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Institutional Review Board (IRB)

Human Subject Research

A human subject is a living person about whom an investigator obtains either

It also includes

  • data obtained from surveys – even if the data is recorded without identifiers.
  • data obtained from observation – even if the data is recorded without identifiers.
  • data obtained from third parties – collecting information about family members make them subjects.

Federal requirements to protect human subjects may apply to research on human specimens (such as cells, blood, and urine), residual diagnostic specimens, and medical information. Research involving existing data, documents, records, pathological specimens, diagnostic specimens, or tissues that are individually identifiable is considered “research involving human subjects.”. (45 CFR 46)

Human Subject+Research=Human Subjects Search

Research about deceased people does not meet the federal definition of research with human subjects.