Mary-Tara Roth, RN, MSN, MPH, Director of the Clinical Research Resources Office, talks to us about what constitutes research and determining whether it involves human subjects, what FDA and OHRP regulations are and which types of studies they govern, the various types of IRB review, common problems with IRB submissions, and the tools and resources available at BUMC/BMC to help guide investigators. An important note is that guidance and regulations can change over time, and it is vital for investigators to keep current with best practices.