Electronic consent with MitID: what does the committee require?

In many investigator-initiated trials, consent is the last thing still done on paper. The form has to be printed in the right version, signed by two people, scanned and archived, so it can be found again during monitoring and inspection. Electronic consent can remove much of that work, in large and small studies alike. It only requires the procedure to be in place before the first participant signs.

The requirements for consent are the same.

Article 29 of the EU Clinical Trials Regulation 536/2014 (CTR) requires informed consent to be written, dated and signed. If the participant is unable to write, consent can be given in the presence of an impartial witness. This also applies when consent is given electronically.

ICH E6(R3) describes electronic consent as an option alongside paper. The guideline's requirements for essential records apply here too. The signed consent must be retained, retrievable and protected, and the system used must have access control, an audit trail and validation proportionate to the risk.

And consent must still be given on the version of the participant information and consent form that the committee has approved. It must not be possible to use a superseded version.

The electronic procedure needs the committee's permission.

For trials of medicinal products, section 8 of Executive Order no. 12 of 2022 (BEK 12/2022) states that the consent form is signed by the trial participant and by the person who gave the information. Under section 8(2), the ethics committee can permit an electronic signature with a security level equivalent to MitID.

The permission covers the procedure. The procedure must therefore be described to the committee, even when the form is entirely unchanged. For a trial that is already running, this will probably be done as a modification to the trial.

For trials under the Danish Committee Act (komitéloven), the National Committee on Health Research Ethics (NVK) accepts a digital signature at MitID level. The switch from paper to electronic signature should still be described to the committee.

The person who gives the information must be delegated.

If someone other than the investigator gives the information, section 5 of BEK 12/2022 requires delegation. In practice, this means the delegation log must show that the person has consent as a task at the site in question, and that the delegation is active on the day consent is taken.

That is also the person who countersigns. An electronic process must therefore tie four things together: the approved version, the delegation, the participant's signature and the countersignature.

Describe the procedure before you apply.

The committee must be able to see how consent works in practice. It helps to have answers to these questions before the application or the modification is submitted:

• How and when is the participant identified, for example with MitID at the moment of signing?
• How do you ensure that only the approved version can be used at the site?
• Who gives the information, and where is the delegation recorded?
• How and when does the person who gave the information countersign?
• How does the participant receive their copy, and how is consent withdrawn?
• What is the paper alternative, and where is the signed copy archived?

Two situations are worth describing separately. One is participants who prefer paper or do not have MitID: what happens then, and how does the signed paper form get into the same archive? The other is multi-site trials, where a new version may be approved but released at the sites on different days. The description should say how a version is made available at each site.

How we handle this in Adhera.

Adhera Sign is built around the same points. A consent can only be started on an approved version, and the person giving the information must be delegated. The participant signs with MitID, and the signed copy is archived in the TMF.