Page 303 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Audit Item
Research Consent Form
Guidance
Location
Coordinator Response to Query
Children's Medical Center at the top of Consent Form
Children's policy IRB
Research Consent Form stamped with IRB Approval Consent form is permissible to be filed in the Medical
Record (i.e., Not a DNA Consent or protected by a Certificate of Confidentiality).
IRB IRB
Consent form Consent form
Yes No
Current Consent Form used (signature date is after form approval date)
Yes No
Patient ID label sticker is present on each page of the consent.
Children's HIM IRB
IRB
IRB
Consent form Consent form
Yes No
Yes No N/A Yes No
Yes No
Yes No
Participant line completed (if 18 years or older) Legally Authorized Representative Printed name Legally Authorized Representative Signature
Consent form Consent form
Person Obtaining Consent Printed name
IRB
Consent form
Person Obtaining Consent listed on the Consent Form Person Obtaining Consent Signature
Children's policy IRB
Consent form Consent form
Yes No Yes No
Interpreter printed Name Interpreter Signature
Assent of a Minor (10-18 yrs of age
IRB IRB IRB
Consent form Consent form Consent form
Yes No N/A Yes No N/A Yes No N/A
If Assent is N/A, indicates reason in consent form or progress note.
Consent form Consent note
or
All dates written by the person signing
No blank lines on the consent (either lined through or "N/A")
If Spanish Consent used, an insigned English version present in the Medical Record for staff reference
IRB IRB
Consent form Consent form EPIC
Yes No N/A Yes No
Standard/
Policy/
Present in Chart (Circle ONLY one)
Joint Commission RI.01.03.05
EPIC
Consent form Consent form
Yes No Yes No Yes No
IRB
Children's policy
Yes No Yes No
2011 Research Chart Audit Tool
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