Please use this flow chart to ask yourself important questions about your project and IRB review:

PART 1: is your project "research" and does it involve "human subjects"?

  • Research = a systematic investigation designed to develop or contribute to generalizable knowledge.
    (Note: An investigator may be a faculty member, student, or staff person. It does not matter whether you intend to publish the results or in what form.)

  • Human Subject = a living individual about whom an investigator conducting research obtains:
    (1) data through intervention or interaction, or
    (2) identifiable private information

⇒ If your project is Research and involves Human Subjects, proceed to PART 2. IRB Review is required.

⇒ If your project does not meet one or both of the above definitions, IRB review does not apply to this project. You are still responsible for abiding by ethical principles, including informed consent, protection of confidentiality, and minimization of potential risk or harm to human participants. We encourage you to make use of the resources on this site and to consult with IRB members if you have further questions.

 

PART 2: might your research qualify for exemption?

Note that exemption is a formal status, regulated by the US Department of Health and Human Services, under the Code of Federal Regulations (45 CFR part 46), and must be determined by the IRB, not by the investigator. The following will help inform what information you submit to the IRB so that it can make this determination.

  • Participation involves no risk or minimal risk (i.e., physical and/or mental harm or discomfort is anticipated to be no greater than ordinarily encountered in daily life)
 True
or
False
  • Subjects can give free and informed consent (i.e., they are not minors, are not prisoners, are not under coercion, and can fully understand the nature of the research, potential risks, and potential benefits)
 True
or
False
  • Release of data can cause NO potential harm to subjects (i.e., if identifiable data were released, subpoenaed, or if subjects' identities were deduced, this would cause NO legal or financial harm, nor would it damage their reputation, employability or personal or business relationships).
 True
or
False

⇒ If you answered "TRUE" to all of the above conditions, proceed to PART 3.

⇒ If you answered "FALSE" to any of the above, or if you are not sure, use the "IRB Proposal Form" to request IRB review of your research.

 

PART 3: might your research qualify for exemption?

  • The research is in an educational setting and involves only normal educational practices (e.g., instructional techniques or strategies, curricula, classroom management).
True
False
  • The research involves only the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior
    AND
    the research does NOT involve elected or appointed public officials or candidates for public office.
True
or
False
  • The research involves only the collection or study of existing data, documents, records, or specimens
    AND
    the information is either publically available OR recorded in such a manner that subjects cannot be identified, directly or indirectly.
True
or
False

⇒ If you answered "True" to one or more of the above in Part 3, use the "IRB Exemption Form" to request IRB determination of exempt status.

⇒ If you are not sure, or if you answered "FALSE" to all of the above, use the "IRB Proposal Form" to request IRB review of your research.