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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)?

#151

Post by miki123211 »

noodlesUK wrote: post #57
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…

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 somethi…

And it's worth emphasizing that this is a good thing.

Civil law systems (which are used in the non-English-speaking parts of Europe for example) don't have this property. In such systems, court precedents don't really exist, so if something isn't clearly defined by law, and there's no extremely ubiquitous legal interpretation that everybody seems to follow, you don't know whether it's legal or not.

For example, the Polish tax authority lets you ask for a tax interpretation for cases that aren't legally obvious, something that I believe the US would have handled via the court precedent system. It's not unusual for two people in identical situations to receive opposite rulings, and Those rulings are not binding on the authority that issued them.

In other words, you don't know how to handle your tax situation, you ask your tax authority, they tell you "hey, we're the tax authority, we're telling you to do x", you do x, they audit you, they say "this isn't clearly defined in law, we now believe you should have done y instead, here's your orange jumpsuit."

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

#152

Post by CharlieDigital »

mmooss wrote: post #144
froindt wrote: post #100

Earlier quoted context omitted.

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…

Maybe the professor was training you and didn't care about the value of your undergraduate study, which was almost certainly not worth the professor's time otherwise.

This is also my take; it's part of the process of practical transfer of knowledge and process.

He did extra work, but it was effectively practice.

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

#153

Post by ikanreed »

mmooss wrote: post #145
ikanreed wrote: post #63

Earlier quoted context omitted.

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…

Has that happened to you?

No, this is a very recent development in science policy.

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

#154

Post by caycep »

mmooss wrote: post #146
thereisnospork wrote: post #98

Earlier quoted context omitted.

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…

Do you have experiences with IRBs? IME, most structures and people want to get along and at worst, gain favors and reduce enemies. People are short-sighted sociopaths, usually.

a neurosurgeon I worked with could get his waiver approved in a day usually. But he made friends w/ all the IRB members and had a significant budget for donuts donations.

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

#155

Post by inetknght »

Kevin_S wrote: post #106

As an academic researcher, it's most frustrating in that it feels like IRB scrutiny doesn't seem to align with risk. I do accounting research. My human-subjects research involves surveying practitioners about their jobs, interviewing them about their experiences, and conducting very simple experiments online that ask them to make decisions. There is virtually 0 real risk to any participants of my studies. IRB does al…

> I do accounting research. My human-subjects research involves surveying practitioners about their jobs, interviewing them about their experiences, and conducting very simple experiments online that ask them to make decisions. There is virtually 0 real risk to any participants of my studies.

Cool, I guess. I wouldn't want to participate if my answers were visible to my employer because honest answers could put my employment at risk.

> As an academic researcher, it's most frustrating in that it feels like IRB scrutiny doesn't seem to align with risk.

As a worker^H^H^H^H^H^Hhuman I find it most frustrating when academics don't understand what things I consider to be risks.

If my answers to your research are leaked, can they be tracked back to me? Onedrive is terrible, just look at Microsoft's repeated flagrant disregard for security. Dropbox is awful too, just look at how easy it is to accidentally a whole folder. Why would you store your data in such places instead of on a research computer with locked down access? That screams to me of a researcher who doesn't understand the value (and risk) of the data they hold. Or perhaps of a researcher who doesn't value that risk appropriately. Perhaps also researcher who doesn't coordinate with their IT department, or an IT department who's equally or worse as competent.

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

#156

Post by ska »

skwb wrote: post #84
ska wrote: post #39

Earlier quoted context omitted.

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.

Sure, there are also cases where it is not needed. But some called out in GP were not typically correct. And often it is opaque to the researchers only because someone did an IRB in an earlier step with usage that covers sharing it with you.

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

#157

Post by mmooss »

bpodgursky wrote: post #148
mmooss wrote: post #139

Earlier quoted context omitted.

> IRB does always give my studies "exempt" status, but it still has to be reviewed. How could they do it more efficiently?: How could they know it's exempt without reviewing it? Should they take researchers' at face value? That seems to undermine the reason we have IRBs, which was unscrupulous researchers. Should we assume they are willing to torture people but not to mislead the IRB? Why shouldn't data be private? H…

> How could they do it more efficiently?: Think about how taxes work. The IRS doesn't check every person. You make rules, you perform random audits. IRBs could easily do the same thing. Set some rules like (simplified) "No IRB necessary if your research doesn't physically touch a person". Researchers will read the rules and skip an IRB if they're in an exempt category. Then just audit at a high enough rate they won't…

Nobody dies if someone's taxes are wrong. Also, IRBs are not usually about lies, but about scientists not understanding the risks and solutions.

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

#158

Post by mmooss »

mmooss wrote: post #146
thereisnospork wrote: post #98

Earlier quoted context omitted.

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…

Do you have experiences with IRBs? IME, most structures and people want to get along and at worst, gain favors and reduce enemies. People are short-sighted sociopaths, usually.

Oops, I meant to say, 'People are not short-sighted sociopaths, usually.' I need to double-check before submission!

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

#159

Post by karaterobot »

rights_reminder wrote: post #135
karaterobot wrote: post #132

Earlier quoted context omitted.

> To put it succinctly this only relates to any entity which applies for a grant, contract, coop. agreement under chapter 6A of 42 USC. But the whole point of the article is that there are other cases when you need IRB approval besides this one. That's one of the myths he's busting.

The point that I was making was that there can be no federal law which requires an institutional review board for private research, which was something the author alluded to in the paragraph after the flow chart: > The government can’t possibly claim to regulate what me and my roommates eat at home! That would be stupid!” Yes, it would be stupid. But who says the world makes sense? Now, would you actually be prosecut…

Then I apologize, I evidently misread your original comment.

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

#160

Post by bpodgursky »

mmooss wrote: post #157
bpodgursky wrote: post #148

Earlier quoted context omitted.

> How could they do it more efficiently?: Think about how taxes work. The IRS doesn't check every person. You make rules, you perform random audits. IRBs could easily do the same thing. Set some rules like (simplified) "No IRB necessary if your research doesn't physically touch a person". Researchers will read the rules and skip an IRB if they're in an exempt category. Then just audit at a high enough rate they won't…

Nobody dies if someone's taxes are wrong. Also, IRBs are not usually about lies, but about scientists not understanding the risks and solutions.

> Also, IRBs are not usually about lies, but about scientists not understanding the risks and solutions

You have never submitted an IRB.

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