I administer the IRBs for 4 different hospitals, though I try to keep the
policies and procedures pretty standard (so I won't go insane!). I hand out
Investigator Information packages that include a memo on IRB submission
procedures and how to use the forms. This package also includes a master
Informed Consent agreement. We require that the consents come to the IRB in
this format, using the same basic wording and headings. I will write
someone's consent now and then (though less often than in the past), but
normally I stay pretty firm and let the investigators know that this is part
of their responsibility. We do not keep copies of the signed forms since
this is the responsibility of the investigator and having those forms in the
IRB office could cause confidentiality issues. The feedback I get on using
the master consent form has been 90% positive. The investigators know that
if they use the format, they have a lot less trouble getting the consent
approved quickly, with fewer revisions.