What criterion would exclude a study from being considered as research involving human subjects?

A study would be considered to not involve human subjects if data is obtained solely from historical archives. This criterion is based on the definition of human subjects, which pertains to research involving living individuals from whom data is collected through interaction or intervention, or through identifiable private information.

When historical archives are used, the data generally comes from records created in the past and does not involve current interaction or engagement with living individuals. This means that the research does not meet the regulatory criteria that focus on the rights and welfare of participants. Consequently, the lack of involvement of living individuals in the study mitigates the ethical considerations typically associated with research involving human subjects. This distinction is vital for ensuring that privacy and ethical principles are upheld in research practices.