CWRU IRB Guidance on NHSR

In an effort to reduce burden on researchers, the CWRU IRB is no longer requiring investigators to submit IRB protocols for projects considered to be “not human subject research” (NHSR). Please use the criteria below as guidance. If one or more of the categories applies to your project, please contact Kim Volarcik in the IRB Office at 368-0134 to confirm the determination of NHSR before proceeding.

For student projects that may not be considered human subjects research, Responsible Investigators may still have their students submit NHSR protocols to the IRB, if they would like for them to experience the IRB process.

  1. It is solely for purposes of quality assurance or improvement, and is not intended as generalizable knowledge. (Please note, QA/QI can have a research component, if so, it does not qualify as NHR) Please consult this checklist for non-binding guidance.
  2. It includes neither interaction with living individuals (including online), nor access to or collection of private, identifiable information about living individuals that is not publicly available. Please refer to HIPAA safe harbor rule for 18 elements of identifiers.
  3. It is a case report of no more than 3 individuals. (Case series of more than three people do not qualify.)
  4. It is a scholarly and journalistic activity (e.g., oral history, journalism, biography, literary criticism legal research, and historical scholarship), including the collection and use of information, that focuses directly on the specific individuals about whom the information is collected.
  5. It a public health surveillance activity, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority (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).
  6. It is 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.
  7. It is authorized operational activities in support of intelligence, homeland security, defense, or other national security missions.