Background and Definitions

  • The levels of review are based upon the Department of Health and Human Services guidelines, effective July 14, 2009.

  • "Human Participants" means a living individual about whom an investigator conducting research obtains data through: (1) intervention or interaction with the individual, or (2) through records of identifiable private information.

  • "Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  • Research to be designed and conducted in a school or organization other than Bethel requires written approval from an appropriate institutional authority. This approval must be submitted with the IRB forms prior to review at the appropriate IRB level.

  • Interpretation of IRB guidelines and determination of the appropriate level of review is made exclusively by the Institutional Review Board, not by the investigator.

  • Individuals are encouraged to consult an IRB Committee Member with questions regarding the appropriate level of review for a study.