Questions

A former GCP student sent me this question today:  "Can you tell me if it is OK for a principal investigator to have his signature Xeroxed onto the ICF for the subject to sign?  This doesn’t seem appropriate to me, but I am having trouble finding anything that says otherwise.  Also, can they sign the ICF in advance of the subject signature, or should it always be after the subject consents to be in the study."

Every class term starts with my passionate admonishment that GCP is more than just knowing the rules, in fact knowing the rules is only a small part of the task.  To understand the rules, we have to think through why those rules exist.  Reading this students' question gave me an unsettling feeling that I am not being very effective at getting this point across.

Whether there is or is not a regulation about pre-signing informed consent forms, whether in ink or by photocopying, stamping, or smoke signals, is entirely beside the point.  The point is not the signature at all.   The point is what the signature represents.  (*Extra credit: is the investigator's signature even required under US regulations?)  My students have all been taught that the signature represents that the investigator's obligations to the patient with respect to the nature of the study, risks and discomforts, alternative treatments, right to withdraw and all the other elements of consent have been met.  Therefore, of course it is unacceptable to pre-sign the form, Xerox a signature onto the form or whatever else this investigator has thought up.



*Answer: No, only the patient's (21CFR 50.27(a)). Under ICH guidelines the consent should be signed by the patient and by the person who conducted the informed consent discussion (ICH E6 4.8.8).