Page 515 - eBook Version 8 Book 1 of 2 JUL 2022

Consent Note Worksheet
Was consent obtained on this date?
Chief Complaint: Research Visit
Visit Type: Consent Visit
-Informed Consent
-Informed Consent with study intervention
-Informed Consent with amendments (re-consent)
-Informed Consent subject turned 18 (re-consent)
Title of Study/IRB#:
Principal Investigator's Name
All inclusion criteria and no exclusion criteria met for this patient to participate in the ( )phase of this study.
Study procedures, potential risks and benefits were discussed with (Relatives/Child):
Informed Consent Obtained: Date and Time
Name of Person(s) Authorizing Consent
Relationship to Patient: (relative/Child)
Assent obtained (if not obtained, reason why): Yes/No/NA
Researcher obtaining consent:
Research consent and separate HIPAA Authorization were reviewed and signed
Translator used?
A copy of the signed research consent and HIPAA authorization has been given to the family.
Patient Education Learning Assessment completed
No study procedures were done prior to signing of the consent (NOTE: RARE Exceptions are permitted if IRB approved).
The person providing consnet was given a chance to review the consent and ask questions.
The voluntary nature of participation and ability to withdraw from the study was emphasized
Standard/ Policy/ Gudance
Location
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
EPIC
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
Present in Chart (Circle ONLY one)
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Notes
Auditor Initials________________________________
MR#__________________________________
Date____________________________
FOR AUDIT PURPOSES ONLY