Final answer:
The 1974 amendment following the Tuskegee study scandal required informed consent for research patients, ensuring participants are fully aware of study risks and benefits and participate voluntarily.
Step-by-step explanation:
The amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) that required informed consent on research patients was legislated after significant historical events increased awareness of ethical problems in medical experiments. The outcry following the revelation of the Tuskegee syphilis study, an egregiously unethical study conducted on African-American men without their informed consent, led to Congress passing legislation in 1974 to protect human subjects in scientific research, including the requirement for informed consent. This principle ensures that participants are fully aware of the risks and benefits of a study and that their participation is voluntary.
Researchers must collect extensive data and submit an Investigational New Drug (IND) application to the FDA's Center for Drug Evaluation and Research (CDER), and during clinical trials, the necessity of informed consent is pivotal to protect the autonomy of participants and to prevent exploitation. Informed consent forms must detail potential risks, voluntary nature of participation, and confidentiality of the data collected. Furthermore, institutions' Institutional Review Boards (IRBs) are tasked with approving experiments, ensuring informed consent forms are provided and signed.