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Institutional Review Board

Researcher speaking with parent and her child

The Institutional Review Board (IRB) oversees all research involving human subjects in accordance with specific provisions in the Code of Federal Regulations (CFR). As required by law, the IRB was established at Villanova to assure protection of human subjects’ rights and well-being.

Federalwide Assurance No: FWA00011841 - expires 05/31/2023.

To report compliance issues, call EthicsPoint Hotline toll free 1-855-236-1443

Submit protocol applications via CAYUSE

Looking to submit an adverse event form? Instead, submit an "incident" report through CAYUSE.

Upcoming deadlines for full board submissions
Month Deadline Meeting Date
January 2020 12/18/19 1/22
February 1/29/20 2/26
March 2/26/20 3/25
April 3/25/20 4/22
May 4/29/20 5/13
June  5/27/20 6/2
July 6/24/20 7/7
August 7/22/20 8/4
September 8/26/20 TBD
October 9/30/20 TBD
November 10/28/20 TBD
December 11/25/20 TBD
January 2021 12/23/20 TBD

Is your study a clinical trial?

  • Does it involve human subjects?
  • Are subjects prospectively assigned to an intervention?
  • Is the study designed to evaluate the effect of the intervention on the subjects?
  • Is the effect being evaluated a health-related outcome? (biomedical or behavioral)

If the answer is "yes" to all of the questions above, then you are conducting a clinical trial.

For information on the clinical trials process at Villanova, please email

Villanova Data Safety Board is under development.

The Compliance Assitance Program (CoAP) is designed to assist researchers in conducting studies that are in accordance with their IRB approved protocols, and to best protect human subjects involved in research. For more information, contact Kaitlin Gottuso.

CoAP Information Document