Regulatory and Ethical Considerations for eConsent in Research

In the last few years, the clinical research industry has seen a bigger push for electronic informed consent (eConsent) than ever before. Although it’s becoming more widespread, there are currently no definitions for eConsent in the Human Subjects Protection– it’s a concept only described in guidance. eConsent typically refers to the use of electronic systems and processes to:

• Convey information related to the study, and/or
• Obtain and document informed consent

These parameters are broad and vague. eConsent can include something as small as research staff collecting an eSignature via PDF, or as large as using a comprehensive eConsent platform. Essentially, if any component of your informed consent process involves an electronic aspect, you’re conducting eConsent.

A Note on 21 CFR Part 11

21 CFR Part 11 only applies to studies subject to FDA oversight. However, even if your study is not subject to FDA oversight, it’s a useful framework as you navigate how to use your eConsent system. Even if it may not necessarily apply, the FDA has documentation on electronic consent and record keeping to consider as you develop an eConsent process.

Consent Requirements Through an eConsent Lens

In the world of eConsent, general informed consent requirements still apply. No matter what type of study is conducted, research staff must convey information about the research in a way so the prospective participant has sufficient opportunity to discuss and consider whether or not participation is right for them. Consent language must be understandable, presented in lay terms, and without exculpatory language. Additionally, the eConsent process must minimize the possibility of coercion or undue influence.

For studies subject to the Revised Common Rule, there are additional requirements. Participants must receive information a reasonable person would want to have, and the process must begin with a concise and focused presentation of key information. Staff must also organize the consent process to facilitate potential participants’ understanding.

Additional Legal Considerations in eConsent

If your study includes an eConsent component, there are additional legal considerations. For example, eSignatures must be valid, and your team must be able to confirm the identity of the participant signing the form. The person signing the form must also be legally able to consent. Thinking about ways to confirm this, as well as accounting for when a legally authorized representative (LAR) may provide consent on behalf of a subject, is critical before even rolling out an eConsent.

An eConsent must also be easy to understand for the participant – which, in most cases, is easier to do via an electronic platform than through paper consent forms. eConsent provides a unique opportunity to ensure the participant truly understands the consent form. Both text and information delivery can become more dynamic, giving staff the opportunity to ensure participant comprehension. This may ultimately lead to fewer dropouts as the study moves along.

Although eConsent provides a greater opportunity for understanding the study, you still need to develop a way for participants to openly discuss what they are reading about, giving them room to ask questions. Additionally, there should not be skip logic in the consent such that a prospective participant can skip crucial research information – all consent content must be presented to the participant so they can review the information and consider it before proceeding.

Institutional Review Board (IRB) Review of Consent

Before using any part of eConsent in research, it must be reviewed and approved by an IRB. While this process is specific to Advarra, your IRB may operate similarly. It’s best to confirm with them before moving forward. When seeking IRB approval at Advarra, the sponsor and site will attest that their eConsent system/process, along with the protocol plan to obtain electronic signatures, conforms to regulatory guidance and IRB ethical expectations for obtaining documented research consent.

Sponsors and sites can provide attestation through responding to a series of statements within the IRB submission. The IRB evaluates responses to the series of attestation statements, and then issues approval to use eConsent. If the IRB has any questions or concerns, they will address them prior to approval.

After the IRB initially approves eConsent usage, they will likely place expectations on the site or sponsor. Prior to using eConsent, submit any subject-facing materials, such as web-linked materials, graphics, glossary, etc. If the eConsent system or protocol plan to obtain documented eSignatures changes, the site or sponsor should submit a modification.

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