Final answer:
Non-therapeutic trials must not favor a treatment in a way that compromises the trial's clinical equipoise or sacrifices participant interest for scientific data. The principle of nonmaleficence underlines the need to minimize harm, and informed consent is essential for ethical clinical trials.
Step-by-step explanation:
According to ICH E6 (R2) Section 4.8.13, a non-therapeutic trial, one in which no direct clinical benefit to the subject is anticipated, should not favor the use of one of the treatments in the trial for the participants involved. This is to ensure that a trial maintains clinical equipoise, which suggests that the interests of participants are not sacrificed in the pursuit of scientific information and data. Among the primary considerations in clinical trials is the ethical principle called the principle of nonmaleficence, stating that any potential harms to participants must be minimized. Moreover, the process of obtaining informed consent is critical, and any violation of this rule, such as providing insufficient information about the nature of a study, undermines the ethical foundation of a clinical trial.