NHSR Designation

NHSR Designation

Eligibility

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 activity does not meet the DHHS or FDA definition of “research.”
  • The activity meets the DHHS or FDA definition of “research,” but does not meet the corresponding regulatory definition of “human subject.”

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Research activities that may meet the criteria for NHSR include use of cadaveric materials; outdated blood products (from the Red Cross or other blood banks); or certain biological specimens if they meet the requirements outlined in the Application for “Not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.

Decision Trees

OHRP has published a decision tree available online which investigators may use to decide whether the NHSR application is appropriate. This decision tree does not take into account FDA regulations and should not be used for FDA-regulated research.
Only the IRB can designate research
as Not Human Subjects Research.

Application Requirements

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:

  • Specimen release form or approval letter if the investigator will be obtaining pathological or diagnostic specimens. The Chairman of the Department responsible for providing the specimens should sign the approval letter. If specimens are being obtained from the Department of Pathology, include a signed copy of the appropriate form described in Special Approvals under “Release of Pathologic Materials.”
  • Amendments to the NHSR designation are allowed only for changes in personnel. Any other change in the research requires that the investigator file a new application.

Submission

Submit all application materials to the OIRB, in Room 470 of the Administration Building (AB). The Administration Building is located at 701 20th Street South, Birmingham, AL 35294-0104. The review process takes approximately 7-10 working days. Please direct any questions to the OIRB at 934-3789.
There are no deadlines for submission
of the Application for "Not Human Subjects Research" Designation.

Page updated: May 8, 2013