Page 402 - eBook Version 8 Book 1 of 2 JUL 2022

4.2 Email consent
Research Administration SOP No: R-Rec-113
SOP Title: Consent by Email, Regular Mail or Fax
The Principal Investigator (PI) is ultimately responsible for obtaining informed research consent or re-consent and may delegate this responsibility to the study CRC or CRA on the study delegation log.
4.3 Regular Mail consent
The Principal Investigator (PI) is ultimately responsible for obtaining informed research consent or re-consent and may delegate this responsibility to the study CRC or CRA on the study delegation log.
4.4 Fax consent
The Principal Investigator (PI) is ultimately responsible for obtaining informed research consent or re-consent and may delegate this responsibility to the study CRC or CRA on the study delegation log.
4.5 Documentation of informed consent
The study team will document the informed consent process as outlined in Clinical Practice Policy 7.14.
5. PROCESS
5.1 IRB Approval: The recruitment plan must be reviewed and approved by the IRB prior to implementation. The electronic Institutional Review Board (eIRB) system smart form section 53.2 and 53.3 will be accurately completed to encompass the procedure being followed to obtain informed consent.
5.2 Email: This consent is ideal if patient/LAR has access to email to receive the consent/HIPAA documents. Email contact information would be collected from patient and consent/HIPAA documents would be sent via secure email through Outlook to the patient/LAR’s email address.
a. Patient/LAR may have given verbal consent via phone to the research study and would need to sign to affirm the verbal consent
i. In the instance of needing a second parent consent, research staff gives a copy of the executed consent and/or HIPAA documents to present parent at the time of research consent or email to the family via secure email (Send Secure feature in Outlook) immediately following the research consent. Instructions will need to be sent to the family on how to open the secure email. After opening the consent and HIPAA documents attached in the secure email, instructions on how to complete the forms will be provided, indicating where to sign and the date and time of verbal consent that was recorded during the consenting process
ii. Confirm with present parent at this time whether it would be preferred to the bring the signed consent signature page to the child’s next appointment if care is followed at Children’s or if parent would like to physically mail the consent page back to research team
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