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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:

  • In August 1947, during the Nuremburg War Crime Trials at the conclusion of World War II, the Nuremburg Code was drafted as a set of standards for judging those involved in reported abuses of human research subjects. It became the prototype for later efforts to ensure the protection of human subjects in research.
  • On July 12, 1974, the National Research Act established the existence of IRBs to review biomedical and behavioral research involving human subjects.
  • In March 1983, federal regulations detailing the basic U.S. Department of Health and Human Services policy for the protection of human research subjects were adopted.
  • On August 19, 1991, the 1983 regulations were updated. Known as Title 45, Public Welfare, Part 46, the current regulations provide comprehensively detailed information about the duties and responsibilities of IRBs.

Administration

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:

  • Committee A: Brenda Sandmaier, M.D.
  • Committee B: David Maloney, M.D., Ph.D
  • Committee C: Mark Thornquist, Ph.D.
  • Committee D: Margaret Madeleine, M.P.H., Ph.D.

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.

Purpose of IRB Review

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:

  • Inpatients and outpatients
  • Donors of organs, tissues and services
  • Informants and normal volunteers, including students who are placed at risk during training

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.

Research Activities that Require Review

A Fred Hutch IRB must review and approve all research activities, or protocols, prior to implementation if they meet the following criteria:

  • The protocols are proposed for use at Fred Hutch
  • The research activities involve human subjects

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.

The IRB Review Process

IRB review includes the following process steps:

  • Applicants submit all relevant materials (such as consent forms, approach letters, questionnaires) in the appropriate number of copies as indicated in the packet. To apply for IRB review for any new protocol or activity, follow the appropriate links at this website. Consent form templates (models) are available. (Note that some activities are exempt from IRB review or may qualify for minimal-risk expedited review. Application materials include qualifying conditions.)
  • IRB chairpersons determine review status (for example, exempt, minimal risk or full). However, review status is subject to change.
  • Once the application materials are received, the IRO screens applications for completeness and assigns reviews for the next open IRB meeting agenda.
  • The IRO notifies each principal investigator, or PI, of the agenda assignment and invites the PI to attend the meeting to answer IRB questions.
  • IRBs notify each PI of the review results by formal memorandum. If an IRB requests modifications, PIs must comply or justify in writing why they feel compliance is not necessary prior to the release of final approval documents.
  • If an IRB requests modifications and no response is received within 30 days, the IRB will contact the PI. If, after 15 working days, the IRB receives no response, it will close the activity.

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

Fred Hutch IRBs approve research based on the determination that the following requirements have been satisfied:

  • Risks to subjects are minimized by using procedures that are consistent with sound research design and do not expose subjects to unnecessary risk.
  • Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of knowledge reasonably expected to result.
  • Selection of subjects is equitable.
  • Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
  • Informed consent will be appropriately documented.
  • Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  • Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Continuing Review

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.

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. 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.

Questions Regarding Human Subjects Regulations or Review

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.