For non-therapeutic trials, according to ICH E6, who must give consent?

In the context of non-therapeutic trials as outlined by ICH E6 guidelines, it is imperative that consent is obtained from the trial subjects themselves. This means that the individuals participating in the trial must provide informed consent, understanding the nature of the study, the procedures involved, potential risks, and their right to withdraw at any time without consequence.

The emphasis on obtaining consent directly from the subjects ensures that they are fully informed and willingly participating in research that does not offer direct therapeutic benefits. This principle reinforces the ethical commitment to respect the autonomy and rights of research participants, which is a cornerstone of ethical research practices.

While other parties, such as the investigator or the IRB/IEC, play significant roles in the oversight and ethical approval of the study, they do not provide consent on behalf of the subjects in non-therapeutic trials. In cases where subjects are unable to provide consent, legally acceptable representatives might be involved, but this is a specific exception rather than the norm for non-therapeutic trials where individual consent is critical.