Page 385 - eBook Version 8 Book 1 of 2 JUL 2022

5.4 Executing the consent form
5.5 5.5
The study team will ensure the following is completed when executing the consent form:
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Handprint the participant’s name on the “Name of Participant” line
All signatories should print their own name and sign with date/time on the appropriate lines in the signature block
If Assent is required:
o If capable, have the minor subject print their name, sign and date/time on the Assent section.
o If the minor subject is not able to write, but has verbalized assent, state this on the Assent line of the consent form and describe the situation in the research consent note.
o IftheminorisnotabletoprovideAssent,enteracommentontheAssent line of the consent form stating the reason, and describe the situation in the research consent note.
o If the minor refuses to provide assent, they are declining voluntary participation, and cannot be enrolled in the study without written approval from the IRB.
Documentation of the Informed Consent and Research Visits
Upon executing the informed consent document, the informed consent process and study visit information should be documented in the subject’s medical record and subject binder. Smart text is available for completion of the consent note in EPIC incorporating all of the required elements of the informed consent documentation. Research progress notes should also be completed upon every patient contact. Such research notes should include the required elements, but should be customary to the more stringent and sponsor-specific requirements. Additionally, policy 7.14 should be followed ensuring that a patient label is affixed to the top, right corner of every page of the ICF and HIPAA form. Additionally, it is expected that a copy of both documents be scanned into the patient’s medical record via secure email: HIM.transport.Fax.documents@childrens.com with exception of consent forms for genetic based research. For additional guidance toward informed consent and HIPAA authorization process and building progress notes templates, please go the research shared and find the Chart Audit tool on the CRC resources folder. It outlines all required elements of consent, HIPAA, research orders, and documentation of consent and research notes.
6. RESOUCES AND FORMS
Adult Recruitment Form is Located on RA Sharepoint
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Research Administration SOP No: R-Rec-101 SOP Title: Consent Process