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.
Federalwide Assurance No: FWA00011841 - expires 05/31/2023.
To report compliance issues, call EthicsPoint Hotline toll free 1-855-236-1443
FAQ Sheets on:
- Revised Common Rule Transition
- Exempt Review Categories
- Broad Consent
- Informed Consent
- Benign Behavioral Intervention
- Limited IRB Review
Other Resources
- Revised Common Rule Training for Investigators
- OHRP Decision Trees (for assistance in determining review categories)
See our NEW Forms and Templates webpage.
- Informed Consent Template - Revised Common Rule Compliant, edited March 2020 (valid for new research through 12/9/21 only).
| Upcoming Deadlines *for Full Board submissions only* 2021 |
||
| Month | Deadline | Meeting Date |
| January 2021 | 1/13/21 | 1/28 |
| February | 2/10/21 | 2/25 |
| March | 3/10/21 | 3/25 |
| April | 4/7/21 | 4/22 |
| May | 4/28/21 | 5/13 |
| June | 5/26/21 | 6/17/21 |
| July | 6/23/21 | 7/15/21 |
| August | 8/15/21 | 8/30/21 |
| September | 9/1/21 | TBD |
| October | 9/30/21 | TBD |
| November | 11/2/21 | TBD |
| December | 11/17/21 | TBD |
| January 2022 | 1/4/22 | 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 orp@villanova.edu.
Villanova Data Safety Board is under development.
The Compliance Assistance 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.