Under certain specific circumstances, the IRB may determine that a research activity does not constitute human subject research (e.g., research involving only coded private information, secondary analysis of de-identified samples).
In October 2008 the Department of Health and Human Services and the Office for Human Research Protections (OHRP) revised and updated specific guidance regarding whether the use of coded private information or specimens is or is not considered research involving human subjects, as defined under regulations for the protection of human research subjects (45 CFR part 46).
If you think your research project does not constitute human subject research, submit a detailed letter to the IRB office explaining the project. Please be certain to include a copy of the grant, etc., if applicable. The IRB Chair, Vice-Chair, or designee will review the submission, and a determination letter will be sent to the Principal Investigator.
Please note: The Principal Investigator should not make the final determination as to whether a project constitutes human subject research or not; that determination may only be made by the IRB.
