Health Canada's 2026 Interim Clinical Trial Policy: What Sponsors and CROs Need to Know

5thPort - Blog - Health Canada's 2026 Interim Clinical Trial Policy What Sponsors and CROs Need to Know

Electronic informed consent was already permitted in Canadian clinical trials. So why did Health Canada introduce a new policy addressing it in September 2026?

The answer lies in how consent is documented. As part of a broader effort to modernize clinical trials, Health Canada introduced an interim policy on September 14, 2026, providing greater flexibility in research ethics reviews, investigator qualifications, and informed consent.

For sponsors and Contract Research Organizations (CROs) conducting clinical trials in Canada, the question is what these changes mean for existing clinical trial operations, particularly as the country prepares to introduce new regulations in 2028.

Why has Health Canada introduced an interim clinical trial policy?

Clinical trials have changed considerably over the years – especially in Canada. Ranked as the 3rd largest globally for the total number of new clinical trials and 4th largest for the total number of active trials in 2023, the country captures about 4% of the global clinical trials market.

A while ago, participants couldn't attend appointments remotely, review study information electronically, or interact with research teams without necessitating a visit to a clinical site. That has in recent years, categorically changed.

Steadily, Health Canada has been working toward a broader modernization of its clinical trial framework, with the goal of reducing unnecessary administrative requirements, supporting innovative trial designs, and making Canada a more attractive location for clinical research.

The new regulations, however, are not expected to come into force until spring 2028.

Rather than wait, Health Canada has introduced an interim policy that provides flexibility in selected areas of clinical trial operations, allowing certain practices to be adopted sooner while the broader regulatory framework is finalized.

What has changed under the interim policy?

The policy introduces three changes that could affect how clinical trials are organized and conducted in Canada.

1. Greater flexibility in research ethics reviews

In multi-site trials, participating institutions may use coordinated ethics review arrangements, including a common Research Ethics Board (REB).

The interim policy simplifies how sponsors notify Health Canada about ethics approvals when the same REB oversees multiple sites. Sponsors must still maintain evidence of the required approvals for each participating site.

This addresses a specific administrative task without removing site-level ethics oversight.

2. Expanded eligibility for qualified investigators

The policy provides greater flexibility in who can serve as a Qualified Investigator (QI).

Appropriately qualified healthcare professionals other than physicians or dentists may be eligible to serve in this role, provided medical care remains under appropriate physician or dentist oversight and responsibilities are consistent with the investigator's qualifications and scope of practice.

This could give research organizations more flexibility in staffing and managing clinical trials.

3. A broader approach to documenting informed consent

The most relevant change for teams managing participant consent is Health Canada's recognition of appropriately documented informed consent, including electronic and certain oral consent processes.

The policy recognizes methods such as electronic signatures, remote consent discussions, and documented oral consent, subject to applicable requirements.

This gives sponsors more flexibility in how consent is obtained and recorded, while maintaining the responsibility to ensure participants make informed decisions.

These changes are outlined in Health Canada's official interim policy notice, that can be found here.

Was electronic informed consent already allowed in Canada?

Yes. And before we continue, this is an important distinction.

Electronic informed consent or eConsent was already possible in Canadian clinical trials before the September 2026 announcement.

Health Canada's Good Clinical Practices guidance already recognized electronic informed consent, subject to conditions such as system validation, appropriate controls, and documented procedures.

However, the regulatory framework placed particular emphasis on obtaining written informed consent. Electronic systems could support that requirement, but the underlying expectation remained centered on written documentation.

The interim policy on the other hand, recognizes a broader range of appropriately documented consent processes – including certain circumstances in which oral consent may be documented without relying on a traditional written signature.

The distinction matters because informed consent is a process, not simply a form that someone signs.

Participants need sufficient information about a study, an opportunity to ask questions, and the freedom to decide whether they wish to participate. How that decision is documented is an important part of the process, but it is only one part.

What does the shift from written to documented informed consent mean for the Canadian clinical trials landscape?

Consider a multi-site clinical trial in which some participants provide consent electronically, while others participate in remote consent discussions.

Research teams must be able to establish:

which consent process was used,
what information participants received,
who obtained consent,
and how the decision was documented.

When these activities take place across multiple sites, maintaining consistent procedures and retrieving complete consent records can become more complicated.

The interim policy gives sponsors greater flexibility in how consent may be documented. That flexibility also makes it important to establish clear procedures for each consent method being used.

For example, if a participant provides documented oral consent during a remote discussion, the research team needs an appropriate way to record that consent, consistent with the approved process. If the consent information changes during the study, the team must also be able to establish which version the participant received and whether additional consent is required.

For sponsors and CROs managing remote or hybrid trials, these considerations are particularly relevant because participants and research personnel may be interacting from different locations.

The operational opportunity is to evaluate whether existing consent processes can accommodate these different methods without creating unnecessary manual work or gaps in documentation.

What should Sponsors and CROs review in their existing consent processes?

For organizations already using electronic consent, the interim policy does not necessarily require a complete overhaul of their systems.

It does, however, provide an opportunity to examine whether existing processes can support the additional flexibility now recognized by Health Canada.

1. Consent procedures and SOPs

Do existing procedures account for remote consent discussions and different methods of documenting consent? Any new approach should be reflected in the relevant SOPs and study-specific procedures.

2. Documentation and record keeping

Can research teams establish which consent information was presented, when consent was obtained, and how the participant's decision was documented? Records should remain accessible for monitoring, review, and regulatory inspection.

This is especially relevant when managing multiple participants, sites, and consent versions.

3. Electronic consent systems

The question becomes – are electronic systems appropriate for their intended use? Sponsors should evaluate electronic signatures, system validation, access controls, and the integrity of consent records in accordance with applicable requirements.

Health Canada's Good Clinical Practices guidance provides good information on that front: Good Clinical Practices – Canada.ca.

4. Participant communication

Can participants review consent information, ask questions, and receive clarification before making a decision? For remote consent processes, research teams should consider how these interactions are facilitated and documented.

Now, these are not new responsibilities. Many already form part of established Good Clinical Practice expectations. But, what HAS changed is the flexibility available in how organizations can meet them.

When will Canada's new clinical trial regulations take effect?

Health Canada's interim policy is intended to operate while the country's broader clinical trial regulatory framework is being finalized.

The final regulations are anticipated to be published in Spring 2027, with implementation expected in Spring 2028 following a one-year transition period, according to Health Canada's regulatory modernization plans.

For sponsors and CROs, this creates a period in which they can evaluate existing clinical trial operations, consider whether the interim policy offers useful flexibility, and prepare for the eventual regulatory changes.

How can 5thPort support electronic informed consent in Canadian clinical trials?

1. Regulatory Compliance

5thPort is designed to support Good Clinical Practice (GCP) requirements and aligns with FDA 21 CFR Part 11 and EudraLex Annex 11 electronic record and signature requirements. The platform is also HIPAA compliant and SOC 2 Type II audited, supporting data security and integrity. Learn more about 5thPort's compliance standards here.

2. One Touch Compliance Report and Audit Trails

5thPort consolidates consent-related activities into a single report called the 'One Touch Compliance Report'. This proprietary report contains date and time-stamped audit trails that gives research teams a centralized record to retrieve during IRB monitoring, audits and regulatory inspections.

3. Version Control and Audit Trails

5thPort allows you to change eConsent forms on the fly and just as importantly, track which version of eConsent forms were filled by participants. 5thPort maintains a digital history of changes, supporting documentation and traceability.

4. Remote eConsent and Electronic Signatures

Participants can review consent documents, flag sections requiring clarification, and sign electronically without needing to be physically present at a clinical trial site. Participants are able to review documents electronically, in the comfort of their own home.

Additionally, 5thPort supports LARs or Legally Authorized Representatives to sign on the participants' behalf, which is helpful in clinical trials involving minors, and those with disabilities.

Explore 5thPort's eConsent capabilities here.

5. Participant Understanding

5thPort helps reinforce participants' understanding of a clinical trial before they provide consent in two ways. First, teach-back comprehension checks help research teams identify areas where participants may need additional clarification. Second, participants can flag sections of the eConsent form they don't understand and add comments or questions directly to those sections.

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Reviewing your clinical trial consent workflows? Connect with the 5thPort team to explore how our platform can support your studies, or email us at info@5thport.com.