UW IRB as a Single IRB

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Institutions and individuals may work together cooperatively on a research project involving human subjects. Often under these cooperative arrangements, multiple institutions and individuals may be engaged in the research. It may be advantageous, or required, to obtain IRB review from only one IRB for some or all of the engaged institutions or individuals rather than seeking IRB review from all engaged parties. This arrangement is referred to by HSD as single IRB (sIRB) review.

2018 Common Rule requirement. Effective January 20, 2020, all of the domestic institutions that are engaged in a federally-supported, non-exempt, cooperative research project must rely upon approval by a single IRB. Health and Human Services (HHS) supported research does not have to comply with the requirement if at least one IRB has approved the research before January 20, 2020.

NIH multi-site policy. For most NIH grant applications submitted on or after January 25, 2018, NIH requires the use of a single IRB for all domestic sites participating in multi-site non-exempt human subjects research.

Other research. For research not subject to the 2018 Common Rule, the NIH policy, or another sponsor’s requirement to use a single IRB, it may be advantageous to the research to obtain IRB review from the same IRB for some or all of the engaged institutions or individuals rather than seeking IRB review from multiple IRBs.

When will UW serve as the single IRB

Except under the terms of existing reliance 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 reliance agreement
• The relationship of the study to other studies (for example, parent and sub-studies)
• Whether the activities of the institutions or individuals represent a significant addition to the activities the UW IRB must review (for example, significantly different procedures or a higher level of risk than it would review without the reliance)
• 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. When HSD cannot guarantee that there will be sufficient IRB member subject 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. 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 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. 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

What Institutions can rely on the UW IRB?

Institutions with a Federalwide Assurance (FWA) that are located within the U.S. are eligible for reliance on the UW IRB. Due to the complexity of international regulations regarding human subjects research, the UW IRB does not review on behalf of institutions outside of the U.S.

Institutions must be engaged in the research. HSD will not generally allow reliance on the UW IRB when the non-UW institution cannot demonstrate that their activities constitute engagement in the research, or when IRB review is required by that institution solely in order to meet its unique institutional policies.

What about individuals who are unaffiliated with an institution or affiliated with an institution without an FWA?

The UW IRB can review on behalf of these individuals when the activities of the institutions or individuals will be directly supervised by the UW PI (meaning that there is no other local PI at the other institution who will supervise the activities). In these cases, UW will extend its FWA to cover the activities of the individuals.

How is the review arrangement documented?

Federal regulations require that an institution or individual’s reliance on an IRB not operated by their own institution be documented along with the responsibilities that each entity will undertake to ensure compliance with the regulations. This is accomplished through reliance agreements.

When a non-UW institution or individual will rely on the UW IRB for research not subject to federal regulations, UW will execute a reliance agreement. Although a formal, written agreement is not required in these situations, HSD considers it best practice for documenting roles and responsibilities related to IRB review.

Reliance agreement options. To support flexibility and tailor the terms of reliance agreements to the circumstances of individual studies, UW makes use of and accepts a variety of reliance agreement templates and structures. These include UW’s own reliance agreement templates, the SMART IRB Master Reliance Agreement, standing agreements with regional institutions, and the agreement templates of other institutions.

Who makes the decision. HSD is the only office authorized to execute reliance agreements on behalf of UW.

Documenting the reliance decision and arrangement. All decisions about reliances are recorded in the associated study workspace in the Zipline system.

What does HSD charge for single IRB review?

At this time, in general, HSD does not charge fees for IRB review. 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 amount of and the mechanism for providing 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 those institutions. This may require additional resources such as the Single IRB Liaison role.

What to expect when working with UW as the single IRB

The GUIDANCE Key Information about the UW as a Single IRB is a quick reference to essential information about the UW IRB. This document answers many questions that relying institutions typically have when considering relying on the UW IRB.

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

Related Materials

GLOSSARY Engagement
GUIDANCE Key Information About the UW as a Single IRB
WEBPAGE Identify the Correct IRB
WEBPAGE Industry Sponsored Research
WEBPAGE Responsibilities of the Lead Study Team
WEBPAGE Steps in the Single IRB Process for Initial Applications

Regulatory References

• 45 CFR 46 [2018 requirements]
• OHRP draft guidance, “Consideration in Transferring a Previously-Approved Research Project to a New IRB or Research Institution”, May 23, 2012.
• OHRP, “Determination of Exception for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements”.
• OHRP sample authorization agreement.
• FDA, “Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB”, May 2014.
• FDA guidance, “Using a Centralized IRB Review Process in Multicenter Clinical Trials”.
• SACHRP guidance, “Attachment A: Initial Considerations for Single IRB Review: Points to Consider”.

Version Information

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Keywords: Internal reliance; Multi-site; Single IRB