Health Canada's Interim Clinical Trial Policy: Coordinated REBs, Competency-Based Investigators and E-Consent

On 14 September 2026, Health Canada gave clinical trial sponsors something they have wanted for years: permission to run trials in a more flexible, more modern way, without waiting for new regulations. The document is an interim policy, file number 26-105996-626, and it advances three targeted elements of the Clinical Trials Modernization initiative through policy rather than through law. It is effective immediately, and it will stay in place until the proposed Clinical Trials Regulations come into force, anticipated for spring 2028.

That word interim matters. This is not a relaxation of oversight. It is a change in how sponsors document ethics approvals, who can serve as an investigator, and how consent can be obtained, with the same accountability sitting behind every one of those changes. It also lands two weeks before the 1 October 2026 ICH E6(R3) implementation deadline, so sponsors are being asked to absorb two shifts at once. This article breaks down each of the three elements, what Health Canada inspectors will now look for, and the practical steps to take before the changes catch you mid-trial.

Executive summary

The essentials for sponsors and trial teams:

Health Canada's interim policy (file 26-105996-626, dated 14 September 2026) advances three elements of clinical trial modernization ahead of the proposed regulations, and it is effective on publication.
Element 1: sponsors of multi-site trials may identify the same research ethics board (REB) for all sites within a streamlined multi-site review, and the Clinical Trial Site Information form now needs the board's contact details only once per trial.
Element 2: the qualified investigator role opens to non-physicians with the right education, training and experience, provided a licensed physician or dentist oversees medical decisions and participant care.
Element 3: written informed consent becomes documented informed consent, allowing remote, electronic and orally-provided consent that is properly recorded under ICH E6 principles.
None of this reduces the sponsor's responsibility. The policy adds a clinical trial inspections section that tells you exactly what records Health Canada inspectors will ask to verify.

What the interim policy changes, and what it does not

The interim policy changes three operational things: how you notify Health Canada about ethics approvals in multi-site trials, who qualifies as an investigator, and how consent may be documented. It does not change a sponsor's core obligation to run trials in accordance with good clinical practices and all applicable ethical, legal and institutional requirements. It is a flexibility, not a discharge.

Health Canada is introducing these flexibilities now because it is still considering comments from the Canada Gazette, Part I consultation on the proposed Clinical Trials Regulations, which closed on 19 April 2026. Rather than make sponsors wait until spring 2028, it is advancing the least contentious elements through policy. The three elements at a glance:

Element	Before	Under the interim policy
Ethics review notification	REB details effectively provided per site	Same REB may cover all sites; contact details given once per trial
Qualified investigator	Physician or dentist only	Non-physicians allowed with medical oversight by a physician or dentist
Informed consent	Written consent	Documented consent, including remote and electronic methods

Element 1: one REB can cover a multi-site trial

Sponsors of multi-site trials may now identify the same research ethics board for all sites where they operate within a streamlined multi-site ethics review process. On the Clinical Trial Site Information form, you only need to include a board's contact information once, as long as that board has already been identified as approving other sites in the trial and its contact details are current. For later sites, the form's ethics section may carry just the board's name and approval date.

This aligns Health Canada with the streamlined review systems that already exist across the country, including Clinical Trials Ontario, CanReview, CATALIS in Quebec, the BC Ethics Harmonization Initiative and others. The administrative saving is real, but the record-keeping duty is unchanged. As the sponsor, you must still obtain and retain records of every REB approval required for each participating site, in line with local requirements, and keep them available for verification during a clinical trial inspection.

Element 2: competency-based qualified investigators

Under the interim policy, a qualified investigator may be a physician or dentist authorized under the Food and Drug Regulations, or an individual who has the education, training and experience to conduct the trial, even if they are not a physician or dentist as required by the definition in C.05.001. Where the investigator is not a physician or dentist, medical decisions outside their licensed scope of practice must be made by a qualified physician or dentist on the trial team who is licensed in that province or territory and responsible for medical oversight and participant care.

This is a competency-based approach aligned to ICH E6 good clinical practice, and it opens investigator roles to a broader range of qualified researchers, provided medical care is assured by a physician or dentist and the researcher's training and scope of practice fit the trial. For sponsors, the practical consequence is documentary. You now have to hold clear records of each team member's education, professional qualifications and competencies, and a defined line of medical oversight, because both will be checked on inspection.

Element 3: from written to documented informed consent

The policy moves the standard from written informed consent to documented informed consent. Consent requirements are considered met where the process is appropriately documented, complies with good clinical practices and ICH E6 principles, and ensures consent is informed and given under the applicable consent laws. In practice, this allows remote or electronic platforms that support real-time, interactive consent discussions using audio and video, and it allows electronic signatures and the documentation of consent given orally, whether in person or remotely.

For decentralized and hybrid trials, this is the missing piece that makes remote consent workable in Canada, and it connects directly to the ICH E6(R3) Annex 2 decentralized trial expectations. The catch is that electronic consent must be validated, secure and auditable. An e-consent platform that cannot produce a defensible audit trail, or that fails to prove who consented, when and to which version of the form, will fail on inspection just as surely as a missing wet-ink signature would have before.

How this collides with the 1 October ICH E6(R3) deadline

The interim policy arrives just before Health Canada's 1 October 2026 ICH E6(R3) implementation deadline, and the two are designed to work together. E6(R3) introduces quality-by-design and risk-proportionality, and the interim policy leans on the same good clinical practice principles for investigator competency and documented consent. Sponsors updating their quality systems for E6(R3) should fold the interim policy into the same effort rather than treating them as two projects.

If your E6(R3) work is still in progress, our ICH E6(R3) readiness plan sets out the quality-by-design and risk-proportionality steps to have in place by 1 October. The interim policy is best treated as an extension of that same readiness exercise, updating investigator qualification records, REB notification practice and consent procedures at the same time as the broader E6(R3) uplift.

What Health Canada inspectors will now check

The interim policy contains a dedicated clinical trial inspections section, which is effectively a checklist of what a Good Clinical Practice inspector will ask to verify. Sponsors must be able to produce REB approval records for each site, an attestation signed and dated by the REB confirming it reviewed and approved the protocol and consent form for that site and operates consistently with good clinical practices, records of the qualifications and competencies of trial team members, and documented consent processes.

The through-line is documentation. Each new flexibility is matched by a record you must be able to show on demand. Sponsors who take the flexibility but skip the paperwork are the ones who will struggle on inspection, and, as the Tavneos ADVOCATE case shows, weak trial documentation can unravel far more than a single inspection finding. Build the records into your SOPs now, before the inspector asks.

Interim policy readiness checklist

Your Clinical Trial Site Information form practice reflects the once-per-trial REB contact rule for streamlined multi-site reviews.
You retain complete REB approval records for every participating site, available for inspection.
A signed, dated REB attestation is on file for each site, covering protocol and consent form approval and GCP-consistent operation.
Where an investigator is not a physician or dentist, a named licensed physician or dentist is documented as responsible for medical oversight and participant care.
Education, training, qualification and competency records exist for every trial team member.
Your consent SOP allows documented consent, including remote and electronic methods, with defined controls.
Any e-consent platform is validated, secure and produces a full audit trail of who consented, when and to which form version.
The interim policy changes are reconciled with your 1 October ICH E6(R3) implementation work in a single quality system update.

Common mistakes to avoid

Reading the policy as a reduction in oversight. It changes how you document, not whether you must.
Dropping per-site REB records because one board now covers all sites. You still retain approval records for every site.
Appointing a non-physician investigator without documenting the physician or dentist who provides medical oversight.
Rolling out e-consent on a platform that cannot produce a defensible audit trail.
Treating the interim policy and ICH E6(R3) as separate projects, and updating the same SOPs twice.
Forgetting that the policy is interim and will be replaced when the Clinical Trials Regulations come into force, anticipated spring 2028.

Frequently asked questions

When did Health Canada's interim clinical trial policy take effect?

It was published on 14 September 2026 (file 26-105996-626) and is effective on publication. It will remain in place until the proposed Clinical Trials Regulations come into force, which Health Canada anticipates for spring 2028.

Does Health Canada now accept electronic informed consent for clinical trials?

Yes. The interim policy moves from written to documented consent, which allows remote and electronic methods, including real-time audio and video consent discussions and electronic signatures. Consent must still be informed, comply with ICH E6 principles and applicable consent laws, and be properly documented with a defensible audit trail.

Can a non-physician be a qualified investigator in Canada now?

Under the interim policy, yes, if the individual has the education, training and experience to conduct the trial and a qualified physician or dentist on the team, licensed in that province or territory, is responsible for medical decisions outside the investigator's scope and for participant care. The competency-based approach is aligned to ICH E6.

Do I still need REB approval from every site in a multi-site trial?

You still need valid REB approval for every participating site before activities begin there. What changes is the notification: the same board may cover all sites in a streamlined review, and its contact details are provided to Health Canada once per trial rather than repeated for each site. You must retain the approval records for every site.

How does the interim policy relate to ICH E6(R3)?

They are complementary. The interim policy is expressly aligned to ICH E6 good clinical practice, and it lands just before Health Canada's 1 October 2026 E6(R3) implementation deadline. Sponsors should update investigator qualification, REB notification and consent procedures as part of the same quality system work they are already doing for E6(R3).

What will Health Canada inspectors check under the interim policy?

REB approval records and a signed, dated REB attestation for each site, records of trial team members' educational and professional qualifications and competencies, and evidence that consent processes were appropriately documented. The policy's clinical trial inspections section spells these out, so build each record into your SOPs and trial master file.

How MFLRC can help

MF License and Regulatory Consultants helps sponsors turn the interim policy into working procedures. We run GCP gap assessments against the three elements, rewrite informed consent and investigator qualification SOPs, build REB coordination and record-keeping procedures, and prepare the trial master file and sponsor oversight documentation an inspector will ask for. If you are drafting or revising your procedures, our guidance on SOPs that pass a Health Canada inspection is a useful starting point, and our overview of Canada's Clinical Trials Portal disclosure duties covers the registration side. Our services span gap assessments, SOP development, QAP services, audits, inspection readiness and validation of e-consent and computerised systems.

Book a GCP readiness review

Conclusion

Health Canada's interim policy is a welcome step toward a more modern, more flexible clinical trial framework, and it lets sponsors adopt coordinated ethics review, competency-based investigators and remote consent years before the new regulations arrive. The reward is real flexibility. The condition is disciplined documentation, because every flexibility comes paired with a record an inspector can ask to see. Sponsors who update their SOPs and trial master file now, alongside their ICH E6(R3) work, will capture the benefit without the exposure. If you are auditing your procedures, start with the SOPs licensed facilities most often get wrong, then close the gaps before the interim policy meets your next inspection.