Who exactly needs to get approval from an institutional review board (IRB)? • Hacker News Board

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

#141

Post by mmooss » Fri, Feb 14, 2025, 4:54 AM UTC

not2b wrote: post #124

rights_reminder wrote: post #109

Earlier quoted context omitted.

It's hard to take the article seriously since 1) It doesn't even reference the relevant law 2) The relevant law is so simple and clear 42 USC 289(a) states: "The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit…

Yes, but a university or other institution will often also require IRB review in additional cases, because maybe they don't want to let researchers accidentally cause brain damage just because a billionaire rather than a government is paying.

Also pharma companies.

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

#142

Post by mmooss » Fri, Feb 14, 2025, 4:55 AM UTC

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…

> nobody seems to have ever been prosecuted

But they have been sued, sometimes for extraordinary amounts, as have their employers, corporate sponsors, etc. And they have lost funding for their research and the trust of everyone above (and of future IRBs). These are powerful disincentives.

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

#143

Post by mmooss » Fri, Feb 14, 2025, 5:05 AM UTC

cm2012 wrote: post #92

IRBs are one of the most wasteful and hurtful institutions in the developing world today. In order to prevent a few possible ethical lapses, they smother hundreds of good potential research. See Scott Alexander's works on IRB review.

> In order to prevent a few possible ethical lapses, they smother hundreds of good potential research.

Doesn't that describe all safety and security measures? Airport security wastes millions of hours in order to prevent a few possible problems.

> ethical lapses

That's quite a euphemism for death and bodily injury. I'm sure you wouldn't mind it yourself.

There is plenty of evidence of what happens without IRBs - just look what happened before IRBs.

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

#144

Post by mmooss » Fri, Feb 14, 2025, 5:08 AM UTC

froindt wrote: post #100

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…

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.

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

#145

Post by mmooss » Fri, Feb 14, 2025, 5:10 AM UTC

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…

Has that happened to you?

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

#146

Post by mmooss » Fri, Feb 14, 2025, 5:12 AM UTC

thereisnospork wrote: post #98

nxobject wrote: post #76

Earlier quoted context omitted.

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…

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.

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

#147

Post by cess11 » Fri, Feb 14, 2025, 6:26 AM UTC

voxic11 wrote: post #70

cess11 wrote: post #52

Earlier quoted context omitted.

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-...

Does that somehow make it something else than public funding?

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

#148

Post by bpodgursky » Fri, Feb 14, 2025, 6:32 AM UTC

mmooss wrote: post #139

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…

> 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 lie.

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

#149

Post by dr_dshiv » Fri, Feb 14, 2025, 8:24 AM UTC

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…

There is a huge opportunity in simplifying and automating IRB review.

Here in the Netherlands (we call it HREC, human research ethics committee) the process takes months and months to get permission to talk to people.

Like, “hey I’ve designed some cool new interaction design, I want to get permission to interview people and do human-centered design iterations.” Yes, you will need to spend dozens of hours on forms and wait months.

It cannot be ethical to put these many barriers on talking to humans. And, if you want to do something like an educational game for kids? Or support for the elderly? Or for your students? Well, those are vulnerable populations, so add a few more months.

Education research is extremely difficult here (in the USA it is exempt). How to conduct research on the use of AI in a class you are teaching? You can’t get retroactive consent.

The system is not reasonable.

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

#150

Post by mionhe » Fri, Feb 14, 2025, 8:55 AM UTC

derbOac wrote: 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".

With medical device development, the IRB represents the institution taking liability for harm to patients. They're there to make sure they aren't about to kill someone or harm them and get the institution sued.

So they take it pretty seriously. More so in countries where it's easy to sue, though.