Institutional Review Board

The IRB oversees all UNE-affiliated research activities involving interactions or interventions with human participants, identifiable data, or biological specimens.

Ethical and Regulatory Standards for Human Research

The IRB ensures that human subjects research conducted under UNE’s oversight meets the highest ethical and regulatory standards. Our review process is guided by:

• The Belmont Report and its core principles of respect for persons, beneficence, and justice
• Applicable federal regulations (e.g., Common Rule, FDA) and relevant agency requirements
• UNE’s institutional policies governing the protection of human participants

Researchers, including faculty, staff, students, and external collaborators, must obtain IRB review before beginning any activity that involves data collection, participant interaction or intervention, or access to identifiable private information or biospecimens.

Getting Started

Before preparing a submission, please review the following information to determine whether you are ready to begin the IRB process.

Frequently Asked Questions

If you are unsure whether your project qualifies as human subjects research, needs IRB review, who may serve as Principle Investigator (PI), or which submission pathway to follow, consult the FAQ page first. Many questions related to PI eligibility and responsibilities, faculty advisor roles, levels of review, submission requirements, IRB decisions, and full board schedule are addressed there.

Training Requirements

All researchers must complete the appropriate online CITI Program training for their research project before engaging in any human subjects research activities. Be sure to register using your UNE‑affiliated email address so your completion records can be verified. Before beginning, check out the CITI Training (PDF) guide. It provides registration instructions and helps you select the course that best aligns with your research project.

Submission Process and Applications

Select the submission type for your research or administrative request, then click the relevant section to access required forms and instructions.

Administrative Submissions

Administrative submissions are reviewed by staff within the Office of Research Integrity and Compliance. They are typically processed within one week of receipt, provided the submission is complete and all required supplemental materials are included.

See below for a list of administrative submission types.

New Exempt Research Projects

Projects with low risk that fall into federally defined exempt categories are considered exempt research. Exempt research projects are reviewed by staff within the Office of Research Integrity and Compliance. New exempt projects should be submitted 2-3 weeks before your anticipated research start date. 

Research Involving PHI of Deceased Individuals Attestation Form: Use this form if your research project involves the access to, use, or disclosure of PHI from deceased individuals.

New Non-Exempt Research Projects

Projects that do not qualify for exempt review, as well as any project deemed greater than minimal risk, are considered non-exempt research. Non-exempt research projects are reviewed by IRB committee members through expedited or full board review procedures.

Expedited review is reserved for specific types of federally defined minimal risk research that do not qualify for exempt review. Applications should be submitted one month before your anticipated project start date.

Full board review is reserved for research involving greater-than-minimal risk. Applications should be submitted at least two months before your anticipated project start date.

Managing Approved Projects: Amendments, Renewals, Closures, and Reporting

Use this section for research projects that already have IRB approval or exemption.

  • Submission Attestation Form (PDF): Use this form to certify that the information provided in a given research submission is true and accurate, and to secure approval of the project by the faculty advisor when the Principal Investigator (PI) is a student.
  • Application for Amendment (for exempt and non-exempt research projects): Use this form to request changes to the study design, recruitment, consent process, or personnel. This form must be submitted and approved before implementing any changes to your approved research project.
    • Amendments involving only key personnel changes are typically processed within three business days of receipt.
    • All other amendments should be submitted 2-4 weeks before the anticipated start date, depending on the complexity of the requested changes.
  • Application for Renewal (for non-exempt research projects only): Use this form for active non‑exempt research projects that have been assigned an expiration date and require continuing review. The renewal application should be submitted 60 days before your project expiration date.
  • Study Closure Report Form (for non-exempt research projects only): Use this form to formally close a non-exempt research project that has been assigned an expiration date. The form must be submitted once you are no longer obtaining data through interaction or intervention with participants, nor collecting, using, or analyzing identifiable private data.
  • New Reportable Event Form (for exempt and non-exempt research projects): Use this form to promptly document any unanticipated problems, adverse events, participant complaints, or protocol deviations that occur during the conduct of the research project.

Additional Guidance

Contact

Board email

irb@une.edu

Headshot of Julie Peterson
Chair, Institutional Review Board
Office of Research Integrity
Headshot of U N E employee Bob Kennedy
Director of Research Integrity
Office of Research and Innovation