Institutional Review Board
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.
To report compliance issues, call EthicsPoint Hotline toll free 1-855-236-1443
*for Full Board submissions only*
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IRB Timelines and Exceptions
Researchers can generally expect to receive initial feedback on IRB submissions within two weeks of reviewer assignment, which follows organizational approval (variable timeline) and ORP-pre-review (typically no more than 2.5 business days). During certain times of year, researchers can expect slight deviations from this cadence. For example, during the periods indicated below, timelines for initial IRB review may extend beyond the typical two-week timeline to account for disruptions to IRB member availability. In most cases, review will proceed within two to three weeks.
In all cases the IRB will make every effort to review research in as timely a fashion as possible, and researchers should communicate extenuating circumstances such as ‘Just in Time’ requests from funding agencies.
Spring Semester (delay periods)
Spring break – March (5 business days)
Easter recess – April (3 business days)
Fall Semester (delay periods)
Fall break – October (5 business days)
Thanksgiving – November (3 business days)
Winter break (closure and delay periods)
While University is formally closed (typically around December 23/24 – January 3/4) review will not proceed. When University reopens, prior to start of Spring semester, review will be on extended timeline as described above.
Researchers planning to begin or modify research at the beginning of the Spring semester are encouraged to submit their protocols prior to winter break towards the end of the Fall semester to avoid delay.
Summer (generally normal cadence)
Review generally proceeds on normal schedule except for ‘Summer Fridays’, if in effect, in which case pre- and post-review activities may not occur. Some limited periods of reduced availability may apply to accommodate reviewer time off.
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 firstname.lastname@example.org.
Villanova Data Safety Board is under development.