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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)?

#61
post #3

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

(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)

(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)

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

#62

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.

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

#63

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 person who makes sure their papers don't contain the word "Woman" or "Historically"?

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

#64
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.

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

#65
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.

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

#66
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…

> 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.

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

#67
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.

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

#68
>"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 :)

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

#69
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…

> 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…

>...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...

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

#70
post #52
post #27

Earlier quoted context omitted.

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.

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?

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-...

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