The protocol is the working document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical research project as well as the background and rationale for the trial. Protocols and amendments must be approved by the Division of Microbiology and Infectious Diseases (DMID) and all the Institutional Review Boards or International Ethical Committees of record.
Informed consent refers to the process by which a volunteer confirms his or her willingness to participate in the research after having been informed of all aspects of the trial that are relevant to the volunteer’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form. Both the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) have regulations that address the informed consent process.
DMID also follows the International Conference on Harmonisation (ICH –E6) Good Clinical Practice guidelines for protocol and informed consent content.
Last Updated November 13, 2014