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

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

#91

Post by ahi »

cal1co wrote: 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…

Also, a great deal of the research organizations like META "just do" wouldn't pass muster with any IRB worth the name.

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

#93

Post by 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.

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

#94

Post by xyzzyz »

nxobject wrote: post #89
xyzzyz wrote: post #80

Earlier quoted context omitted.

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.

When HN was an entrepreneurship oriented community, the overwhelming attitude had been that it’s better to ask for forgiveness than permission. That’s because even if you’re doing something clearly good and morally unimpeachable, having to ask for permission slows you down and invited bikeshedding. Now that HN is a general industry forum, the attitude is more favorable towards preventing risk at a cost of reducing amount of value produced.

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

#95

Post by memhole »

billjive wrote: post #90
appleorchard46 wrote: post #56

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…

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…

Some of that vagueness is intentional and not always for nefarious reasons either. When getting my the FCRA cert, there definitely a few requirements that were obviously very open ended so the gov could either pursue a potential unforeseen circumstance or not stifle business. The vagaries in laws has always been interesting to me. Unfortunately, I don't remember any definitive examples since I took the test years ago now.

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

#96

Post by Xcelerate »

dekhn wrote: post #66
Xcelerate wrote: post #47

Earlier quoted context omitted.

> 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 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.

Yeah but now I just switch my perspective from thinking of it as a formal deductive system to thinking of it as an optimization problem.

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

#97

Post by asimpleusecase »

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.

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

#98

Post by thereisnospork »

nxobject wrote: post #76
caycep wrote: 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.

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.

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

#99

Post by sfpotter »

appleorchard46 wrote: post #62
sfpotter wrote: post #59

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 hea…

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.

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.

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

#100

Post by froindt »

jp57 wrote: post #44

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.

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.

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