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Peter Gerdes's avatar

Uhh why is an IRB reasonable? No one ever stopped to check if that kind of organization is an effective check on unethical research much less that it does a good job of balancing the ethical interests of those who will be helped by discoveries or who want to be research subjects to help others with the risks of harm to participants.

Is it reasonable that academic research be ethical? Of course! But why should an IRB be better at determining that than say requiring sign off from the department or from some randomly selected academics in the field (the way we do peer review)! After all those people are most likely to be familiar with how those studies work in practice. And since IRBs have their own interests it isn't clear there is any advantage in conflict of interest either.

And when we look back at the scandals like Tuskegee that prompted IRBs there isn't much reason to believe they would have been stopped by IRBs. These weren't opsy we didn't think or that harm nor carried out by one rogue researcher ... they were the result of systemic unconcern with the welfare of certain groups -- concern which an IRB of that era might well have lacked as well.

The IRB system seems to have been designed around liability and public relations concerns more than a serious consideration of ethical concerns.

Ellen Grantz's avatar

MUDD, by increasing transparency, would also mitigate against bias in research that *overlooks* harm in human subject research. Indeed, NIH-sponsored SAFER research (on supervised injection sites) conducted by Brown University is breathtaking in its willful exclusion of impact to communities, including felony assault in the immediate vicinity of the sites in East Harlem and Washington Heights. A forthcoming investigation which I coauthored, will shortly be released in CivilizationWorks.org.

Peter Gerdes's avatar

This is exactly why the IRB system is a problem. People disagree over policy and whether or not you study the impacts some communities will implement such programs. If you block research on a policy that is being implemented in the wild on the grounds it might be harmful to some people you can never actually collect good evidence to prove that conclusion.

And yes IRBs seem selective in what kind of harms they are willing to consider. Some of this is simply ignoring harms to non-participants which seems unjustified but is perhaps pragmaticly necessary.

But how do you do any social research given that almost any intervention could be claimed to potentially increase criminal behavior and thus harm someone?

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I think the standard should be much looser. If it is within the range of things that might be tried outside the bounds of a study -- lots of people do think things like injection sites are a good policy -- you get to do it in a study. It is never more unethical to do something AND learn from it than just do it.

Ellen Grantz's avatar

That's a contradiction—the research made it through the current IRB system. What the system failed to see, is that the researchers have a conflict of interest. The self-dealing in institutional research is well documented and needs to be checked.

https://petrieflom.law.harvard.edu/2026/04/15/the-ethics-of-junk-science-its-time-for-a-reboot/

Peter Gerdes's avatar

Re: conflict, are you suggesting the fact that the research program benefits the researcher is a problematic conflict of interest? Researchers will always benefit from discovering important new interventions so how exactly do you propose research should be done if the person who believes in the idea isn't allowed to create an experiment to test it?

Would you say that if GlaxoSmithKleine invents a drug they think could stop alzheimers they should be prevented from running a study to show it does? After all, they don't just get academic status they might gain billions of dollars. If so, who else is going to put in the time and the money to test someone else's theory? Or are you imagining some giant department of research which runs all studies anywhere with uninterested bureaucrats? That seems like a very poor fit in a huge number of cases.

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My point above was that if I accept what I took to be your reason for saying it shouldn't have passed an IRB it shows why IRBs are a problem. Any rule that -- based on a concern of indirect community harm -- prevents us from running a study to test the effects of an intervention while allowing the same intervention to occur frequently outside of a study is a horrible rule.

That literally exposes more people to the potential harm because we are never allowed to gather the information to see the intervention is harmful. I get it if you think these programs are bad but many people are convinced enough of the opposite to implement them without the benefit of evidence so shouldn't we at least try to see who is correct?