Page 514 - eBook Version 8 Book 1 of 2 JUL 2022

Research Consent Form Worksheet
Standard/ Policy/ Gudance
Location
Present in Chart (Circle ONLY one)
Notes
Is this a DNA/Genetic Consent?
Yes
No
Is this a Non-English speaking Consent Form?
Yes
No
If a short forms is used is there an English long form present?
Yes
No
N/A
Children's Medical Center at the top of Consent Form
Children's Policy
Consent Form
YES
NO
Research Consent Form stamped with IRB approval
IRB
Consent Form
YES
NO
Consent for is permissible to be filed in the Medical Record (i.e., Not a DNA Consent)
IRB
Consent Form
YES
NO
Current Consent Form Used (signature date is after form approval date)
IRB
Consent Form
YES
NO
Patient ID label sticker is present on each page of the consent.
Children's HIM
Consent Form
YES
NO
Participant signature line completed (if 18 years or older)
IRB
Consent Form
YES
NO
N/A
Participant name hand written
IRB
Consent Form
YES
NO
Legally Authorized Representative Printed Name
IRB
Consent Form
YES
NO
Is English the subjects/Legally authorized representative's primary language?
HHS
Face sheet
YES
NO
Legally Authorized Representative verified
IRB
Face sheet
YES
NO
Legally Authorized Representative Signature
IRB
Consent Form
YES
NO
Person Obtaining Consent Printed Name
IRB
Consent Form
YES
NO
Person Obtaining Consent listed on the Consent Form
Children's Policy
Consent Form
YES
NO
Person Obtaining Consent Signature
IRB
Consent Form
YES
NO
Was an Interpreter required?
Children's Policy
Consent Form
YES
NO
Interpreter Printed Name
IRB
Consent Form
YES
NO
N/A
Interpreter Signature
IRB
Consent Form
YES
NO
N/A
Assent of a Minor (10 - 18 years of age)
IRB
Consent Form
YES
NO
N/A
If Assent is N/A, indicates reason in consent for or progress note.
IRB
Consent Form or Consent Note
YES
NO
N/A
All dates and time written by the person signing
IRB
Consent Form
YES
NO
No Blank Lines on the consent (either lined through or "N/A")
IRB
Consent Form
YES
NO
If Non-English consent is used, an unsigned English version present in the Medical Record for staff reference
Children's Policy
EPIC
YES
NO
N/A
Auditor Initials________________________________
MR#__________________________________
Audit Date____________________________
Name of person obtaining consent:____________________________________________ Date consent signed____________________