Bulgaria CTIS Part II Impartial Witness Consent Requirements

When an independent witness is required

Conditional. Bulgarian Good Clinical Practice requires an independent witness to be present when the participant or legal representative cannot read during the informed-consent discussion.

Conditional. Under Regulation (EU) No 536/2014, where the participant cannot write, consent may be given and recorded by appropriate alternative means in the presence of at least one impartial witness. The witness signs and dates the consent document.

These are functional triggers. Do not add a witness merely because a participant is elderly, has a disability, belongs to a vulnerable population or is accompanied by a family member.

Who can serve as the witness

Bulgarian Good Clinical Practice defines an independent witness as a person who:

• does not participate in the clinical trial
• has no interest in the clinical trial
• cannot be influenced by the trial participants
• is present for the consent process when the participant or legal representative cannot read
• reads the ICF and other written participant information as required by the procedure

The witness should therefore be genuinely independent of the trial decision and able to understand the information being presented. A convenient site staff member who participates in the trial should not be used simply to fill a signature line.

Required patient-facing documents

The BDA does not publish a separate national witness-consent template in its current Part II list. The standard Bulgaria PIS and ICF remain the core documents.

Mandatory. The Bulgaria participant information and ICF are submitted in Bulgarian, together with the Bulgaria English version. If the study population makes the witness pathway foreseeable, include a clear witness signature and attestation section in the relevant ICF rather than leaving the site to amend the authorised form.

The witness statement should describe what the witness is confirming. It should not imply that the witness is consenting on behalf of the participant.

Consent procedure when the participant cannot read

Bulgarian Good Clinical Practice requires the independent witness to be present during the informed-consent discussion. The written ICF and other information are presented, read and explained to the participant or legal representative. After the participant or representative orally confirms the decision to participate, the witness signs and personally dates the ICF.

Through the signature, the witness confirms that the written information was accurately explained and understood and that consent was given by the participant or legal representative.

Where the participant is capable of signing and dating despite being unable to read, the participant should do so after the information has been explained. The witness signature documents the witnessed process.

Consent procedure when the participant cannot write

Regulation (EU) No 536/2014 permits consent to be given and recorded by appropriate alternative means when the participant cannot write. At least one impartial witness must be present and the witness signs and dates the informed-consent document.

The application should describe the intended alternative means clearly enough for the ethics assessment. Do not invent a mark, fingerprint or electronic method without ensuring that the method is appropriate for the participant and compatible with the approved consent procedure.

Signature logic

A witness pathway may involve:

• the participant or legally designated representative, when able to sign
• the person conducting the informed-consent interview
• the independent or impartial witness

The witness does not replace the interviewer signature. The witness also does not become a legally designated representative merely by witnessing the process.

If the participant is a minor or an adult who cannot legally consent, apply the relevant representative signatures first, then add the witness only if the reading or writing trigger is present. The Bulgaria minor consent guide and Bulgaria legal-representative guide explain those pathways.

What to state in the witness attestation

A concise witness attestation should match the actual approved procedure. It can document that the witness was present, that the information was read and explained, that questions could be addressed and that the participant or representative freely confirmed the decision.

Avoid asking the witness to certify medical eligibility, legal capacity or investigator compliance beyond what the witness actually observed.

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