Page 396 - eBook Version 8 Book 1 of 2 JUL 2022

Research Administration SOP No: R-Rec-102
SOP Title: Type of Consent Processes and Documentation
5.4 Procedure Process Map
Face to Face Consent 4.1
D004
Obtain Most Recent IRB Approved Informed Consent and HIPAA Form from eIRB
Locate a Private Area to Conduct ICF Discussion
Review all Elements of the Research Study with the LAR and/or Patient
Allow Time for the LAR and/or Patient to Read the IFC and HIPAA Forms and Ask Questions
Assess Level of Comprehension. Stress Voluntary Nature of Study
If Subjects are (10 - <18) Obtain Assent to Participate
Obtain Signatures from LAR/Patient
Provide LAR/ Patient with Copies of ICF and HIPAA Forms
Document ICF Process in Patients Medical Record
Subjects (10 -
Interest Shown in Review ICF and HIPAA and Ask Questions <18) years of age Study provide assent to
participate
LAR/Parent Sign the Consent and HIPAA Forms
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R112
10/01/20
Provided clarification of 21CFR 11 requirements; Included reference to RA guidance and COVID command structure and the advisement to complete this process virtually whenever possible.
R112
R112
04/01/20
Added Adult Recruitment guidance and request form
R112
R112
09/01/20
Added more clarification of the ICF self- audit resources and documentation resources such as smart text in EPIC and the HIM email for scanning the ICF into the patient’s eMR.
DXXX
R-Rec-102
08/01/2022
Removal of COVID restrictions and ongoing modifications.
R112
Page 5 of 5
LAR / Patient CRC / CRA Start
Finish