WU IRB is the Reviewing IRB

Once you have received notice of award (such as just in time funding) or have been awarded your grant, a new project application should be submitted in myIRB.  From the create project page in myIRB, click the blue sIRB New Project form under the WU sIRB Review column. See the sIRB Research Guide for additional instructions. 

Once you have submitted your sIRB New Project form and it is approved by the WU IRB, the WU sIRB staff will reach out to the participating site PIs with instructions and tools regarding required agreements and submitting the site application for IRB review. WU sIRB staff will not send out this information prior to IRB approval of the New Project form as the sites cannot submit until that time.

The site application is the application submitted by each site within the multi-site research after the project application is approved, it can be viewed as the ‘child’ application.  This application includes information about the sites research activities including site specific recruitment, enrollment and consent.

There are 2 types of modifications that can be created in myIRB -a site modification and a project modification. Site modifications should be submitted by the site PI (or their delegate) when the change only impacts a single site, such as a change in the coordinators name on the consent form or recruitment material. Please see the Single IRB Reference Manual for Site PIs and Study teams under sIRB Guidance.

Only the PI of the Project application (or their delegates) may submit a project modification. Project modifications should be submitted when a change impacts the overall study design, the protocol, the consent or study wide recruitment or questionnaires. Once a project modification is approved, the HRPO staff make a determination if a site needs to be notified or modified.  If the modification is just an update that does not require changes to the site application, the site PIs will receive an email stating that a project modification has been approved with a note about what was updated (such as: This modification includes an updated protocol or this modification includes updated subject data collection instruments).  If the modification requires changes to the site application, such as consent changes, a site modification will be created.  This may result in additional changes being requested by the HRPO office to the sites.

Continuing reviews are calculated based on the project approval dates.  All sites (regardless of approval date or onboarding date) will have the same expiration date.  The lead site will create the project level CR form which will create a site CR form for each site and also notify each site PI/delegate via email that they need to log into myIRB and complete their CR form.  Once all sites enter their CR information and sign off on the forms, the CR will be submitted to the HRPO office for review.

Sites cannot complete CR forms until the lead PI had created the project level CR. If you feel you should have already received a request for a project level CR, please contact the lead site PI.

If a local IRB has asked for your documentation of continuing approval before you have received continuing approval from the WU IRB, contact your local IRB to discuss what you should provide to them and at what time.  The WU IRB is unable to assist with local continuing review documentation requests or address any timelines that specific sites may have for their non-regulatory continuing review.

Once the project application is approved and a site begins their application, the site can access the protocol, any project level recruitment material, the template consent and subject data collection instruments by clicking on the protocol tab from the project summary page. The template consent form will also be provided to the study teams at the external sites through email in the Reliance Packet.

Unfortunately, once the form is waiting PI signature, no additional changes can be made and the draft cannot be pulled back.  The PI will need to sign off on the form and the coordinator or PI should contact the IRB office to request the form be sent back so the additional changes can be made.

Unfortunately, the email that is sent to the PI is automated and cannot be generated again.  The PI can always sign into myIRB with their WUSTL key or HPRO ID and ‘sign off’ on the form.  Once the PI logs in, the form will be in their inbox.  They can click on the file folder icon under the To Do column.  The system will prompt them to enter their credentials and the form will be moved onto HRPO for review.

Sites do NOT need to provide a site-specific consent form to the WU IRB. The external study teams will receive an email from the Washington University HRPO office. This packet will contain the reliance addendum, template consent form with site specific highlighted areas that can be altered and the local context questionnaire.  The external site should work with their local IRB to complete the Reliance packet.  The reliance packet will be attached to the myIRB site application for review and approval by the Washington University IRB.

There could be several reasons you may not be able to see the study in myIRB. These are the most likely reasons:

• If you are not the PI, you must be logged in as the PI’s delegate to see the study. Please see the Single IRB Reference Manual for Site PIs and Study teams under sIRB Guidance.
• If you have not yet started a draft site form, you will not be able to see the study in myIRB. Please see the Single IRB Reference Manual for Site PIs and Study teams under sIRB Guidance.

Site study teams should not be added in myIRB in most cases. The WU IRB is not responsible for approving or tracking study team members. Those that obtain HRPO IDs should be limited to those that act as delegates to the PI.

myIRB only stores users who have appropriately obtained HRPO IDs. If the PI or the study team member you are looking for is not showing up in the drop down list, that is because they have not completed the HRPO ID process. Single IRB Reference Manual for Site PIs and Study teams under sIRB Guidance.

No, we are not able to resend these system generated emails. If you cannot locate the email after looking in Junk and Spam, you will need to start a new HRPO ID request. These emails come from myIRB@wusm.wustl.edu.

First, verify that you are clicking on the Log In with HRPO ID button to log in to myIRB. Using the other buttons such as WUSTL key will not allow you to log in.

You need to also check that you completed the process. The process involves receiving an email form myIRB and clicking a link to verify your email address. After you have done this, you will receive a notification that your ID has been approved 1 to 2 days later. If you didn’t click on the link to verify your email your request won’t be reviewed or process. If you cannot locate the email after looking in Junk and Spam, you will need to start a new HRPO ID request. These emails come from myIRB@wusm.wustl.edu.

If you are attempting to log in for the first time and receiving a message stating your security questions have not been answered, please contact HRPO for assistance as you will need a link sent with a temporary password.