Anesthesiology & Pain Medicine >> Research >> Institutional Review Board (IRB) Approval >> Steps for Conducting Clinical Research
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Institutional Review Board (IRB) Approval Information
Steps

Steps For Conducting Clinical Research

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  • STEP 1: Design Excellent Clinical Research

    Designing excellent clinical research takes experience and a good mentor is always helpful. However, a great place to start is to follow the guidelines laid out by the CONSORT and STROBE statements.

    CONSORT Statement
    The CONSORT (CONsolidated Standard for Reporting Trials) Statement consists of a set of recommendations for reporting randomized controlled trials (RCTs). It is a good idea to consider these recommendations when you are designing and launching your study.
    Click here to access the CONSORT Statement.
    STROBE Statement
    The STROBE (STrengthening the Reporting of Observational studies in Epidemiology) Statement consists of a checklist of items that should be included in reports of observational studies (cohort, case-control, and cross-sectional studies).
    Click here to access the STROBE Statement.

  • STEP 2: Researcher Preparation

    1. Determine if your research requires UW IRB review. Please keep in mind that it is best to error on the conservative side. If you fail to obtain IRB approval when it is needed, you will not be able to publish your research!
    2. Determine if the UW IRB is the right IRB for review.
    3. Determine which applications to use.

  • STEP 3: Departmental Review & Approval

    Submit any materials that will eventually go to the UW IRB to Lisa Flint (206-543-7817; lyflint@uw.edu) for departmental review and approval. Dr. Domino assigns faculty reviewers and reviews all materials and responses.

  • STEP 4: IRB Review & Determinations/Actions

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

  • STEP 5: Conduct of Research & Reporting

    If anything needs to change - complete and submit a "Modification Form" to the IRB. Approval must be received before the change is implemented.

    If there are any problems with the research, inform the IRB using a "Problem Report Form" as soon as possible (in some cases, this must be done within a specific time frame).

  • STEP 6: Continuing Review

    Once approved by the IRB, the research must be reviewed at least annually.* This involves the preparation and submission to HSD of a "Status Report Form" at least 6-weeks before the anniversary of the last IRB approval.

    *The IRB can require review more frequently where there are specific concerns. Exempt research does not need to undergo continuing review.

  • STEP 7: Ending the Study

    Please remember to keep the Department informed of all active IRBs, renewals, and when terminated.

    If all research-related activities with human subjects have been completed, and all data collection and analysis of identifiable private information described in the IRB-approved research plan have been finished, then the human subjects research study has been completed.

    When a human subjects research study has been completed, the investigators no longer are required to obtain continuing review and approval of that study by the IRB. UW researchers should inform the IRB that a study has ended by selecting "CLOSE IRB Application" on the "Status Report Form" that is submitted following the end of the study.

    Once a study has been completed, investigators may keep the data they collected, including identifiable private data, if consistent with the IRB-approved research plan. Investigators should continue to honor any confidentiality protections of the data, as well as any other commitments that were agreed to as part of the approved research (e.g., providing information about the study results to research subjects, or honoring commitments for compensation for research participation).