Welcome to the world of Human Subjects Research! We look forward to working with you.  

Use these steps to prepare for your upcoming Human Subjects Research protocol application. 

 

understand  Understand Human Subjects Research 

Studies that include both research  AND  human subjects are considered to be Human Subjects Research (HSR). Only HSR  studies require IRB review or Exemption. Read more about the definition and discover what does or does not qualify as HSR.  

If you are uncertain whether your project requires IRB approval or you believe that your project does not require IRB review and you want official determination documentation from the IRB, submit the Human Subjects Determination Worksheet via DocuSign. You can also fill out the NIH Decision Tool: Am I Doing Human Subjects Research? to determine if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research. **Note: This tool should not be used as the sole determination of exemption. Please reach out to the IRB for any questions or clarification.

Explore the IRB website to learn the IRB basics – committee functions, operating principles, types of review, application information, find standard templates, and more.  

blue lightbulb  Complete Training 

Determinewhich prerequisite Human Subjects Research course to take depending on your role and responsibilities. Students should refer to their syllabus, instructor, or PI for guidance. CITI Training completion records are uploaded twice a week, a Key Associate (view only) accounts will be created to TOPAZ during the upload. 

TOPAZ logo  Starting in TOPAZ 

TOPAZ is MSU’s protocol management system.

Key Associate (view only) accounts will be created when required IRB training is complete. Trainings are uploaded twice a week.

If you need to have your privileges updated in TOPAZ, please complete the form. This can only be done, once your training is completed and you have a view only account. Once your account has been updated you will recieve an email notification. These requests are usually processed within 48 business hours.

Get familiar with TOPAZ by reviewing our short How-To Videos, FAQs, and Tips.  

blue submit button   Submit your IRB Application 

Onceyou have been granted access, login to TOPAZ to begin your application.  

  1. Under Compliance, choose Human Protocols. 
  2. Hover over Protocols, and choose Create Original Protocol. 
  3. Select the appropriate form. See Types of Review orcontact the IRB Administrator with questions.  
  4. Fill out the form and answer all required fields – SAVE after each section to avoid losing your work. 
  5. Click Submit at the top; click through all final prompts to finalize.  
  6. See Forms and Applications for expected turnaround timelines. Any IRB feedback or revision requests will come through the TOPAZ system via email. 

 

blue question mark  Questions? 

Refer to our overall IRB FAQs or TOPAZ FAQs.  

The IRB Administrator can be reached via irb@montana.edu or (406) 994-4706 with quick questions or feel free schedule a consultation via Outlook Calendar for inquiries over 15 minutes.  

For general TOPAZ or training questions, contact the ORC Training Coordinator.   

 

Arrows  Transitioning from Another Institution 

Current CITI Training records from your prior institution can be transferred to MSU. Contact the ORC Training Coordinator for assistance. We will let you know of any additional courses needed to meet MSU baseline requirements.  

Schedule a meeting with the IRB Administrator to discuss your ongoing research. Options may include creating new protocols for review at MSU or setting up a Reliance Agreement with your prior institution. Such options will depend on funder requirements, review level, and stage of the research.  

Other items for discussion may include: 

  • What is your area of research? 
  • Are you the lead PI on any of the protocols?  
  • How many protocols will you be transferring? 
  • When is your start date at MSU and do you have a netID established yet?  
  • Does your institution require a data sharing agreement to bring data to MSU?  
  • Will the ongoing work continue to include prior institution colleagues participating as protocol personnel?