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Lets say a rich person has the funds to create a US-based research institution that does not receive any form of public or private funding with the exception of said persons bank account. Will this institution be able to run experiments on human subjects without IRB approval? Nothing extreme like giving people new medicine or trying out novel surgery techniques but rather something mundane like collecting surveys or conducting psychology experiments.

At which point does it become illegal to run an experiment with no oversight within US jurisdiction?

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    Collecting private information, data, even surveys are generally governed by law (that applies to all). I am not familiar with US legal system, but in other countries, it is common that you suppose to obey different regulation about how to collect data, how to handle personal data, etc independently from your status.
    – Greg
    Commented Apr 28, 2021 at 4:41
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    "Psychology experiments" are not necessarily mundane, and certainly not all are more mundane than all medical or surgical interventions - in fact, many of these are quite mundane.
    – Bryan Krause
    Commented Apr 28, 2021 at 17:59

3 Answers 3

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It really depends on exactly what you are doing: "surveys" and "psychological experiments" are not the same. The regulations providing for IRBs in the United States are governed by the Common Rule, a policy of the Department of Health and Human Services.

The first paragraph:

§46.101 To what does this policy apply?

(a) Except as detailed in §46.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. ... Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this policy.

The definition of "institution" is broad:

(f) Institution means any public or private entity, or department or agency (including federal, state, and other agencies).

The short answer is these rules exist to protect regular people, so there is a broad authority to regulate research, it is not tied to federal funding. Private IRBs exist to do exactly what you are asking about. It becomes illegal when you start doing research that isn't part of the exemptions, although I would strongly recommend engaging an expert to make determinations for you.

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  • First of all, failure to comply with an administrative rule is not "illegal"; something is "illegal" only if it is prohibited by statute. And regardless of the the policy says, there is no legal basis in the United States of America for sanctioning anyone who is not in business with the government for performing non-invasive psychological research without going through an IRB process.
    – Buzz
    Commented Apr 29, 2021 at 0:19
  • @Buzz I look forward to your answer, then. Commented Apr 29, 2021 at 1:58
  • @Buzz 'failure to comply with an administrative rule is not "illegal"; something is "illegal" only if it is prohibited by statute' I don't know about the US, but here in the UK, one would have to be very careful about how one was defining "administrative rule" and "statute" to be confident of the truth of that statement. Commented Apr 29, 2021 at 19:10
  • In the US, government agencies are frequently authorized by statute to make legally binding regulations. These are compiled in the Code of Federal Regulations which has sections regarding FDA requirements for approving both drugs and devices for sale and standards of ethical review for research supported by the Federal government. Failure to comply carries legal penalties that can be severe. Commented Jun 8, 2021 at 2:26
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I'll address the academic, rather than legal aspects of the question. All legitimate scientific journals require ethics review for published human subjects research. Any human subjects research which is has not passed ethics review must not be published. In my opinion, any such research is not part of main-stream science. So the answer is no.

It is generally accepted that these are not research, and therefore not human subjects research:

  • Testing a commercial product to see if customers like it.
  • Experiments whose results will be kept secret.

However, all activities need to be ethical, even if they are not subject to IRB requirements.

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  • What if you publish a paper on a preprint server without ever submitting it to a journal? Commented Apr 28, 2021 at 6:06
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    @JonathanReez Biorxiv will delete it. biorxiv.org/submit-a-manuscript Commented Apr 28, 2021 at 9:43
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    +1. If you do otherwise-legit academic research without an IRB, but then can't publish it, is it really academic research? For all practical purposes, not really. Probably one reason why Google and Facebook prolifically contribute to the AI literature but not the psychology literature.
    – cag51
    Commented Apr 28, 2021 at 15:17
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    Interesting assertion that if it ain't published research it ain't research. Says much. Commented Apr 28, 2021 at 17:22
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    @Aruralreader Indeed, for all the hate that the publishing industry gets, publication itself is central to the "quality control" process for scientific research, and the distinctions between the academic publishing process versus the publishing process for everything else ("It's on my blog!") can't be swept away.
    – Bryan Krause
    Commented Apr 28, 2021 at 17:57
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I speak, with trepidation, because of my former membership in three IRBs. I became a member in two cases because I got in trouble myself. When I was a member I pressed for scrupulous adherence to the law and institutional policy. IRB members and staff are frequently fuzzy on both. As a member I needed to have a copy of the law, the regulations, and institutional policy close at hand.

Your question requires arcane knowledge both of Federal law and of other practices. What you ask might be legally possible but might be foolish. The role of IRBs tends to be expansive. Most institutions require that all research be reviewed according to Federal standards because it makes their job easier. They also usually require that a determination that research need not be reviewed by made at least by the staff of an IRB. Many journals, by no means all, require that research be reviewed appropriately.

There are also state laws that apply. One of the more obscure ones I learned was that our state emancipated all underage women who had a baby for all legal purposes except for the ability to give consent for medical research. Go figure.

In short, your life will be easier if your institution has an IRB and has an agreement with a Federal agency to conduct its own reviews. It will also be made easier if the staff of the IRB understand the actual law, the accreditation standards for IRBs (yes, even those exist), the definition of "generalizable knowledge" (a total mystery), and shows some common sense about what is risky or not, and who is a patient or not.

So while what you ask might be legally possible under some, or even many, circumstances, if you want to participate in modern research with humans or even with animals and then publish that research in credible journals, you need the technical staff that usually support an IRB or an animal research committee.

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