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.
US Food and Drug Administration. FDA guidance for industry: acceptance of foreign clinical studies. March 2001.
6.
De RoyPG. Helsinki and the Declaration of Helsinki. World Med J.2004; 50(1):9–11.
7.
21 CFR §50.27(b)(2).
8.
International Conference on Harmonization. Guidance for industry: ICH E6 good clinical practice: consolidated guidance. Section 4.8.9, May 1997.
9.
21 CFR §50.25(a)(5).
10.
International Conference on Harmonization. Guidance for industry: ICH E6 good clinical practice: consolidated guidance. Sections 2.11 and 4.8.10(o), May 1997.
