Statement

This document and the accompanying links will describe the process for determining the level of IRB Review and Approval needed for any campus community member conducting research as part of or on behalf of Valparaiso University.

Valparaiso University Departments/Personnel

• Office of Sponsored and Student Research (part of the Office of the Provost)

• Institutional Review Board
  • IRB Chair
  • IRB Committee
• Valparaiso University Researchers
  • Faculty Research
  • Staff Research
  • Student Research

 Overview of Process

• The IRB Process is initiated by first determining what type of review, if any, is needed by the IRB Board
  • This process begins by submitting the Human Subject Research Determination questionnaire
  • Students and Faculty/Staff may use the same form 
  • If additional review is needed, the researcher will be prompted to complete one of the following:
    • Application for Exempt Review
    • Application for Limited Review
    • Application for Expedited or Full Review
  • Submitters should also have completed Ethics Training
• The workflow for review of these applications happens in Perceptive Content, within the Operations Department, Office of Sponsored Research Drawer
  • Faculty Sponsor review and approval, and IRB Committee approval will use Perceptive Experience (web-based)
  • The Director of Sponsored Research and IRB Chair will use the Perceptive Content Desktop client for processing
• Additional Information can be found on the Office of Sponsored and Student Research website

Process Specific Tools

• MachForms
• Perceptive Content
• Perceptive Experience

Procedures

IRB - ALL Forms Completed

1. Researcher (Primary Investigator aka PI) completes and submits the form
   1. Forms include:
      1. Human Subject Research Determination
      2. Application for Exempt Review
      3. Application for Limited Review
      4. Application for Expedited or Full Review
   2. Forms may be used by student or staff/faculty researchers and the document name is determined by selections within the form to denote a Student request for workflow
2. Upon submission, the form is routed into Perceptive Content to the Office of Sponsored Research workflow queue and the Project Title is populated in the Perceptive document key field
   

Scan & Link in Perceptive Content 

1. All forms first arrive in the OSR Scan & Link queue. Scan & Link is completed by a member of Enterprise Processes & Projects (EP&P) within IT. 
   1. In this queue the form is Scanned and Linked with Colleague to capture data specific to the form
      1. For student-submitted forms, the XRIC screen in Colleague is used to populate the student and faculty-sponsor information
         1. Select the student researcher by typing their name, click on the student name when presented with a list of results for your search
         2. 
         3. When prompted, select the Course for which the research is being completed
         4. 
         5. You will be prompted to select an additional course, just click Finish after selecting the first course
         6. On the Perceptive document page, click the 'Gold Key' to add the Colleague data to the document
         7. 
      2. For faculty-submitted forms, the FCTY screen in Colleague is used
         1. Select the faculty member by typing their name
      3. For staff-submitted forms, the NAE screen in Colleague is used
         1. Select the staff member by typing their name
         2. On the Perceptive document page, click the 'Gold Key' to add the Colleague data to the document
2. Following Scan & Link, route the document forward.
3. 
4. The document goes to the OSR - Doc Sort queue
   1. IRB documents requiring faculty sponsor review are routed to OSR - Faculty Sponsor Review
   2. Other IRB documents are routed to OSR - IRB Chair Review

OSR - Faculty Sponsor Review

1. A Perceptive Experience Task is assigned to the Faculty Sponsor to review and confirm their willingness to serve as sponsor
2. The Faculty Sponsor will receive an email notification that they have a task to review
3. The task can be opened and reviewed in the same manner as Registrar Requests
4. For this Task, the appropriate faculty Text Stamps are
   1. OSR - IRB Faculty Sponsor Approved
   2. OSR - IRB Faculty Sponsor Denied
5. After the faculty review task is complete the document moves to the IRB Chair Review queue

Applications for IRB Review

IRB - Human Subject Research Determination

1. Routes to OSR/IRB Chair Review queue
2. IRB Chair reviews the determination, and if all is in order Routes Forward to the OSR - Archive queue
   1. If a question remains, the chair may manually assign a task to PI using the OSR - PI Response Task template.
   2. After resolving the question, Route Forward to the OSR - Archive queue

IRB - Application for Exempt Review

1. Routes to OSR/IRB Chair Review queue
2. If IRB Chair needs further information from PI, manually assign a task to PI using the OSR - PI Response Task template.
1. PI reviews and adds notes, completes task
2. Repeat until Chair has sufficient information.
3. OSR/IRB Chair Approves, applies stamp
4. Message content: On [date], the IRB determined that your project is exempt from IRB oversight. You may proceed with  your project. Best wishes for a successful project!
   1. Note: Denials will be handled manually by IRB Chair as they are rare.
5. Send message to PI with notification of status based on Approved stamp
6. Route to Archive

IRB - Application for Limited Review

1. Routes to OSR/IRB Chair Review queue
2. If IRB Chair needs further information from PI, manually assign a task to PI using the OSR - PI Response Task template.
   
   1. PI reviews and adds notes, completes task
   2. After PI completes task it routes back to Chair Review queue
   3. If additional Committee Review is needed, Chair routes back to Committee Review and/or assigns manual tasks to Committee Members using the OSR - Review Task template
   4. to assign the task to EACH committee member, check the 'Create Individual tasks...' box 
      1. Committee members use Text templates or assigned Sticky Note templates to add comments or questions
      2. Add 'Committee Reviewed' stamp when done with comments, but not ready for final approval
      3. Add 'Committee Member Approval' or Denial if review complete and decision made
   5. Repeat until Chair has sufficient information.
3. After Committee review and PI responses are complete, IRB Chair applies their Approval or Denial stamp
   1. Denials will be handled manually by IRB Chair as they are rare.
4. IRB Chair routes forward to IRB Archive
5. Upon routing forward, Approval email is then sent to the PI/Submitter
   1. Message content : Dear [PI Name], On [date], the Valparaiso University IRB determined that your project, [name of project], was approved using a limited review process.  You may proceed with your project.  If your project requires material, procedural or personnel changes or if an adverse event occurs, you are required to notify the IRB. Best wishes for a successful project! Mike Watters, IRB Chair

IRB - Application for Expedited or Full Review

1. Routes to OSR/IRB Chair Review queue
   1. IRB Chair does initial review and Routes Forward to Committee Review queue
   2. Assign task to all Committee Members of new application to review
2. Committee members review and add annotations, notes, questions for PI
   1. Add Text to specific areas of form where clarification is needed or with questions
   2. Apply stamp OSR - IRB Committee Member Reviewed if response from PI is needed
   3. Apply stamp of approval or denial if no additional response from PI is needed
      1. OSR - IRB Committee Member Approval
      2. OSR - IRB Committee Member Denial
   4. Complete Task
3. After all tasks complete routed to OSR - Chair Review queue
4. After committee members initial review is complete IRB Chair assigns manual task to PI for response
5. PI responds to committee questions/notes
   1. Add Text to respond to questions or with clarification
   2. Complete Task
6. Route to Committee Review
7. Repeat 2-6 until Committee members have made a final decision and assigned their approved or denied stamp 
8. IRB Chair assigns their OSR - IRB CHAIR Approval or OSR - IRB CHAIR Denial stamp
9. Message sent to PI with result of IRB Review and copy of final document

On [date], the Valparaiso University IRB determined that your project, [name of project], was approved using a/an [exempt/limited/expedited/full] review process.  You may proceed with your project.  If your project requires material, procedural or personnel changes or if an adverse event occurs, you are required to notify the IRB.   If your project lasts longer than one year, an annual check-in is required to update the IRB on the project's status.  For projects requiring a full review, you must seek annual re-approval by the IRB.  Best wishes for a successful project!

Mike Watters

IRB Chair

1. Document will be routed forward to OSR - Archive

Additional Applicable Documents