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Institutional Review Board

About the IRB

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What Is the Institutional Review Board?

The Institutional Review Board (IRB) is a hospital-based committee established to protect the rights and welfare of the children and families who participate in research activities conducted under the auspices of Children's and affiliated research organizations.

The IRB reports to the president of the research institute.

View our institutional authority page (PDF).

Responsibilities

The IRB is responsible for ensuring that basic ethical principles as well as federal regulations, state law and institutional policy governing the protection of research participants are applied to research activities.

The IRB is authorized to approve, require modification of or disapprove all research activities that fall within its jurisdiction.

The Office for Human Research Protections (OHRP), a branch of the U.S. Department of Health and Human Services, has granted Children's the authority to perform these activities under the hospital's Federalwide Assurance Number, FWA00002443.

Membership

IRB members are appointed by the hospital's medical director. A broad representation of pediatric specialties is found among the scientific members, including medicine/pediatrics, nursing, surgery, anesthesiology, child psychiatry, pharmacy, laboratory medicine, social work and biostatistics.

In addition to the scientific members, the IRB includes non-scientists, as required by federal regulation. Non-scientist members include representatives from Pastoral Care and Interpreter Services and members from the community who are not affiliated with Children's.

Cooperative Review Agreements

Children's has cooperative agreements with the following local institutions:

  • University of Washington
  • Fred Hutchinson Cancer Research Center
  • Group Health Cooperative
  • Multicare Health System (Mary Bridge Children's Hospital)

These agreements establish IRB review procedures for research involving the respective institutions. Research that can be reviewed under these cooperative agreements can reduce the need for duplicate IRB review.

University of Washington

The agreement with the University of Washington allows researchers to use Children's IRB for research that involves both institutions.

The University of Washington will accept Children's IRB review and the researcher does not need to apply for separate IRB approval at the University of Washington.

If Children's researchers with joint appointments at the University of Washington receive funds through the university for a research project that is wholly conducted at the university (does not involve Children's patients or facilities), the research is reviewed by one of the university's IRBs.

Fred Hutchinson Cancer Research Center

Children's cooperative review agreement with Fred Hutchinson Cancer Research Center was amended in July 1999 with the establishment of the Seattle Cancer Care Alliance.

Under the Alliance, pediatric bone marrow and stem cell transplants are done at Children's. Under this cooperative agreement, Children's accepts the review of the Fred Hutchinson Cancer Research Center's IRB for studies that involve children receiving bone marrow or stem cell transplants.

Group Health Cooperative and Multicare Health System (Mary Bridge Children's Hospital)

The cooperative agreements with Group Health Cooperative and Multicare Health System are limited to cooperative group protocols sponsored by the National Cancer Institute (NCI).

These studies are referred to as Children's Cancer Group (CCG), Children's Oncology Group (COG) or Pediatric Oncology Group (POG) protocols. Group Health Cooperative and Multicare Health System send IRB representatives to the Children's IRB meeting when NCI cooperative group protocols are being reviewed.

Group Health Cooperative and Multicare Health System accept Children's IRB review for these protocols.

Federalwide Assurance

Children's IRB has a Federalwide Assurance (FWA) on file with the federal Office for Human Research Protections (OHRP).

This assurance is an agreement between Children's and the OHRP, which acts on behalf of the Secretary of Health and Human Services.

The FWA outlines the principles and guidelines that govern the institution, faculty and staff in the protection of the rights and welfare of the participants in the research conducted at or sponsored by Children's, regardless of the source of the funding.

If you are conducting research at Children's, see Responsibilities While Conducting Research at Children's.

Children's FWA number is FWA00002443. (For our current FWA expiration date, please visit the OHRP database.)

Children's IRB number is IRB00000277.

Children's IORG number is IORG0000167. 

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