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Human Subjects Division (HSD)

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IRB Review Types

Research is reviewed according to the potential level of risk to subjects, federal regulatory guidelines, and stage of the research.

  • Exemption
  • Minimal Risk ("Expedited")
  • Full IRB
  • Modification
  • Continuing Review
  • Non-compliance
  • Adverse Events/Unanticipated Problems

Related Questions And Answers

  • Does all research go through the same review process?

    No. There are three types of research, each of which receives a different level of review.

    1. Exempt Research

      The University of Washington applies the federal regulations and guidance about exemption to all UW human subjects research, regardless of funding or funding source. The staff of the Human Subjects Division (HSD) are the only individuals authorized to determine that research activity is exempt from federal regulations. In addition to the federal criteria, HSD requires that exempt research involve no more than minimal risk and that interactions with subjects must include some type of consent process that provides the subjects with basic information about the research.

      Researchers do not have the authority to determine that their own research qualifies for exempt status. The research may not begin until the researcher has received notification from HSD that the research qualifies for exemption. Exempt status is granted for a five-year period.

    2. Minimal Risk Research

      Research falling into minimal risk categories is reviewed by a subcommittee of the IRB (use form UW 13-11). You may also hear the term "expedited review" used in conjunction with the review of minimal risk research; describing the ability of the research to be reviewed by a subcommittee - not that the review process is necessarily faster.

    3. More than Minimal Risk Research

      Research falling into categories considered to be of more than minimal risk requires review by the full Committee (use form UW 13-11).