Apply for Review
The sequence of IRB activities for your study
APPLY for IRB approval ←
MODIFY the approved study
RENEW your IRB approval
REPORT events and new information
CLOSE your IRB application
What you should have already completed
- Be sure that you need IRB approval. Is your planned activity considered UW human subjects research? See steps 1-4 of “Do I Need IRB Review?”
- Be sure that the UW IRB is the correct IRB to review your research. See step 5 of “Do I Need IRB Review – Is the UW IRB the Right IRB?”
Required skills and tools
- Word processing skills. Know how to use the “track changes” feature of Microsoft Word documents, and be able to create and modify footers for Word documents. It is best practice for each of your Word documents to have a footer that contains the document name and the date/version number.
- PDF documents. Know how to scan a paper document (or convert a Word document) in order to create an electronic PDF format document.
- Zipline basics. Know the basics of how Zipline (the IRB application software) works. See the Zipline Online Help Library.
- Zipline roles and permission. Understand the types of roles and permissions that are allowed by Zipline. For example, the principal investigator (PI), PI proxy, primary contact, etc.
- Zipline registration. Make sure that anyone who you wish to be able to see and/or edit your IRB application is registered in Zipline before you begin preparing the Zipline SmartForms part of your IRB application.
The parts of your application
|IRB Protocol form required
This is a Word document that you complete and upload to Zipline. Related application documents, if appropriate for your study
These are Word or PDF documents that you complete and upload to Zipline.
Study-specific documents, as appropriate for your study required
Zipline SmartForms required
What to do: First, select the forms
IRB Protocol OR IRB Protocol: No Contact with Individuals
Use the No Contact form only if you will have no interaction of any kind (in person, email, internet, social media, etc.) with your subjects.
Study Roles Addendum
Always use this form unless you are the only person involved in conducting your research or unless you are requesting authorization to have an external (non-UW) IRB review your study.
- Department of Defense
- Department of Energy
- Drug, biologic, botanical, supplement
- Emergency exception to informed consent
- Genomic data sharing
- Medical device
- Multi-site study
- Participant results sharing
These provide specialized information. To decide whether you need any of them: read the last question in Section 1 of the IRB Protocol form.
What to do: Other steps
- Complete the forms you identified in Step 1.
- Prepare your other study documents for uploading.
- Create any documents that do not already exist. For example, create a study consent form.
- 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 paper document by scanning them as a PDF.
- If you need a Confidentiality Agreement as indicated by your answers in the IRB Protocol form: complete the form and obtain the necessary signatures.
- 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 IRB application.
- Create the Zipline part of your application. Log into Zipline, and click on the Create New Study button. Answer the questions, and follow the instructions about uploading the application form(s) and other documents you have prepared.
- Check your application for completeness and consistency, by using the Hide/Show Errors activity.
- Request approval by your faculty advisor, if you are a student, fellow, resident, or post doc, by clicking on the Manage Ancillary Reviews activity.
- Submit your application to HSD. This can be done only by the PI or PI Proxy. Click on Submit and then click on OK.
- Mail your Confidentiality Agreement. If your study requires a Confidentiality Agreement, mail it to HSD at UW Box 359470.
What to do: If you are preparing the application for someone else
Principal investigators (PIs) often ask their study coordinators to prepare the draft IRB application. Follow the same steps outlined above, with the following additions:
- Identification of the PI. Question 6 on the Basic Information Zipline SmartForm page 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.
- Application submission. The application must be submitted by the PI or an assigned PI Proxy. When the application is ready, send the PI an email with a link to the study by copying and pasting the URL. The PI can 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 application, 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 the IRB’s review. The ongoing status of your application is displayed in the workflow graphic at the top of the study workspace in Zipline.
Three common, high-impact mistakes (and how to prevent them)
- Selecting the wrong version of the IRB Protocol form. (IRB Protocol versus IRB Protocol: No Contact with Subjects).
Prevention: Read the instructions of the No Contact version. “No contact” means no interaction of any kind (in person, email, social media, internet).
- Inappropriate answers to the data security questions. This IRB Protocol question is about what data security measures are appropriate for your data.
Prevention: Read the Guidance on Data Security Protections. Find out from your department IT staff whether your department IT systems meet the appropriate requirements for data security.
- Not providing the e-GC1 number for any grant that is supporting the research. This information makes it much easier and faster for OSP (Office of Sponsored Programs) 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. If there is no funding flowing through the Office of Sponsored Programs, such as for internal UW funding or a gift, select “OSP not Involved” and type “N/A” in the box for the e-GC1 number.