When writing electronic informed consent into a protocol, it is most important to:
- describe each step of the informed consent process,
- why the step is being performed,
- how each step will be performed,
- when will each step be performed,
- and where each step will be performed.
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How do I provide REDCap electronic document templates to my IRB reviewer?
Below you can find some example protocol language that has been used before at CCHMC.
Example eConsent language for IRB protocols
Please find below template text that can be used in the IRB application to describe the specific steps for obtaining consent electronically. This language may be used as is or modified when initially completing or amending IRB applications for use of e-Consent:
The patient consent process will be conducted using a REDCap-based electronic consent form. The consent form has been developed in REDCap, a secure, web-based, HIPAA-compliant, data collection platform with a user management system allowing project owners to grant and control varying levels of access to data collection instruments and data (e.g. read only, de-identified-only data views) for other users. Potential participants will participate in the consent process by (select method):
- Being approached in-person at a CCHMC Clinic and accessing the REDCap survey via iPad or other portable electronic device and/or
- Self-initiated access of consent forms on personal portable electronic devices using posted QR codes or web-links on study posters, brochures, or websites. Self-initiated accessing of consent forms may occur in clinic or at home.
During the in-person consent process, patients will be consented by a member of the key study personnel.
For self-initiated consent, contact information will be provided (email and phone) for prospective patients to contact a member of the key study personnel with questions, prior to consent.
Patient signatures will be obtained using a (select method: typed signature, PIN number, written signature – via stylus/cursor, etc.). Upon completion of the consent, patients will be provided with a copy of their version of the consent document by (select method: printing a pdf copy of the consent form in clinic, emailing copy of the consent form, providing participants with a business card/brochure with the web link to the appropriate version of the consent, provide home address for mailing of a hard copy of the consent).
Signed consent documents will be housed electronically in REDCap's File Repository.
Example eConsent language for IRB protocols
eConsenting IRB Justification Document
Electronic informed consent will be developed and implemented using REDCap. REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data (including 21 CFR Part 22, FISMA, and HIPAA-compliant environments), it is specifically geared to support online or offline data capture for research studies and operations. The CCHMC REDCap team has templates available for research use for eConsenting which includes Consent to be a Research Subject and Authorization to Use or Disclose (Release) Health Information that Identifies You for a Research Study (HIPAA). The REDCap electronic consent format does not accommodate the current CCHMC formatting which includes headers with logos and stamps on each page and will, therefore, require some modifications.
* For the Consent, the IRB approved consent document will be uploaded into the database instrument. The IRB approved consent will be modified to an electronic format that includes all the same elements found on the paper document (i.e. IRB number, approval dates, and CCHMC logo, etc.). The elements of the consent requiring a signature has been added as a generated field. The instrument includes fields to capture full name, signature, and date and time of the signature for the consenter, and witness and conditional text that states that all signatures are associated with the Subject ID# registered in the database. When completed REDCap will generate a footer that contains the long date and time the document was submitted and “Confidential” listed in the header as an added precaution to preserve the research participants' confidentiality. (see PDF attachment
). REDCap's 'Auto-Archiver + eConsent Framework' will be used. The 'Auto-Archiver + e-Consent Framework' survey option adds two things to the typical survey-taking process. 1) Before a participant completes the survey, an extra certification page is added to end of the survey that displays an in-line PDF copy of their survey responses in which they will be asked to confirm that all information in the document is correct. Once they confirm all is correct, the survey will then be marked as complete. The survey will not be considered complete until they fulfill the certification step. 2) Upon completion of the survey, a static copy of their responses in the form of a consent-specific PDF will be stored in the project's File Repository. The consent-specific PDF may have the values of the e-Consent Framework Options inserted at the bottom of each page in the PDF. These values (i.e., name, date of birth, etc.) are added to the PDF as extra documentation of the identity of the person who is consenting.
The HIPAA Consent is queued to automatically open once the consent has been signed and all logic is satisfied.
* For the HIPAA and Notice of Privacy Practices the IRB approved consent document will be uploaded into the database instrument. The instrument includes fields to capture full name, signature, and date and time of the signature for the consenter, and witness and conditional text that states that all signatures are associated with the Subject ID# registered in the database.
* Signature process:
Participants and Witnesses will type their first and last name into a text box, sign their name in the signature field with a stylus or finger and then click “Now” by the date field to automatically enter the date and time. A copy will be printed or sent electronically to the subject per their preference. If emailing a signed consent, please be sure to include #secure in the subject line of the email. This will ensure that the PHI within the consent is sent securely.
* eConsenting Process:
Subjects presenting to clinic will be given an electronic tablet with the preloaded IRB approved and HIPAA documents for the specific study. Subjects will be given time to read through the consent form(s) and then the study coordinator (or designee) will review the consent, and any study handouts with the participant. Once the consenting process has been completed and all questions have been answered, the study and HIPPA consents will be signed and dated by the subject and witness and submitted via the REDCap database. Subjects will elect either a printed or electronic copy of the ICF documents and will receive documents as per preference. Signed and submitted documents will be available as a PDF in REDCap's File Repository. A PDF of the eConsent document will be sent to CCHMC HIM per requirements and long-term storage will be at the CCHMC approved vendor, LabArchives, which is 21CFRPart11 compliant.
Attachments:
For your convenience a hyperlink has been attached to this request. The hyperlink shows the view from the participant
and the consenting designee.
Hyperlink: ____________
Another example:
- Process of Obtaining Informed Consent
<<Describe how informed consent will be obtained. Define ages/circumstances in which assent and/or parental consent will be required.>>
Consent, parental permission and/or assent will be obtained from all patients before any study-related procedures are performed. Written assent will be obtained from participants 11 years of age and older. The investigator will be available to answer any questions that the participant or parent may have regarding procedures, risks, and alternatives. The consent process will be documented on the informed consent progress note.
Consent may take place by several methods: in-person paper consent, in-person electronic consent (using REDCap for the eConsent) or over the phone (via paper or REDCap for eConsent). Signatures of the subject and study staff may not always occur on the same date depending on how and when the subject returns the signed consent. No matter the consenting process, study procedures will not occur prior to a fully executed consent form. Consent will be obtained following the CCHMC consenting SOP. REDCap eConsent will not replace the consenting method, it will be used as an additional resource for signing the consent form. A copy of the consent form will either be given to the subject in paper form or emailed to them via REDCap depending on how the consent is completed. In all cases, the consent process will be documented on the informed consent process note and a copy of the signed consent(s) will be kept in the patient’s medical record.
Staff will make sure that the eConsent database is updated as soon as possible after a new version of the paper consent is approved. Staff will also make sure paper consents are used to consent eligible subjects in the event that the eConsent database is not updated prior to eligible subjects being available for consent approach by a member of the study staff. For the reasons described, the eConsent will not be submitted to the IRB for approval.
The study team will monitor the age of each participant. If a participant turns 18 during their study participation, the investigator or study coordinator will approach the participant during a routine clinic visit to confirm they would like to continue their participation in the study. The participant will be asked to sign a fresh consent form, documenting their consent.
In the case that an eligible participant is non-English speaking CCHMC’s institutionally approved “Informed Consent Process and Documentation” and “Short Form Consenting Process” (Standard Operating Procedure for Research Involving Human Subjects – SOP Number 41-1.4 and 41-1.8 respectively) will be followed to consent the non-English speaking individual. An IRB approved full translation of the consent document or Short Form consent document in the participant’s preferred language will be provided to the participant along with a copy of the full English consent. A translator will be present during the entire consenting process and the IRB approved full English consent form will be read to the participant in their preferred language. The participant will also be given time to read the full translation or Short Form consent document and ask questions pertaining to the research study. Informed consent will be appropriately documented when the participant and consenting individual signs and dates the language-specific consent document or Short Form consent document and the IRB approved full English Consent. The participant will be given a signed and dated copy of both documents to keep. The consenting individual will fill out an “Informed Consent Process Note” to document the consenting process.
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