Cornell University Office of Research Integrity and Assurance

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Institutional Review Board for Human Participants

Cornell University operates a Human Research Protection Program to protect the rights and welfare of individuals who volunteer to participate in the research mission of the University. While the ultimate responsibility for the treatment of all human participants in research rests with the individual researcher (faculty, students, or staff) who has been given the privilege to conduct research with humans, the Institutional Review Boards exist as a safeguard to promote the ethical and responsible treatment of human participants in research.

Cornell University operates its Human Research Protection Program under two separate Federal Wide Assurances (FWA) filed with the U. S. Department of Health and Human Services (HHS): one for the upstate campus principally located in Ithaca (FWA 0004513) and a separate FWA for the Weill Cornell Medical College principally located in New York City (FWA 0000952).

University policy requires that all research that involves human participants, regardless of the source of financial support, must be reviewed and approved by the Institutional Review Board (IRB) before it can be initiated. Guiding this review process by the IRB is the application of federal and state laws and various ethical principles, particularly those articulated in the Belmont Report: (1) Respect for Persons, (2) Beneficence, and (3) Justice.

In accordance with University policy, "Human Participant" is defined as "[A] living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." "Research" is defined as "[A] systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Unsure if your research activity needs IRB review?

A Decision Tree has been developed for investigators to determine if a proposed activity is covered under the Human Research Protection Program. If the proposed activity is covered under the Human Research Protection Program it would require (a) review and approval be the Institutional Review Board or (b) Exemption from IRB Review by the Office of Research Integrity and Assurance (ORIA) before the activity can be initiated. In addition, investigators, students, and staff should freely consult with ORIA if they have questions about whether or not an activity involves humans and meets the institutional definition of "research" regardless of whether or not the overall activity is considered research.