Page 403 - 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
1. Research personnel provides prepaid envelope to the family to return signed document in event that child will not return to Children’s in the near future – Research personnel should ensure that research mail code and name of recipient is indicated on bottom of envelope to ensure it will be delivered to correct area
iii. Family receives document – either request a read receipt or if the secure email is sent to a non-Children’s email address in Outlook or other email server (Gmail, Yahoo, etc.), a receipt will be sent to the sender’s mailbox indicating that the document has been opened
iv. Provide instructions in the body of the email on how to complete the consent and/or HIPAA documents and scan and email a copy of the executed documents back to the research team
1. Instruct family to mail back the original signed consent and/or HIPAA documents to the research team in the prepaid envelope provided to file in the patient’s research record as soon as possible
2. If applicable, instruct family to bring the original signed consent and/or HIPAA documents back to the research team to file in the patient’s research record during the child’s next scheduled appointment at Children’s
a. Call family to remind them to bring signed document to next appointment about 1-2 days in advance in order to ensure that document will be returned timely
5.3 Regular Mail: This is a good method if re-consent is necessary and the patient does not follow care at Children’s anymore/infrequently
a. Get IRB approval to call family or mail a letter with the consent and/or HIPAA documents to direct parent or patient on how to sign/complete forms as necessary
1. Include contact information for any questions or concerns
b. Compile packet of consent and/or HIPAA documents to be sent via certified
mail
c. Confirm address of patient over the phone or through the medical record
d. Send packet via certified mail with directions on how to complete forms and
provide prepaid envelope or postage to return consent and/or HIPAA
documents to research site
e. Upon receipt of documents by research team, return a copy of consent and/or
HIPAA forms to patient for their records
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