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Office of Research & Sponsored Programs

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Research Integrity & Education

Does My Project Need IRB Review?

All research projects that meet the definition of human subjects research must submit their proposal to the IRB office. 

You have two options for submitting your research proposal:

     Option 1: If human subjects research, fill out formal IRB application via IRBNet.

     Option 2: If not human subjects research, fill out the Human Subjects Research (HSR) Determination Form (formerly Appendix E) and email to

is my project human subjects research?
  • Research  is defined in the Code of Federal Regulations, 45 CFR 46.102(d), as a systematic investigation designed to develop or contribute to generalizable knowledge. 
  • Human subject is defined in the Code of Federal Regulations as "a living individual about whom an investigator conducting research 1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR 2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

*ALL HUMAN SUBJECTS RESEARCH MUST OBTAIN IRB APPROVAL PRIOR TO STUDY ACTIVITIES (that includes obtaining participants, emailing participants, or displaying recruitment materials)

I'm still not sure...

If you are still not sure if your project qualifies as human subject research, please follow these steps:

Step 1: Fill out Assessing Your Project. (If you are a student investigator, discuss with your faculty sponsor.)

Step 2: If you assess your project as NOT human subjects research, you are strongly encouraged to complete the Human Subjects Research (HSR) Determination Form (formerly Appendix E) for documentation.

  • Please submit the form directly to: Within 10 business days, a review will be conducted and a formal letter will be issued from the DU IRB stating whether a project meets the definition of human subject research. 
  • For Program Evaluation Projects: Complete the Human Subjects Research (HSR) Determination Form (formerly Appendix E) for documentation purposes. 

Step 3: If you are still unable to make a determination, please contact the IRB office for a consultation.

DU investigators are encouraged to submit their proposed research to the IRB for ethical and regulatory review. The IRB will provide the necessary documentation by issuing formal IRB determination letter for professional and academic endeavors.


Examples of Activities Determining Whether IRB Review is Required