Consent Process (Including Informed Consent Documents)

  1. Should the time be included as part of the subject's signature on an Informed Consent Document? 

 

1. Should the time be included as part of the subject's signature on an Informed Consent Document?

Only if this is a sponsor requirement.  Neither the UI IRB or WIRB currently require the time the subject signs the informed consent document to be included in the informed consent template.  During a UIHC Joint Commission audit in the summer 2013, they recommended all forms and documents requiring a patient signature include the both the date and time all applicable documents were signed.  This requirement only applies to documents signed by patients\subjects that are part of the “Designated Record Set.”  The informed consent document is not included in this designated record set.  Instead, the informed consent document is retained in the research related files and a Record of Consent is added to the subject’s medical record.  The Record of Consent is signed by the research team, not the subject.