Submission of this form is only required prior to use of human data or specimens that are coded, de-identified, or publicly-available, or derived from Social Media, and the investigator believes their use does not constitute Human Subjects Research (HSR).

The HARC Office will review submissions and make a determination of whether the use meets the regulatory definition of HSR in order to comply with the DOE Order for Protection of Human Research Subjects 443.1C.chg1. When applicable, investigators will then receive Not HSR determination letters as proof of appropriate review.