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Let's say a researcher has a somewhat controversial research project (such as a vaccine challenge trial). Is it considered legal to keep applying for institutional review board (IRB) until you eventually get accepted? For example, you start from this list of independent IRBs and go down the line until someone finally approves what you're trying to do. Would the researcher be obligated to disclose rejection from other IRB boards or could they point to the latest approval and consider the permit is given to them to start the project?

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    If you are really seeking a legal opinion, then the Law SE is the place.
    – Jon Custer
    Sep 9 at 13:48
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    Could you spell out IRB once, please?
    – Dirk
    Sep 10 at 6:04
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    @John Custer that doesn't mean the question is off-topic here, though.
    – henning
    Sep 10 at 15:24
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    @Dirk The tag summary seems pretty good: "An IRB (Institutional Review Board), also known as an independent ethics committee or ethical review board, is a group that reviews and monitors research involving human subjects."
    – Teepeemm
    Sep 10 at 17:31
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From the FDA:

  1. If an IRB disapproves a study submitted to it, and it is subsequently sent to another IRB for review, should the second IRB be told of the disapproval?

Yes. When an IRB disapproves a study, it must provide a written statement of the reasons for its decision to the investigator and the institution [21 CFR 56.109(e)]. If the study is submitted to a second IRB, a copy of this written statement should be included with the study documentation so that it can make an informed decision about the study. 21 CFR 56.109(a) requires an IRB to "... review ... all research activities [emphasis added] ...." The FDA regulations do not prohibit submission of a study to another IRB following disapproval. However, all pertinent information about the study should be provided to the second IRB.

So, at least for research relevant to the FDA (which would include vaccine challenge trials in support of FDA approval), subsequent IRBs would have to learn of previous rejections. It may be possible to work around a particularly stubborn IRB this way, but I doubt an IRB is going to want to approve many studies that have a track record of repeated rejection by others.

For multi-site studies governed by the NIH, the new rule is that one IRB is chosen. It used to be that every site involved had their own IRB that had to approve the study; the new centralized scheme seems like it would be more open to choosing a permissive IRB as the single IRB, but as far as I can tell this has to be chosen ahead of time; you couldn't iterate through each of the site IRBs until you found one that was happy with the proposal. I haven't been through this process, though, so I'm not certain what the explicit protections are there.

At my own institution, and I imagine at most every major US research university at least (I have far less familiarity with human subjects research protections outside the US so I can't speak to that), there is only one IRB. Having a solid institutional process for ethical review is one of the criteria that funding agencies consider when awarding grants. You can't go to an independent IRB and overrule your local IRB. There may be different people who review applications but their selection is not up to the researcher. It might be possible for a researcher to shop around at different institutions to house the study, but that's far more unusual than doing the work at their home institution (and would require finding collaborators at all of those other institutions).

IRB approval is a bit of an exhausting process, and it isn't as simple as "submit your application -> approved or denied" - there can be a lot of back-and-forth with IRB over gritty details.

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  • Excellent answer! So sounds like IRB strategies are only available to companies doing clinical research and the only viable strategy is "jurisdiction shopping" where you have to guess in advance which IRB is most likely to stamp their approval. Sep 9 at 14:40
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    @JonathanReez Yeah, but I would argue that controversial research is in some ways much much more risky for a company than for an academic. You really, really don't want to tick off the regulators that approve your products. Shady research practices also don't look good in the newspapers. Companies and other researchers definitely do the "jurisdiction shopping" you mention (I hear whispers of this a bit because my own institution has a particularly strong reputation as a stickler - rumors go around that people avoid us because of that).
    – Bryan Krause
    Sep 9 at 14:46
  • From a quick Google search it sounds like an actual thing. Sep 9 at 14:51
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    @JonathanReez Yeah, I'd group that in with the "jurisdiction shopping" as you term it, though; they didn't get rejected and then move on, they just chose to not continue the process that required more disclosure. Not excusing them by any means, but not quite the scenario you initially described in the question.
    – Bryan Krause
    Sep 9 at 14:53
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    This is from the FDA. Other federal agencies have their own (similar) statements @JonathanReez, so the rules actually apply very broadly. There is also a federal database of IRB decisions.
    – Buffy
    Sep 9 at 16:52
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I think this would be difficult to do for most, and also unethical unless changes were made to the proposal after each "try".

Difficult, since most researchers are associated with a university who has a single board (perhaps a few for different disciplines). The university won't like research that hasn't passed their own board.

There are other boards, of course, but if one of them tells you no and points out ethical flaws in the design, it would be an ethical lapse to try to "shop the proposal" around without change. The ethical flaws remain.

Better to modify the design to avoid the issues and go back to the same board.

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  • What if you honestly believe that the IRB is wrong and want to try your luck until you find a sympathetic soul? Sep 9 at 13:47
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    @JonathanReez - that isn't going to change the fact that the places I know of have one IRB that they use for a given field. If it doesn't pass that board, then it doesn't happen.
    – Jon Custer
    Sep 9 at 13:49
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    The ground is shaky all the way down. If you have an emotional commitment to some line of research that other scholars feel is problematic, you are probably the one that is wrong.
    – Buffy
    Sep 9 at 13:49
  • @Buffy Your (excellent) comment should be part of the answer, perhaps the conclusion. Sep 9 at 14:04

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