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… (More)