Latvia Impartial Witness Consent Requirements

When an impartial witness may be used

Conditional. Article 29 permits an appropriate alternative means of consent when a participant is unable to write. At least one impartial witness must be present. Examples may include a physical inability to sign or another writing barrier, provided the person can understand the information, decide voluntarily, and communicate the decision.

Do not use the witness route to solve a language barrier. Provide information in a language the participant understands and use a qualified interpreter where needed. The interpreter may act as witness only if independence, competence, and the approved procedure allow both roles without a conflict.

Do not use an impartial witness as a substitute for the legal representative of an adult who cannot consent. Use the Latvia limited-capacity and legal representative guide for that pathway.

Witness eligibility

The witness must be independent of the trial and free from undue influence. The witness should not be a member of the study team or someone whose interests depend on enrollment. A relative or carer may also have an interest in the decision, so the site should select a person whose impartiality can be supported and documented.

The protocol or site procedure should define who may serve, how conflicts are checked, and how confidentiality is protected. Train sites to arrange a witness without delaying urgent clinical care or pressuring the participant.

Documents and procedure

Mandatory when the pathway is planned. Describe the alternative consent method in the Recruitment and Informed Consent Procedure template. State how capacity, inability to write, witness impartiality, accessible information, questions, voluntary agreement, and document copies are handled.

Use the standard Latvian information sheet unless another accessible format is needed. Add a witness statement or signature block to the consent record that identifies:

• the participant and document version
• the reason an alternative means was used, without unnecessary health detail
• the alternative means by which consent was expressed
• confirmation that the information was accurately explained and apparently understood
• confirmation that consent was freely given
• witness name, role or relationship, signature, and date

If an interpreter is involved, include separate interpreter identification and attestation unless the approved document validly combines the roles.

Signatures and dating

The person conducting the consent interview signs and dates the consent document. The impartial witness also signs and dates it. The participant signs if physically able. If not, record the approved alternative mark, oral confirmation, assistive method, or other means.

All required people should complete their entries during the same consent process. Give the participant a copy of the signed and dated record in an accessible form. The blank document uploaded to CTIS remains unsigned.

Later consent and withdrawal

If the barrier to writing resolves, the original witnessed consent remains the consent record. A fresh signature is not automatically needed unless the protocol, approved procedure, or a revised information set requires renewed consent.

The participant retains the right to refuse or withdraw at any time. Make the withdrawal method accessible and do not require a handwritten request if the person cannot write.

Review the final version with the Latvia patient-facing document QC checklist, and return to the Latvia CTIS guide hub for every other consent variation.