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Human Subjects Division (HSD)


Researcher Preparation

Do my activities need IRB review?

Faculty, staff, or students at the UW who plan to conduct research that involves people (human subjects - directly, through records, or other data or specimens) are likely to need IRB review and approval before starting the research. Some activities may not require IRB review, although they may seem to be research with human subjects, such as class assignments, program evaluation, or quality assurance/improvement efforts. If you are uncertain if the activities you are planning require review, contact the Human Subjects Division.

Is the UW the right IRB for review?

The UW IRB reviews the majority of human subjects research conducted by UW researchers.

There are exceptions:

  • Industry-sponsored and -initiated clinical trials >> Western IRB (WIRB)
  • Research with one of three state agencies - DSHS, DOH, and L&I >>Washington State IRB (WSIRB)
  • Cancer research >> Cancer Consortium IRB (CC-IRB)
  • Research at an institution/organization with which the UW IRB has a Cooperative Agreement, for example . . .
    • Seattle Children’s Hospital
    • Virginia Mason Med.Ctr./Benaroya Research Institute
    • Group Health Cooperative
    • Swedish Medical Center

Which application should I use?

Most research reviewed by the UW IRB is submitted using the Standard IRB Application. Other options include the applications for Exempt determinations, Use of Identifiable Data/Specimens, and Repositories. If your research will be reviewed by another IRB - check their web sites and instructions.

Change Notes

  • Noted 07/29/2010 @ 04:28pm
    Keyword newly added.
    - selsayed

Related Questions And Answers

  • 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.
  • What is research?

    "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute "research" for the purposes of the regulations that guide and govern how research is conducted in the United States, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. It may be important to understand the following about research:

    • It is basically a study that is done to answer a question.
    • Scientists do research because they don't know for sure what works best or to better understand why or how things happen.
    • Some other words that describe research are clinical trial, protocol, survey, or experiment.
    • Research is not the same as treatment.