Determination of required content of the informed consent process for human participants in biomedical research conducted in the U.S. A practical tool to assist clinical investigators.

Clinical Investigators conducting biomedical research involving human participants in the U.S. are responsible for the content of the consent document(s) and for the conduct of the informed consent conference(s) with the human participants. The content of the consent forms and consent process may be governed by two different sets of U.S. regulations and may be impacted upon by separate, generally accepted, international guidelines. It can be difficult and confusing for an Investigator to determine which set(s) of regulations or guidelines apply to which studies. This article compares the two sets of U.S. regulations and two sets of well-respected international guidelines with respect to their requirements for the content of the consent document and consent conference. A practical decision tree is proposed as a tool to assist Investigators in determining which set(s) of requirements is applicable to a particular study.