Does any of you know whether the FDA regulations include information about what can and cannot legally be charged to the patient and/or third-party providers for clinical trials and if so, what is the cite?

It is my understanding that we COULD charge patients and/or third-party providers for anything that is "usual and customary" treatment but not for research procedures and/or products; but I don't know where I got that.

It seems to me that we're seeing more and more contracts come through with some charges to the patients and/or third-party providers.  Does this seem to be a trend?  What are other institutions are doing about it?

Thanks for whatever info you can provide.

P.S.  My apologies for the incorrect subject heading on my earlier memo; obviously, I did a "reply" and forgot to change the subject line!

Debbie Smith
UT Memphis
xxxxxx@utmem.edu