When is IRB review and approval needed?
When determining whether a research project meets the definition of Human Subjects Research and needs IRB review, please consult the Human Subject Research Determination Worksheet to help guide you in the decision-making process.
If you are not the Principal Investigator (PI must be a full time, regular GW faculty member), you should first discuss your research with the PI before contacting the OHR. If you are unsure if the project requires review by the OHR or the IRB, you should submit the completed Determination form to the OHR inbox (email@example.com). The OHR will review completed forms upon request.
Note: GW permits PIs to make their own assessments if they are engaged in human subjects research. Determinations only need to be submitted to the OHR if requested by the funder or sponsor or if the PI is unsure if IRB review and approval is required.
These worksheets serve as guides to help you determine if your research project requires submission to the OHR
- Human Subject Research Determination Worksheet (HRP-207)
- List of Variables Example (tool when submitting a Determination request).
- FDA Human Subject Research Determination Worksheet (for clinical investigations that involve submission of data to the FDA).