External IRB Review of UW Research
In most cases the UW IRB reviews UW research. However, it may be appropriate for a non-UW (“external”) IRB to review the research.
- Multiple IRB reviews
- What is an external IRB?
- When will the UW rely on an external IRB?
- What if I want to use an external IRB?
- Reliance agreements overview
- Existing reliance agreements
- Local context review
- Researcher responsibilities for externally reviewed research
- Guide for FHCRC and Seattle Children’s Investigators
Multiple IRB reviews
When two or more institutions are engaged in a specific research study with human subjects, each of the engaged institutions must provide for its own IRB review. In many situations this means that multiple IRBs will review one research study. These multiple reviews may be organized in a number of ways and are sometimes overlapping.
To reduce the number of IRBs that review one study, the engaged institutions can enter into reliance agreements by which one institution’s IRB may review the activities of the other institution as well as its own activities. Alternatively, the engaged institutions may choose to rely on an IRB from another organization (for example, an independent IRB such as WIRB or a central IRB such as the National Cancer Institute IRB).
What is an external IRB?
An external IRB is any non-UW IRB that performs review of UW research. These can include independent IRBs, IRBs affiliated with regional partners such as Seattle Children’s, and national central IRBs such as the National Cancer Institute IRB. The UW is willing to rely on an external IRB for many different types of studies – however, this review must be authorized by HSD in advance.
When will the UW rely on an external IRB?
Some UW research must be reviewed by a specific external IRB.
|Type of research||Criteria||Which external IRB?|
|Non-oncology, industry studies||
||WIRB or Advarra. See the webpage about Industry Sponsored Research for more information.|
|Oncology-related, industry studies||
||The PI may choose either WIRB or Advarra or the Cancer Consortium IRB operated by FHCRC.|
|Non-industry, Cancer Consortium studies||
||Cancer Consortium IRB (CC-IRB), operated by FHCRC.
Note that in some situations, some studies that would otherwise be reviewed by the CC-IRB may be reviewed by other IRBs such as:
|Studies with any involvement of the Washington State Department of Corrections||
||Washington State IRB must review this involvement. The UW IRB may or may not also need to review some aspects of the study.|
The UW will also rely on an external IRB through existing cooperative agreements with some regional institutions or an existing Central IRB (CIRB) agreement.
UW may also rely on an external IRB in other situations. HSD will evaluate the nature of the study and the qualifications of the reviewing IRB to determine whether UW will rely on the selected external IRB. Common situations that are appropriate for external IRB review include:
- To meet a sponsor requirement. For example, in order to comply with the NIH single IRB requirement.
- When the study is a Trial Innovation Network (TIN) study that will be reviewed by a TIN central IRB.
- When another institution is conducting most of the research. For example, when UW’s only involvement is the analysis of identifiable data and/or specimens collected by another institution.
- When the study is related to an existing study or series of studies reviewed by an external IRB.
UW will not rely on:
- International IRBs or Ethics Review Committees (ERCs)
- IRBs of the U.S. Veteran’s Health Administration, for example the VA Puget Sound Health Care System.
HSD may infrequently and in compelling circumstances issue exceptions to the policies above.
What if I want to or have to use an external IRB?
If you want or have to use an external IRB instead of the UW IRB, follow the instructions under Ask for Non-UW IRB review. HSD must authorize the use of any external IRB for each study, even under pre-established cooperative or CIRB agreements and even if you are required to use an external IRB because of the Single IRB Mandate or because your study is industry-sponsored-and-initiated.
After you have submitted your request in Zipline, HSD will:
- Assess the information provided to determine whether it is appropriate to rely on the external IRB. If it is not appropriate, HSD will work with you to select another external IRB or obtain review from the UW IRB.
- Confirm or establish any necessary reliance agreements.
- Assess the protocol and provide local context information to the reviewing IRB if required.
- Provide documentation to you that the study can be reviewed by the external IRB. This documentation should be provided to the external IRB.
Reliance agreements overview
Reliance agreements (also known as authorization agreements, memorandums of understanding, individual investigator agreements, master agreements, etc.) are formal, written agreements in which one institution or individual gives permission for an IRB to review research on their behalf. The UW must enter into these agreements before the research is reviewed by the external IRB in order to give permission to the external IRB to review research on its behalf.
When is an agreement needed?
An agreement is needed for non-exempt research involving human subjects in which the UW is engaged when HSD has agreed to allow an external IRB to review the research instead of the UW IRB. Agreements are not required when the UW IRB will review UW’s involvement in the research.
Agreements are needed even if the UW is only engaged in a portion of the research (for example, when a UW researcher receives and analyzes identifiable data or specimens for a larger project) and UW will rely on an external IRB.
What about exempt research?
In most cases, the UW does not rely on the exemption determinations of other institutions and will issue its own determination. However, for a limited number of studies, HSD may accept the exemption determination of another institution if that determination is in line with HSD’s policies for exempt research. In these situations, a formal reliance agreement may not be necessary.
Who negotiates and signs the agreement?
All reliance agreements must be signed by representatives of the UW at HSD. Investigators are not allowed to sign agreements on behalf of the UW.
HSD will review the agreement to assess the terms and obligations, and may need to negotiate certain terms with the other organization.
How long does it take to establish a reliance agreement?
This can vary significantly and depends on the complexity of the study, the complexity of the agreement, and the requirements of the external IRB. It can occasionally take several weeks or longer to evaluate the agreement and obtain the necessary signatures from both parties. In order to expedite this process, UW has already entered into several standing agreements, and will frequently use them rather than renegotiating new agreements.
Existing reliance agreements
UW has entered into several standing reliance agreements. These pre-negotiated agreements establish the terms of reliance and a common understanding of the roles and responsibilities of reviewing and relying institutions.
See the full list of reliance agreements.
Local context review
IRBs must consider many different regulations as part of their review, including state and local policies. Some external IRBs will require information about the state and local policies that apply to UW research. External IRBs request this information in a variety of ways, e.g. worksheets, surveys, questionnaires. If the external IRB requires this information for the study, HSD will analyze the protocol and consent materials and will work with the UW PI to provide information about local context considerations.
Researcher responsibilities for externally reviewed research
UW PIs are responsible for following the policies of the external IRB. This includes submitting to the reviewing IRB using their forms and processes (or assisting the lead site with that process), following their reporting requirements for unanticipated problems and new information about the study, and complying with the stipulations of the IRB’s approval.
UW PIs are also responsible for:
- Ensuring that any relevant financial conflicts of interest are disclosed to the reviewing IRB and that conflict of interest management plans issued by the Office of Research are given to the reviewing IRB.
- Obtaining any required ancillary review and approvals and providing the results of these reviews to the reviewing IRB if requested.
- Making copies of IRB approvals available for inspection by monitors and auditors
See the External IRB Checklist for UW Researchers for a detailed list of responsibilities.
Guide for FHCRC and Seattle Children’s Researchers
- GUIDE: FHCRC and Seattle Children’s Investigators: UW Engagement in Human Subjects Research
- ONLINE TUTORIAL: When the UW is Not the Right IRB: Navigating the External IRB Process (Opens in a new window. You may need to log in with your UW NetID.)
- External IRB Initial Review Process Diagram