Regulatory requirements and informed consent

The protection of the rights and welfare of study subjects is a hallmark of clinical research practice in most countries. However, it is important to keep in mind what is informed consent and what a signed informed consent form means. In the United States, informed consent requirements apply to all clinical investigations regulated by the FDA as well as clinical investigations that support applications for marketing permits for products regulated by the FDA. It is important to note what is informed consent and what a signed informed consent form means.