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Human Subjects Division (HSD)


About the IRB


Research involving human subjects must be reviewed and approved by an Institutional Review Board (IRB). At the UW, several IRB committees serve this function. The Human Subjects Division (HSD) provides administrative support, makes regulatory determinations and facilitates IRB review; assisting researchers throughout the process.


HSD staff have the authority to make specific determinations:

  • that activity IS or IS NOT research and/or involving human subjects, or
  • that research qualifies for exemption.

The IRB has the authority to take the following actions related to human subjects research:

  • Approve
  • Conditionally Approve
  • Require Modifications
  • Defer
  • Disapprove
  • Terminate or suspend some or all parts of a study

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).

  • How do I get involved in a research study?

    There are many ways to find out about research studies. If you have a specific interest, such as a certain disease, condition, or topic, the internet is a tremendous resource. Many college and university departments will also list studies that are going on and how to participate on their departmental web sites.

    As you proceed towards involvement, ask lots of questions about the study and what participation might mean for you.

  • If I am a student, do I have to participate if it is a class or program requirement?

    Yes, and no...

    Please see OHRP guidance on this issue

  • What are some good questions to ask before deciding to participate?

    What are some good questions to ask before deciding to participate?

    • Where will the research take place? How do I get there?
    • How long will it last? How much of my time will it take?
    • What exactly will happen to me in the research?
    • What are the potential risks? How likely are they to occur?
    • Is participating in the study likely to benefit me? Will the study benefit others?
    • Are there other options – such as alternative procedures or treatments besides the ones being studied? How do the alternatives compare with this study?
    • How will my privacy be protected? Can anyone find out that I am participating in this study?
    • Will I have to pay for any of the study procedures or treatments? If so, how much? Will my insurance pay?
    • When I am in the study, will the researchers work with my regular caregiver or doctor or teacher?
    • What if I am harmed by the study?
    • Will I be paid for participating in the study? What if I drop out of the study before it’s over?
    • Whom do I call if I have questions or problems?
  • What is an IRB and who are its members?

    An Institutional Review Board (IRB) is the group or committee that is given the responsibility by an institution to review that institution’s research projects involving human participants. The primary purpose of the IRB review is to assure that the safety, rights, and welfare of the human participants are protected.

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