UW IRB as a Single IRB

When will UW serve as the single IRB

These guidelines describe when UW is able to serve as the single IRB (sIRB) for multi-institutional research funded or supported by any federal agency, except the Department of Justice (DOJ).

Except under the terms of existing cooperative agreements and in unique circumstances approved by HSD management, the UW IRB is not able to serve as the single IRB when:

• The study is industry-sponsored-and-initiated, or
• The study is not federally funded or supported, or
• UW is not engaged in the research, or
• UW has determined that the study is exempt.

These criteria are intended as a reference for researchers who are planning multi-institutional research and should be considered as general guidelines, not rules. Researchers are encouraged to consult with HSD at hsdrely@uw.edu to confirm any single IRB plans when preparing funding applications. HSD cannot guarantee UW IRB review for any multi-institutional research for which it has not been consulted. HSD will assess each multi-institutional study and work with the PI to determine the appropriate single IRB arrangement. The unique aspects of a study as well as the following factors may impact HSD’s decision:

• Whether the study should be reviewed by another IRB under the terms of a cooperative agreement
• The relationship of the study to other studies (for example, parent and sub-studies)
• Whether a study requires expedited or full board review
• Whether the UW IRB has sufficient expertise to review the research
• The number of sites
• The complexity of the review

When is UW able to serve as the single IRB?
UW is the prime (direct) awardee. Other institutions are receiving subawards from UW. and/or UW is the formally designated regulatory Coordinating Center.	Almost always. Exceptions: All work with human subjects will be done by other organizations, and UW does not have a role as the coordinating center, primary author of the protocol, etc. The size of the study is greater than HSD’s capacity. HSD anticipates that this will be approximately 15 or more sites for an interventional study and 30 or more sites for an observational study. When HSD cannot guarantee that there will be sufficient IRB member expertise to review the research. HSD will make all reasonable effort to ensure that there will be sufficient IRB member expertise. This may involve working with the PI and their department to identify potential IRB members or consultants and requesting funding for IRB member support. However, if expertise cannot be guaranteed, UW IRB cannot review the study. If UW cannot serve as the single IRB, HSD will work with the PI to identify and pursue other options.
UW is one of multiple prime (direct) awardees with no clear lead or coordinating institution. (For example, NIH Multiple PI designation, NSF Co-PI designation)	Case-by-case basis. Dependent on: Whether UW is engaged in the research How much of the interaction with subjects will be done by UW vs. other institutions Whether UW has a “lead” role, e.g. wrote the protocol, significant scientific work, etc. The number of sites Whether the UW IRB has sufficient existing expertise to review the research
Prime awardee is another institution without an IRB. UW is receiving funding via a subaward (e.g. SBIR, STTR)	Case-by-case basis. In many cases, HSD may consider the prime awardee responsible for contracting with an appropriate independent IRB. Dependent on: How much of the interaction with subjects will be done by UW vs. others institutions Whether UW has a “lead” role, e.g. wrote the protocol, significant scientific work, etc. The number of sites Whether the UW IRB has sufficient existing expertise to review the research
Prime awardee is another institution with an IRB. UW is receiving funding via a subaward.	Almost never. HSD considers the prime awardee responsible for providing IRB review in most cases. Exceptions: The prime awardee’s only engagement is receipt of funding, and UW will be doing the majority of the work with human subjects
Other funding situations	Case-by-case basis. Dependent on: How much of the interaction with subjects will be done by UW vs. others institutions Whether UW has a “lead” role, e.g. wrote the protocol, significant scientific work, etc. The number of sites Whether the UW IRB has sufficient existing expertise to review the research

What does HSD charge for single IRB review?

At this time, in general, HSD does not charge fees for IRB review. In some circumstances, for example for very large or complex studies, HSD may request that investigators provide support for the incremental (increased) costs directly attributable to establishing and conducting the sIRB review and oversight for the non-UW participating institutions. In these cases, HSD management will work directly with researchers to establish the mechanism for, and the amount of, the support.

Are there any other budget considerations?

It is important for UW researchers to plan for the additional staffing resources to successfully coordinate sIRB review. HSD’s Zipline application system is only accessible to individuals with UW NetIDs. Because of this, the UW study team will need to prepare and submit all materials on behalf of the non-UW institutions, as well as communicate information from the UW IRB to the institutions. This may require additional resources such as the Single IRB Liaison role.

What to expect when working with UW as the single IRB

When planning to work with UW as the sIRB, researchers should be aware that:

• To facilitate sIRB arrangements, UW has established reliance agreements with several other regional institutions. Additionally, UW is a SMART Participating Institution. However, this does not mean that the reliance process for each study is complete. Each non-UW institution must formally document their agreement to rely on the UW IRB for each study.
• All PIs from non-UW institutions relying on the UW IRB must follow HSD’s requirements for reporting problems and other information that may impact the IRB’s determinations. They are also responsible for following their institution’s reporting requirements, for example for reporting breaches of confidentiality under HIPAA.

Find more information about the application process at Steps in the Single IRB Review Process.