Poland Impartial Witness Consent Requirements

When an impartial witness may be used

Conditional. Article 29 provides an alternative when the participant or legally designated representative is unable to write. Informed consent can then be given and recorded by appropriate alternative means in the presence of at least one impartial witness.

This pathway concerns the ability to record consent in writing. It is not a substitute for decision-making capacity. If an adult cannot give informed consent, use the Poland limited-capacity and legal representative consent guide instead.

A witness also does not turn an otherwise invalid consent process into a valid one. The person giving consent must still receive the required information, have time to consider it and make a voluntary decision.

Poland uses the CTR one-witness rule

Current NKB good practice expressly addresses a potential conflict between Article 29 of Regulation 536/2014 and the Polish Physicians Act provisions for medical experiments.

For a medicinal clinical trial governed by the Clinical Trials Regulation, NKB states that the consent may be recorded by alternative means in the presence of at least one impartial witness. The witness signs and dates the informed consent document.

NKB also explains that the general Polish rule requiring at least two witnesses for certain medical-experiment oral-consent situations does not apply here. The Clinical Trials Regulation applies to the medicinal clinical trial and Article 29b of the Polish Physicians Act directs such trials to the dedicated clinical-trial legal framework.

Do not build two signature lines into the ICF on the assumption that two witnesses are legally required for the CTR route.

What the witness does

The witness is present for the alternative consent process and provides an independent record that the consent was given when the person could not write.

Mandatory where this route is used. The impartial witness signs and dates the informed consent form. The person conducting the consent interview also signs and dates in accordance with Article 29.

The participant or legally designated representative should receive a copy of the informed-consent documentation.

The witness is not the person who gives consent on behalf of a capable participant. Keep the witness signature line visually and legally separate from the consent-giver and investigator or interviewer signature lines.

Witness impartiality

Article 29 requires an impartial witness. The current NKB good-practice page confirms the role but does not publish a separate exhaustive list of eligible occupations or relationships.

The site procedure should therefore define a practical method for selecting someone whose independence from the decision can be supported. Avoid using a person whose role or relationship creates an obvious conflict with the participant's voluntary decision.

Record the witness's name, signature and date in the approved document. If the sponsor needs additional identifiers for traceability, keep them proportionate and consistent with privacy requirements.

Do not add unnecessary personal details simply because a witness is present.

Alternative ways to record consent

NKB notes that appropriate alternative means may be used when the person cannot write. Its current good practice gives oral consent recorded audiovisually as an example.

If the trial plans a specific alternative method, describe it in the Part II consent procedure before use. Address how the person receives the information, how the decision is recorded, what the witness observes and how the record is retained.

Do not introduce audio or video recording at site level without checking the approved procedure and data-protection implications. Recording itself involves processing personal data and may capture sensitive health information.

Documents to prepare

If the witness route can reasonably occur in the intended population, prepare it prospectively rather than hand-editing the standard ICF after approval.

The Poland document set may include:

• a Polish PIS and ICF with a clearly labelled impartial-witness signature and date block
• instructions stating when the witness block is used
• the Recruitment and informed consent procedure describing the reason for using an impartial witness, witness selection and the consent method
• an approved description of any audio, video or other alternative recording method if such a method is planned

The European Commission v2.0 procedure template contains a dedicated section for the impartial-witness pathway and asks for the reason, selection process and procedure.

Polish language and communication support

Mandatory. The participant-facing documents submitted for Poland should be in Polish under the current European Commission language table.

An inability to write is not the same as an inability to understand Polish. If a participant needs language or communication assistance for a separate reason, address that need in addition to the witness route.

Do not automatically label an interpreter as the impartial witness. If one person is proposed to perform more than one role, the approved procedure should establish that every requirement for each role is satisfied and that impartiality is preserved.

Signature block design

Keep the signature logic easy for the site to follow. A witness section should identify the function of each signature rather than showing several unlabeled signature lines.

A clear structure can include:

• participant or legally designated representative consent record using the approved alternative means
• interviewer name, signature and date
• impartial witness name, signature and date
• statement explaining what the witness attests to

The statement should match the actual procedure. Do not make the witness attest to medical facts, capacity assessments or information they did not observe.

At CTIS submission and at the site

At CTIS submission, upload the blank controlled Polish ICF and the procedure describing the witness route. The participant, representative and witness do not sign the dossier copy.

At the consent visit, use the current authorised version. Complete the approved alternative consent process, obtain the required interviewer and witness signatures and dates, and provide the participant or representative with a copy.

If the same trial also includes minors or emergency enrollment, keep those pathways separate in the procedure. The Poland minor consent and assent guide and Poland emergency enrollment guide explain those additional conditions.

Use the Poland patient-facing document QC checklist to verify the witness signature block and procedure. Return to the Poland CTIS Part II guide hub for all Poland guides.