Projects that meet the regulatory definitions of both "research" and "human subjects" are considered Human Subjects Research (HSR) and require IRB review or an official exemption determination. If your activity does not meet both criteria, IRB oversight is typically not required.

If you are unsure whether your project qualifies as Human Subjects Research, or you need documentation for funding or publication, please complete the HSR Determination Worksheet via DocuSign. The IRB is responsible for making the final determination per federal regulations.

*Western SARE applicants: Do not fill out the DocuSign version. Instead, submit this worksheet with your proposal materials to Western SARE. Download HSR Determination Worksheet.

 

1) Is your project "Research"?

Under 45 CFR 46.102(I) (Common Rule), research is defined as:

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

  • A systematic investigation is a prospective plan that involves data collection and analysis to answer a research question or test a hypothesis. This includes interventional studies, surveys, interviews, program evaluations, or observational methods.
  • Generalizable knowledge is information intended to apply beyond the specific population or context being studies--often through publication, presentation, or the development of policy, theory, or practice.

If your project lacks a formal plan, is not intended to be broadly applicable, or is solely for internal use, it may not meet the definition of research under the Common Rule.

 

2) Does your project involve "Human Subjects"?

Per 45 CFR 46.102(e), a human subject is defined as:

"A living individual about whom an investigator (whether professional or student) 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 or manipulations of the subject or their environment for research purposes.

Interaction includes communication or interpersonal contact between the investigator and subject.

Identifiable Private Information is data for which the identity of the subject is or may readily be ascertained by the investigator.

 

For more definitions, see the Human Subjects Research Glossary

 

Activities That Typically Do Not Qualify as Human Subjects Research

Some activities do not meet the definition of "research" or do not involve "human subjects" as defined by federal regulations. These may include:

  1. Journalism or documentary projects

  2. Biographies or literary criticism

  3. Legal research

  4. Oral histories or historical scholarship focused on specific individuals (without generalizable intent)

  5. Public health surveillance conducted under a public health authority

  6. Criminal justice agency activities for investigative or prosecutorial functions

  7. Certain in-class only projects

  8. Internal Quality Improvement (QI) and Quality Assessment (QA) activities

 

Note: Some projects may involve both research and quality assessment. In such cases, IRB review may still be required.

 

Need Help?

View our guidance on Program Evaluation.

Complete the HSR Determination Worksheet via DocuSign for an official determination

Email the IRB office at IRB@montana.edu with any questions