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Human Subjects Division (HSD)

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Full IRB Review

Research that does not qualify for exempt or minimal risk review undergoes review by the full IRB committee. IRB applications are assigned to a biomedical committee or a social behavioral committee, according to the nature of the risk involved in the study.

Each IRB is required by federal regulations to have at least five members. A primary reviewer is assigned for the review of each Initial Application, Modification, and Status Report; however, all members of the committee review each item that is assigned to the agenda for discussion at an IRB meeting.

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).

  • Does my research require review?

    If you are a faculty or staff member, or a student at the University of Washington, and your research involves the use of human subjects (either directly or through records or other data such as specimens or autopsy materials), your research requires human subjects review and approval before beginning the research.

  • How long does the IRB review process take?

    Multiple factors affect the time required for IRB review. They include:

    • type of application
    • level of review (e.g., exempt, minimal risk, full committee)
    • complexity of the study
    • involvement of other compliance offices or institutions
    • quality and completeness of the application when first submitted

    We encourage researchers to plan for sufficient time for review based on the research and their particular situation. Here are some general recommendations based on HSD's current workload:

    • Allocate adequate preparation time before submission, in most cases a minimum of two weeks to one month.
    • For full IRB review, plan for at least 12 to 16 weeks for the review and approval process.
    • For Minimal Risk review, plan for at least 6 to 8 weeks.
    • For Exempt review, plan for at least 2 to 3 weeks.
  • How long is approval valid?

    Approval is generally valid for one year from the date of Committee approval.

  • What is the IRB review process?

    The “Life Cycle” of a Human Subjects Application can be described as having six phases:

    1. Researcher Preparation
    2. Department Review and Approval
    3. IRB Review and Determinations/Actions
    4. Conduct of Research and Reporting
    5. Continuing Review
    6. Ending the Study

    A diagram of the Human Subjects Application Life Cycle describes what happens within each phase.