Page 413 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-104 SOP Title: e-Consenting
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o PostalMail:Consentsmaybesignedbytheparticipants,andthenmailedback to the study team for signature.
▪ A consent note should be drafted to explain the difference in signature dates between the research participant and the study team.
o E-Mail: Signed consents may be photographed/scanned and emailed back to the study team for signature.
▪ A consent note should be drafted to explain the difference in signature dates between the research participant and the study team.
Provide copy of consent to participant/LAR
o PostalMail:Fullyexecuted(signedconsents)maybemailedtoparticipants
o Encrypted Email: signed consents may be emailed to participants using encryption (type SecureMail in the subject line of the email before sending)
Save consent documentation
o AllsignedcopiesoftheconsentmustbeuploadedtoEPIC(atUTSWandbased upon institutional policy at affiliate institutions) unless the IRB waived this requirement
o A consent note explaining how the informed consent process was completed should be entered into EPIC (if required) and research records
o Save the signed consent(s) in the regulatory files for future audits and monitoring visits
o Consentmaybesavedelectronically(thereisnorequirementtoprintthesigned electronic consents or maintain a hard copy of the original signed version)
Usage of Adobe Sign
• Access Adobe Sign by going through the start menu then clicking “Adobe Acrobat DC”
• Using the “Tool” menu, access the “Forms and Signatures” section and open “Adobe Sign”
• Upon the new page being opened, select the appropriate consent/HIPAA document under “select a file”
• Once selected, the file will open. The user will need to select “Adobe Sign” on the right-hand menu
o ForolderstudiesthathaveaseparateHIPAA,theuserwillneedtoaddthe document using “Add a file” at this time
• A new page will populate, and the user will need to enter the following: o Emailaddressforparticipantifovertheageof10years
o parent/legalguardianemailaddress
o ResearchCoordinator/ResearchAssociateemailaddress
o Select“Specifywheretosign”
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