Electronic informed consent, or eConsent, is no longer a novel approach to clinical research. Regulators around the world increasingly recognize electronic, remote and technology-enabled approaches to informed consent as part of modern clinical trial conduct.
But the regulatory environment has changed significantly.
The most important development is not a single new eConsent regulation. Instead, updates to Good Clinical Practice, electronic systems guidance and national clinical trial frameworks are changing how sponsors can design, document and manage informed consent.
ICH E6(R3) is central to that change. FDA issued E6(R3) as final guidance in September 2025, describing the revision as a modernization of GCP that embraces innovation in trial design, conduct and technology while emphasizing quality by design, participant protection and risk-based approaches. FDA subsequently withdrew its E6(R2) guidance in April 2026.
At the same time, regulatory developments in the United States, European Union, United Kingdom and Canada are providing clearer frameworks for electronic records, remote interactions and alternative ways of documenting consent.
For sponsors, CROs and clinical trial sites, the question is therefore changing. It is no longer simply, "Can informed consent be electronic?"
Increasingly, the question is: How can electronic informed consent be implemented in a way that protects participants, supports understanding, verifies identity where required, preserves reliable records and meets the requirements of every jurisdiction involved in a trial?
What is eConsent?
Electronic informed consent, commonly called eConsent or eIC, uses electronic systems and processes to provide information about a clinical trial and obtain and document a participant's informed consent.
FDA has recognized that eConsent may employ multiple forms of electronic media. Its dedicated eConsent guidance dates to 2016 and remains part of the current framework. FDA states that the information presented to participants, the process used to obtain consent and the documentation of electronic informed consent must satisfy applicable regulatory requirements.
Modern eConsent can go beyond displaying a traditional informed consent form on a screen. Depending on the protocol, population, jurisdiction and ethics approval, an electronic consent experience may include digital text, images, video, interactive information, remote discussions with study personnel, electronic signatures and electronic delivery of consent documentation.
That broader definition has become particularly important under ICH E6(R3).
What changed with ICH E6(R3)?
ICH E6(R3) represents one of the most important changes to the global Good Clinical Practice framework in years.
FDA issued E6(R3) as final guidance in September 2025. The agency says the revision increases flexibility for modern trial designs, data sources and technology while advancing quality by design, risk-based quality management and proportionality.
Those principles directly affect informed consent.
Under E6(R3), varied approaches can be used to provide trial information. These can include different text formats, images, videos and telephone or video conferencing with study personnel. The guidance also explicitly recognizes that informed consent can involve a physical or electronic signature and that obtaining consent remotely may be appropriate.
This is an important change in emphasis.
From a document to a process
The older regulatory environment often resulted in eConsent being approached primarily as an electronic version of a paper informed consent form.
E6(R3) puts greater emphasis on informed consent as a process.
Participants should receive information that is clear and concise and should have adequate opportunity to ask questions and decide whether to participate. The method used to provide information can vary according to the trial and participant population.
This opens the door to more participant-centered consent experiences while maintaining the fundamental protections associated with informed consent.
Remote consent is explicitly recognized
Remote consent is another important development.
E6(R3) states that obtaining consent remotely may be considered when appropriate. It also establishes expectations around participant identity and the role of the investigator or delegated site staff in the consent process.
Remote does not mean unsupervised.
Participants still need sufficient opportunity to understand the trial and ask questions, and applicable IRB, IEC and local regulatory requirements continue to apply.
Multimedia can support the consent process
E6(R3) also recognizes approaches such as images, videos and different text formats as possible ways of communicating trial information.
That matters because electronic consent can now be considered as more than a digital document delivery mechanism.
The technology can potentially be used to make information easier to navigate and understand, provided the consent process remains compliant with applicable requirements and approved by the relevant ethics bodies.
How is ICH E6(R3) different from E6(R2)?
The difference is partly technological, but it is also philosophical.
E6(R2) was developed in an era when the conventional site-based clinical trial remained the dominant operational model. Technology could be used, and separate regulatory guidance supported electronic informed consent, but the GCP framework itself did not describe today's digital and decentralized approaches as explicitly.
E6(R3) incorporates technology directly into the modern GCP framework.
The change can be summarized this way:
Previously: Electronic consent could be used within an informed consent framework originally built largely around conventional trial processes.
Now: The GCP framework itself explicitly accommodates electronic signatures, remote consent, multimedia information and technology-enabled trial conduct.
Importantly, the core ethical principles have not changed. Consent must still be voluntary. Participants must still receive appropriate information. They must still have an opportunity to ask questions. IRB or IEC oversight still applies. Participants must still be informed about relevant new information that could affect their willingness to continue.
The modernization is primarily about how those principles can be implemented.
What are the FDA eConsent requirements in 2026?
There is no single new FDA "eConsent regulation for 2026."
Instead, US eConsent operates within a collection of regulations and guidance covering informed consent, IRB oversight, electronic records, electronic signatures and Good Clinical Practice.
FDA's 2016 electronic informed consent guidance remains directly relevant. It explains that FDA's requirements for electronic records and signatures, informed consent and IRBs are found in 21 CFR Parts 11, 50 and 56 respectively.
FDA also issued updated general informed consent guidance in August 2023, replacing guidance originally issued in 1998.
Two more recent developments are especially important for electronic clinical systems.
In October 2024, FDA finalized guidance on electronic systems, electronic records and electronic signatures in clinical investigations. The guidance addresses how electronic systems and records can be considered trustworthy and reliable and generally equivalent to paper records and handwritten signatures.
Then, in September 2025, FDA finalized ICH E6(R3), further integrating modern technology and risk-proportionate approaches into its GCP framework.
Together, these documents provide a much more contemporary regulatory framework for eConsent than existed a decade ago.
Did 21 CFR Part 11 change in 2026?
This is an important misconception to avoid.
21 CFR Part 11 itself is not a new 2026 regulation.
Part 11 dates to 1997 and remains in effect. It establishes criteria governing certain electronic records and electronic signatures used to satisfy FDA requirements.
FDA explains that Part 11 applies to electronic records created, modified, maintained, archived, retrieved or transmitted under FDA record requirements, as well as certain records submitted electronically to the agency.
What has evolved is FDA guidance on applying electronic record and signature requirements to today's clinical technology.
FDA's final October 2024 guidance addresses modern electronic systems and IT services and provides additional recommendations on a risk-based approach to validation. It also addresses technologies used to remotely acquire clinical trial data.
For eConsent systems, this means sponsors and technology providers should think beyond whether an electronic signature can technically be captured.
The broader electronic record environment can involve controls related to system access, record integrity, authentication, auditability, retention, availability and reconstruction of the clinical investigation.
FDA notes, for example, that during an inspection it may request records and data needed to reconstruct a clinical investigation, including associated metadata and audit trails.
What Part 11 means for eConsent
When Part 11 applies, electronic records and signatures must be managed within the appropriate regulatory controls.
For a modern eConsent system, relevant considerations can include:
- secure access and authentication
- controls around electronic signatures
- reliable electronic records
- appropriate validation
- audit trails where applicable
- record retention
- accurate and complete copies
- preservation of associated metadata
- security and data integrity
The key change is therefore not that Part 11 suddenly requires something fundamentally different in 2026. It is that newer FDA guidance explains how longstanding electronic-record principles should operate within a much more technologically sophisticated clinical trial environment.
What are the EU eConsent requirements in 2026?
The European environment is also evolving, although eConsent requirements cannot be reduced to one uniform rule that applies identically across every country.
The EU Clinical Trials Regulation provides the central regulatory framework for clinical trials in the European Union. In addition, European regulators have developed recommendations addressing decentralized trial elements.
An updated Recommendation Paper on Decentralised Elements in Clinical Trials was issued in October 2025 through the Accelerating Clinical Trials in the EU initiative. The document specifically addresses the informed consent interview, digital participant information and informed consent signatures.
However, national requirements remain important.
The European Commission's current Clinical Trials Regulation resources specifically provide Member State information for national Part II requirements. A revised informed consent and participant recruitment procedure template was also introduced, with full implementation beginning September 1, 2026. The template allows Member State-specific legislative requirements to be identified.
For multinational studies, this distinction is critical.
A sponsor cannot assume that because an electronic or remote consent workflow is acceptable in one European country, exactly the same implementation will automatically satisfy requirements everywhere else.
Instead, global eConsent needs to combine standardization with local configurability.
What changed in UK informed consent regulations in 2026?
The United Kingdom introduced one of the clearest regulatory changes of 2026.
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 came into force on April 28, 2026. The UK Health Research Authority describes the reforms as the country's largest package of clinical trial regulatory reforms in more than 20 years.
Among the changes are new simplified arrangements for seeking and evidencing informed consent in qualifying low-intervention clinical trials.
This does not eliminate informed consent.
Instead, it introduces greater proportionality into how consent can be sought and evidenced.
HRA guidance says the approach must continue to ensure that consent is informed, freely given and explicit. The simplified arrangements apply only when specific eligibility conditions are met, including requirements concerning the authorized use of the investigational medicinal product and the absence of additional medication, interventions or diagnostic procedures solely for trial purposes.
The important broader trend is proportionality.
Rather than assuming every trial requires exactly the same method of presenting and documenting informed consent, the regulatory framework can allow the process to reflect the characteristics and risk of the research.
What changed in Canada in 2026?
Canada provides another particularly clear example of this regulatory evolution.
Health Canada's current GCP guidance incorporates ICH E6(R3) principles. It recognizes written consent in paper or electronic form, states that remote consent may be considered when appropriate and recognizes the use of text, images, videos and other interactive methods in the informed consent process.
Health Canada also states that electronic informed consent forms are generally acceptable when applicable regulatory and ICH requirements are met.
Its guidance specifically addresses system validation, required consent elements, record retention, procedures for conducting electronic consent and electronic signature controls.
An additional change arrived in September 2026.
Health Canada's interim policy for modernizing its clinical trial framework introduces acceptance of nontraditional approaches to documented informed consent, including remote and electronic methods.
The policy states that moving from "written" to "documented" informed consent enables approaches including real-time remote discussions using audio or video, electronic signatures and documentation of consent provided orally, either remotely or in person.
That is a meaningful change in regulatory thinking.
The emphasis shifts away from assuming that valid consent must always be evidenced by one traditional type of document and toward demonstrating that a valid consent process occurred and was appropriately documented.
eConsent regulations: Then versus 2026
The regulatory evolution becomes clearest when the older and newer models are compared directly.
Earlier approach2026 directionPaper-based processes often served as the operational baselineElectronic formats are explicitly recognized in modern GCPeConsent often replicated the paper ICF electronicallyDigital consent can support a broader informed consent processConsent was primarily associated with site-based interactionsRemote consent may be appropriateConsent information was predominantly document and text basedText, images, video and interactive methods can be consideredTechnology was addressed through separate electronic-system guidanceTechnology is increasingly integrated into the GCP framework itselfStandardized processes were often applied broadlyRisk-based and proportionate approaches receive greater emphasisElectronic signature compliance was a major focusThe entire electronic record, system and consent process receives attentionGlobal deployment required extensive country-by-country interpretationGreater international harmonization exists, but local requirements still matterConsent could be treated operationally as a point-in-time eventOngoing communication, updated information and re-consent remain important considerations
What has not changed?
The modernization of eConsent regulations does not weaken the fundamental requirements of informed consent.
Technology does not replace participant protection.
Participants still need information necessary to make an informed decision. Consent must remain voluntary. Participants need opportunities to ask questions. Investigators and delegated study personnel retain responsibilities for the consent process. Ethics review remains essential. Relevant new information may require updated consent materials and potentially re-consent.
ICH E6(R3), in fact, continues to state that participants should have adequate opportunity to ask questions and decide whether to participate. It also requires revised consent materials to receive IRB or IEC approval or favorable opinion before use.
The technology is changing. The underlying ethical purpose of informed consent is not.
What should sponsors look for in an eConsent platform in 2026?
As regulations evolve, evaluating eConsent technology solely on its ability to digitize and electronically sign an informed consent form is increasingly insufficient.
Sponsors should consider whether an eConsent system can support the complete consent lifecycle.
That can include configurable consent experiences, electronic signatures, identity controls, version management, re-consent, remote interactions, participant access to consent documentation, multimedia information, auditability, validated electronic records and appropriate record retention.
Global studies add another requirement: localization cannot simply mean translating an informed consent form.
An eConsent platform should be capable of accommodating differences in national and local consent requirements while preserving a consistent core process across the study.
That becomes especially important as regulators simultaneously pursue two goals that can appear contradictory: greater global harmonization and greater flexibility.
The technology needs to support both.
What do the 2026 eConsent changes mean for clinical trials?
The regulatory direction is becoming increasingly clear.
Electronic consent is moving from an alternative to conventional informed consent toward an integrated part of modern clinical trial infrastructure.
ICH E6(R3) explicitly accommodates electronic signatures, remote consent and varied methods of presenting information. FDA has modernized its guidance for electronic clinical systems. European regulators have provided more detailed recommendations for decentralized trial elements. The UK has introduced proportionate consent arrangements for qualifying low-intervention trials. Canada has moved further toward the concept of documented rather than exclusively written consent in its September 2026 interim policy.
That does not mean eConsent regulation is becoming less rigorous.
In many respects, the opposite is happening.
As regulators become more comfortable with remote and digital processes, sponsors need to demonstrate that those processes preserve participant protection, understanding, traceability, record integrity and appropriate investigator oversight.
The biggest change is therefore not simply the transition from paper to electronic consent.
It is a transition from digitizing a document to designing a complete digital consent process.
For sponsors and clinical research organizations, that creates an opportunity to rethink informed consent around the participant rather than around the limitations of paper, while maintaining the controls required for regulated clinical research.
