Which organization does not require assent from incompetent subjects, while ICH does?

The correct choice is the FDA, as it does not require assent from incompetent subjects in the same way ICH guidelines do. The FDA's regulations allow for consent to be obtained from legally authorized representatives for individuals who are unable to provide informed consent themselves due to incompetence, such as children or those with cognitive impairments. In these cases, the emphasis is on ensuring that the rights and welfare of such individuals are protected through the consent of their guardians or representatives.

In contrast, the ICH E6 guidelines specifically entail a requirement for assent from incompetent subjects when they are capable of providing it, which means that researchers must make a reasonable effort to involve them in the decision-making process regarding their participation in research. This principle is designed to respect the autonomy of individuals, even if they are not legally capable of giving consent.

The other organizations, such as the EMA, WHO, and MHRA, have their own frameworks and guidelines, but the most notable difference in this context pertains to how they address the requirement for assent compared to the ICH E6 guidelines.