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Human Subjects Review Program

IRBManager

IRBManager is an electronic system for IRB application submission and management of IRB-related study records. The system provides automation to the IRB application and review process with conditioned questions, training verification with CITI, electronic signatures and routing, and email notifications. It also allows for collaboration between researchers when completing the IRB application, as well as collaboration with the IRB office during IRB review of the application. The system maintains all IRB-related records for your studies.

Click IRBManager and use your CWU credentials to log in.

The IRBManager User Guide provides instructions to help users login and begin submissions as well as information about:

  • IRBManager functions and terminology
  • Roles and permissions
  • Submitting applications for Continuing Review or Modification
  • Locating approved protocols and associated materials

The HSRC application

The HSRC application in IRBManager is an all-in-one form. It must be completed for an initial submission (new study) for exempt and non-exempt research.  You will be asked to select the level of review on the last question of the first page of the application.  You may choose from one of four response categories:  1) Determination of Human Subjects Research or HSRC oversight, 2) Request for Exemption, 3) HSRC application (non-exempt research), and 4) Register/Request IRB Authorization Agreement (not common for most investigators).  Regardless of the selection made, the form is designed to guide you through the decision process.  Questions are conditioned to show up or hide based on the responses in the progression of the application.

Before you complete the application process:

1. All study personnel including faculty sponsors must log into IRBManager using their CWU credentials to establish an account in the system and BEFORE being added to an application.  For non-CWU study personnel, contact the HSRC administrator to obtain a login and password in IRBManager.

2. IRBManager recognizes CITI certification and expiration dates for individuals whose CWU email account was used to set up the CITI account.  If a different email account was used in CITI, you must change it to match the CWU email.

For non-CWU study personnel who complete CITI training at a different institution, you must log into CITI and affiliate with CWU completing any additional modules required to satisfy CWU's requirements.

If you have recently taken CITI training and it is not recognized in IRBManager, please allow the system to update overnight before submitting your application. If the system still doesn't recognize the training after the update, contact the HSRC administrator.

 

Modifications, Continuing Review and Study Termination

To submit modification requests, requests for continuing review, or termination reports, you must open the initial submission (original study).  Once you are in the study, you can select from a list of forms available and a description of each form.  For more detailed information, see the IRBManager User Guide.

 

Signatures and Routing

IRBManager automatically routes completed forms to the next step in the review process based on information provided.  For example, faculty sponsors for student-led projects will automatically receive the completed application for review and electronic signature after the student has finished and submitted the form.

Signing the form involves entering username and password.  Emails will notify supervising investigators or department chairs when an IRB application needs review or signature.

 

Email Notifications

As a protocol is being reviewed through IRBManager, investigators will receive emails with updates and instructions.  If an instruction email is received, you must log into IRBManager, access the relevant study, complete the action, and re-submit the form.  The emails will contain a link that will create direct access to the project to simplify the process.  If the instructions are not followed, then the HSRC will not be able to complete the review/approve the project.

 

Transitioning Existing Studies into IRBManager

Basic protocol information has been imported into IRBManager for studies approved or exempted prior to August 1, 2018.  Basic protocol information has also been entered into IRBManager for paper-based applications currently in the review process.  For more information on how to view existing studies, see the IRBManager User Guide.

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