Institutional Review Board

Board Members

Guidance and Forms

* ElectronicRecruitment4.17.15.doc
Electronic Recruitment Guidelines
* AdverseEffectReportUpdated 4.16.14.docx
Adverse Event Reporting Form: Use per VU policy and in the case of ANY adverse event.
* Informed Consent Template 2018-01-17.docx
Informed Consent Template
* Protocol Template 2017-11-16.docx
Protocol Template - If you would like to obtain a copy of any documents referenced within the Protocol Template, please contact
* VillanovaIRBGuidelines-01-22-2018.doc
VU IRB Guidelines - Please read this document before completing the application.
* IRB Checklist Organizational Approver 2016-11-1.docx
Checklist for Organizational Approver
* Individual Investigator Agreement_March 2017.docx
Individual Investigator Agreement

Decision trees, provided by OHRP, for IRB's determination of level of review.



All protocols should be submitted through Cayuse. A checklist for submission is found within the Application document.

Protection of the rights and well-being of human subjects involved in research is a concern of Villanova University (VU) and is mandated by specific provisions in the Code of Federal Regulations (CFR).  As required by the federal regulations, the IRB was established at VU to assure protection of human subjects and to ensure compliance with the regulations.  

The University’s IRB policies and procedures apply to any research activity which involves human subjects, whether such research is undertaken on a large or small scale, whether it is preliminary or fully designed, whether it is student or faculty research, whether it is funded or non-funded, and whether it involves minimal risk or more than minimal risk.

The IRB is appointed by our Institutional Official for Human Subjects Research, who provides Assurance (Federalwide Assurance No: FWA00011841 - expires 10/15/2019) to the federal government that human subjects are protected in VU's research.

Please review our guidelines before submitting your protocol for review. 

The VU IRB meets monthly to review protocols requiring full board review. Protocols eligible for expedited or exempt review are evaluated on a rolling basis. ORA issues approval.  

If you require resources in order to carry out a regulatory aspect of a project, please contact ORA at or ext: 94220