This question was inspired by some wrong information on this site.

Human subjects research usually requires review by an ethics committee (IRB). Some research is "exempt" under US law. If my research is "exempt," can I skip the ethics process?

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    Funny approach to both ask a question and then answer it yourself :-) Feb 2, 2020 at 8:45
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    @WolfgangBangerth Not really, self-answering questions is perfectly valid and even encouraged on the network. If it a good Q&A, it doesn't matter who ask and answers or even if its the same person doing so.
    – Polygnome
    Feb 2, 2020 at 12:39
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    ethical obligations > legal obligations. Feb 2, 2020 at 17:29
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    @glglgl One of the core principles of SE is that question and answers should be voted on based on merit / quality. It doesn't matter who asks and answers. If its a good answer, upvote, if its a bad answer, downvote. I don't see how making the author more prominent would improve anything. But if you like, you can make your case on Meta, but I very much doubt it would catch on.
    – Polygnome
    Feb 3, 2020 at 12:10
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    @glglgl this conversation happens on most self-answered questions, so you can use that as the indicator you're looking for. Feb 3, 2020 at 16:06

1 Answer 1



No, you cannot skip all the process. The word "exempt" is misleading. The exemption is from most regulatory requirements, not institutional or journal requirements. Exemption is specific to the regulations of the United States.

Regulations do not require IRB review of exempt research. Regulations do require determination. Depending on your institution's policy, the determination might not be conducted by the IRB. But usually it is. If your institution permits it (which is highly unlikely), you may be able to conduct the determination yourself.

The regulations do not specify who at an institution may determine that research is exempt under 45 CFR 46.101(b). However, OHRP recommends that, because of the potential for conflict of interest, investigators not be given the authority to make an independent determination that human subjects research is exempt.

The regulations do not require that someone other than the investigator be involved in making a determination that a research study is exempt. What they do require is that there be accurate determinations so that non-exempt research ends up being reviewed by an IRB. Because of the potential for conflict of interest in this situation, OHRP's long-standing recommendation is that investigators not be given the authority to make an independent determination that human subjects research is exempt.


Note that ethics processes which are permitted under United States regulation may be a crime in other countries.

Journal Policy

Furthermore, reputable journals require IRB approval for publication. The Helsinki Declaration §23 says,

The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins.

While the Helsinki Declaration is specific to medical research, journal policies typically apply the same requirement to non-medical, human subjects research. For example, Nature and Science.

How do I avoid the process?

You can avoid the process if you are not doing research or if you do not involve human subjects.

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    It is extremely risky for an institution to allow investigators to make determinations for themselves as to whether or not their research is exempt. The institution could get into a great of trouble if a researcher made a poor decision. As a result, most institutional policies require the IRB or some administrative official to certify exemptions. Feb 2, 2020 at 5:15
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    Actually, your first "No" is misleading. You may be able to skip the process in the US, depending on what other regulations apply to your research. What you cannot avoid, however, is ethical practice itself. An exemption is exemption from review, not from ethical behavior. However, nothing suggests that you should avoid review even when you can. Better to have institutional backup on your plans, no matter the rules.
    – Buffy
    Feb 2, 2020 at 12:32
  • @Buffy "An exemption is exemption from review" That's still wrong. Feb 2, 2020 at 14:52
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    @Buffy Absolutely not. You are confounding "exemption from review" with "exemption from a regulatory requirement for review" which are different. As the answer says, regulation requires a determination; institutions and journals require processes when regulation does not. Feb 2, 2020 at 15:04
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    @MichaelMacAskill "using open datasets that were gathered by someone else who obtained ethical approval," That is wrong. The ethical process required for secondary research varies depending on the circumstances. See CFR 45§46.104(d)(4 and 8). At the very end is the situation where review is required. Feb 2, 2020 at 23:42

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