IRBs and DSMBs Posted on November 21, 2007 Alan F. Schatzberg (bio) discusses the role of the IRB and DSMB.

The IRB really does look at safe guards and informed consent, but it doesn’t do a monitoring on a routine basis other than maybe yearly for a progress report so [the DSMB] is really much more interactive, real time, and it comes — it becomes useful, as pointed out today by Chip Reynolds if there is a kind of an untoward event to determine whether it was due to the treatment or it doesn’t just have to be a drug treatment, it could be a somatic treatment, it could be psychotherapy, it could be a psychosocial treatment of some form. So if something happens, somebody suicides and they were on psychotherapy, to review it to see if it makes sense to continue, what was the cause of the adverse event, et cetera.

Well, the PI would report to — if it was an experimental drug, investigational drug, or investigation use, it would report to the FDA and it would report to the IRB. But the IRB might not have the expertise on it, right? So, this really has the expertise that you could in fact assess the risk benefit as you go along.

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