Principal Investigator Resources
These resources are available to Villanova principal investigators to help create, submit, and manage their research protocols. Villanova's IRB utilizes Cayuse Human Ethics software to manage research applications. Cayuse specific resources can be found on the Application Requirements webpage.
Exemplar and Blank Applications
Below are blank and exemplar versions of Cayuse applications for researchers to fill out alongside their Cayuse submissions. The exemplar versions are previously approved Cayuse applications edited for anonymity. These are provided for researchers to see the types of information required for IRB approval. Please be aware that the questions could be different on the Cayuse application because it is frequently evaluated for efficiency and accuracy.
- Blank Help Me Determine Application
- Exemplar Help Me Determine Protocol
- Blank Exempt Application
- Exemplar Exempt 2 Protocol
- Exemplar Exempt 3 Protocol
- Blank Expedited 7 Application
- Exemplar Expedited 7 Protocol (Example 1)
- Exemplar Expedited 7 Protocol (Example 2)
Exemplar Informed Consent Templates
Below are exemplar versions of the required informed consent templates. These are provided for researchers to see the types of information and phrasing applicable for the consent templates for different levels of IRB review.
- Exemplar Exempt Informed Consent Form (Example 1)
- Exemplar Exempt Informed Consent Form (Example 2)
- Exemplar Expedited Waiver of Documentation Information Sheet
- Exemplar Expedited Written Informed Consent Form
Protocol Creation Resources
- Advertisements
- Exempt Determinations
- Expedited Review
- External Collaborators in Research
- Applicability of FERPA in Research
- Full Board Review
- Generalizable Knowledge
- Help Me Determine Application & NHSR Determination
- International Research Guidance
- Informed Consent
- Limited IRB Review
- Payments in Research
- Privacy and Confidentiality
- Raffles
- Researcher Engagement
- Types of Data
- Waivers of Consent and Documentation
Protocol Management Resources
- Closure Guidance
- Considerations for Renewal of IRB Approval
- Exempt Modification Guidance
- Expedited and Full Board Modification Guidance