I see a BIG problem with the sponsors' request.

The whole point of IRB approval is to rule out ways in which the
subject can become hurt through their participation in the study.  If
a subject can hurt themselves  by  not following the instructions,
then something's wrong with the study.

That's the point of a foolproof plan: the fools can't muck it up.

I'm being glib, but look at it this way: supposing a drug had a
hazardous side effect if it was used under certain preventable
conditions, but was benigh otherwise.  I wouldn't expect an IRB  to
shrug off the side effect.  I would expect the IRB to demand the
researcher aggressively screen out people who would not or could not
follow the directions , and to insist on approval of the screening
methods.  Alternatively, they might require the drug be administered
only by licensed medical personnel in clinical settings.

I somehow doubt I'm being more draconian than an IRB would be  - or
should be! -- in these circumstances.

--
I can answer any question.
"I don't know" is an answer.
"I don't know yet" is a better answer.

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