VCOM Institutional Policy and Procedure Manual

Edward Via Virginia College of Osteopathic Medicine

Effective Date: October 15, 2009

Signature on File ____________________________ Dixie Tooke-Rawlins, D.O. Dean and Executive Vice President

Signature on File ___________________________ James F. Wolfe, Ph.D. President ___________________________________________________________________________________________ VCOM Procedure on Obtaining Informed Consent ____________________________________________________________________________________ P URPOSE The purpose of the VCOM Procedure on Obtaining Informed Consent is to describe the process to be followed for obtaining and documenting informed consent for all subjects participating in clinical studies being conducted or coordinated by Academic Primary Care Associates (APCA), or any faculty practice of the Edward Via Virginia College of Osteopathic Medicine. S COPE This Standard Operating Procedure (SOP) applies to all Informed Consent processes in Clinical Research, and subsequent documentation obtained at any VCOM affiliated clinical site. RESPONSIBILITY The Principal Investigator and/or study coordinator will obtain written Informed Consent from all Clinical Research participants. This SOP must be reviewed annually by the Associate Vice President for Research. REGULATIONS To ensure an effective informed consent process, investigators must comply with all applicable federal regulations (e.g. 21 CFR 50, and 45 CFR 46.116,117). These regulations mandate the inclusion of eight basic elements of informed consent. Depending on the nature of the study, six additional elements may be required. DEFINITIONS Informed Consent is the ongoing educational process that occurs between the investigator and the prospective subject, allowing time for both parties to exchange information and ask questions. 1. 2. 3. 4. 5.