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Institutional Review Board

East Tennessee State University

How To Submit a New Study

First Steps

  • Have you completed CITI training for human research within the last 3 years? If not, please visit the CITI website to complete or refresh your training.
  • Have you recieved IRB Manager Training and been assigned a username and password?
  • If you are a student submitting a study to the IRB, check out our Student Checklist.
  • If you are a faculty member advising a student's study submission, check out our Faculty Checklist.
  • Obtain appropriate permissions or approval from all external sites prior to submitting your study to us for review.

Plan ahead: The review process could take 4-6 weeks from the time all documents are submitted correctly.

Get Set-up in IRB Manager

IRBManager is a web-based system designed specifically for the IRB review process, all the way from submission to approval letters. Before you can use IRBManager, you must:

  1.  Download the “Request for Login form” from the website or email Katherine Siglin () to request one.
  2. Scan and email your signed form to  or hand deliver to the IRB office in Ross Hall, Room 423.
  3. Complete the 30 minute phone training that will be scheduled after your form is received.You will need a phone and a computer with a WIFI connection to complete the training.

Information Needed to Complete Your Submission

 

  • Resources (population, time, staff & facilities)
  • Study staff info
  • Review Type: Exempt, Expedited, Full 
  • Study Details & Objectives
  • Procedures for Recruitment & Enrollment of Participants
  • Informed Consent documentation 
  • Roles, Risks, Benefits, Payments, and Costs to Participants
  • Privacy (about the person) & Confidentiality (about the data)
  • Conflict of Interest
  • Ensure all study staff have completed their CITI training

Common Attachments You May Need

  • Informed Consent Document  (note that we have templates on our website for download).
  • Survey/Interview Questions
  • Letters, Ads, Flyers
  • Email/Phone Script
  • CV/Resume
  • References/Bibliography
  • Approval Letter or email from any external sites (not required for submission but is required before final approval can be issued)

 

Using IRB Manager to Submit Your Study

Access IRB Manager's homepage:

  • Login using the credentials provided to you in your IRB Manager phone training. Make sure the Client box says: ETSU

irb manager login page

  • After login, you will be directed to the homepage, or "dashboard" view. Click the "Home" button at any place throughout the system to come back to this dashboard view.

Click "Start xForm" from the dashboard view. 

irb home page

Choose the appropriate New Protocol Submission according to the location of the research

new protocol submission options

 

Complete and submit the xForm, including attachments where applicable.

 

new protocol submission default page

  • Use the Next buttons and the Drop Down Menu to navigate through the form. The Next buttons will not let you go on if you have required information still needed on a page. You will need to use the Drop Down Mento navigate to another page.
  • Use the Save for Later button if you need to take a break. 
  • If you are a student, add your faculty advisor under the Collaborators feature. 
  • Throughout the form, use the Add Note feature to add additional information or clarification to any field.

After you have completed the form, type in your password.

sign and submit the nps

Submit your form

submit nps

 

I Submitted my Protocol: What's Next?

Once submitted, your Protocol will go through the following review stages:

  • Faculty Attestation (for students)
  • IRB Pre-Review
  • Dept. Chair/Head Signs xForm (for non-students)
  • IRB Initial/Coordinator Review
  • IRB Chair Review
  • IRB Reviewers
  • If approved, Approval Letter!
    (Note: There are additional review stages for VA and MSHA studies.)

We can send your form back to you at any stage for revisions and corrections.

 

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