My understanding is IRB is not a governmental regulation but an institutional regulation. For example if you want to design a study and then have acme medical center take part in conducting it, you would need to pass the Acme IRB. Governmental funding may also have restrictions that require you to have some kind of IRB review.
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)?
#112My understanding is IRB is not a governmental regulation but an institutional regulation. For example if you want to design a study and then have acme medical center take part in conducting it, you would need to pass the Acme IRB. Governmental funding may also have restrictions that require you to have some kind of IRB review.
It's quoted in another comment but 42 USC 289(a) requires the establishment of an IRB in any institution applying for federal grants, among other things. So it is a law that there exist some sort of IRB for any "biomedical or behavioral research" and my guess is most institutions see 99% of their research falling under behavioral.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#113Earlier quoted context omitted.
I've worked in MRI AI both in academic and non-academic centers, including technology that has received 510K clearance. I admit it sounds pedantic, but I'm not discussing IRB *exemptions* that are sometimes required by an institution nor am I discussing BAAs. I was specifically talking about the specific IRB applications (which I've submitted and signed before) that the blog author was talking about. Yes, HIPAA and o…
MRI are Class II devices and until last year exemptions for IDE applications and for not obtaining written informed consent specifically excluded devices that by design or intent deposit energy in humans (regardless of overall study risk. Last year the FDA finally extended some power to IRBs to harmonize with HHS research regulations which have allowed IRBs to waive consent for minimal risk studies for a long time. B…
I don't disagree with anything you're saying necessarily, but a lot of people are conflating my statement of IRB exemption with having an explicit IRB authorization. I guess more to my point is people seem to be failing to understand the role of retrospective research (and I will easily concede that different institutions have different legal interpretations) and how it's an important part of research. Don't get me wrong, you absolutely still have regulations about what you can and cannot do with that data, but saying you need an IRB for everything doesn't match the reality that I've seen first hand.
That said, there's plenty of buying and selling of radiological images for industry development on the second hand market. Now where the line of "research" vs. "industrial" work is, well that's something I would leave to legal council. But as you said any sort of "altering" of clinical outcomes is a clear IRB is required zone like DL based recon.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#114This is what good lawyers do: dig in to the sausage factory. What's interesting is how agencies push the limits on what they can do. All agencies do this to one extent or another. And they obviously won't tell you if they're doing that to you or not. Granted authority and actual authority are different. It's worth remembering that when dealing with any bureaucracy.
As a note, the FDA circulars in particular (like the labeling one) aren't technically law, but because they're (1) put out by the FDA and (2) a good summary people treat them as law. The thought is that you can always point to the circular if you need to.
You should read the actual regulations as well, but that's work so lots of people don't do it.
Here's an example of why you should read the regulations. Technically, supplements can't make structure/function claims. However, you can submit your structure/function claim to the FDA. Once you do that you can make that particular structure/function claim on your labels. Since the FDA has no process in place to actually review those claims your structure/function claim is suddenly valid.
It's amusing.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#115Earlier quoted context omitted.
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…
It seems you'd answer your own questions here and maybe some of your frustration if you actually proceeded to read the rest of the article, which explains quite clearly the point being made. You being exasperated by the tone or style isn't really relevant to the substance of what was written about, or to anyone else really.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#116The article suggests that simply agreeing with friends to experiment with diets would trigger the IRB requirement, and cites a NY state law requiring affiliation with an IRB-enabled institution to do human research. But the "definitions" section of that New York law says:
2. "Human research" means any medical experiments, research, or scientific or psychological investigation, which utilizes human subjects and which involves physical or psychological intervention by the researcher upon the body of the subject and which is not required for the purposes of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of medical condition for the direct benefit of the subject. Human research shall not, however, be construed to mean the conduct of biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice, or to include epidemiological investigations.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#117Earlier quoted context omitted.
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…
If you're really asking what the point of humor is, I don't think there's any answer you'll find satisfying. I'll take a stab at it though.
In this case, it functions as a hook; it's there to give you a slight chuckle before diving into a long and relatively dry informative article. It's some clear sarcasm makes you evaluate the supposed assertion made - that people who push for IRB evaluations are meanie-heads - and challenges any preconceived notions you might have of it being a simple "this is good" or "this is bad" thing either way because of course it's not that simple. This invites the question to the reader: if it's not as simple as that, then how is it actually?
Of course, if the tone doesn't land and you read it as a factual statement - and, importantly, it's so distasteful that you immediately bail and don't read the rest of the article to see what it's actually about, and just assume it's a petulant tirade against IRBs - none of that works. If you're at all interested, I would recommend reading some Adam Mastroianni / Experimental History posts, as it has a very similar feel but plays to the strengths of the tone a bit better (IMO). This one [0] actually touches on the use of humor in scientific papers, and I think makes a pretty good case for why clinical language isn't necessarily a good thing.
[0] https://www.experimental-history.com/p/the-rise-and-fall-of-...
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#118An 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…
Violations of federal regulations (rules) are usually handled as administrative or civil matters. Prosecution is very rare and only possible for a limited set of rule violations. If you're contemplating doing something in a regulatory gray area then you can ask the competent agency for a formal opinion letter stating whether that thing would or wouldn't be a violation. They are required to issue those letters although it can be a slow process. Once you get an official approval letter that generally shields you against any sort of enforcement action.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#119Earlier 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…
Nah. There's no valid reason for lawmakers to delegate so much authority to bureaucrats. We should eviscerate the administrative state and if legislators want to prohibit something then they ought to specifically write it down. If that means it becomes harder and slower to pass new laws then that's fine. It should be a careful and deliberative process.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#120IRBs 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.
IRBs dont prevent ethical lapses; they reduce the liability of the contractee/grantee.