Re: Consent forms for human research
J. Matuk, Coordinator, Res. Compliance 05 May 1995 10:40 EST
Our IRB doesn't necessarily have a preference regarding "I am being
asked..." vs. "You are being asked..." , but it does require that the
consent form be CONSISTENT throughout the document in how the subject
is addressed.
Regarding understanding: When we were audited by the FDA in '89, the
auditor cited us for having approved consent forms with the phrase,
"If you sign below it means you have read...and understood...the
information...". He said that a subject can sign that s/he has READ
the information, but s/he cannot sign that s/he has UNDERSTOOD the
information.
We have since deleted that reference from our consent form guidelines.