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Category: myIRB FAQs
Begin by selecting myIRB from the menu on HRPO’s website or navigate to https://myirb.wusm.wustl.edu. Then choose the appropriate log-in method, as described below.
WUSTL Key Login: Use this button to log in if you are a Washington University faculty member, employee or student.
BJC-NT User Login: Use this button to log in if you are of Goldfarb School of Nursing or you are an employee of Barnes Jewish Corporation AND Washington University IRB is the IRB that reviews your research.
HRPO ID Login: Use this button if you have received a HRPO ID.
The first time you log in to the system, you must complete your profile. After saving your profile, select the appropriate menu option to create a new project, navigate to other spaces in the system, or use the logout link to exit the system.
Note: When you login and create a project, YOU are listed as the Principal Investigator. If you are completing the application for someone else, you must first log in as a delegate of this person.
The first time you login to the system, your profile page will automatically display for review. During subsequent visits to myIRB, you can access your profile by clicking the Personalize tab in the red, top menu then selecting “Update my profile”.
If your contact or demographic information is incorrect, you will need to request it be corrected, as described below. Updates made in other systems will flow over to myIRB (generally the next day or within 72 hours)
- WUSTL faculty and staff should contact their department business administrator (usually the person who processes payroll) or Human Resources (for SOM HR call 314-362-7196, for Danforth HR call 314-935-5990) to request corrections be made in HRMS.
- WUSTL students should contact the Office of Student Records (314-935-5959) to request corrections be made in the Student Information System.
- BJC users are required to use the BJC IS Support Portal (ServiceNow) to submit a ticket to the BJC IS Helpdesk. Use the direction here to create and complete the ticket, as this can help ensure correct and timely processing of the ticket. If you have questions related to ServiceNow or submitted tickets, call the BJC IS Helpdesk at (314-362-4700).
- HRPO ID users should use the “Request a change” link available on their myIRB profile page.
Please note: users who received limited access will have blank fields in the profile they view. This is because a smaller volume of information is collected for limited access users. Only information requested in the limited access registration form will appear in the user’s profile. Fields that appear blank are not needed and are not used for any purpose.
All users need to follow the directions on the profile page (including entering an academic degree) and have the option of adding a hospital pager.
BJC users and HRPO ID users should also enter their CITI ID (see OBTAINING YOUR CITI ID for direction).
In addition to completing the profile, HRPO must have record that human subjects training (CITI) is complete before individuals can be approved to engage in research.
Most questions in myIRB have an associated information button. It is a red circle with a question mark. It can be found in the draft form you are working on next to the myIRB question number.
You can also call HRPO at 314-747-6800 to speak with a HRPO staff member or use one of our other help services found here.
- Log in to myIRB.
- Click on “Personalize” at the top of the page, then click on “Update my delegates”.
- Enter the first three letters of the last name of the delegate, then select the appropriate delegate from the dropdown menu, then click on “Add Delegate”.
- The delegate will now be listed in the box titled User Delegates.
By default, myIRB grants each delegate access to all of his/her PI’s projects. Additionally, each delegate will be copied on all email notices the system generates about the PI’s projects. There is a way to change the settings using a feature in myIRB called the Delegate Permission System (DPS) which allows the PI to specify which projects a delegate can access and be notified about. PIs should carefully consider the decision to activate the DPS because once it is turned on, it requires ongoing maintenance by the PI.
- As the PI you can review a project online. Click on the myProject tab and select the “Draft Forms” tab. Click on the “review” link to the right of the application.
- Just as PI can review a project online, any individual named as a delegate to a PI can review the project online. Log in to myIRB, click on “delegate login” in the upper right-hand corner and then click on login to the right of the PIs name. Navigate to the myProject tab and select the “Draft Forms” tab. Click on the “review” link to the right of the application.
- You also can print a copy of the form. To do this, go to the Inbox of the PI and click on the “Draft Forms” tab. Then choose the “Review” link on the right side of the form. Then click on “View a printer friendly version of this form,” select the middle character and print the form.
You can log on to myIRB, open the myProjects tab then navigate to “Pending Forms” and click the IRB ID number of your study. At the bottom of the screen, under “History”, click on the link for the form you are wanting to track (this can be “New” for the new project application, “Mod” for a modification, “CR” for a continuing review, or “Mod/CR” for a modification + continuing review application). The pending form is typically at the top of the list. Once you have chosen the form link, click on the “Form Workflow” tab at the top of the screen. Under “History,” you will see where your application is in the workflow.
To check whether or not your study has been scheduled to a full board agenda (and when), choose the “IRB ID Number” link under “Pending Forms” for the study you are interested in. This link will take you to the Project Summary Page for the project. Go to the bottom of the Project Summary page to the section marked “History.” If your application has been scheduled to a full board meeting, the date of the meeting will be listed under the column titled “Agenda Date.” If there is no date listed under “Agenda Date” for your application, then the study has not yet been scheduled to a full board meeting.
Based on your responses to myProject Section 4, your study requires review by another committee at WU, such as the Protocol Review and Monitoring Committee (PRMC), the Radioactive Drug Research Committee (RDRC) the Institutional Biosafety Committee (IBC), the Embryonic Stem Cell Research Oversight committee (ESCRO), or the Conflicts of Interest Review Committee (CIRC). The appropriate committee is notified via myIRB when your responses meet the criteria for notification. Each committee has its own review requirements and you may need to submit separate paperwork to their office before they can complete their review. The other committee will notify HRPO when their review is complete. After other committee reviews are completed the system will automatically route the form for IRB review. If you have any questions regarding review by another committee, please contact their office directly. Information for each committee is available using the links on the myProject Index of the form in progress.
The individual may need to complete their myIRB Profile.
To complete the “myIRB profile” the individual you wish to add will need to log into myIRB. The first time they login to the system, their profile page will automatically display for review and completion. Individuals can be selected and added to the team list, but their human subjects training (CITI) must be complete to submit the form.
It could also be that you are not clicking “save” when you are adding the individual to the application. After selecting the research team member from the dropdown menu, you must click “Save” to the far right of the line in order to add the individual to the research team. Click “Remove” to delete a research team member. To make any change to the individual’s involvement you must click “Edit”, then “Save” again.
Washington University IRB takes on oversight of these individuals on a case by case basis. An agreement with the individual or their institution will be required if it is determined that the WU IRB will serve as their IRB.
You may request to add study team members from other institutions via a Limited Access request. See FAQ titled, “How does someone request a Limited Access ID?” for information on how to submit the request in myIRB. The individual will need to complete CITI training and obtain a Limited Access ID.
To request a Limited Access account the individual you wish to add must go to the myIRB login page the “Request Limited Access” button. The electronic request form will open. A CV or resume and CITI documentation must be attached to the completed form.
After submitting the form, the individual will need to monitor their email account for a verification email that should arrive within a few minutes. The individual must click the link in this email before the request can be processed by HRPO staff.
When the request for the account has been processed, another email will be sent. If there are questions the staff member processing the request will send an email. If approved, myIRB will send the email to the person requesting access. The email will contain a temporary password and directions for logging-in to update the myIRB profile, which will be required the first time they log in to the system.
Note: A limited access ID provides a way to add a non WU/BJH/SLCH person to the study team, but users with limited access will not be able to access any study information in myIRB.
After the Limited Access ID request [link limited access ID request to How does someone request a limited access ID] has been approved and the person has completed their profile, the PI or delegate will be able to request to add this person in the study team section of myIRB by typing in their name as they would for adding other study team members.
You will be asked to describe their role in the study. When describing the role of an individual, please list all procedures they will conduct and all data they will have access to and if that data is identifiable or not.
When HRPO reviews the study, it will be determined if the WU IRB is able to serve as the IRB of record for the individual. An agreement with the individual or their institution will be required if it is determined that the WU IRB will serve as the IRB.
Note: Individuals with limited access IDs are not able to access any study applications in myIRB.
-myIRB profile is incomplete or human subjects training (CITI) has not been completed.
-The IRB stamp is missing from recruitment and consent documents
-Consent and recruitment documents are not saved in Rich Text Format (RTF).
-The assurance document is not signed by the appropriate individuals.
-Consent/assent documents do not follow the templates available in myIRB
-Consent/assent documents are too technical for potential subjects.
-There is inconsistent information between the application, consent, or recruitment documents.
-The IRB cannot understand the rationale for changes because the modifications are not adequately described
Consent templates can be downloaded by selecting a template from the drop-down menu under the “Consent/Assent Documents and Information Sheets for Exempt Studies”, then clicking “Select Template”.
Instructions on writing a consent and suggested consent language is available by clicking the links below “Select Template”.
Call HRPO at 314-747-6800 to discuss how to correct the errors.
Common errors may include the inclusion of “tracked changes” or comment “balloons” containing text or the inability to print of the document in full size.
The majority of recruitment materials must be stamped and must be on the appropriate template to be stamped. The template can be accessed from two places in the system:
- The first is from the recruitment methods/materials question in the application. An attachment box will open below the question for the relevant material you selected. To the right of the attachment box the gray “Generate Stamped Blank Template” button will appear when the template is required.
- The second is in the Attachments section available at the end of the application or from the Index. Scroll down the page until you reach the section describing the recruitment material you selected. The gray “Generate Stamped Blank Template” button will appear below each recruitment material that requires use of the template.
Once you have generated the template, save this document to your computer or local network drive. Edit it as needed for your study. Further guidance for editing is available in the Attachment section under “Other Supporting Documents”. Click the gray arrow on the left-hand side of the screen to access the “Instructions for Working with the Stamped Blank Template.
When you are ready to save DO NOT change the document type! It must remain in Rich Text Format (RTF). You may however choose a different name for your document.
After saving, return to the question in the application about recruitment methods/materials or return to the Attachments section. Use the attachment box provided for the type of material you selected to upload or add your file(s).
You may not be saving your response. In order to add an entry to a table in myIRB you must click “Save” to the far right of the line. To remove the information before it is saved click “cancel”.
Click “Remove” to delete a funding source that has been saved. To make any changes in the type, source, grant title, or name of PI on grant you must click “Edit”, then “Save” again.
myIRB allows the use of a decimal point for this field. For example, 6 months would be entered as .5.
To modify an approved study:
- Log on to myIRB.
- Click the tab that says “myProjects”
- From the open projects list under the “All Projects” tab, click on the IRB ID number of the study you wish to modify.
(NOTE: If you have already started a modification for the study, you will have a draft open under the tab “Draft Forms.” Click on the name of the study under “Draft Forms” to open the application you have started. You would then begin with #5 below.)
- Clicking the IRB ID number will take you to the Project Summary page of the approved study. From there, use the “Create Form” list in the upper right corner to select “Modification/Update Form”. You could also choose “Modification/Update + Continuing Review Form” if you are doing a modification with your continuing review application.
- You’ll be taken to the Project Index. Modify the content in the applicable sections of the project application itself. If you wish to change or add a document to the application, open the Attachment section (by navigating to the end of the application or use the myIRB link to open the myIRB Index then click the Attachments” option).
- To modify an approved document, select the “EDIT” function at the right on the line of the attachment you wish to modify and follow the steps given to modify the document and attach the revised document back to the application. Do NOT delete any previous versions of the document and follow the edit process to attach the revised document as a new version on top of the current document.
- Submit the Modification form. You do not need to sign a new assurance document unless you are requesting to change the Principal Investigator.
Only one modification or continuing review for a study can be created at a given time. If you get an error when you go to create a modification, continuing review or combined modification/continuing review, it means one of these forms has already been created in your drafts or is pending review. To find it, click “myProjects” and then the tabs “Draft Forms” and “Pending Forms.” For drafts, click the title to open the revision you have started. Contact HRPO for information about editing a pending form.
There are a few possible reasons:
- First, check to make sure that you started by opening the Consent Document template from the myIRB system. This template has the IRB stamp already included in it. If you use a template from another source, the IRB stamp is not included. Next, if you opened the myIRB template, check to make sure that you saved the document as an .RTF file. Changing the document to .DOC or .DOCX file will cause you to lose the IRB stamp. Re-saving the file in .RTF format should resolve the issue.
- If using a Macintosh, you may have a compatibility issue. The myIRB stamped templates are compatible when running Microsoft Office 2004 for Mac with Update 11.3.3 or a later version of Microsoft Office for Mac. For more information about this or other updates refer to: http://www.microsoft.com/mac/downloads.
- Additionally, the Mac must be set to open and save the stamped template as a .RTF file. Typically, the default setting on a Mac is to open .RTF files using a text editor (such as Macintosh Editor or WordPad), but the stamp can only retain its functionality when opened using a full word processor like Microsoft Word. It may help to download the template without opening it, save it to your Mac, open Microsoft Office for Mac then navigate to the template and open it.
- If the above suggestions do not relieve the problem, you may want to visit the support page for Microsoft Office for Mac at http://www.microsoft.com/mac/support. Or if you have Mac support, you may want to visit http://www.apple.com/support/ to contact the Genius Bar (the Apple Product user support service).
If you have followed the recommendations above and continue to receive the error, it’s possible the tokens that allow the stamp to work have been damaged. Refer to the directions for Replacing a Damaged myIRB Approval Stamp.
If using a Macintosh, you may have a compatibility issue.
The myIRB stamped templates are compatible when running Microsoft Office 2004 for Mac with Update 11.3.3 or a later version of Microsoft Office for Mac. For more information about this or other updates refer to: http://www.microsoft.com/mac/downloads.
Additionally, the Mac must be set to open and save the stamped template as a .RTF file. Typically, the default setting on a Mac is to open .RTF files using a text editor (such as Macintosh Editor or WordPad), but the stamp can only retain its functionality when opened using a full word processor like Microsoft Word. It may help to download the template without opening it, save it to your Mac, open Microsoft Office for Mac then navigate to the template and open it.
If the above suggestions do not relieve the problem, you may want to visit the support page for Microsoft Office for Mac at http://www.microsoft.com/mac/support. Or if you have Mac support, you may want to visit http://www.apple.com/support/ to contact the Genius Bar (the Apple Product user support service).
Updating the software and adjusting the settings on a Mac will prevent the issue from occurring when using other templates in the future, but it is likely the tokens that allow the stamp to work have been damaged. To fix the existing document you will also need follow the directions for Replacing a Damaged myIRB Approval Stamp.
Yes. Reminders of continuing review due dates will be sent to the PI, delegates, and contact persons via email. The reminders are sent based on the Last Possible Submission Date (LPSD) of the study. The LPSD is the date that you need to have your study submitted to our office to ensure that you can obtain review and approval PRIOR to the expiration date. The expiration date for your study can be found on the approval memo and the approval stamp on your consent and recruitment documents and is also located on the Project Summary page in myIRB.
Not all studies require a Continuing Review. If no study expiration date is listed on the approval memo, a continuing review is not required.
How do I close my study in myIRB?
- Log on to myIRB.
- Click the tab that says “myProjects”
- From the open projects list under the “All Projects” tab, click on the IRB ID number of the study you wish to close.
NOTE: If you have a draft form open (such as a modification or continuing review) you must delete this draft before starting the closure form.
- Clicking the IRB ID number will take you to the Project Summary page of the approved study. From there, select “Project Close Form”.
Once a study is closed, the closure is permanent. If the PI later decides s/he wants to resume the research, a new project submission is required and must be approved prior to resuming the research.
Closed studies by default no longer appear in the PI’s inbox. To view a study after it has been closed, go to the PI’s inbox, select the myProjects tab then open All Projects. Change the filter (far right of the page) to show studies where the project status is “Closed” (or “Any”). Click the “Go” button to refresh the page refresh and you should be able to view the closed studies.
HRPO does not provide a formal memo acknowledging or approving the closure report form, but the myIRB system contains documentation of the closure. To obtain documentation of a closure, find the closed study (as instructed in the FAQ Where can I find a study once it is closed in myIRB?), click on the IRB ID then save/print the Project Summary Page. Next look in the History section of the Project Summary page and click on the Close link. The Form Review tab will be displayed. Click on the link for “View a printer friendly version of this form.” The printer friendly version will open in a new window. Save/print a copy then close the window. Lastly, click on the Form Workflow tab. Save/print a copy of the workflow. The combination of these three documents should serve as satisfactory documentation that the report was received and processed by the IRB.
The following list of baskets shows where your application is in the workflow process:
- Other Committee Review: When responses in a form indicate review is required by another committee at the institution and the form is routed out of the PI’s inbox, it will route to this basket, which serves as a holding pen for the form until all other committee reviews are completed. For new project applications, choose myProjects then click the Project Status tab and refer to the indicators to learn the status. For all other pending and approved forms, navigate to the Project Summary page, find the form under the History section and click the Other Reviews link on the right. The committee(s) triggered in the form will display along with the dates and documentation HRPO received from the committee.
- Admin Prescreen: The application has been received in the HRPO and is being reviewed to ensure that the correct form has been used, all questions have been answered on the application, all attachments are present, etc. Until the project moves out of this basket, the application is not considered ACCEPTED by the HRPO as a complete application.
- HRPO Staff Review: The application is being given a more in-depth review by HRPO staff.
- Expedited HRPO Staff Review: The application is being given a more in-depth review by a member of HRPO’s expedited review team.
- Full Board HRPO Staff Review: The application is being given a more in-depth review by a member of HRPO’s full board review team before it will likely be prepared for a full board meeting.
- IRB Chair Review: The application is under review by an IRB chair designee (for Expedited Review).
- PI Review (requires attention from the PI): The application has been returned to the PI’s myIRB Inbox with questions for the PI to address. The PI/delegate(s)/contact persons on the research team have received an e-mail notification.
- Pre-Meeting Prep: The application and materials are being prepared for a full board meeting.
- Scheduled: The application has been scheduled for a full board meeting. The meeting date can be viewed on the Project Summary page. Scroll down to “History,” find the application, and look at “Agenda Date.”
- Post-Meeting Prep: The application has been reviewed at a full board meeting and is waiting for minutes from the meeting to be written and approved by an IRB chair.
- Approved Pending (requires attention from the PI): The application has been reviewed by the full board and is approved pending specific modifications by the PI. The PI/delegate(s)/contact persons on the research team have received an e-mail notification.
- Tabled (requires attention from the PI): The application has been reviewed by the full board and was tabled at the meeting pending modifications and/or clarifications by the PI. The PI/delegate(s)/contact persons on the research team have received an e-mail notification.
- Disapproved: The application has been reviewed by the full board and was disapproved. The PI/delegate(s)/ contact persons on the research team have received an e-mail notification.
- Withdrawn: For new project, modification, modification + continuing review, and continuing review applications, this means that the application has been withdrawn, either at the request of the PI, or by the IRB if the PI failed to respond in a timely manner to the HRPO’s request for more information. The PI/delegate(s)/contact persons on the research team have received an e-mail notification.
For Reportable Event Forms (REFs), this means that the reported event submitted on the REF did not meet the criteria for reporting to the IRB.
- Approved: The application has been approved and is waiting for final paperwork approval in the HRPO.
- Facilitated Review: Forms will land in this basket when a request to rely (on the review of another IRB) exists and HRPO has finished processing the form. Because HRPO is not the IRB of record, there will not be any approval memos or stamped consent or recruitment materials available in myIRB for forms that underwent facilitated review. The PI/delegate(s)/contact persons on the research team have received an e-mail notification.
- Acknowledged: The REF was reviewed by the IRB chair or convened IRB and has been acknowledged. You can check whether or not the review was done by the IRB chair or the full IRB by using the “REF” tab on the Project Summary page and looking at the information under the “Status” column.
- Released: The application has been approved and released to the PI. The PI/delegate(s)/contact persons on the research team have received an e-mail notification.
Studies eligible to transition to the 2018 Common Rule can only make the transition at the time of Continuing Review using CR1.0 “Would you like to transition this study to the new 2018 Common Rule regulations?”
If you answer this question “Yes” the decision is permanent and the entire 2018 Common Rule applies to the study going forward until it closes.
If you answer “No” to transitioning to the 2018 Common Rule, you will continue to be asked at each subsequent Continuing Review whether you want to transition at that time.
Important note: Once a response is entered and saved, the questions will be locked for editing and the response can only be changed by removal of the draft or withdrawal of the pending form.