What is required by ICH E6 if there is no intended clinical benefit to the subject?

When conducting clinical trials, particularly under the guidance of the ICH E6 guidelines, it is crucial to be transparent about the nature of the study and its implications for participants. If a clinical trial does not offer the subjects any intended clinical benefit, there is a specific requirement to provide a statement of no benefit to ensure that participants are fully informed about what their participation entails.

Providing a statement of no benefit serves to clarify the role of the subjects in the study, indicating that while they may be contributing to valuable research, their personal health outcomes may not improve as a result of their involvement. This aspect is vital for maintaining ethical standards, as it allows potential participants to make informed decisions about whether to join a trial, based on a clear understanding of the risks and conditions.

In contrast, other options might imply that benefits or outcomes are expected or are part of the informed consent process without addressing the lack of intended clinical benefit directly. Therefore, a statement explicitly indicating the absence of expected benefits aligns with the ethical principles emphasized by ICH E6, ensuring that the rights and well-being of trial participants are respected.