Rebecca -

I have found that you have to be very careful that what is stated in the
consent form as to what costs the subject and/or his/her insurance company
is/are responsible for are consistent with the budget and agreement.  For
example, if the consent form states that "these procedures are considered
standard of care and will be your (the subject's) responsiblity, I expect
that those costs will not be included in the budget (more and more these
days the sponsor is trying to define study procedures as "standard of
care").  If the consent form states that "these procedures are free of
charge to you (the subject) and will be paid for by the sponsor," the
budget should reflect this and neither the subject nor the insurance
company should see a bill.  Because I have both the IRB and the
grants/contracts functions in my office, I can get my hands on the consent
form quite easily to be certain that the budget is consistent with the
consent form - I do this routinely.  Bottomline, we hold the PI to whatever
is stated in the consent form.  Hope this helps.

- Margo

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Margo Hinkle
Associate Director
Research Administration
Research Office
Evanston Hospital
2650 Ridge Avenue
Evanston, Illinois 60201

Phone:  708-570-2533
FAX:  708-570-2933
e-mail:  xxxxxx@merle.acns.nwu.edu
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