Does Your Project Need an IRB?

IRB approval is needed when your project meets the definition of human subject research.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102).

• Generalizable knowledge includes information presented to a broader audience or published with the intent of drawing scientific conclusions or increasing the body of scientific knowledge and can be applied to populations outside of the specific study population.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research (45 CFR 46.102):

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens.
  • Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
  • Interaction includes communication or interpersonal contact between investigator and subject.

• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
  • Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
  • Identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Researchers who are in doubt about whether an activity constitutes research with human subjects should consult with the HRPP or the IRB Chairs. IRB approval is needed prior to recruitment of participants, consent/assent process, data collection, and/or gaining access to identifiers.