The initial responsibility to seek guidance for determination on whether an activity or research project constitutes human subject research rests with the investigator. The investigator should seek this guidance from the HRPP to make a determination about the activity or research project based on the definitions of “human subject” and “research” (see Section 1.3). For guidance on whether an activity or research project constitutes human subjects research, investigators should use the Evaluate My Project tool on the HRPP website. 

Investigators will be held responsible if they do not seek an unbiased determination on the activity or research project and should therefore retain the determination letter from the Evaluate My Project tool as documentation for confirmation. When research involves the use of coded private information or specimens, and the investigator makes an initial determination that the research does not include “human subjects”, the investigator must request confirmation in writing from the appropriate IRB office. All requests must include a sufficient description of the activity and the rationale for the investigator’s initial determination.

 Determinations on whether an activity constitutes human subject research will be made according to the definitions in Section 1.3 of this document. Determinations regarding activities that are either clearly human subject research or clearly not human subject research, may be made by an experienced IRB staff member. Determinations regarding less clear-cut activities will be referred to the IRB Chair, sub-committee, or IO/IO designee.

Documentation of all determinations made through the IRB Office will be recorded and maintained in the IRB Office. Email and other written requests will be responded to in writing and a copy of the submitted materials and determination letter/email will be kept on file.