Ask the Experts: What Is E-consent? What Are E-signatures?

What Does E-consent Mean to the IRB?

Electronic consent can refer to the process by which a participant’s signature is obtained and documented electronically, and it can also refer to other aspects of the informed consent process. E-consent can describe the exact representation of the IRB-approved document on an electronic device as well as refer to a consent process using electronic devices and audio-visual aids. The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have issued a joint guidance titled Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers.

Is an E-signature Different from E-consent?

Yes, but often the terms are used interchangeably which can lead to confusion. E-signature is specific to the documentation of consent while e-consent refers to the process of consent which includes technology and can support or replace a face-to-face, wet-ink signature process. In the draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers,” the FDA defines e-signature as “a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.” FDA does not define e-consent.

Is E-consent Different from Remote Consent?

E-consent can be used as part of a remote consent process, but remote consent does not necessitate that e-consent is utilized. For example, informed consent obtained via a telephone conversation with a paper copy of the signed consent mailed to the research site would be an example of remote consent that is not e-consent.

Does E-consent or Remote Consent Require IRB Review and Approval?

Yes. The consent process and any modification to the prior approved consent process must be submitted to the IRB for review and approval. Additionally, the IRB must review and approve the e-consent materials (including consent language) and any modifications to the e-consent materials that the participant will view or receive. The IRB must also review any e-consenting tools used in conjunction with a paper or e-consent, such as questions or methods used to gauge participant comprehension of key study elements. If an approved static consent form will not be altered, but will be uploaded to an electronic platform, the document does not need to be submitted as an e-consent. However, if additional technology is used to obtain consent when a static consent form is used, the process is considered e-consent, and how e-consent will be utilized in this scenario must be reviewed by the IRB.

WCG IRB’s specific requirements for review of e-consent can be found on page 24 of the WCG IRB Guide for Researchers. When WCG IRB approves a remote or e-consent process that is not part of a protocol or a separately submitted document, it is documented on Certificate of Action as “Alternative Consent Process approved.”

Does the IRB Consider Compliance with 21 CFR 11 (part 11)?

If the research is FDA-regulated and the submission indicates that the consent signature will be obtained and documented electronically, the IRB will ask the submitter to confirm that the system used to generate electronic signatures is compliant with 21 CFR Part 11. Part 11 does not apply to wet ink signatures that are uploaded to an electronic system. Part 11 compliance is also not required if a wet-ink signature is scanned and uploaded by the participant and transmitted via email or fax to the investigative site.

Do All Consent Requirements Still Apply?

Yes, all elements of consent required by 21 CFR 50.25 and 45 CFR 46.116 must be present in e-consent forms. When implementing an e-consent process that is remote or asynchronous, special consideration should be paid to the availability of the research team for questions. Additionally, the process should ensure that the participant receives a copy of the consent document. FDA guidance recommends that the consent form provided to the participant is a signed copy which includes the date of the signature.

What About E-consent for Non-FDA Regulated Research?

The consent process and any modification to the consent process must be submitted to the IRB for review and approval. If the research is not subject to FDA regulation, the Part 11 requirements do not apply to the e-signature. In addition, for research that meets the requirements, a waiver of documentation of consent by the IRB would make signatures not required. Furthermore, in “Use of Electronic Informed Consent Questions and Answers,” the HHS has provided the following guidance:

“OHRP recognizes that it may not be possible or necessary for all types of research covered by 45 CFR part 46 to verify that the person signing the informed consent is the subject or the subject’s LAR who will be participating in the research study. OHRP encourages investigators to apply a risk-based approach to the consideration of subject identity. For example, social behavioral minimal risk research will not typically warrant such verification. In addition, informed consent may be waived for minimal risk research meeting the requirements t 45 CFR 46.116(d).”