>>> "Deborah (Debbie) L. Smith 901 448-5587" <xxxxxx@UTMEM1.UTMEM.EDU>
- 9/21/98 4:11 PM >>>
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?

The FDA Information Sheets are a good place to start. There is a
section specific to your info needs. They list 21CFR812.7(b) and
21CFR812.20(b)(8) for devices and 21CFR312.7(d) for drugs and
biologicals. Also the IRB regs (21CFR50.25(b)(3)) specify how the
subject is informed of the charges.

Hope that helps.
Bruce

Bruce Steinert, Ph.D.
Department of Urology
William Beaumont Hospital
3601 West Thirteen Mile Road
Royal Oak, Michigan  48073-6769
(248) 551-2572 (voice)     (248) 551-8107 (FAX)

The trouble with doing something right the first time is that nobody
appreciates how difficult it was.