At-a-Glance: Is IRB Review Required?
Version: October 14, 2025
Guidance
This guidance is an at-a-glance guide to assist researchers in understanding submission requirements for research or non-research activities.
| Activity | Description | IRB Submission? |
| Case Reports (Medical) | The University of Utah IRB does not require review of case reports. The case report may only include three or fewer patients and cannot include any procedures conducted with prior research intent.
The author of the case report must protect the confidentiality of the patients. Waivers of authorization must be obtained, as necessary. Some journals may require documentation of consent by the patient. Authors should complete the Case Reports Using Existing Data Worksheet and keep a copy. Learn more about this topic: |
No |
| Chart Reviews (retrospective or prospective review of identifiable health information) | The collection of individually identifiable data about a series of patients for dissemination or contribution to generalizable knowledge, or for potential recruitment into current or future research. | Yes |
| Classroom Assignments/Research Methods Classes | Activities designed for both educational purposes and to contribute to generalizable knowledge. | Yes |
| Activities designed strictly for educational purposes that teach research methods or demonstrate course concepts. The activities are not intended to create new knowledge. | No, however instructors have an obligation to protect students and others. | |
| Clinical Investigations | Clinical investigation is a term used in the Food and Drug Administration (FDA) regulations meaning any experiment that involves a test article (e.g., drug, device, or biologic) and one or more human subjects. It qualifies as a clinical investigation if it requires FDA approval before starting or the results are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. Clinical investigations must be reviewed and approved by the University of Utah IRB and must abide by FDA regulations.
Learn more about this topic: |
Yes |
| Community Advisory Board (CAB) or Steering Committee | Creation of, or consultation with, a Community Advisory Board (CAB) or Steering Committee to provide input on study design and/or assist in interpreting research findings. | No |
| Emergency Use of an Investigational Drug or Device | FDA regulations [21 CFR 56.104(c)] permit the emergency use of a test article without prospective IRB review. FDA regulations require that any subsequent use of the test article at the institution have prospective IRB review and approval.
Data from an emergency use may not be reported in a way that implies that the activity was a prospectively planned systematic investigation designed to develop or contribute to generalizable knowledge. Emergency use is specifically emergency clinical care and is not considered research. Learn more about this topic: |
Yes, an Emergency Use of a Test Article Application (page 1, question 4 of the New Study Application). |
| Expanded Access – sometimes called “Compassionate Use”
|
The Food and Drug Administration (FDA) Expanded Access Program allows the use of an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies.
Learn more about this topic: |
Yes, an Application for Expanded Access of an Investigational Drug or Device (page 1, question 4 of the New Study Application). |
| Humanitarian Use Device | A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease that affects fewer than 8,000 individuals in the United States per year. Before an HUD under an approved HDE can be used at the University of Utah or its affiliates for clinical care, approval by an IRB is required, except for emergency use.
Learn more about this topic: |
Yes, an Application for Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (page 1, question 4 of the New Study Application). |
| Journalism | Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected.
Learn more about this topic: |
No |
| Medical Practice | Standard medical practice, innovative care, or off-label use of FDA-approved drugs, biologics, devices, or other substances is not considered research when it is conducted solely in the course of clinical care, does not involve the systematic collection of safety or efficacy data, and is limited to the prevention, diagnosis, mitigation, treatment, or cure of disease in affected individuals. | No |
| Oral History | Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected.
Learn more about this topic: |
No |
| Program Evaluation or Quality Assurance | Program evaluation assesses the effectiveness of a program using data to determine if goals are met and to guide improvements. It does not test hypotheses or involve experimental interventions. Data collected solely to improve or inform programs – such as teaching evaluations or customer service surveys – typically does not qualify as research.
Quality assurance ensures that processes and procedures meet established standards, emphasizing compliance and operational integrity. These activities aim to improve local systems and are not typically designed to produce generalizable knowledge. Examples include curriculum reviews or compliance checks. Learn more about this topic: |
Yes, a Request for Non-Human Subject Research Review (page 1, question 4 of the New Study Application). |
| Quality Improvement Project – Health Care Improvement | Health care improvement projects that do not meet the federal definition of research (45 CFR 46) do not require IRB review. These (non-research) projects may be published, although the word “research” should not be used to describe the project.
The Health Care Improvement Self-Assessment Tool is a brief series of questions designed to help faculty and improvement teams quickly determine if their improvement effort is subject to Institutional Review Board (IRB) review. If a project starts as a local quality improvement project but the findings are of interest and the project investigator chooses to expand the findings into a human subjects research study, IRB review is required at that time. Learn more about this topic: |
No, if the self-assessment tool indicates that the project is not research, IRB review is not required. |
| Research Involving Only Decedents’ Identifiable Information
|
Research involving identifiable data from individuals who are deceased requires IRB review to obtain a HIPAA authorization waiver for review of identifiable protected health information (PHI). The Research on Decedents’ Information (HIPAA) Form must be approved prior to conducting this activity. | Yes, complete the Research on Decedents’ Information (HIPAA) Form and send to irb@hsc.utah.edu. |
| Research Preparation
|
Access to Protected Health Information (PHI) to design a research study or to assess the feasibility of conducting a study requires IRB approval prior to beginning research preparation. Note, contacting prospective participants for prep to research activities (feasibility) is not permitted. The Research Preparation Form must be approved prior to beginning research preparation. | Yes, complete the Research Preparation Form and send to irb@hsc.utah.edu. |
| Repositories – data, specimens, etc. | Building or maintaining a registry or database for current or future research purposes requires IRB approval. Using identifiable data from any database or registry for research purposes needs IRB approval.
The IRB considers each project on a case-by-case basis and will apply the appropriate human research protection regulations and HIPAA regulations, as applicable. Some projects may not be considered human subjects research but still be subject to HIPAA privacy regulations. Learn more about this topic: |
Yes |
| Secondary Analysis of Public-Use Datasets | The University of Utah IRB has a list of datasets/repositories that it has found to be stripped of identifiers and which is publicly available. As a result, research using this data does not rise to level of “human subject research”.
Research projects involving analysis of secondary data from these pre-approved, publicly available datasets/repositories do not require prior University of Utah IRB approval. Researchers wishing to conduct analysis of secondary data from a dataset or repository that is not on the pre-approved list are invited to submit a Request for Non-Human Subject Research Review. Note: if using a limited-data set, it is human subjects research, and a full IRB application should be submitted. Learn more about this topic: |
Research involving analysis of secondary data from pre-approved, publicly available datasets/repositories do not require prior IRB Approval.
If the research involves a de-identified dataset that is not pre-approved, submit a Request for Non-Human Subject Research Review (page 1, question 4 of the New Study Application). |
Please contact the IRB Office at (801) 581-3655 or irb@hsc.utah.edu for additional guidance.