Using human subjects in your research
If your research involves human subjects or is regulated by the Food and Drug Administration (FDA), it requires review and approval from an institutional review board (IRB) or the Human Subjects Office.
Start by answering these questions:
1. Is it human subjects research?
- Is your research a systematic investigation?
- Is the study designed to contribute to generalizable knowledge?
- Do you intend to use the findings for publication or presentation outside of your department or organizations?
- Does it involve collecting information or specimens from living individuals through interaction or interventions?
- Will you collect, use, analyze, or create identifiable information or biospecimens about living individuals?
2. Is it research involving the FDA?
- Does the research involve the study of a drug, biologic, or device for which administration is dictated by the protocol?
- Will research data be reported to the FDA?