Final answer:
According to ICH-GCP guidelines, lack of intended clinical benefit to research subjects must be clearly communicated in informed consent discussions and forms, ensuring that participants are aware of the risks and absence of personal medical benefit, maintaining ethical standards in clinical research.
Step-by-step explanation:
According to ICH-GCP guidelines, if there is no intended clinical benefit to the research subjects, this must be explicitly stated during informed consent discussions, and similarly reflected in the written informed consent form and any other written information provided. Informed consent is a critical process in which a research participant is educated about what to expect during a study, including any risks involved, and the implications of the research, before obtaining the individual's voluntary agreement to participate.
As part of meeting ethical standards in clinical research, informed consent materials must clearly outline that there is no expected benefit for the participant when this is the case. This ensures the participants make an informed choice about their involvement based on complete and accurate information about the potential risks and the lack of direct personal benefit. Additionally, the informed consent should reiterate that participation is voluntary and can be withdrawn at any time without any penalty.