Good Clinical Practice (GCP) Practice Exam

The presence of an independent witness during the informed consent process is crucial as it serves to protect against coercion or undue influence. This measure adds an additional layer of scrutiny to the consent process, ensuring that the participant is making an informed decision voluntarily and without external pressure. The independent witness can help to confirm that the individual giving consent understands the information provided and is not being unduly influenced by researchers or other parties involved in the trial.

The witness also acts as a safeguard to ensure that the consent process was conducted fairly and ethically. Their role is vital in upholding the participant’s rights and enhancing the integrity of the research process, providing reassurance that consent has been handled appropriately. The presence of an independent observer can facilitate trust in the process, as participants may feel more comfortable knowing that there is a neutral party present to witness their consent.