Final answer:
The FDA and ICH both set forth requirements that ensure informed consent forms must detail the potential benefits and risks of a study, including alternatives. The FDA can additionally require post-approval studies to continue ensuring the safety and efficacy of the drug for the consuming public.
Step-by-step explanation:
When it comes to the requirements for informed consent in clinical trials, both the FDA (Food and Drug Administration) and the ICH (International Conference on Harmonisation) provide guidelines ensuring that the subjects are fully informed of the benefits and risks involved, including the potential risks and benefits of alternative treatments. In an informed consent form, the participants must receive information that is critical for making an informed decision about their voluntary participation in a clinical trial. This includes the details of the study, potential risks, implications, and the confidentiality of collected data.
The FDA has the authority to mandate additional studies or implement risk management plans after a therapy is approved, to maintain the safety of the participants and monitor long-term effects. Before any clinical trials involving human subjects can begin, researchers must submit an Investigational New Drug (IND) application to the FDA's CDER and, after approval, continuously analyze data on effectiveness and safety during trials. Post-marketing surveillance is also a critical component of maintaining drug safety, which involves monitoring the drug as it is used by a broader population.