6

We have discussed before that consequences for not getting approval might include: (1) not be able to publish in a reputable journal, and (2) getting sanctioned or fired by your employer. But I am wondering: what other consequences could you face in really serious cases? Could you lose your eligibility for federal funding? Could you go to jail? Personal liability for any harm? The HHS "common rule" doesn't seem to lay down any possible penalties.

To make this more concrete, here is an example. Bob is a computer engineer who has no real training in human subjects research. He gets a federally-funded grant about using machine learning to detect tumors in a publicly-available dataset. On the grant proposal, he correctly says that no human subjects research is anticipated. But his initial results show that (say) a certain ratio of potassium and chocolate kills brain tumors. So, Bob gets very excited and gets a bunch of people he knows to take potassium + chocolate in various doses and then draws their blood. He has clearly crossed the line here: among other problems, he is storing human blood and PII. What kind of consequences could Bob face?

4
  • law.stackexchange.com/questions/362/… has some info. I'm presuming you are limiting this to the USA, or do you want more broadly. May still be better off over on Law SE.
    – Jon Custer
    Aug 18, 2022 at 21:47
  • Thanks for the link, and good point, I have now tagged this USA. But I would not limit the scope to just legal consequences -- for example, the answer may be that there is a well-defined process that results in serious academic sanctions (e.g., ineligibility for federal funding); if this is the case, I'd be very interested in that answer.
    – cag51
    Aug 18, 2022 at 23:41
  • 2
    It might be important for Bob to be able to prove that his subjects gave informed consent to having their blood drawn. If they didn't, then (as far as I know) drawing their blood would be a crime (battery) and could result in jail time. Aug 19, 2022 at 1:22
  • Very good point, though I'm trying to constrain the question to "merely" serious procedural violations. Once we have actual complainants or damages, there are many "individual factors," many of them legal rather than academic.
    – cag51
    Aug 19, 2022 at 3:33

4 Answers 4

2

Depends on how far it goes. For example, if it somehow triggers an investigation of your institution, and your institution's Human Subjects protocols are really problematic, your institution could conceivably lose their compliance number, and become ineligible for government funded research.

The procedure for this is described here. In most cases, the funding agency will merely "assist" your institution's misconduct proceedings. However, if it finds that your institution was itself deficient, it can take action against the institution and/or move the investigation to its own misconduct board. As for the researcher, the worst that can happen is getting fired, barred from receiving additional funding, barred from advising the HHS, and forced to return any funds "spent in support of the activities that involved research misconduct." And of course if the research involved other crimes or torts, those may lead to additional consequences.

I'm sure any infraction you're talking about falls well short of this, but I do want to point out if this is serious, coordination with your institution might become important.

5
  • This is how FERPA works, as I explained here -- FERPA complaints require the school to respond, and a common response is to say "yes, the professor broke our policies and has been fired." So I can certainly buy that IRB situations like Bob's would be handled similarly. Have you seen this happen first-hand? Would you expect Bob's case to follow this path?
    – cag51
    Aug 19, 2022 at 0:37
  • @cag51 I was thinking more along the lines of an Office of Scientific Integrety investigation, It would be more likely if we were talking about funded research.In Bob's case, he could argue, right up until he went to publish that this wasn't research. That would be disingenuous, at the very least, but it would be a strong defense. Aug 19, 2022 at 1:16
  • That's an interesting point....in the Bob example, I did stipulate that he had a federal grant, but it's true that any investigation would have to prove that Bob's illicit activity was tied to the funded project rather than some other work.
    – cag51
    Aug 19, 2022 at 3:28
  • I deal with my rib in interesting ways, and they often start with their question "is this research?" Sometimes the answer we arrive at is "no" Aug 19, 2022 at 11:52
  • 1
    So you got me started down the road to find the reference I was looking for, and it largely agreed with what you said. So, accepting this answer. I also added a paragraph with the reference and a quick summary -- if you'd prefer not to have this paragraph in your answer, just let me know and I'll move it to a separate answer.
    – cag51
    Aug 19, 2022 at 20:36
5

The statutes about IRB approval of research are all about eligibility for federal funds and the expected consequences are threats of losing current and future funding for the researcher and their institution. Institutions are expected to (and do) take this very seriously, as serious sanctions could practically destroy an entire university's research program. A criminal case would only likely appear by related activity that is covered by other statutes.

Criminal prosecution for research misconduct is very rare in the US. I am unable to find any cases on the specific situation described here: failing to obtain IRB approval. However, I think another case may be instructive:

https://www.nature.com/articles/nature.2015.17660

Rare is the scientist who goes to prison on research misconduct charges. But on 1 July, Dong-Pyou Han, a former biomedical scientist at Iowa State University in Ames, was sentenced to 57 months for fabricating and falsifying data in HIV vaccine trials. Han has also been fined US$7.2 million and will be subject to three years of supervised release after he leaves prison.

You will not find anywhere a statute in US law that states criminal penalties for falsifying HIV vaccine data, despite the sentence in this article that suggests this. However, further in the article you will read:

In February 2015, he pled guilty to two felony charges of making false statements to obtain NIH research grants

These are the sorts of crimes that could potentially be charged in this sort of case. Not getting IRB approval isn't a felony; lying to the government about getting IRB approval might be. I found at least one example where someone was charged for submitting fake IRB approvals to the NSF, though they settled in a deal that did not require admitting to criminal wrongdoing, only return of funds and restrictions on future funding.

Civil liability is more likely, though plaintiffs are probably more interested in suing institutions with deeper pockets than individual investigators.

1

The penalties you suggest wouldn't be levied for failure to obtain IRB approval, per se, but certainly could apply to some kinds of research misbehavior. The IRB system was created to try to assure that some sorts of unethical studies aren't carried out in the future, but it is the studies themselves, and how subjects are treated, for which legal penalties could accrue.

I would guess (only a guess) that the same applies to losing eligibility for federal funding and similar administrative penalties. If a study is actually carried out that has unethical elements (that might have been caught by an IRB review) a person might lose eligibility. But it is the study, not the IRB, approval that would seem to be the important factor.

On the opposite side, if an unethical study is carried out after getting IRB approval it won't lessen the potential penalties. Whether it would accrue back to the board itself, I wouldn't know, but it might in an extreme case (guessing again). Culpability would need to be shown, of course.


IANAL, just using common sense and general philosophical principles.

3
  • I suspect you are right that this would largely be a contractual issue rather than a criminal one (since the grant is a contract that would doubtless have a provision about IRB approval). Still, I am surprised if there is no well-defined procedure that spells out how serious breaches are dealt with and what sanctions can be awarded. Consider Bob's case for example -- this is fairly serious misconduct; someone could have really been harmed. But since they weren't, I can't imagine the police would get involved, and a civil judgment seems unlikely without damages.
    – cag51
    Aug 18, 2022 at 23:35
  • @cag51, among other things, Bob might be sued by any of the participants who assert they might have been harmed and weren't able to give effective consent if they were misled. I doubt that actual harm would have been necessary. But the existing cases of research misconduct might weigh heavily with a jury. Even fraud statutes might apply around the consent issue. And note that, as I said, IRB approval isn't a guarantee that bad things won't happen.
    – Buffy
    Aug 18, 2022 at 23:44
  • Skipping IRB approval will probably weigh against the researcher during trial, especial in fields where IRB approval is part of legal regulations. For example, ignoring industry standard practices is often used to establish negligence.
    – Brian
    Aug 19, 2022 at 14:45
-2

Getting IRB approval is not intended to prevent unethical or dangerous research from happening. It is only necessary to ensure that published research satisfies minimal ethical standards, and it protects the institution to some degree.

In the example you cite, Bob is not only doing unethical research, but is possibly endangering his participants' health. As a consequence, lack of IRB approval is probably the least of his worries: The law will likely contain provisions that make such conduct illegal and punishable. That the resulting research might not be publishable is a consequence of substantially lesser relevance in my view.

1
  • 2
    This makes sense, but IRBs are generally required by the funding agency too, not just by the journal (at least in the US -- see the "common rule" linked above). And flaunting rules by agencies like HHS can easily lead to serious consequences, which in some cases could include incarceration. But I've never found anything detailing what might happen with this IRB rule specifically.
    – cag51
    Aug 19, 2022 at 0:33

You must log in to answer this question.

Not the answer you're looking for? Browse other questions tagged .