FDA Public Meeting Report on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications".

Potential drug interactions with hormonal contraceptives are an important public health concern. A public meeting on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implication" was hosted by the United States Food and Drug Administration (FDA). The meeting endeavored to provide an opportunity for the FDA to seek input from experts on the public health concerns associated with the use of hormonal contraceptives and interacting drugs that might affect efficacy and safety, including pharmacokinetic/pharmacodynamic considerations, in the design of drug interaction studies of hormonal contraceptives for drug development and approaches to translating the results of drug interaction information into informative labeling and communication.

Informed consent procedures: an experimental test using a virtual character in a dialog systems training application.

Researchers are generally trained to administer informed consent by studying approved guidelines, but still can fail to satisfactorily answer questions from potential participants. An application using a virtual character allowed novice participants to practice administering informed consent. This character was designed to behave as a potential participant for a study and asked many of the questions research participants typically ask, such as queries about the study itself, the sponsor, timing, selection procedures, confidentiality, voluntariness, benefits and risks, and contact information.