Request Authorization- External IRB Reviewing

Print Print

Table of Contents

Steps for Submitting

Overview

All authorization requests must be submitted via Zipline, UW鈥檚 eIRB system. Zipline is a document management system where you upload your application form and other study documents and fill out a series of electronic SmartForms. For definitions of Zipline terms:

While all documents must be uploaded before you can submit, the order of the application steps is flexible. You may find it better to create the study record in Zipline and then complete the Word-based IRB application form, especially if you plan to be a PI proxy for a study.

Everyone who needs access to the Zipline application must complete a one time self-registration process in Zipline before they can be added to the application. Each person must be added to the application before they are able to access it. This includes:

  • The principal investigator
  • Any study team members who will need to view or edit the application

A UW NetID is required to register. For more information:

All authorization requests must include the External IRB Review Request Form. Use the most recent version of the form, available on the HSD website and in Zipline. Upload documents in Microsoft Word format. e.

In addition to the External IRB Review Request Form, you will need to upload other study documents in Zipline. The study documents should be uploaded in Microsoft Word format whenever possible and should not be password protected.聽

Review Section 5: Required Attachments in the Request External IRB Review form for a comprehensive list of documents that should be included with an application requesting review by a non-UW IRB.

Once your documents are ready, login to Zipline to create a new study record, complete the SmartForm application, and upload the study documents.

To create a new study record, select Create New Study from the menu:

create new study

General Tips

  • Use the help bubbles throughout Zipline for additional context if you鈥檙e unsure how to answer a question.
    Zipline help bubble icon showing contextual help
  • Navigate through the application sequentially by selecting Continue at the bottom of each page.
    Screenshot of the Continue button in Zipline
  • Jump between pages using the left鈥慼and navigation menu when you need to review or update specific sections.
  • Save your progress and return later by selecting Save and Edit Study if you need to complete the application in multiple sessions.
    Edit Study button under Next Steps in Zipline

SmartForm Instructions for External IRB Studies

SmartForm Name and Attachments SmartForm Tips
Basic Information SmartForm Page

No attachments

  

The Basic Information page on the SmartForm should indicate that:

  • The study is multi-site or collaborative (for most applications) (Question 4)
  • You are requesting authorization for an external IRB to do the review (Question 5)
Basic Local Site Information Page

No attachments

In a few words, summarize your activities as a participating site in this multi-site or collaborative research study. If your site will be conducting all portions of the research, type 鈥淎LL.鈥� If your site will be conducting only certain portions or the research, include a summary.

For example:

This study includes both adults and children as research subjects; however, at this site, we will include only children. Therefore, we will conduct only those procedures related to children.
External IRB Page聽

  • External IRB Request Form
 If your external IRB is not on the list, contact HSD staff at hsdrely@uw.edu before you complete your application so it can be added to the list for you to select.
Study Funding Sources SmartForm Page

Attachments:

  • Grants, contracts, and other funding information聽for funded research that is not industry-sponsored and industry-initiated
  • Do not include funding proposals for industry-sponsored and industry-initiated studies
 For funding administered through UW:

  • Include the e-GC1 number as the Grants Office ID (Item 3). This information makes it much easier and faster for the Office of Sponsored Programs (OSP) to allow the release of your funds for human subjects research.

Zipline Funding FAQs
Additional Local Funding Sources Page聽

No attachments

 Funding information is collected on the Study Funding Sources page, leave this page blank
Local Study Team Members SmartForm Page

No Attachments

Can鈥檛 find someone on the list? Make sure that they鈥檙e registered in Zipline.

Add everyone who needs access to the application, including anyone who should be designated as a PI proxy. People must be listed on this page in order for the PI to be able to designate them as a proxy.

Students/medical residents- Do not list your faculty advisor. Adding your faculty advisor on this page prevents them from completing faculty advisor review of your application.
Study Scope SmartForm Page

No Attachments

 Answers on this page should reflect UW activities only.
Local Research Locations

No Attachments

If your research location is not included for selection, select Other.

If your research consists solely of obtaining records, specimens, or other information without interacting with the participants, select No direct interaction with participants.
Drugs SmartForm Page (if applicable)

  • Documents related to a specific study drug, such as documentation of the IND, the Investigator鈥檚 Brochure, or the Package Insert (Item 3 in the Add Drug Information Window)
  • Any related documents not specific to a study drug, such as correspondence from the FDA or study sponsor (Item 3)
 Identify all drugs to be used on human subjects as part of this study. In particular, include all information the IRB needs to identify and evaluate any investigational new drug.

An investigational new drug (IND) number is assigned by the FDA to a drug that the FDA allows to be transported across state lines for use in clinical studies prior to receiving marketing approval.

Identify each IND used in the study. For each IND number, attach one of the following:

  • Sponsor protocol with the IND number
  • Communication from the FDA or sponsor with the IND number
Devices SmartForm Page (if applicable)

  • Documents related to a specific study device, such as documentation of the IDE or HDE, the Package Insert, or any relevant communication specific to the device (Item 3 in the Add Device Window)
  • Any related documents not specific to a study device, such as correspondence from the FDA or study sponsor (Item 3)
 Identify all devices to be evaluated for safety and effectiveness or used as an HUD on human subjects. Include all information the IRB needs to identify and evaluate any device with exemptions or claimed exemptions. Also, attach information from the study sponsor or the FDA verifying the exemption status of each exempt device.
Study Related Documents Page (Only available for multi-site or collaborative studies)

  • Study protocol or another document that provides a detailed description of the research
  • Any materials you have received from the external IRB that you have been directed to give to the HRPP/IRB office
  • Documentation of the sponsor or other institution鈥檚 requirement for external IRB review
 Do not upload consent materials on this page.
Local Site Documents Page

  • Draft or template consent templates, if they are available from the sponsor, coordinating center, lead site, or the external IRB (Item 1)
  • UW PI鈥檚 Curriculum Vitae or biosketch (Item 3)
  • SUPPLEMENT Other REDCap Installation or Other E-Consent Tool Attestation Letter (if required) (Item 3)
  • SUPPLEMENT Diversity Plan for Clinical Trials (if required) (Item 3)
 Single site studies should also include the documents listed for the Study Related Documents page.

The Manage Ancillary Review activity is used to obtain and document faculty advisor review when a student or medical resident is the principal investigator (PI) for the IRB application. Do not add the faculty advisor to the study team on the Zipline application before the faculty advisor has submitted the faculty advisor review. The system will not allow a member of the study team to submit an ancillary review for the study.

The faculty advisor review may occur concurrently with HSD or IRB review of an application. However, final IRB approval will not be issued until the required faculty advisor review is completed.

Your faculty advisor will receive an email notification when the application is submitted to HSD. For more information:

screenshot of the Manage Ancillary Reviews activity

Checking the application for errors and omissions helps you to include all the relevant information, which is essential for receiving a timely review of your study. Automatic system error checking identifies any omitted answers to questions that are required for every application. A red asterisk (*) indicates required questions.

HSD also recommends looking over the forms to see what you may have missed, especially:

  • Questions that are relevant to your study but are not required for all studies (no asterisks)
  • Documents that should be attached

The Submit activity must be completed once the authorization request is ready to go to HSD. This activity:

  • Must be completed by the PI or the PI Proxy
  • Changes the application state from Pre-Submission to Pre-Review
  • Sends the item to HSD for review
  • Removes the study team鈥檚 ability to make edits while the study is in review unless HSD requests more information or a change to the study

For more information:

Screenshot of the submit button

What to Expect After Submitting

An HSD staff member will be assigned to your application as the IRB coordinator. The PI, any PI proxies, and the primary contact will receive email notifications:

  • If HSD staff need additional information or changes to authorize the request
  • When your request has been authorized

You can check the application status in the study workspace in Zipline at any time. After your request is authorized, the study will move to Pending sIRB Review in Zipline.

diagram showing pending sIRB review
After you receive approval from the external IRB, send documentation to hsdrely@uw.edu. HSD will upload approval documents to the study record in Zipline and change the study status to 鈥淎ctive鈥�. You do not typically need to send approval documents from WCG IRB or Advarra. WCG IRB and Advarra automatically send approval documents to HSD when hsdrely@uw.edu is listed as a study contact in either Connexus or CIRBI.

Until HSD receives these documents, the status of the study in Zipline will be 鈥淧ending sIRB Review鈥� and the PI will receive a reminder every 6 months that approval documents have not been received.