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Scientific research has produced substantial social benefits and posed some troubling ethical questions. Some dates important in the development of institutional review boards, or IRBs, include the following:
Today, four IRBs review biomedical and behavioral research involving human subjects at Fred Hutch. The IRBs review all research submitted by Fred Hutch and the Fred Hutch/University of Washington Cancer Consortium. The Fred Hutch IRBs review any research project involving research participants, regardless of its funding source.
Fred Hutch IRBs review and approve research in accordance with U.S. Department of Health and Human Services regulations at 45 CFR 46. In addition, for studies involving products regulated by the U.S. Food and Drug Administration, the Fred Hutch IRBs comply with the requirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312 and 21 CFR 812.
The chairs of each IRB are:
The Institutional Review Office, or IRO, administers all activities requiring IRB review. The IRO reports directly to the Office of the Director of Fred Hutch.
Fred Hutch IRB meetings are held four times per month. View the schedule of meetings and submission deadlines.
The purpose of IRB review is to ensure that ethical standards for the care and protection of human subjects have been established and that research activities are in compliance with all pertinent regulations (federal, state and local) and with Fred Hutch policy.
The term "human subjects" may include the following:
In addition, the term "human subject" is not limited to activities involving the intact human, but extends to activities involving the use of human embryos, fetuses, abortuses, organs, tissues, body fluids, or graphic written or recorded information.
A Fred Hutch IRB must review and approve all research activities, or protocols, prior to implementation if they meet the following criteria:
In addition, researchers must submit for review and approval all amendments and revisions to ongoing, approved activities prior to implementation. Cooperative review at other institutions may be acceptable under specific conditions.
IRB review includes the following process steps:
Activities cannot be implemented, nor Certificates of Approval signed, until the IRB has issued approval and all required modifications have been confirmed complete.
Fred Hutch IRBs approve research based on the determination that the following requirements have been satisfied:
Except for studies determined to be exempt or Not Human Subjects, a Fred Hutch IRB must review all activities at least once annually. The IRO notifies PIs approximately 10 weeks prior to annual review dates.
Any grant, fellowship or contract application (new or renewal, competing or noncompeting) submitted to a funding agency must include an indication of IRB approval for all activities proposing the use of human subjects. Grants are signed indicating IRB approval as "pending" only if IRB application information is in the IRO awaiting either agenda assignment or final approval.
A 60-day follow-up period (from the date of the grant application submission) is allowed to complete the IRB review. It is the PI's responsibility to insure that all forms and other documents are submitted to the IRB so that review may be completed within the 60-day period.
Once completed, the IRB office will send a copy of the subsequent (or follow-up) Certification of Approval to the PI and the Office of Sponsored Research, which will forward a copy to the appropriate agency.
Please direct questions or concerns about human subjects regulations, FDA regulations on investigational new drugs or devices, emergency treatment acknowledgements, or other policies and procedures involving human subjects to an IRB analyst.