Page 404 - eBook Version 8 Book 1 of 2 JUL 2022

Research Administration SOP No: R-Rec-113
SOP Title: Consent by Email, Regular Mail or Fax
5.4 Fax: This consent process is ideal if the patient/Legally Authorized Representative (LAR) has access to a fax machine to receive the consent/HIPAA documents.
a. Fax contact number would be collected from patient and consent/HIPAA documents would be sent via secure fax machine.
b. Once documents are received, patient/LAR would need to be called to receive instructions from the research team on how to complete the document in real time over the phone
c. Patient/LAR would receive consent/HIPAA documents and sign as applicable
d. Patient/LAR would send back the signed copies to the research staff in order
for the research staff to sign in real time
e. Research personnel would fax a copy of the completed, signed documents to
the patient/LAR and the original would be retained in the research record
5.5 Documentation: After informed consent is obtained from the patient and/or LAR, complete and thorough documentation of the consent process is necessary for good clinical practices and to comply with Children’s research regulations.
a. EPIC Documentation: If the study is not a genetic research project, the consent/re-consent process must be appropriately documented in the patient’s electronic medical record (EPIC).
b. Research Record Documentation: If the study has a genetic component, the consent/re-consent process must be appropriately documented in the patient’s research record on a paper Progress Record. A template for the Progress Record may be found through Childnet.
i. Note to File: A regulatory Note to File may be appropriate to explain the need for alternative means of obtaining informed consent. The Note to File will be completed, signed and stored in the patient’s research record for later reference upon self or regulatory audit of the study records.
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R113
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
R113
R113
04/01/20
Added Adult Recruitment guidance and request form
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