When is IRB review and approval needed?

Determination of Engagement in Human Subjects Research

When deciding if a research project will require a determination of exemption or IRB review and approval, 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 (ohrirb@gwu.edu). 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 PIs determine if research requires submission to the OHR

  1. Human Subject Research Determination Worksheet
  2. List of Variables Example (tool when submitting a Determination request). 
  3. FDA Human Subject Research Determination Worksheet (for clinical investigations that involve submission of data to the FDA).

Milken Institute School of Public Health Researchers