Selecting the Right IRB

Is Fred Hutch IRB the Right IRB?

Fred Hutch (FH) is the lead PI’s primary appointment:  Fred Hutch IRB is usually the right IRB for most Fred Hutch research (cancer-related or non-cancer related).

University of Washington (UW) is the lead PI’s primary appointment:  Fred Hutch IRB reviews cancer-related studies on behalf of the University of Washington (UW) if the research is more than minimal risk.

Seattle Children’s (SCH) is the lead PI’s primary appointment:  Fred Hutch IRB is not the right IRB, with very rare exceptions.  Generally, Fred Hutch IRB only reviews on behalf of Seattle Children’s if the lead PI’s primary appointment is Fred Hutch and SCH is also engaged as an institution. 

Note about dual appointments:  Generally, the PI’s primary appointment is determined by the primary institution that pays their salary.

Note: Exempt and Not Human Research (NHR) determinations are institutional determinations made by Fred Hutch for Fred Hutch PIs. Typically, Fred Hutch will not rely on an external IRB to make an Exempt determination for our site. Please contact the IRO Director prior to seeking an Exempt or NHR determination from any external IRB.

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Does This Study Require a Single IRB (sIRB)?    

Today, updated regulatory requirements mean that there are more circumstances in which an external IRB must review research in which Fred Hutch is engaged:

• Federal regulations and policy. The Revised Common Rule federal regulations and NIH policy now require the use of a Single IRB, or sIRB, for most federally funded research that involves more than one institution. The single IRB will almost always be a non-Fred Hutch IRB (i.e., external IRB) when another institution is the lead institution for the study or is conducting most of the research. See How to Determine when a Single IRB (sIRB) is Required for additional details.
• Sponsor requirement. Many funders and research networks now expect a single IRB to do the review, or they require the use of a central/commercial IRB such as Advarra or WCG. These external IRBs may have been selected to serve as the sIRB when there are a large number of sites across the country, and it would be too challenging for an academic/research institution’s IRB to review all the sites.

Factors to consider in selecting an sIRB

The lead PI is responsible for selecting a single IRB when it is required. Depending on the size and scope of the study, you may want to consider several factors when selecting a sIRB:

• Does the IRB hold AAHRPP accreditation?  If not, Fred Hutch as an accredited institution is limited in relying on them.
• The IRB’s capacity:  for example, if the study has 20 or more sites, is the IRB prepared to review that number of sites quickly and efficiently?
• The IRB’s expertise in relation to the study procedures, populations, or other special considerations.
• The IRB’s turnaround times, if a rapid study initiation is essential to the aims of the study.
• The IRB’s fees. You may wish to obtain quotes from several IRBs in order to compare costs and services.
• Your team’s familiarity with the IRB’s processes, policies, systems, and forms.

Planning ahead for single IRB

For federally funded studies, consult with the IRO about selecting the sIRB prior to submitting the funding application. The IRO recommends that you do this before obtaining confirmation from participating sites about their willingness to rely on the selected sIRB.  The IRO cannot guarantee its willingness to support the use of a sIRB that has been selected without its consultation and approval, because of the requirements imposed by our accrediting body.

After assessing the acceptability of the proposed IRB, the IRO may provide the Fred Hutch investigator with a letter of support upon request. This should be retained for study records. If desired, a copy can be included in the grant proposal.

If any non-Fred Hutch Consortium institutions (UW or Seattle Children’s) are engaged in the research, each of these organizations will need to agree to the sIRB arrangement and to provide their own confirmation of the agreement.

The IRO is available at IRO@fredhutch.org to consult about factors involved in selecting IRBs and how to approach each IRB.

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Selecting an External IRB

The term external IRB refers to any non-Fred Hutch IRB that reviews research in which Fred Hutch as an institution is engaged. Fred Hutch is willing to rely on an external IRB for many types of studies—but the review must be authorized by the IRO in advance.

Learn about choosing a non-Fred Hutch IRB at How to Ask for an External IRB Review.

Which External IRBs are allowed for Fred Hutch-engaged research?

See the Reliance Agreements page for a list of external IRBs that Fred Hutch investigators often rely on for IRB review. External IRBs not listed may also be used, with prior authorization by the IRO.

The IRO must grant authorization for the use of any external IRB for each study in which Fred Hutch is engaged, even under pre-established cooperative agreements or other agreements.

Which External IRBs are NOT allowed for Fred Hutch Research?

Fred Hutch does not rely on:

• International IRBs or Ethics Review Committees (ERCs). For international research, Fred Hutch typically utilizes dual review, in which Fred Hutch IRB (or another U.S. IRB) reviews the study to U.S. standards, and the country’s ethics committee also reviews to its standards. 
• IRBs of the U.S. Veteran’s Health Administration – for example, the VA Puget Sound Health Care System.
• Generally, any domestic IRB that does not hold AAHRPP accreditation, with the exception of the Cancer Consortium institutions.

Industry-Sponsored Studies

Fred Hutch IRB does not typically serve as the sIRB for industry-sponsored studies for sites outside the Cancer Consortium. However, Fred Hutch IRB can review industry-sponsored studies on behalf of any Cancer Consortium sites.

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