Ireland CTIS Impartial Witness Consent Requirements

When to use an impartial witness

Plan the witness route when the participant or representative can make the decision but cannot independently read the written information or complete the normal written signature. Examples include inability to read or write and some physical limitations.

Do not use a witness merely because the participant needs extra explanation. Do not use the witness pathway to avoid an approved translation or interpreter when the issue is language.

Who can act as witness

The witness must be independent of the trial and free from improper influence by people involved in the trial. Select someone who can understand the information and observe the full consent discussion.

The witness cannot:

• consent on behalf of the participant
• replace the Irish legally designated representative
• interpret a language they are not formally serving and documented as an interpreter for
• sign without observing the information and decision process

Where one person has more than one role, document why that is appropriate and ensure independence is not compromised.

Conduct the consent discussion

Read or accurately explain the information sheet and consent form to the participant or representative in the witness's presence. Use communication aids and an approved interpreter if needed. Allow time for questions and confirm understanding.

The participant or representative gives consent using the approved signature, mark or alternative method. The witness then signs and dates the consent form to attest that the information was accurately explained, apparently understood and freely accepted.

Record why the witness was required. NREC has specifically expected a witness signature field and the reason for witness involvement to be present where the pathway applies.

Document design

Include fields for:

• participant or representative name and approved mark or signature method
• witness name, signature and date
• witness confirmation of impartiality and attendance for the full discussion
• reason the witness was used
• person conducting consent, signature and date
• interpreter details and attestation where a separate interpreter is used

Reflect the pathway in the recruitment and informed-consent procedure uploaded in Part II. Do not add unused witness blocks to every consent form if they could confuse routine signing.

Ireland has no dedicated mandatory national witness-consent template. Adapt the accepted SIS and ICF and the EU recruitment and informed-consent procedure template to document the witness process and attestation.

Special situations

If the participant lacks decision-making capacity, follow the limited-capacity and representative-consent guide. A witness cannot cure lack of capacity.

If enrolment occurs in an emergency before consent, follow the emergency enrolment guide. A conveniently available witness is not a substitute for the Article 35 conditions.

For electronic consent, validate how identity, the participant's mark or alternative indication, witness presence, date and the final signed copy are captured.

Submission checks

• The need for a witness is defined in the consent procedure.
• The witness is independent and attends the full discussion.
• The participant or representative remains the decision-maker.
• Translation and interpreting needs are handled separately.
• The reason for witness use is recorded.
• Signature, date and attestation fields are complete.
• The participant receives a copy of the completed consent record.
• Site staff are trained on the pathway.

Return to the Ireland CTIS Part II guide hub for every national consent pathway.