Forgot to add in my last message.....our IRB many years ago went round and
round with a similar issue.  We had a for profit company performing innovative
cancer treatments that were definitely NOT covered by insurance.  You can
imagine the ethics involved.  These were desperately ill patients willing to
try anything as treatment.  The company was obviously (for profit) charging
for their services.  The cost was high.  Many months went by while our IRB
deliberated this issue.  Finally a decision was made to allow it for a "trial
period" of 6 months or so and re-evaluate.  The company was required to come
up with a plan for treatment of individuals who could not afford the service.
It ended up being an assistance program of some sorts.  Although I don't recall
all the particulars, it worked for awhile and then the company folded.  I'm
hoping we don't encounter that issue again....it was in the 1980's.
Rebecca Bacon
EVMS