not what I argued.

Sorta off topic but the FDA doesn't care so much about SAR unless you're directly programming the MR machine's pulse sequence. If you're just doing quantification of some brain structure for monitoring a biomarker, they're primarily concerned if your product 1) matches an existing prerequisite and 2) functionality that your product achieves performance that you say it does. That is why the marketing around most of the early DL / AI based radiology startups were focused on language for "study prioritization" rather than more specific claims.

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

#84
post #39

Earlier quoted context omitted.

> 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 usuall…

This is correct. IRB will be simple is not the same as not needing one.

I have published multiple papers in peer review journals where we were not covered by IRBs. That is not to say other research ethics standards don't exist, but that IRBs are simply one portion of the healthcare research regulations.

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

#85
post #10

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 I…

I’m a radiologist, and I’ve worked on these sorts of research studies before. You absolutely do need an IRB to do deep learning on clinical MRIs. I’ve had to write IRBs just to collect retrospective MRIs. Even for studies that are potentially IRB exempt, going through the exemption request takes hours of work on my part and weeks to months before the IRB grants the exception.

As other commenters mention, the “theoretical risk to a human” encompasses nearly all research. For what I do, any imaging studies that aren’t de-identified pose a theoretical risk to patient privacy. If you try to de-identify images, you learn that this is nearly impossible. Sure, you can try your best to scrub DICOM headers, but these headers are mis-used by vendors, so identifying information can appear almost anywhere. You could delete the headers entirely, but then you lose a lot of metadata that you may need to properly display the images. Further, people contend that you can identify individual peoples’ faces if you 3D-reconstruct CT/MR images, so then you have to expend resources to delete faces from all head/neck/brain imaging. Confirming that this was done properly requires manual review and limits the size of your dataset.

Edit: I think the disagreements here are partly due to institutional differences in IRB requirements and partly due to conflating “IRB exemptions” with the idea of not having to interact with the IRB at all. You always have to interact with the IRB—even just to obtain an exemption. While obtaining IRB approval is a cumbersome process, obtaining IRB exemption is only slightly less cumbersome. I’m sure this varies across institutions, but I’ve been at three different large urban academic centers, and obtaining exemptions has been a multi-month process at all three.

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

#86
post #77

Earlier quoted context omitted.

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 c…

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 p…

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.

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

#87
post #41

> 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 suffici…

>"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.

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...

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

#88
post #29

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".

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.

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

#89
post #80

Earlier quoted context omitted.

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.

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.

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.

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

#90
post #34

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 bein…

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 c…

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.

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