Why is IRB Submission Required?

IRB submission is required for all research projects using "human subjects" as defined by the Federal Policy for the Protection of Human Rights 45 CFR 46, the Food and Drug Administration (FDA) regulations 21 CFR 50, 56 , and with the Federalwide Assurance granted by the Office of Human Research Protections (OHRP).

Federal Definitions

(from 45 CFR 46):
  • RESEARCH is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

  • HUMAN SUBJECT is a living individual about whom an investigator (whether professional or student) conducting research obtains:

    1. data through intervention or interaction with the individual, or
    2. identifiable private information.
The iStar "Study Application Questions and Guidance" references the regulation or guidance that is applicable to each element on the application form. Please use this resource to help answer any federal, state, or local human subjects regulation questions you may have.

Please click on the following links to obtain more information about conducting research using human subjects