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)
Who exactly needs to get approval from an institutional review board (IRB)?
131–140 of 165 posts
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#132The 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".
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…
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.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#133This is just as confusing and explosives and energetics research. Explosives are regulated by the ATF, but can also fall under regulations of the DOT and the EPA. And if your doing any pulse power z pinch or electronic detanator experiment or research, then that's also regulated. Keep in mind this also has state regulations and ordinance to worry about and its almost like they are trying to get you to accidentally ma…
As a random citizen, you'd perhaps get away with an online self-service form, as a small company or startup you might need a form and an interview, but the entire "talk to 4 different agencies at different levels of abstraction" seems like a waste of time for everyone when it can be done in one go (provided the thing you wanted to do is common enough that it doesn't require some extreme documentation and safeguards etc).
If 100000 people were to want to try out a potato canon, it should be sufficient to do something at a local level where you select "I wanna play with a potato canon for a bit" in some drop-down, and it might ask you if you intend to shoot at people or not, and if you have enough room to experiment with this without hurting anyone (including yourself). If yes, problem solved, no need to fill out a form, if unsure or no, fill out a form since you probably are doing something novel, or something you might not want to do. If this then means some other agency at some other level needs to get notified, sure, automate that, who cares. If it turns out you filled out your form and specified radio active potatoes, perhaps one of those other agencies might want to have a chat first to see if everything is okay.
But the default of "talk to an arbitrary number of agencies in every case" is not great.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#134The 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…
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#135Earlier 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…
> 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 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 prosecuted for violating those rules?
Author says "those rules" without actually citing anything.
There is no scenario in which the Secretary of HHS can create rules which would do what the author was suggesting. It is not even something Congress could do, which is why they haven't created a statute which goes beyond their authority in requiring these boards for anything other than research receiving federal funding. If the Secretary were to create such a rule, it would obviously exceed his authority.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#136Re: Who exactly needs to get approval from an institutional review board (IRB)?
#137Earlier 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…
The author actually go into how universities make their own rule that potentially affects teachers and students doing research with their own time and resources.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#138As 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…
As far as I know, it's possible to get OneDrive even HIIPA compliant, but I don't think so for Dropbox.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#139As 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…
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? How hard is it?
> a Kinesiology dissertation study where they were asked to do extremely strenuous physical activity. He fainted(!) at one point from the activity. And it seemed to them that there were relatively few safeguards from that happening.
Informed consent is essential to an IRB; your friend would have read and signed something detailing the activities and risks. Strenuous excercise to the point of exhaustion is a part of sports performance research, at least. As long as you inform people, they have the power to opt-out (not prisoners, 6 year olds, etc.), and no undue risk.
Re: Who exactly needs to get approval from an institutional review board (IRB)?
#140As 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…
>Onedrive is fine, but dropbox is not for some reason As far as I know, it's possible to get OneDrive even HIIPA compliant, but I don't think so for Dropbox.
https://help.dropbox.com/security/hipaa-hitech-overview
In keeping with the theme of the OP, I don't know if that's been tested in court, soooo... Take that all for what you will.