July 13, 202
DF/HCC Research Community,
Many investigators have asked about the use of electronic informed consent and the use of electronic signatures on consent forms. Please review these important updates regarding the electronic documentation of informed consent.
What are the regulatory and policy requirements for electronic consent?
For FDA regulated research, the electronic consent must be compliant with 21CFR Part 11. Research under HHS regulations also requires an authenticated signature. The DFCI IRB policies state that all research will meet the equivalent protections as HHS and FDA, in which case an authenticated signature would be required, unless a waiver of consent documentation was granted by the IRB.
The DFCI IRB also serves as the HIPAA privacy board for all DF/HCC research and by law HIPAA authorizations also require an authenticated signature. Therefore, consents that contain HIPAA provisions will need to utilize a compliant electronic signature system or have an alteration of HIPAA authorization appropriately reviewed and approved by the IRB.
In addition, any electronic informed consent (eConsent) system used for DF/HCC human subject research must be made accessible to the DF/HCC Office of Data Quality (ODQ). The ODQ must be able to view and verify that the consent process is compliant and appropriate.
What electronic informed consent systems are appropriate for use at DF/HCC?
Investigators must ensure they are using a system that is approved by their home institution and configured to satisfy all applicable regulatory requirements for their type of research. In addition, investigators must ensure they have IRB approval to obtain written consent electronically.
When electronic consent is approved by the IRB, it will be the responsibility of the study team or the home institution to build and maintain a compliant electronic consent system, including all new versions of amended consents. One such system is MGB’s REDCap. Please see the RISC website for further information.
Does the use of an electronic informed consent document require prior IRB review and approval?
Yes, the IRB must approve the use of an electronic informed consent document. For existing protocols, this requires an amendment. For new protocols, the electronic informed consent can be part of the initial submission.
The submission must include details about the system to be used and documentation that the system has been validated and approved for use by the home institution. If the presentation of the consent form to subjects will be different than the approved PDF consent form on OncPro, screenshots of the electronic consent presentation must also be submitted. However, the expectation is that the content of the electronic consent must match the PDF in Oncpro since you should not have 2 different consents for the same study .Any additional materials linked in the consent document must be provided for review as well.
With the next iRIS release, the New Protocol Application will be updated to include questions about the eConsent process. Research teams will be asked to confirm whether an eConsent process will be used, and if so, to confirm whether the system is able to provide an authenticated signature and meet all applicable regulatory requirements. There will also need to be a description of the recruitment and consenting procedure consistent with how the eConsent is being administered.
When submitting an amendment, please update the section pertaining to consent to check the box for eConsent and answer the questions that subsequently appear. For investigator-initiated research, the protocol document must be updated.
Can subjects electronically sign the PDF consent form that is currently approved and posted to OncPro?
No. As per the above, investigators must use an institutionally-approved electronic consent system and an amendment must be submitted to the IRB.
However, as per previous guidance, researchers may conduct consent discussions over the phone and the person obtaining consent can provide a copy of the consent form to the participant via email, fax, or mail. The participant (or legally authorized representative, when applicable) must print and sign the paper consent form by hand.
Can electronic consent and paper consent be used on the same research protocol?
Yes, a single protocol can use both electronic consent and paper consent. If electronic consent is approved for DF/HCC research, ODQ will continue to maintain a current paper consent on OncPro. Subjects who sign consent on paper initially can be re-consented later via electronic consent, or vice versa. The content of both consents should be identical and the study team is responsible for making sure the 2 versions are identical.
Is a paper consent form still required?
Yes, a paper consent form must always be submitted for IRB approval and posting to OncPro. The paper consent form will still be used in the following situations:
- When research involves DF/HCC institutions that do not have access to the eConsent system.
- When the eConsent system does not support the use of a legally authorized representative and/or non-English speaking participants.
- If a participant requests the paper consent form for any reason, or does not have the capability to use, access, or navigate the eConsent system.
Where can I get more information about electronic informed consent?
Researchers are encouraged to review the posted OHRS Guidance related to electronic consent. If you have questions about eConsent systems available at your institution, please contact your institutional clinical trials office.