Does Your Study Need IRB Review?

The Office for Human Research Protections (OHRP) defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 

To meet the threshold for oversight by the Human Research Protection Program (HRPP), a project must include both research and human subjects. 

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. 

Create a submission in Kuali and answer YES to the question Is this a request to determine if this project requires IRB review? You will complete a short form and submit that to our office for review. You will either receive a Not Human Subjects Determination, or be instructed to fill out a complete application for review. 

How do I know if my project meets the federal definition of research?

Research Is:

Systematic investigation

Typically 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.

• Includes: observational studies, interview or survey studies, group comparison studies, test development and interventional research

• Not systematic investigations: oral history, journalism, phenomenological activities

• Gray area: program evaluations – design and intent are determining factors

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:

1. 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.

2. 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, onsets of disease outbreaks, or 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 and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

3. 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.

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

How do I know if my project includes human subjects?

A Human Subject Is:

A living individual about whom an investigator conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

  • Intervention includes physical procedures by which data are gathered and manipulations of the subjects or the subjects’ environment that are performed for research purposes.

  • Interaction includes communication or interpersonal contact between investigator and subjects. The interaction may be as remote as an anonymous, online survey

  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

  • Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

  • Identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.