Are researchers allowed to keep applying to various IRBs until they finally get a seal of approval?

Question

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?

Answer 1

From the FDA:

26. 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.

Answer 2

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.