About Human Subject Research

Human Subject Research

Human subject research is defined as any research study or systematic investigation conducted that involves the use of living individuals about whom a researcher obtains data through interaction or intervention or from whom the researcher obtains identifiable private information that is then used to develop generalizable knowledge.

Systematic investigation involves either qualitative or quantitative data collection and analysis that proposes a research objective and set of procedures intended to acquire knowledge, develop a theory, or answer a research question. Generalizable knowledge has been defined by the Department of Health and Human Services as information transformed into knowledge brought into general use or that can be applied to wider or different contexts.

Common examples of human subject research designed for generalizable knowledge are dissertations, conference presentations, and scholarly publication in addition to any data designed for all-purpose use regardless of its eventual distribution.

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Human Subject Research Criteria

Any scholarly activity that meets any of the following areas must go through IRB review:

  • the intent to publish or present,
  • the intent to develop a doctoral dissertation,
  • the intent to conduct scholarly research outside of the United States,
  • the researcher having access to any type of identifiable private information,
  • data banking of personal informant information for future research purposes,
  • a pilot study,
  • collecting in-person, phone, or Skype surveys, interviews, or observations that have the intent to generalize findings
  • retrospective record review with existing personally identifiable data, including collection of historical controls for regulated studies
  • audio or videotaping individuals in situations when people are not normally expected to be recorded or when people are personally identifiable by voice or by image
  • the intent to conduct an ethnographic study of a group in a natural setting to generate a broader understanding of the group or population
  • the use of online survey research to collect individuals’ data or perceptions to generalize findings
  • classroom activities that are intended to be published or presented in dissertations, conference presentations, or journal publications

Note for studies intended to be on or conducted in University of Phoenix

If the researcher’s expectation is to use the University of Phoenix faculty, staff, or students in the scholarly activity, the researcher should seek Committee on Research (COR) approval first.