Originally Published MX July/August
2002

GOVERNMENTAL &
LEGAL AFFAIRS

IRB Compliance:
The Clinical Study Sponsor's Obligations

A noncompliant
oversight board at a study site could jeopardize a manufacturer's new-product
introduction.

Anna
J. Baldwin-DeMarinis

Clinical trials of
medical and in vitro diagnostic (IVD) devices can take years to complete and cost
a million dollars or more. One major imperative of such trials is the protection
of the human subjects who are enrolled, an FDA requirement. To satisfy FDA in
this regard, an institutional review board (IRB) must review the clinical research,
and trial participants must give their informed consent to be subjects.

IRB
reviews and the form for obtaining informed consent must both comply with federal
regulations. Touching on informed consent only incidentally, this article focuses
on how the manufacturer of an investigational device or diagnostic product can
determine the FDA compliance status of IRBs at the sites where the firm intends
to conduct—or has already conducted—clinical trials. A trial sponsor