On 12/17/2021 6:40 AM, yuv via mailop wrote:
* On the big issue, the ENROLLMENT OF HUMAN SUBJECTS WITHOUT CONSENT
into the study, I have been told that "[t]he IRB determined that our
study does not constitute human subjects research."


I haven't gone through an IRB process. So I've no idea what the dynamics, practical criteria, or typical outcomes are from them.

But this particular decision seems bizarre. Beyond concern for this IRB repeating the error, it occurs to be that it could be replicated by other IRBs.

That makes me wonder about the possible benefit of independently-developed guidance that might be circulated among them. Possibly from a respected anti-abuse organization?


d/
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