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What should I do if I am asked to review a paper that should have been reviewed by an ethics committee, but was not? Assuming the paper is missing the statement that it was reviewed, and the paper clearly states that data was collected from human subjects.

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    Refuse it on the grounds it needs to go before the ethics committee.
    – Solar Mike
    Jan 29, 2020 at 11:06
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    Note that the requirement for IRB (in the US) has a few exceptions. And it may also be too late for IRB. Retroactive approval is something that I doubt is possible. Inform the editor, of course.
    – Buffy
    Jan 29, 2020 at 11:14
  • A search will turn up more, but here is an example: eandireview.com/…
    – Buffy
    Jan 29, 2020 at 11:35
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    Inform the editor. All further steps depend on their response. (They might convince you that your assumption is wrong. They might tell you that the information is just missing from the manuscript due to an oversight. They might stop the review process, reject the manuscript and inform the authors' institution. etc.)
    – user9482
    Jan 29, 2020 at 11:43
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    @Roland That could be an answer ;-) Jan 29, 2020 at 12:35

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I think it's quite a leap to jump from the fact that there is no such statement to the conclusion that it has not been reviewed. You should ask for clarification on that point in your review, rather than outright rejecting it.

Also, there are different rules in different countries, and the notion of an IRB might not exist, or the procedure may go by a different name. In our department, for instance, a formal process of ethical approval was only implemented a couple of years ago.

So, short answer: ask what ethical procedure was followed, and how that relates to the obligations in the country and/or university the researchers and the participants are based.

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    "the notion of an IRB might not exist" This is wrong. All legitimate journals require ethical review of human subjects research, even if the country does not. Jan 30, 2020 at 10:15
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Your first step should be to contact the editor with your concerns. It may be that the research falls under one of the exceptions for which IRB approval is not needed. See, www.eandireview.com, for example, though there are others. Both NHS and NIH list some exceptions.

However, even if an exception applies but you think that the research was, in fact, unethically conducted, then you may refuse to review. It is your duty, actually, but you should't do so silently. In fact, it might be best to point out your ethical concerns in a review.

I'll also note that retroactive approval is generally against the rules: explicitly disallowed. So, sending the paper back to get a review that isn't already in place is not an option if it were required in the first place. The purpose of the IRB is to protect human subjects, not to check a box. So approval needs to come first.

But the problem may simply be one of presentation in the paper as noted by Roland, and a simple edit would correct it. But it is up to the editor to communicate that to the authors.

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    Rejecting a paper because it lacks an IRB certification is, in some form, also a kind of review :-) Jan 29, 2020 at 14:46
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    @WolfgangBangerth, yes, of course, but refusing to review is a bit different. And it is up to the editor, not the reviewer to actually reject. But if you think something is unethical, then a reject recommendation is certainly appropriate.
    – Buffy
    Jan 29, 2020 at 14:48
  • I recall that I and other users on this site previously explained to you that you didn't understand what an "exemption" is. Jan 30, 2020 at 10:18
  • @AnonymousPhysicist, sorry, I don't think that happened.
    – Buffy
    Jan 30, 2020 at 10:40
  • academia.stackexchange.com/questions/138646/… Maybe it was just me and not any other users. Jan 30, 2020 at 10:59
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I'd review it as normal, but add a note (to the comitee, perhaps also the author) stating concerns about the need to involve the ethics comitee, with a short but clear explanation as to why I think it is required.

Rationale: I might be mistaken, perhaps it is being reviewed by said comitee in parallel, ...

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