Bulgaria CTIS Part II Minor Consent and Assent Requirements

Bulgaria age bands for clinical-trial consent

Children under 14

Mandatory. A clinical trial involving a child who has not reached 14 years of age requires written informed consent from both parents or from the guardians of the child, in accordance with Article 97 of the Bulgarian Medicinal Products in Human Medicine Act and Chapter V of Regulation (EU) No 536/2014.

The parents' or guardians' consent must represent the presumed will of the child and can be withdrawn. The child's explicit wish to refuse participation or to withdraw must be taken into account.

The child must receive information about the trial, risks and benefits in a form the child can understand. Bulgarian law requires this information to be provided by a physician experienced with children and adolescents.

A separate national Bulgaria assent template for children under 14 is not published in the current BDA Part II list. The legal requirement is age-appropriate information and respect for the child's views. A sponsor may use a separate child information or assent document when that is the clearest way to meet the requirement.

Participants aged 14 to 17

Mandatory. For a participant from age 14 until reaching 18, written informed consent is obtained from the young person and both parents, or from the custodian where applicable.

The BDA specifically requires the ICF intended for this age group to contain a signature field for the minor. This is not only an assent line. Bulgarian law requires the 14 to 17 year old participant's written informed consent alongside the required parental or custodian consent.

If one parent is unknown, deceased, deprived of parental rights, or does not hold parental rights following divorce, written informed consent is given by the minor and the parent who exercises the parental rights.

Which documents should be prepared

The exact structure can vary with age and protocol complexity, but the Part II set should make each consent route unambiguous.

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

For children under 14, the set normally needs:

• parent or guardian information and consent document
• age-appropriate child information or assent material where the child's maturity makes a separate document useful
• clear signature logic for both parents or guardians on the legally effective consent

For ages 14 to 17, the set normally needs:

• adolescent-appropriate participant information
• an ICF that includes the young person's signature field
• parent information and signature fields for both parents, unless the documented national exception applies
• custodian signature pathway where applicable

Do not create a single generic minor form that hides which signatures apply to which age group.

Information and assent

Regulation (EU) No 536/2014 requires minors to receive the consent information in a way adapted to age and mental maturity. The minor's explicit wish to refuse or withdraw must be respected when the minor is capable of forming an opinion and assessing the information.

Bulgarian law reinforces this by requiring understandable information on the trial, possible risks and benefits. For younger children, assent is therefore a participation process even where the legal consent comes from parents or guardians.

Use simple age-appropriate language. Explain visits, procedures, discomfort, treatment, optional samples and the right to say no in terms suitable for the intended age group.

Parent and guardian signature logic

Mandatory. Do not reduce the Bulgaria requirement to a single parent signature by default.

For a child under 14, consent is from both parents or guardians. For a participant aged 14 to 17, consent is from the young person and both parents, or the custodian. The specific single-parent exception in Article 97 applies when the other parent is unknown, deceased, deprived of parental rights, or lacks parental rights after divorce.

The CTIS document should make the exceptional route identifiable without forcing sites to improvise a signature block.

Refusal, dissent and withdrawal

The child's or adolescent's expressed refusal or wish to withdraw must be taken into account. Parent, guardian or custodian consent may also be withdrawn without negative consequences for the minor.

Participant-facing wording should therefore avoid implying that a parent's signature removes the minor's right to object. The site process should also explain how a young participant can raise concerns or say that they no longer want to continue.

Re-consent at age 18

Mandatory when the participant reaches legal competence during the trial. Regulation (EU) No 536/2014 requires the participant's express informed consent before the person can continue in the clinical trial after reaching the national age of legal competence. In Bulgaria, the minor-specific national rules cover participants until 18.

Plan the re-consent document and trigger in advance for trials with long treatment or follow-up. The adult consent version should reflect the participant's current trial stage rather than simply repeating information that is no longer relevant.

Optional samples, pregnancy and other additional documents

Conditional. If optional future use of data or samples is proposed, apply the same age-specific consent and parent or custodian logic. Do not make the optional choice a condition of main-trial participation. See the Bulgaria secondary use consent guide.

Conditional. For adolescent pregnancy follow-up, ensure the pregnancy document uses the correct minor and parent or custodian consent pathway for the participant's age and legal status. See the Bulgaria pregnancy follow-up guide.

If a minor cannot read or cannot write, the witness process may also need to be considered in addition to the minor consent rules. The Bulgaria impartial witness guide covers that procedure.

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