Documentation Of The Informed Consent Process For On-Site Subject File


Sample Template:
Documentation of the Informed Consent Process for On-Site Subject File
IRB Approval Date:
IRB Expiration Date:
Study Title:
Subject ID:
Consent obtained by:
Date of Consent:
Check all that apply
The subject meets all eligibility requirements.
Was the subject’s comprehension assessed to ensure that the subject
understands the research and the risks and benefits involved in the study?
Subject was given a copy of the California Experimental Subjects’ Bill of Rights.
Subject signed the UC HIPAA Research Authorization for Release of Personal
Health Information for Research.
Discussed, explained and reviewed the consent form with subject.
 Written consent was obtained (per IRB approved consent process)
 Surrogate consent was obtained (per IRB approved consent process)
All of the subject’s questions were answered/concerns addressed. (document
multiple subject contacts below)
 Subject did not have any questions/concerns
Subject was given time to review the consent form and to discuss participation in
this study with family members/others.
The subject has agreed to participate in the study and signed/dated the most
current valid IRB approved consent form prior to the start of any study procedures.
A copy of the signed and dated consent form was given to the subject.
The original signed and dated consent form was placed in the research record or
separate binder.
Was there early withdrawal from research participation? If yes, note reason.
Sample Consent Process Checklist 11.24.14


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