Research activities that do not meet the definition of human subjects research in the HHS/FDA regulations may qualify for the designation of “Not Human Subjects Research” (NHSR). For example, an activity might not be human subjects research because:
The IRB will provide a determination about whether an activity is human subjects research when there is uncertainty about whether the activity is research (e.g., quality improvement activities, program evaluations, and public health investigations).
Research activities that may meet the criteria for NHSR include use of cadaveric materials; outdated blood products (from the Red Cross or other blood banks); or certain biological specimens if they meet the requirements outlined in the Application for “Not Human Subjects Research Designation.”
Research involving other items that originated in human beings (e.g., specimens) or will be derived from items that originated in human beings (e.g., cell culture) is reviewed as described in the sections on Exemption, Expedited, or Convened review.
Only the IRB can designate research
as Not Human Subjects Research.
To apply for the NHSR designation, the investigator must submit the original (signed) Application for “Not Human Subjects Research” Designation. Additional application requirements are determined by specific protocols: