Page 304 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Consent note in Medical Record completed as below:
Joint Commission
EPIC: Progress note or Scanned document
Yes No
Chief Complaint: Research Visit
Visit Type: Consent Visit (If inpatient Title of Study/IRB#:
Principal Investigator's Name:
All inclusion criteria and no exclusion criteria met for this patient to participate in the { child:}.
} phase of this study. Study procedures, potential risks and benefits were discussed with {Relatives -
Informed Consent Obtained: Date: Time: Name of Person(s) Authorizing Consent: Relationship to Patient: {Relatives - child:
Assent obtained (if not obtained, reason why): Yes___No___Not applicable___ 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.
2011 Research Chart Audit Tool
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 consent 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.
HIPAA
Children's Policy
EPIC: Progress
note or Scanned
document Yes No N/A
If HIPAA Authorization is in the Medical Record, there is no mention of "DNA"
IRB
EPIC Yes No N/A EPIC Yes No N/A
If Spanish HIPAA present in Medical Record, unsigned English version also present for stafff reference
Children's Policy
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