As a long time IRB member, I find that plain language  guidelines have been 
ignored by the folks writing consent forms in the  pharmaceutical and medical 
device industry. Part of the problem is that  plain language recommendations 
are not the same as plain  language requirements. 
 
Several years ago a drug company Vice-President told me that  their consent 
form writers must strictly adhere to federal regulations in order  to comply 
with those regulations. Anything they write that isn't compliant with  those 
regulations is seen internally as being non-compliant, and can create  serious 
job problems. So, even though plain language guidelines and  recommendations can 
make consent forms easier to read, such guidelines have been  routinely 
ignored because they make consent forms "non-compliant!" From this  regulatory and 
compliance perspective, plain language is seen as a  compliance problem not a 
communication solution. 
 
I know this doesn't make much sense, but the drug and device  industry 
obsesses over being compliant or non-compliant with federal  regulations. Corporate 
lawyers assume that their company will not get into  regulatory trouble if 
they use consent language from the Federal Register--even  if prospective 
subjects can't understand it. 
 
If federal agencies want consent forms to be written in plain  language, it 
would help if they would provide some "compliant" examples of  actual plain 
language consent forms and require plain language consent forms.  Current plain 
language recommendations and templates have accomplished very  little. 
 
Mark Hochhauser
 
 
Mark Hochhauser, Ph.D.
Readability Consultant
3344 Scott  Avenue North
Golden Valley, MN  55422-2748
Phone:  763-521-4672
Cell: 612-281-1517
Fax: 763-521-5069
email: _MarkH38514 at aol.com_ (mailto:MarkH38514 at aol.com) 




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