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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?

Anonymous Physicist
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    Funny approach to both ask a question and then answer it yourself :-) – Wolfgang Bangerth Feb 02 '20 at 08:45
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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 02 '20 at 12:39
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    ethical obligations > legal obligations. – President James K. Polk Feb 02 '20 at 17:29
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    @Polygnome: sure, it's a totally valid approach -- it's just rarely employed and consequently funny :-) – Wolfgang Bangerth Feb 02 '20 at 20:09
  • @Polygnome While I see it the same as you, but nevertheless I would find it better if the SE system would indicate it as "self answer" somewhere at the top. – glglgl Feb 03 '20 at 10:20
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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 03 '20 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. – Carl Kevinson Feb 03 '20 at 16:06

1 Answers1

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Regulation

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.

Source

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.

Community
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Anonymous Physicist
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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. – Brian Borchers Feb 02 '20 at 05:15
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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 02 '20 at 12:32
  • @Buffy "An exemption is exemption from review" That's still wrong. – Anonymous Physicist Feb 02 '20 at 14:52
  • You seem not to have read it all, or refuse to accept the facts of the situation as it is, not as you would like it to be. Suppose that I modify it to "An exemption is an exemption only from review...". Now will you accept it. Or is it your position that all statements about "exemption" are just noise from the government, intended to mislead. – Buffy Feb 02 '20 at 14:57
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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. – Anonymous Physicist Feb 02 '20 at 15:04
  • "ethics processes which are permitted under United States regulation may be a crime in other countries." Can you explain exactly what is meant by this? Ethics processes in the US might not meet standards required in other jurisdictions but that doesn't meet the processes themselves are necessarily crimes. That is a very high bar to cross. – Michael MacAskill Feb 02 '20 at 23:23
  • "You can avoid the process if you are not doing research or if you do not involve human subjects." There are all sorts of research involving human subjects that don't require ethical approval. For example, using open datasets that were gathered by someone else who obtained ethical approval, on the understanding the data would be made openly available for novel research projects. – Michael MacAskill Feb 02 '20 at 23:27
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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. – Anonymous Physicist Feb 02 '20 at 23:42