Create an account in e-irb (our electronic submission system

For questions please contact the IRB office 573-882-3181, Chrisitne Hueske will be your contact for IRB issues and will get you to the appropriate IRB specialist.

Before you begin your application make sure you have completed IRB training

Initial View:

When you first log into the e-irb the page should look like this:

You can always return to this page by clicking on ‘main menu’ at the top menu located under eIRB 3.7

IRB Forms:This shows all of the forms available for the HS IRB. (A description of the forms can be located further down in this document)

Open Saved IRB Project:This allows you to see all projects that are started (even if you just open a form and then close out of it)

Document Storage:This allows you to look up your digital documents. It will display the list of open studies with two circles, one to add new documents and the other to view the documents. You cannot add a document unless a form has been started but not submitted (such as the application or an amendment)

Compliance training: This is where users can go to view the date they completed the training.

Update Personal information: If you are an employee, your information is pulled from people soft and cannot be updated by the HS IRB. Please contact Human Resources if this information is incorrect. If you are a student or an external user (someone not associated with the University of Missouri) you can update this information. Please do NOT enter your home address.

Personal Document storage:this is where you should upload a copy of your resume/CV. It is needed for the IRB to determine if the person is qualified to do what they are requesting to do. This is also where you can locate HIPAA waivers for case reports if you are the investigator listed on the waiver.

The HS IRB may upload documents that pertain only to this person that are not related to a particular study such as a Preparatory to research.

IRB Forms

When you click on this link it looks like this:

Applications:

Please choose the Health Sciences formsas forms cannot be transferred between Campus and the Health Sciences.

There are several types of applications

Types
HS Exempt
  • When should I use this?
The exempt application is most commonly used for survey, questionnaires, focus groups and interview type studies that do NOT include children.
Note: exempt applications do not require a formal consent – see section on consent for more information
What supporting documents need to be submitted?
  • The questions/survey that will be asked
  • A brief cover letter or information that is provided to the subject to get them to participate including the following: it is research, it is voluntary, how long it will take, how to reach someone if they have questions.
HS Record Review
  • When should I use this?
This application is typically for retrospective review of information such as a chart review of medical records. This application can also be used for prospective chart reviews.
What supporting documents need to be submitted?
  • The HIPAA waiver if accessing the medical record, billing records, IDX or other systems that fall under HIPAA.
  • If the study is VA a protocol, data safety plan and the VA HIPAA waiver are required.
HS Application
When should I use this?
This application should be used for any study that is not a record review, exempt or an HUD.
What supporting documents need to be submitted?
  • A protocol
  • Consent if applicable
  • HIPAA if applicable
  • If applicable, any other documents that are needed to support a complete submission of the study. These may include the following: a drug package insert, description of devices, any surveys, diaries, advertisements, etc.
HS Humanitarian Use Device (HUD) Form
When should I use this?
This application should only be used for Humanitarian Devices as deemed by the FDA. This is not for research. You will know if you have an HUD because the sponsor will tell you.
What supporting documents need to be submitted?
  • The Sponsor will provide a protocol and the information that is needed.
Additional forms:

HS Exempt Annual Update
This form is for the annual review of exempt projects.
HS Inclusion/Exclusion Exception
Use this form to request to enroll a subject that does not meet the inclusion/exclusion criteria.
HS On Site Death Report

Use this form to report a death of a study participant. If the death is related to the study complete the event form as well.

HS Project Personnel Change
Use this form to add or remove study personnel. Please remember to include their role and if they are consenting.
HS Amendment Request
Use this form for any amendment to any existing, ongoing, approved protocol.
HS Requested Identification Numbers
Use this form to update the system with the clinicaltrials.gov number or to add a people soft number after the study has been approved.
HS Monitoring Reports
Use this form to submit all reports from monitors(not the DSMB) that review the on-site study. The report is required to be submitted within one week of receipt.
HS Event Report
Use this form to report an unanticipated problem or a deviation.
HS Completion / Withdrawal Form
Complete this form for all projects that have completed or are being withdrawn
HS Cumulative AE Log
This is a tool for users to track events that do not need to be submitted to the IRB. The user will get notified that the event is not being reviewed as these are not seen by the IRB.

HS Continuing Review Report
Regulations require each study be reviewed at least once a year. This is the form to be used for the annual review.
Other Required Forms (Templates)

This is a link to the templates (consents, HIPAA, etc) which is located on the main IRB page prior to logging in.

Deleting Items in the E-IRB

Deleting a form:

If you start a form (application, amendment, etc) and decide you no longer need the form AND you have NOT submitted it electronically, you can delete the form from the system.

  1. Go to ‘my save projects’

  1. Click on the circle that says ‘project forms’ for the project you wish to delete the form from.
  1. The forms (application, amendments, CRRs, etc) associated with that project will be displayed. Look for the one that you wish to delete.

  1. The third circle under the first row is to delete the form.

Theoption to delete is not available after the form has been submitted to the IRB.

You can delete an uploaded document that has been uploaded prior to submission of the form prior to the form being electronically submitted.

  1. Click on ‘uploaded docs’

  1. The button to delete is located to the far right.

Once the form has been electronically submitted you cannot delete the digital document.

Navigating the Digital (uploaded) Documents in E-IRB

There are two ways to get to the uploaded documents. The first is to look at them from the screen that lists all of the projects. The second is to open the project and look at the documents associate with the review. We will start with looking at the uploaded documents from the screen that shows all of the studies.

To see the ALL of the uploaded documents for theentire study:

  1. Go to my saved projects(either from the main menu or from the menu under the e-IRB 3.7)
  1. Look at the list and find the study you want
  1. Select the button labeled uploaded documents.
  1. All documents may then be sorted according to the type by clicking on the box in the top left hand corner.

To see uploaded documents for a certain review within a study (such as the application, an amendment, CRR or an event):

  1. Go to my saved projects
  1. Select the button named‘project forms’
  1. All forms(application, CRRs, Amendments, etc) associated with that project will then be displayed.
  1. To view the documents for each type of review click the button labeled ‘uploaded docs’.

For example, if you click uploaded docs for the Continuing review, you will only see documents associated with the CRR. When you sort from this view, the system will only show the type of document being sorted (protocol, HIPAA, Informed Consent)associated with that review and NOT for the entire study.

If you want to change which form (amendment, CRR, Application, etc) you are seeing the documents for click on the box in the upper corner that selects the review key number.