Does Your Project Need IRB Review?

Portland State University’s Human Research Protection Program (HRPP) protects the rights, safety, and welfare of individuals participating in research conducted under the auspices of PSU.

All human subjects research conducted by PSU faculty, staff, or students must be reviewed and approved before the study begins.

Quick Access Resources:

Consult this table for further guidance: Comparison of research versus non-research activities

Review this document for examples of projects that do and do not require IRB review

Start Here: Quick Determination

Use this quick guide before reviewing the full definitions below.

Step 1: Is it Research?

Research
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

In simpler terms:

• Are you following a structured plan to answer a question?

• Are you trying to produce findings that apply beyond your specific setting?

Step 2: Does it involve Human Subjects?

Human subject
A living individual about whom an investigator (whether professional or student) conducting research:

• • Obtains information or biospecimens through intervention or interaction, or

  • Obtains or uses identifiable private information or identifiable biospecimens

In simpler terms:

• Are you interacting with people (e.g., surveys, interviews)?

• Or using data that can be linked back to identifiable individuals?

Outcome

• If YES to both --> IRB Review is  required

• If unsure --> submit determination request in Kuali or meet with our HRPP staff during office hours.

If your project is being conducted solely for a course, internal improvement, or program evaluation, it may not require IRB review—but a determination is recommended. 

Definitions and Examples

What Counts As Research

As defined by 45 CFR 46.102(l) (the Common Rule)

Is it a systematic investigation? 

This is typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. A scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective(s) and a set of procedures intended to reach the objective(s), i.e., to acquire knowledge, develop a theory, or to answer a question.

Examples include: 

• Observational studies 

• Interview or survey studies 

• Group comparison studies 

• Test development 

• Interventional research

Not typically systematic investigations: 

• Oral history

• Journalism

• Phenomenological activities

Grey Area:

• Program evaluations – design and intent are determining factors

Is it generalizable knowledge?

The intent or purpose of the systematic investigation is dissemination of findings (publication or presentation) outside of OSU.

• Intended to have an impact (theoretical or practical) on others within one’s discipline.

• Dissemination with the intent to influence behavior, practice, theory, future research designs, etc. are contributing to generalizable knowledge.

  • Consider: Would this project be conducted as proposed if the PI knew that he or she would never receive any form of academic recognition for the project, including publication of results or presentation of the project at an academic meeting?

The following activities are NOT research:

As defined by 45 CFR 46.102(I) (The Common Rule)

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.

Public health surveillance activities

Including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. 

Such activities are limited to those necessary to allow a public health authority to:

• identify, monitor, assess, or investigate potential public health signals

• detect onsets of disease outbreaks

• examine conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). 

Such activities include those associated with:

• providing timely situational awareness 

• priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

Criminal Justice Activities

Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

National Security Activities

Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Resources

Consult this table for further guidance: Comparison of research versus non-research activities

Review this document for examples of projects that do and do not require IRB review

If you still are not sure, you can submit some brief details about your project to our program for review and a formal determination.