The Kefauver-Harris Amendments enacted in 1962 were groundbreaking in their attempts to ensure the safety and effectiveness of all new drugs on the U.S. market. The amendments gave the FDA specific authority to approve a manufacturer's marketing application before a drug could be available for commercial use. Firms now had to prove safety and provide substantial evidence of effectiveness for the drug's intended use. The required evidence had to consist of adequate and well-controlled studies. The amendments helped establish rules of clinical drug investigation and the informed consent of study subjects. The amendments also required that drug-related adverse events be reported to the FDA.
What kind of consent would be called an informed consent? Could you also paraphrase the sentence in simple English?