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Dans Law was not in effect in 2007 and therefore does not apply to these events. Dans Law applies to a stay of
commitment order by a judge following a judicial commitment hearing. It does not prohibit research consenting
during a stay of commitment but requires certain extra steps to ensure voluntary informed consent in those
circumstances. A stay of commitment is different than a 72 hour hold. There is no law, regulation or IRB policy
(effective in 2007 or now) that presumes a person is incapable of consent while on a 72 hour hold or prohibits
an investigator from recruiting or consenting a subject during this time frame.
However, as the IRB investigation report states, the IRB has determined that the issue of recruiting subjects
while on a medical hold merits further consideration. The Executive Committee will evaluate whether new IRB
rules should be adopted to refine or restrict research consent under these circumstances.
I hope the answers to these questions will be helpful to you. Thank you for writing.
Sincerely,
Debra
Dykhuis
Debra A. Dykhuis
Executive Director
C: