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 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.
- Research Determination Request: Use this form for an official determination regarding whether your project meets criteria for non-human subjects research (NHSR).
- Student Classroom Project Exclusion Application: Use this form if you are faculty teaching a course involving research methods or systematic investigations (e.g., activities involving both data collection and quantitative/qualitative analysis) conducted through interaction with individuals outside the course. The application must be submitted at least two weeks before the semester in which the course is taught.
- Clinical Case Studies (or Case Report): Use this submission package if you intend to discuss or share a case study with individuals outside the workforce of the HIPAA-covered entity (e.g., medical institution). The application must be submitted before the case study presentation or publication.
- Research Approved or Exempted by an External IRB: Use this form if you are (or will be) engaging in research activities for a project that was approved or exempted by an external IRB.
- Review of PHI Preparatory to Research: Use this form if you are reviewing patient medical records to design a research project, determine project feasibility, or assess participant eligibility for a research project.
- Decedent Research (deceased individuals only): Use this form if your research project involves the access to, use, or disclosure of PHI from deceased individuals only.
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.
- Application for Exempt Research Projects
- Participant Information Sheet Template (Exempt Projects Only)
- Principal Investigator Certification (PDF)
- Supplemental Form: Transnational Research: Use this form if your research includes in‑person activities outside the United States or online-only research (e.g., online surveys, interviews, or remote data collection) with participants located outside the United States.
- HIPAA Forms (as applicable):
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.
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.
- Application for Non-Exempt Research Project
- Principal Investigator Certification (PDF)
- Supplemental Form: Transnational Research: Use this form if your research includes in‑person activities outside the United States or online-only research (e.g., online surveys, interviews, or remote data collection) with participants located outside the United States.
- Investigational Device Information Form
- Assent and Consent form templates for non-exempt research projects:
- HIPAA Forms (as applicable):
- HIPAA Authorization Template for Research Purposes
- Request for a Waiver of HIPAA Authorization for Research Purposes
- 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.
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.
Tools and Resources for Preparing Your Submission
Use the following tools and resources when drafting project materials for review.
- Research Proposal Guidance for Exempt Projects Involving Interviews and Surveys (PDF)
- Research Proposal Guidance for Exempt Projects Involving Retrospective Chart Review (PDF)
- Guidance for Drafting a Readable Participant Information Sheet or Consent Form (PDF)
- Guidance for Using a Master List in a Research Project (PDF)
- Guidance Distinguishing Public vs. Private Online Groups Research Recruitment (PDF)
- Guidance for Recruiting Students as Research Participants (PDF)
- Guidance for Building, Managing, and Closing REDCap Projects (PDF)
- Student Classroom Project Guidelines (PDF)
Additional Guidance
Responsible Conduct of Research (RCR) Training
HHS Office of Human Research Protections (OHRP)
HIPAA Privacy Rule
UNE Policies and Procedures
Contact
Board email