Institutional Review Board

Institutional Review Board

The Institutional Review Board (IRB) at Avila University reviews research involving human participants to ensure that it is conducted ethically and in compliance with applicable federal regulations and institutional policies.

The IRB’s primary responsibility is to protect the rights, welfare, and privacy of individuals who participate in research conducted by Avila faculty, staff, and students, as well as certain external researchers working with the Avila community.

When IRB Review Is Required

You may need IRB review if your project:

• Involves human participants (for example, surveys, interviews, focus groups, observations, or interventions), and
• Is intended to contribute to generalizable knowledge (for example, conference presentations, publications, theses, dissertations, or publicly shared reports).

Not sure if your project requires review? You are encouraged to consult the IRB before beginning your project.

Getting Started With an IRB Application

Before submitting your IRB application, complete the following steps:

1. Determine whether your project requires IRB review (see “When IRB Review Is Required”).
2. Work with your faculty sponsor (required for student researchers).
3. Prepare all required materials, which may include:
   • IRB application form
   • Informed consent form or consent script
   • Recruitment materials (emails, flyers, social media posts)
   • Research instruments (survey/interview questions, protocols)
4. Complete the required Human Subjects Research Training, if applicable (e.g., CITI or other institutionally approved training).
5. Submit all materials as a single document to AcademicAffairs@avila.edu.

IRB Review Levels and Decisions

All submissions are reviewed to determine the appropriate level of review:

After review, the IRB will issue one of the following decisions:

Important: Research activities may not begin until you receive written IRB approval or an official determination that your project does not require review.

Responsibilities After Approval

Once your study is approved, you are responsible for:

• Conducting research only as described in the approved protocol
• Protecting participant privacy and confidentiality at all times
• Submitting a Modification/Amendment Form before making any substantive changes to procedures, instruments, consent language, or personnel
• Promptly reporting any unanticipated problems, adverse events, or concerns involving risks to participants or others

For some studies, the IRB may require a status update or continuing review. Use the Study Status Update / Continuing Review Form when:

• Requested by the IRB, or
• Required to maintain approval for ongoing research beyond the initial approval period.

You must submit a Study Closure Form when:

• Data collection is complete, and
• Analysis of identifiable data is complete.

Closing your study ensures that IRB records are accurate and complete and documents that all human subjects protections obligations have been met.

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Forms and Resources

The following forms and resources are available to support investigators. These resources are provided as downloadable Word documents and linked directly from this section.

Download Document	Description
IRB Application	Required submission form for all research proposals involving human participants.
Study Status Update / Continuing Review Form	Use when requested by the IRB or to maintain approval for ongoing research.
Modification / Amendment Form	Required before making substantive changes to an approved protocol.
Study Closure Form	Submit when data collection and analysis of identifiable data are complete.
Informed Consent Templates	Templates for adult, minor, online/anonymous, and other participant populations.
Appendix A: Do I Need IRB?	Decision aid to help determine whether your project requires IRB review.
Appendix B: How to Write an Informed Consent Form	Guidance document for drafting informed consent language.
IRB Research Checklist	Pre-submission checklist for investigators to verify complete applications.

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Training and Investigator Support

Avila University strongly encourages early consultation with the IRB, particularly for student and first-time investigators.

Investigators may be required to complete the U.S. Department of Health and Human Services Human Subjects Research Training before IRB approval is granted. Proof of completion should be submitted with the application.

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Compliance and Scope

The Avila University IRB operates under federal regulations governing research with human participants and applicable institutional policies.

The IRB reviews research conducted by Avila faculty, staff, and students, and may also review or coordinate approvals for external researchers whose projects involve the Avila community.