I administer 4 IRB's at this time, for 3 different hospitals.  Our sample
consent forms are included in the investigators information package and the
study consents must be in the same format and wording.  We require the second
person to be used, the rationale being that the investigator is the one
telling the potential subject about the study and should never make
assumptions about the subjects understanding.  We have found that the use of
"I understand..." can be confusing or intimidating because it starts to sound
like legalize and using that term has absolutely no bearing on subject
comprehension.  Also, using this terminology in the consent will be of no
help in a court case; first because the consent form is an informational
document and not a legally binding contract and second, because if the
informed consent does not inform (regardless of what tense or style is used)
it won't be of any help in court.

I found a lot of useful information at a Drug Information Association conferen
ce I attended in October of 1992.  The conference topic was informed consent
and the consent process and included the results of some research into
consent comprehension and retention of information.  DIA has proceeding from
this conference which should be available.  Their phone number is (215)
628-1229.

 Bottom line:  keep the language simple and straight forward; at a 6th or
7th grade reading level; explain all technical terms; avoid excessive verbage
- get to the point; do not crowd words onto the page (subject comprehension
drops through the basement if you do); use small paragraphs and plenty of
white space; use a type style and size that is easy for the subjects to read;
keep telling them that they can and should ask questions; and adding an extra
page or two is always better than craming too many words into to small a
space.

Hope this is useful.

Rebecca