Impartial witness

Impartial witness – is an individual who is present during the informed consent procedure to observe the consent discussion and the signing of the informed consent form (ICF). Witness is particularly required where potential subject is unable to read or write, or when there are concerns about the participant’s ability to understand the information provided.

Witness is responsible for ensuring that informed consent was conducted ethically, and that patient voluntarily consent to participation without coercion or undue influence.

Definitions

ICH E6(R2)

1.26 Impartial Witness:

A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject .

Role of impartial witness

The role of the impartial witness is to ensure that the informed consent process is conducted properly, and that the participant’s rights and well-being are protected. The impartial witness must be independent and unbiased, with no personal interest in the outcome of the research study. Witness is typically not involved in the conduct of the study or the provision of study procedures to participants.

The impartial witness observes the consent procedure and discussion between the investigator (or delegated site personnel) and the patient, ensuring that all relevant information about the study is provided, questions are answered, and that the participant voluntarily agrees to participate.

If the patient indicates consent, the impartial witness signs the informed consent form alongside the subject, confirming that the consent process was conducted appropriately. So this is to confirm that impartial witness was present during the informed consent process, ensuring that the patient appeared to understand the study and provided voluntary agreement to participate.

See also

Another relevant pages

• Informed consent