Lithuania CTIS Limited-Capacity Participant and Legal Representative Consent Requirements

When this pathway applies

Use this pathway when an adult participant cannot provide valid independent informed consent because the person's health state prevents a reasonable assessment of their interests, or where a formal legal status means another person has a role in consent.

Do not use the pathway simply because a participant is elderly, seriously ill or has a diagnosis that may sometimes affect cognition. Capacity should be assessed for the actual decision.

Lithuanian Bioethics Committee guidance treats persons unable because of health to reasonably assess their interests as a vulnerable population. The Clinical Trials Regulation adds specific protections for incapacitated subjects.

Who may give consent

Lithuanian law determines who is entitled to consent when the participant cannot.

The official English text of the Law on Ethics of Biomedical Research describes routes involving a spouse, specified close relatives, an appointed representative, a guardian for a person adjudged incapacitated in healthcare matters and a curator together with the person where legal capacity is limited in healthcare matters.

The correct route depends on the participant's factual and legal status. The site should therefore document the legal basis for the person signing rather than rely on a generic relationship label such as "family member."

Mandatory. The recruitment and consent procedure should identify which categories of legally entitled representative may be used and how the site will verify the representative's authority.

Participant information and involvement

The Clinical Trials Regulation requires an incapacitated participant to receive information in a way adapted to the person's capacity to understand it.

Lithuanian law follows the same principle. The participant should be involved in the information and consent process as far as possible.

Prepare:

• a representative information and consent form
• participant information adapted to the person's level of understanding where the participant can engage with the decision
• the recruitment and consent procedure describing capacity assessment and representative verification
• a re-consent pathway if the participant later regains capacity

The participant document should not be replaced by silence merely because a representative signs.

Dissent and objection

Mandatory. The explicit wish of an incapacitated participant who can form an opinion and assess the information to refuse participation or withdraw must be respected under Article 31 of the Clinical Trials Regulation.

Lithuanian law also requires the investigator to take account of the participant's wish not to participate or to withdraw when the participant can understand the information.

Explain in the procedure how the site identifies and records dissent, including non-verbal objection where clinically relevant.

Trial eligibility for incapacitated participants

Consent alone is not enough.

Article 31 requires the trial to be essential with respect to the incapacitated population, directly related to the participant's medical condition and supported by a benefit and risk justification. The Regulation also restricts incentives, allowing only compensation for expenses and loss of earnings directly related to participation.

The Part II participant documents should not overstate benefit or hide the additional protections applying to this population.

Re-consent if capacity changes

Mandatory when capacity is regained. If a participant becomes capable of providing their own informed consent during the trial, obtain the participant's consent for continued participation as soon as the applicable legal and clinical circumstances permit.

The recruitment and consent procedure should explain who assesses the change in capacity and which current ICF version will be used.

Do not continue indefinitely under representative consent when the participant can validly decide for themselves.

Signature logic

At CTIS submission, submit blank Lithuanian participant and representative forms.

When consent is obtained:

• the legally entitled representative signs where representative consent is required
• the person conducting the consent interview signs and dates the consent record
• the basis of representation is documented
• the participant signs or otherwise records their own consent when the legal pathway requires or permits it
• the participant's assent, agreement or objection is documented according to capacity

For a participant or representative who cannot write, use the Lithuania impartial witness guide.

Country-specific document checks

Before submission, confirm that:

• the documents are in Lithuanian
• the consent procedure describes capacity assessment
• the legal representative pathway reflects Lithuanian law
• the participant receives adapted information
• dissent is addressed
• re-consent after regained capacity is planned
• the representation basis can be recorded on the consent form
• the protocol inclusion criteria are consistent with the vulnerable-person pathway

Use the Lithuania patient-facing QC checklist for the package-level review.