Relevant IRB policies/procedures:
Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions.
At the conclusion of World War II, during the Nuremburg War Crime Trials, the Nuremburg code was drafted as a set of standards for judging those involved in reported abuses of human subjects in biomedical experiments. This code became the prototype of later codes designed to ensure the protection of human subjects in research.
On July 12, 1974, the National Research Act established the existence of Institutional Review Boards to review biomedical and behavioral research involving human subjects. In March of 1983, the current Federal regulations detailing the basic Health and Human Services Policy for the protection of human research subjects were adopted and updated August 19,1991. These regulations, known as Title 45, Public Welfare, Part 46, detail more comprehensively the duties and responsibilities of Institutional Review Boards.
At FHCRC, there are 3 Institutional Review Boards:
The purpose of IRB review is to review research activities involving human subjects, 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 FHCRC policy.
The term "human subjects" may include patients, outpatients, donors of organs, tissues and services, informants and normal volunteers, including students who are placed at risk during training. However, 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.
All research activities (protocols) proposed for use at Fred Hutchinson Cancer Research Center by FHCRC staff personnel that involve human subjects must be reviewed and approved by an IRB prior to implementation. In addition, all amendments and/or revisions to ongoing, approved activities must be submitted for review and approval prior to implementation. Cooperative review at other institutions may be acceptable under specific conditions. Contact the Institutional Review Office for more information.
All activities requiring IRB review are administered through the Institutional Review Office. This office reports directly to the Office of the Director of FHCRC. For a listing of IRO staff, functions, and contact information, see the contact page.
IRB meetings are held three times per month. A schedule of meetings and submission deadlines is available online.
Application for review by an IRB for any new protocol or activity is done by clicking on the appropriate item at this web site. All relevant materials, i.e., consent form(s), approach letters, questionnaires, etc., must be submitted in the appropriate number of copies as indicated in the packet. Model consent forms (templates) are available.
An activity may qualify for minimal risk expedited review or be exempt from IRB review. Conditions of qualifications are detailed in the application materials. Final review status determination (i.e., Not Human Subjects, exempt, minimal risk or full) will be made by the IRB Chairperson and once established is subject to change.
There are three IRBs at the FHCRC. They review and approve research in accordance with Department of Health and Human Services (DHHS) regulations at 45 CFR 46. In addition, for studies involving products regulated by the FDA, the FHCRC IRB-01 ("Committee A"), IRB-02 ("Committee B"), and IRB-03 ("Committee C") comply with the requirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812.
Committee A, B, and C review any and all research submitted by FHCRC and the Fred Hutchinson/University of Washington Cancer Consortium. Any research project involving research participants, regardless of its source of funding, is reviewed by one of the IRBs.
Upon receipt in the Review Office, applications are screened for completeness and assigned to the next open agenda. [submission deadlines and meeting dates].
Each Principal Investigator is notified of his/her agenda assignment and invited to attend the meeting to answer IRB questions.
Each Principal Investigator is notified of the results of the meeting by formal memorandum. If modifications are requested, principal investigators must comply or justify in writing why they feel compliance is not necessary prior to final approval documents being released. If modifications are requested and no response is received within thirty days, the Principal Investigator will be contacted. If, after 15 working days, no response has been received the activity will be closed. Activities cannot be implemented, nor Certificates of Approval signed, until the IRB has issued approval and all required modifications have been confirmed complete.
Criteria of Review and Conditions of Approval
The IRB approves research based on the IRB determination that the following requirements have been satisfied:
All activities must be reviewed at least once annually (except for studies determined to be exempt or Not Human Subjects). Each Principal Investigator is notified approximately 10 weeks prior to expiration by the Institutional Review Office. Certifications of Approval
Certifications of Approval
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. The Institutional Official authorized to sign off on funding approval is Karen Hansen, Director, Institutional Review Office, or her designee, James Riddle, IRO Assistant Director. Grants are signed indicating IRB approval as "pending" only if IRB application information is in the Institutional Review Office awaiting either agenda assignment or final approval. A 60-day follow-up period is allowed from the date of the grant application submission to complete the IRB review. It is the Principal Investigator'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 Principal Investigator and the Office of Sponsored Research. Office of Sponsored Research will forward a copy to the appropriate agency.
Questions or concerns about the human subjects regulations, FDA regulations on investigational new drugs or devices, emergency treatment acknowledgements, or other policies and/or procedures involving human subjects should be directed to an IRB Analyst. See the contact page for phone numbers and email addresses.