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My understanding in this case is not that the IRB declined to review the study plan, but that (quoting the study authors) "The IRB of UMN reviewed the study and determined that this is not human research (a formal IRB exempt letter was obtained)." (more information here: https://www-users.cs.umn.edu/~kjlu/papers/clarifications-hc....)

Do you think that the IRB was correct to make the determination they did? It does sound like a bit of a grey area




From the letter:

> The IRB of UMN reviewed the study and determined that this is not human research (a formal IRB exempt letter was obtained). Throughout the study, we honestly did not think this is human research, so we did not apply for an IRB approval in the beginning.

So the statement is a bit unclear to me, and I’m hesitant to come to a conclusion because I have not seen what they submitted.

As I read this they are saying:

* we explained the study to irb and asked whether it met their definition of human subjects research - based on our description they said it is not human subjects research

* therefore we did not apply to irb to have the study assessed for the appropriate type of review.

Exempt is a type of irb review, basically it is a low level desk review of a study. It does not mean no one looks at it, it just means the whole irb doesn’t have to discuss it.

I can see both sides of this. Irbs focus on protection of the rights of research participants. The assumption in cognitive models is of direct participants. This study ended up having indirect participants. I would argue that is the researchers job to clarify and ensure was reviewed. However, there is almost certainty this study would have been approved as exempt.

I think the irb likely did the right thing based on the information provided to them. The harm that HN is identifying does not fall within the normal irb definitions of harm anyways...which is direct harm to people. The causal chain HN is spun up about is very real...just not how irb views research typically




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