How to Ask For a Non-UW IRB
HSD authorization must be obtained after a researcher identifies the need for an external IRB. HSD must authorize the use of any external IRB for each study, even under pre-established reliance agreements. See a visual depiction of the process: External IRB Initial Review Process Diagram
When to start
Submit your request to use the external IRB when you are ready to start applying for IRB review (for funded research, this is typically after you have received a notice of award or a favorable score) and when you have enough information to complete the REQUEST External IRB Review form that must be submitted in the Zipline system.
In order to complete the request in Zipline you will typically
- need a copy of the fully approved protocol and any template consent forms that have been approved by the reviewing IRB, and
- have developed a plan for how the study will be carried out at UW (e.g. will you need access to PHI for recruitment), and
- have obtained any instructions from the reviewing IRB or coordinating center about what documents they require.
Submitting a request in Zipline before you have this information will not speed the request process.
You may submit your request at the same time you submit to all other necessary compliance/administrative offices. This allows for concurrent review. For industry research, budget approval and a finalized contract (Clinical Trials Agreement) are not necessary before asking for (and receiving) authorization for use of an external IRB from HSD.
Initiate the process
Submit an application in the UW’s Zipline e-IRB system. The application process is similar to the standard IRB application process but the system branches on the first webpage when you indicate you are requesting authorization for an external IRB to review the study instead of the UW IRB. Be sure to upload any materials already provided by the external IRB, lead site, or coordinating center. The REQUEST External IRB Review form is always required. Pre-requisite: The UW researcher and the person preparing the Zipline application must already be registered in the Zipline system.
Three common, high-impact mistakes (and how to prevent them)
- Beginning the request process too soon or without having enough information.
Prevention: Check with the lead study team, coordinating center or reviewing IRB to make sure you have all the necessary documents and understand the reviewing IRBs timeline for executing reliance agreements and reviewing site submissions.
- Providing a study title in Zipline that is inconsistent with the protocol title.
Prevention: Provide the full, complete title that is the same as the title on the protocol document and on any funding.
- Not providing the e-GC1 number for a grant that is supporting the research. This information makes it much easier and faster for OSP to allow the release of your grant funds for human subjects research.
Prevention: Provide the e-GC1 number where it is requested on the Zipline Funding SmartForm, or add the word “pending” if the number is not yet available.
What to expect after submitting
An HSD staff member will be assigned to your request, usually within one business day. You will receive an email notice if additional information is needed and also to inform you about the outcome of HSD’s evaluation of your request.
Authorization can take one day to several weeks, depending on whether it is necessary to establish a new reliance agreement, how complex the agreement is, and whether HSD will need to provide local context information to the external IRB. UW has already established several standing agreements and will use them whenever possible instead of negotiating a new agreement.
- Ensure that the proposed external IRB is appropriate and qualified. This step is minimal or unnecessary if the researcher already obtained a Letter of Support about the external IRB for a grant application or if the external IRB is one of the many already-established review arrangements. If the external IRB is not appropriate, HSD will work with the UW PI to select another external IRB or obtain review from the UW IRB.
- Confirm or establish any necessary reliance agreements. These are legally-binding written agreements by which one institution or individual gives permission for an IRB to review research on their behalf. HSD is the only entity authorized to sign on behalf of the UW. Reliance agreements are required by federal human subjects regulations. The UW has already-established generic written agreements with many IRBs (e.g., Seattle Children’s). Sometimes also called authorization agreement, memorandum of understanding, master agreement.
- Provide local context information to the external IRB, if required. IRBs must consider any applicable state or local laws, or institutional policies that apply to the UW research. External IRBs request this information through questionnaires, worksheets, or webforms. Though the request may be received by the UW researcher, the information should be provided in collaboration with HSD to ensure its completeness and accuracy.
- Provide documentation authorizing the use of the external IRB. Zipline sends an automatic email notification to the UW researcher when HSD authorizes the use of the external IRB. HSD’s authorization will be documented in a Letter of Authorization. This is the signal that the researcher can now apply to the external IRB. The Letter is a permanent part of the Zipline e-file and can be downloaded by the UW researcher at any time. It should be provided to the external IRB with the IRB application.
Applying to the External IRB
UW researchers must use the system, forms, and processes of the external IRB. Consult the external IRB’s webpage or office for information or assistance.
- UW researchers participating in collaborative or multi-site research should consult with the lead researcher or coordinating center to find out who will be responsible for submitting the UW application to the external IRB.
- In all cases, the IRB application should include a copy of the Letter of Authorization provided by HSD. Some IRBs (such as Seattle Children’s and Fred Hutch) will not review UW research without the Letter.
When you have received documentation of the external IRB’s approval for UW, send the approval documentation to HSD (email@example.com). Until HSD receives these documents, the status of the study in Zipline will be “Pending sIRB Review” and the PI will receive a reminder every 6 months that approval documents have not been received. HSD will upload approval documents to the study record in Zipline and change the study status to “Active”. You do not typically need to send approval documents from WCG IRB or Advarra to HSD. WCG IRB and Advarra automatically send approval documents to HSD when firstname.lastname@example.org is listed as a study contact in either Connexus or CIRBI.
During the Research
The Zipline application requesting authorization to use an external IRB should be updated only when:
- There is a change in UW PI.
- There is a need to allow new members of the study team access to the study in Zipline.
- There is a change in the Reviewing/External IRB.
- The study has been closed by the Reviewing/External IRB.
- The study will use an e-consent platform to obtain documentation of consent and you have not already obtained HSD’s acknowledgement that the platform is acceptable for use in the study. HSD must assess whether the e-consent platform is acceptable under UW policy and WA state requirements before you can use it.
For information about how to submit a study update or closure, visit instructions on changing external IRB studies.
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 external IRB and that conflict of interest management plans issued by the Office of Research are given to the external IRB.
- Obtaining any required ancillary review and approvals and providing the results of these reviews to the external IRB if requested.
- Making copies of IRB approvals available for inspection by monitors and auditors.
See the CHECKLIST External IRB, UW Researchers for a detailed list of responsibilities.