Can an independent institution run experiments without IRB approval?

Question

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?

Answer 1

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.

Answer 2

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 Any human subjects research which is has not passed ethics review must not be published.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.

Answer 3

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.