I write (and revise) a fair number of consent forms annually. I have
not heard any complaints from Feds, investigators, the IRB, or patients with
either first person construction or the "I understand" phrase. Patients may
be more inclined to ask questions if they sign a consent stating that they
"understand" rather than just "volunteer to participate." Additionally, our
IRB application packet includes a sample consent form that begins "I
understand ...".

The majority of recent concerns deal not with who agrees to what, but who
will pay for what. We must be very specific the procedures AND COSTS that
will not be covered by the study. This will occassionally get a discussion
going.

There might be legal benefits from a signed "understand" consent if
push comes to shove in the event of a mishap. I have no supporting data,
but it seems a logical hypothesis.

Hope this helps,
Bruce

Bruce W. Steinert, Ph.D.
Department of Urology
William Beaumont Hospital
3601 West Thirteen Mile Road        (810) 551-2572 (Voice)
Royal Oak, MI  48073-6769           (810) 551-8107 (FAX)