Netherlands CTIS Impartial Witness Consent Requirements

When an impartial witness may be used

Conditional. Plan the witness pathway when a person can understand and decide but may be unable to write, sign or read the written material because of a physical, sensory or literacy-related limitation.

Examples can include severe motor impairment, visual impairment or inability to read. First provide accessible information and reasonable communication support. A witness is needed only when the authorised consent record cannot be completed in the ordinary way.

Do not use an impartial witness when the real issue is lack of decision-making capacity. Use a legally designated representative in that case. The Netherlands limited-capacity consent guide explains that pathway.

Witness eligibility

The witness should be independent of the trial and not unfairly influenced by the people involved. The person should be able to understand the information and observe the full consent process.

Avoid using the investigator, delegated study staff, sponsor staff or anyone with a financial or professional interest in recruitment. A family member may not be sufficiently independent where pressure or competing interests are possible.

Document the witness's identity, basis for impartiality and reason for involvement. The witness does not become the participant's representative and does not make the decision.

Dutch participant information

Mandatory. Provide the participant or representative with Dutch information in an accessible format. The reviewing MREC or CCMO assesses the Dutch participant document.

Adapt presentation to the person's needs. This can include large print, compatible electronic text, audio support or having the information read aloud. The content must remain aligned with the authorised Dutch IVO or other population-specific document.

If the person does not understand Dutch, provide information in a language they understand and follow the translation rules. An interpreter and an impartial witness perform different functions. One explains language. The other observes and attests to the consent process.

Submission documents

Recruitment and informed consent procedure

Mandatory when the pathway is planned. Complete section 5 of the harmonised Recruitment and Informed Consent Procedure template. Explain why a witness may be needed, how the witness will be selected and how the alternative consent will be given and recorded.

The version 2.0 procedure template becomes the only accepted version for new Part II submissions from 1 September 2026.

Information, consent and witness attestation

Conditional. Adapt the Dutch information and consent package to include the approved alternative method and a witness attestation. There is no separate Netherlands national witness template that replaces the trial-specific form.

Submit the blank document in CTIS with the Subject information and informed consent form materials. It is signed during the consent event, not at application submission.

The witness statement should confirm that the information was accurately explained or read, questions were addressed, the person appeared to understand, and consent was given freely. It should identify the alternative means used to record consent.

Consent procedure

The impartial witness should be present throughout the information and consent discussion. The participant or representative should have the same opportunity to ask questions and take time to decide as any other person.

Use the approved alternative record, such as an audio or video record, an electronic method, a mark or another method suited to the person's ability. Protect privacy and retain the record as essential trial documentation.

Do not ask the witness to answer for the participant. The person's own words, choices and indications of consent must remain clear.

Signatures and records

The person obtaining consent signs and dates the form. The impartial witness signs and dates the attestation after observing the complete process. The participant or representative signs or marks the document if able, or gives consent through the approved alternative method.

Give the participant or representative the information in an accessible form and a copy of the completed consent record. Document the reason for the witness, the witness selection, format used and any interpreter separately.

If the barrier later resolves, do not automatically repeat consent without a reason. Re-consent is needed when required by the authorised protocol, new information or another legal trigger.

Witness versus other roles

Witness versus legal representative

A legal representative makes the consent decision for a person who lacks capacity. An impartial witness observes the process for a person who can decide but cannot complete the ordinary written record. The roles must not be merged.

Witness versus interpreter

An interpreter supports language understanding. The interpreter does not automatically qualify as the impartial witness. If one person is proposed for both roles, justify independence, competence and the absence of conflict in advance.

Witness versus emergency deferred consent

A witness cannot authorise enrollment when neither the participant nor a representative can consent within an emergency window. That requires an approved Article 35 pathway. See the Netherlands emergency enrollment consent guide.

Final checks

• The participant or representative has capacity to decide.
• The need for a witness is based on inability to complete ordinary written consent.
• Accessible Dutch information is available.
• Any translation or interpreter need is handled separately.
• Section 5 of the harmonised procedure template is complete.
• The witness is independent and present throughout.
• The alternative recording method is authorised and privacy-protective.
• The participant's own decision remains visible.
• The witness attestation, witness signature and researcher signature are included.
• The site retains the complete record and gives an accessible copy to the participant.

Return to the Netherlands English CTIS hub for the complete guide series.