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

When the legal-representative pathway applies

Conditional. Use this pathway when the adult is legally unable to provide the informed consent required by Chapter V of Regulation (EU) No 536/2014 and Bulgarian law.

Do not infer legal incapacity merely because a participant has dementia, psychiatric illness, acute disease, communication difficulty or another condition. If the person can legally consent and can understand the nature, significance, scope and potential risks of the trial, the standard adult consent route applies.

Bulgarian Article 96 states that informed consent for an incapacitated adult is given by the person's legal representative. In the specific situation referred to in Article 162(3) of the Bulgarian Health Act, consent is given by the person appointed by the court.

Required document set

The exact form structure depends on the study, but the Part II package should make the legal and participant roles clear.

Mandatory. Prepare Bulgarian participant-facing information and consent documents, together with the corresponding Bulgaria version in English.

For an adult who cannot legally consent, the set should normally include:

• information for the legally designated representative
• a legal-representative consent form or clearly structured representative signature section
• participant information adapted to the adult's ability to understand
• participant assent or acknowledgement fields when the person can meaningfully take part in the process
• re-consent materials if capacity may return during the trial

The current BDA Part II list does not publish a separate national legal-representative ICF template. The documents must therefore be built around the Clinical Trials Regulation, Bulgarian Article 96 and the general Bulgaria participant-document rules.

Participant information and involvement

Mandatory. The adult participant must receive information about the trial, possible risks and benefits in a form appropriate to the person's ability to understand. Regulation (EU) No 536/2014 also requires the incapacitated subject to receive the Article 29 information in a way adequate to capacity and, as far as possible, to take part in the informed-consent procedure.

Do not address the representative only. Prepare an explanation that the participant can use, even when the legal consent comes from another person.

Bulgarian Good Clinical Practice also states that when participation depends on the consent of a legal representative, the participant is informed at a level consistent with the person's ability to understand and personally signs and dates the written consent if able.

Legal representative requirements

Mandatory. The legal representative's consent must represent the participant's presumed will and may be withdrawn without negative consequences for the participant.

The representative should receive the full information needed to make the decision, including trial purpose, procedures, risks, expected benefit or absence of benefit, alternatives, withdrawal, insurance, privacy, samples and contacts.

The document should identify the representative role without inventing a broader category of proxy decision-maker than Bulgarian law permits.

Consent and signature logic

During trial conduct, the legally designated representative signs and dates the consent, and the person conducting the consent interview signs and dates it under the Clinical Trials Regulation. Where the participant can understand and sign, include the participant in the process in accordance with Bulgarian Good Clinical Practice.

The CTIS versions submitted for assessment are blank review copies. Do not upload completed participant or representative signatures as the application consent form.

Objection and dissent

Mandatory. Bulgarian law requires the expressed wish of the incapacitated adult to refuse participation or to withdraw to be taken into account by the investigator and, when necessary, the principal investigator. Regulation (EU) No 536/2014 requires the explicit wish of an incapacitated subject who can form an opinion and assess the information to be respected.

The PIS and ICF should therefore explain that the representative's authorisation does not erase the participant's own objection.

Re-consent if capacity changes

Conditional. If the participant later becomes capable of providing legally valid informed consent, obtain the participant's own consent before continuing protocol activities for which current consent is required. Build this transition into the study process when fluctuating or recoverable capacity is foreseeable.

The re-consent document should reflect the participant's current point in the study. Explain what has already happened, what participation remains and what choices are now available.

Emergency enrollment is a separate pathway

Do not use legal-representative consent as a substitute for the Article 35 emergency exception when neither the participant nor representative can be reached within the therapeutic window. Emergency enrollment has a separate set of conditions and a requirement to seek consent without undue delay afterward. See the Bulgaria emergency enrollment consent guide.

If the representative or participant cannot read or cannot write, the independent-witness process may also apply. See the Bulgaria impartial witness consent guide.

Optional future data and sample use

Conditional. Optional future use should be separated from the main trial decision. Apply the representative and participant involvement rules to that optional choice and make clear that refusal of future use does not cancel main-study participation. See the Bulgaria secondary use consent guide.

For the complete country guide library, return to the Bulgaria CTIS hub.