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

dynomight.net

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

#71

Post by jhbadger »

web007 wrote: 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.

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

#72

Post by nxobject »

scarmig wrote: post #65
web007 wrote: 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…

In this analogy, you're also asking permission from the IRB to ride a bike or skateboard.

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.)

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

#74

Post by 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)

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

#76

Post by nxobject »

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.

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

#77

Post by cal1co »

appleorchard46 wrote: post #56
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…

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 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.

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

#78

Post by motohagiography »

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.

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

#79

Post by nxobject »

ikanreed wrote: post #63
nxobject wrote: post #22

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

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 perso…

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.

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

#80

Post by xyzzyz »

spondylosaurus wrote: post #67
web007 wrote: 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…

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.

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