Supplements-11-02-2003

One of my articles, published in 2000, opened with this statement: "In some ways, clinical drug research is a service that research participants can choose to buy-or not buy. Some participants (consumers) may benefit from buying a product (a new drug); many researchers (salespeople) will be paid for each subject they recruit."1

Informed consent is a process, not just a form signed by prospective study subjects. Documents such as the Code of Federal Regulations describe the elements of informed consent, but lack substantive direction on the process of obtaining consent.1-2 The purpose of this article is to provide guidelines for obtaining informed consent. This guide can be useful to anyone involved in clinical research, particularly newcomers to the industry.