There are FDA Regs. that address the issue of charging for investigational
drugs (21 CFR 312.31).  There is also a prior approval process is one has
sufficient reason to charge.  In general, the FDA and OPRR believe that the
cost of investigational drugs should be borne by the sponsor (21 CFR 312.7).
All of the above deals directly with invest. drugs.  Our local IRB stands
by this.  If the sponsor wants to charge, we require them to provide documentati
 on (FDA letter) stating approval.

In other cases where such an arrangement is for charges for standard care
of a disease, we allow third party billing but require investigators to note
in the consent that the subject MAY be responsible for costs incurred should
insurance be denied.

Hope this helps.
Rebecca Bacon
Eastern Virginia Medical School
xxxxxx@PICARD.EVMS.EDU