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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. Only the IRB can designate research as Not Human Subjects Research.

Research activities that may meet the criteria for NHSR include use of cadaveric materials or data; outdated blood products (from the Red Cross or other blood banks); deidentified data or specimens from an existing study, from a non-research source, or from a publicly available repository if they meet the requirements. If you are using data from a publicly available source, you must provide the web site URL or other documentation from the source in order for the OIRB to verify it is available to the general public.

Quality improvement projects and program evaluations may not be considered human subjects research; however, UAB policy requires the OIRB to make that determination.

When all of the conditions are met, the four activities listed in 45 CFR 46.102(l)(1-4) of the 2018 Revised Common Rule have been deemed to not be activities that are human subjects research.

For purposes of this part, the following activities are deemed not to be research:

  • (1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  • (2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  • (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

 For information about Case Reports see the UAB HRPP Policy on Case Reports – POL043

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.

Application Requirements

To apply for the NHSR designation, the investigator must submit an initial application through IRAP, using the IRB ePortfolio. 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 person who has the authority in the Department responsible for providing the specimens should sign the approval letter. The letter should state they agree to provide the specimens and if they are de-identified or, if coded, the source will not break the code enabling the PI to readily ascertain the identity of the individuals. 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 the investigator to submit a new application electronically.

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.