What legislation requires informed consent in clinical investigations?

The Kefauver-Harris Amendment, passed in 1962, is significant in requiring informed consent in clinical investigations. This amendment came as a response to the need for more stringent regulations following the thalidomide tragedy, where an unapproved drug caused severe birth defects. As a result, the amendment established guidelines that necessitated manufacturers to provide evidence of drug safety and effectiveness before receiving FDA approval. Informed consent became a critical component of this process, ensuring that participants in clinical trials are fully aware of the risks and benefits of their involvement, thus protecting the rights and welfare of human subjects in research.

The other options do not directly relate to the requirement of informed consent for clinical trials. The Food, Drug, and Cosmetic Act lays the groundwork for the regulation of food and drugs but does not explicitly mandate informed consent. The Drug Enforcement Administration Act is focused on the regulation of controlled substances and does not pertain to the informed consent process. The FDA Modernization Act, while it updated several areas of FDA policy, does not specifically address the need for informed consent in clinical investigations as a requirement.