IRB Proposal Decision Tree
Question 1: Does this research involve human participants?
- If YES, then proceed to question 2.
- If NO, then do not submit an IRB research proposal.
Question 2: Is this research? Research is defined by HHS as “a systematic investigation designed to develop or contribute to generalizable knowledge” [45 CFR 46.102(d)]. Please see the Faculty Assurance Form for Classroom Projects for a more detailed description.
- If YES, proceed to question 3.
- If NO, then do not submit an IRB research proposal. Instructors should complete and submit the Faculty Assurance Form for Classroom Projects.
Question 3: Does the project involve vulnerable populations* or greater than minimal risk to participants?
- If YES, then complete researcher training and submit an IRB proposal at least one week prior to a scheduled IRB meeting. The proposal will undergo full Board review.
- If NO, then proceed to Question 4.
Question 4: Will this research be presented or published outside the classroom, including thesis publication?
- If YES, then complete researcher training and submit an IRB proposal at any time for expedited review by the IRB.
- If NO, then this qualifies as a classroom research project. The instructor should complete and submit the Faculty Assurance Form for Classroom Projects.
Additional Decision Tree Resources
- The U.S. Department of Health and Human Services (HHS) maintains helpful Human Subject Regulations Decision Charts that provide additional details to aid your planning. You may also wish to visit the HHS Guidance page.
*Vulnerable Populations
*Students under the age of 18 participating in educational research are not considered vulnerable populations, provided that the research is conducted in established or commonly accepted educational settings and involves normal educational practices.
Read more on vulnerable populations using the NIH links below:
