UW Research

Ask for Non-UW IRB

Request for Authorization

Using a non-UW IRB (“external IRB”) to review a UW research study must be authorized by HSD. Additionally, some external IRBs require information about local laws, policies, and other context. HSD will analyze the protocol and provide some of this information to the reviewing IRB. The UW researcher initiates the authorization and local context review request by submitting a REQUEST: External IRB Review form.

What you should have already completed

When you should submit

Industry Research. At the same time you submit to all other necessary compliance/administrative offices. This allows for concurrent review. Budget approval and a finalized contract (Clinical Trials Agreement) are not necessary before asking for (and receiving) external IRB authorization from HSD.

Grant Funded Research. After you have received a notice of award or a favorable score. Note that you will need to submit a copy of the protocol, draft consent forms and additional materials that may be sent to you by the reviewing IRB. For example, study sites reviewed by TIN Central IRBs are sent “welcome” packets that include detailed instructions. You should wait to submit to HSD until you have received this packet.

Other Research. When you have enough information to complete the REQUEST: External IRB Review form and supply the additional documents listed below.

Required skills and tools

The parts of your Request

REQUEST: External IRB Review form required
This is a Word document that you complete and upload to Zipline. Additional documents, if appropriate for your study
These are Word or PDF documents that you obtain and/or complete and upload to Zipline.

  • Grant application
  • Detailed description of the research (e.g., a study protocol)
  • Draft consent forms if they are available. Review the UW Guide to Consent Elements for Externally Reviewed Studies to make sure your consent materials include required elements.
  • Study Roles Addendum for studies reviewed by non-commercial IRBs
  • Investigator Brochure, package insert, or device manual for studies involving an investigational drug or device
  • Any forms that the external IRB wants the UW IRB office (HSD) to complete

Other documents, if appropriate for your study

What to do: The first step

Complete the REQUEST: External IRB Review form.

What to do: Other steps

  1. Prepare your other study documents for uploading, as identified on the REQUEST: External IRB Review form.
    • Create any required documents that do not already exist.
    • Label electronic and paper documents with a title, date, and version number. A footer in the document is usually the best place for this information.
    • Create an electronic version of any study documents (but not the REQUEST: External IRB Review form) by scanning them to PDF.
    • Give each electronic document a unique and descriptive name to help distinguish them in Zipline.
    • If you need a Confidentiality Agreement: complete the Agreement and obtain the necessary signatures.
  2. Register in Zipline. Individuals who must be registered in Zipline include: you, the principal investigator (if you are not the PI), anyone that you want to see and/or edit your request, and (for student PIs) your faculty advisor.
  3. Create the Zipline part of your request. Log into Zipline, and click on Create New Study. Answer the questions. Be sure to answer YES to the question about the use of an External IRB. Follow the instructions about uploading the REQUEST: External IRB Review form and other documents you have prepared.
  4. Check your request for completeness, by using the Hide/Show Errors activity.
  5. Request approval by your faculty advisor, if you are a student, fellow, resident, or post doc, by clicking on the Manage Ancillary Reviews activity.
  6. Submit your request to HSD. Click on Submit and then click on OK.
  7. Send your Confidentiality Agreement. If your study requires a Confidentiality Agreement, mail it to HSD/Reliance Team at UW Box 359470.

What to do: If you are preparing the request for someone else

Principal Investigators (PIs) often ask their study coordinators to prepare the materials requesting authorization for external IRB review. Follow the same steps outlined above, with the following additions:

  • Identification of the PI. Question 6 on the Basic Information SmartForm will automatically list you as the PI. To identify the actual PI, select the PI’s name from the drop-down list provided with this question. If the PI’s name is not on the list, ask him/her to self-register in Zipline. Registration is necessary to ensure that the PI’s name appears on the list.
  • Request submission. The request must be submitted by the PI or an assigned PI Proxy. When the request materials are ready, send the PI an email with a link to them in Zipline by copying and pasting the URL. The PI can then submit the request by clicking on Submit and then:
    • Log in and submit the application by clicking on Submit and then on OK, OR
    • Assign the PI Proxy (which may be you) so that the PI Proxy can submit the study on the PI’s behalf.

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. The ongoing status of your request is displayed in the workflow graphic at the top of the study workspace in Zipline.

When HSD has authorized your request, you will be provided with documentation of the authorization.

Three common, high-impact mistakes (and how to prevent them)

  • Providing a study title in Zipline or on the REQUEST: External IRB Review form that is inconsistent with the protocol title.
    Prevention: On the REQUEST: External IRB Review form, provide the full, complete title that is the same as the title on the company protocol document and on the contract.
  • 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.
  • Providing a Study Protocol or Investigator’s Brochure that is locked and/or password protected which means it cannot be read by HSD staff.
    Prevention: Be sure that the uploaded version of these documents is not locked and/or password protected. HSD does not have a system for storing passwords for these documents.

Ask for help

Contact a HSD Reliance Administrator at hsdrely@uw.edu or 206.543.0098 if you have any questions or need help.

More information