I have been writing consent forms for 25 years -- some have been for
rather complex, integrated projects (a dozen consents at one time is
not unusual).  We have been careful not to mix pronouns.  We do use the
first person and have tried to limit the use of the phrase "I
understand..."  I most often use this expression with important elements,
such as "I understand that I must not become pregnant during this study."
I've not had complaints about this phraseology from the IRBs involved.

If you have an investigator with an affinity for the second person, I
definitely would stay away from "you understand" statements.  I
definitely don't like third-person consents -- gets into the gender
problem... "he/she", etc.

Note to Celia Walker:  I'd be interested in knowing which OPRR
publication you referenced ("cf Tips for Single Project Assurance") so
that I could more completely address the alleged coerciveness of "I
understand" statements.

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Evelyn J. Ford, Research Administrative Manager
ASRI Neurosciences Research Center, Allegheny Campus
Medical College of Pennsylvania and Hahnemann University
Pittsburgh PA 15212  U.S.A.
412.359.4499 FAX
412.359.4475 voice
xxxxxx@singer.asri.edu
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