Necessary Elements in the Fundamentals of Human Subjects Research is a program initiated by the Human Research Protection Office and offered in collaboration with the Office of the Vice Chancellor for Research, the Center for Clinical Studies, and the Siteman Cancer Institute to provide timely information on topics of interest and concern to researchers. The Investigator-Initiated program provided practical information for those researchers who already hold or wish to hold the Investigational New Drug Number (IND) or Investigational Device Exemption (IDE). Being the IND or IDE holder also makes one the sponsor, giving the investigator the regulatory responsibility of being an investigator-sponsor. Information on what these responsibilities entail were provided in this program.