Czechia CTIS Part II Limited-Capacity Participant and Legal Representative Consent Requirements

When this variation is required

Use a limited-capacity or legal-representative pathway when an adult cannot provide legally valid informed consent for the trial or when a court decision limits the person's ability to make the relevant healthcare decision.

Do not equate a diagnosis with legal incapacity. SÚKL's KLH-22 asks the sponsor and investigator to distinguish the participant's actual ability and the scope of any court decision.

Article 31 of Regulation (EU) No 536/2014 sets the EU conditions for clinical trials involving incapacitated subjects who did not consent or refuse before losing capacity.

Required participant and representative documents

Conditional. Prepare participant information adapted to the person's ability to understand. KLH-22 recommends reducing length and complexity where needed rather than giving the participant only the representative's full legal document.

Conditional. Prepare information and consent for the legally designated representative when the representative must make the legally relevant decision. The representative needs enough information to make the decision under Article 31.

For an acute or severely deteriorated participant, KLH-22 recommends two information stages where appropriate: a short basic version suitable for the acute state and fuller information after stabilisation for continued participation.

The exact document set depends on whether the protocol uses standard representative consent or Article 35 emergency enrollment. If prior representative consent is impossible within the therapeutic window, use the Czechia emergency enrollment guide.

Determining who gives legally valid consent

SÚKL's KLH-22 addresses partially restricted legal capacity by reference to the court ruling.

If the court ruling says the participant cannot make decisions about healthcare, the appointed representative provides the legally relevant consent. If the ruling does not remove the participant's ability to make the relevant healthcare decision, the participant may be able to consent personally.

Do not invent a representative hierarchy in the PIS/ICF. The document set should reflect Czech legal status and the specific participant situation.

A caregiver may consent to the caregiver's own involvement in study activities, but that does not make the caregiver the legally designated representative for the participant.

Participant information and involvement

Article 31 requires incapacitated participants to receive the Article 29 information in a way adapted to their capacity. The participant should take part in the consent process as far as possible.

In practice, use shorter sentences, direct descriptions of procedures and risks and a format suited to the participant's cognitive or communication ability. The goal is not to remove material information but to make participation understandable at the level the person can use.

Objection and dissent

Mandatory. Respect the explicit wish of an incapacitated participant who can form an opinion and assess the information to refuse participation or withdraw.

The representative's consent does not allow the trial team to ignore a participant's meaningful objection. Build this into investigator instructions and, where useful, into the participant-facing form.

Consent and signature logic

Submit blank Czech forms in CTIS. The participant and representative do not sign at application submission.

When representative consent is required, the legally designated representative signs and dates the applicable consent and the person conducting the consent interview signs and dates under the Article 29 process.

If the participant can also express willingness, document that involvement in the manner appropriate to the participant and approved document set.

Electronic consent is possible, but SÚKL's accepted electronic-signature criteria apply.

Re-consent if capacity changes

Mandatory when the participant regains the ability to consent. Once a participant becomes capable of giving informed consent personally, obtain the participant's own informed consent for continued participation as soon as the applicable legal and clinical situation allows.

The document should not treat representative consent as permanent when the underlying incapacity is temporary. Plan a re-consent trigger for fluctuating or recoverable conditions.

If capacity deteriorates after a participant has already given valid consent, assess the protocol, Czech law and approved consent pathway before replacing the participant's own prior decision with a representative process.

Czech national PIS/ICF requirements still apply

The adapted participant and representative documents should retain the applicable SÚKL national content, including the EU CT Number, full trial title, ethics committee email, results-availability statement, source-record access wording and copy-of-consent statement.

The Czech language rule also applies. Standard routine bilingual PIS/ICF versions are not permitted.

Use the Czechia patient-facing QC checklist to verify that the capacity pathway, signatures, withdrawal wording and data use are internally consistent.