Getting Started
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 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.
Sign up for TOPAZ
TOPAZ is MSU’s protocol management system. Request to be added to the TOPAZ system. Our staff will set up your user profile, and then you will then be able to login to TOPAZ using your MSU netID and password.
Get familiar with TOPAZ by reviewing our short How-To Videos, FAQs, and Tips.
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 by the Office of Research Compliance to TOPAZ twice a week.
Submit your IRB Application
Onceyou have been granted access, login to TOPAZ to begin your application.
- Under Compliance, choose Human Protocols.
- Hover over Protocols, and choose Create Original Protocol.
- Select the appropriate form. See Types of Review orcontact the IRB Administrator with questions.
- Fill out the form and answer all required fields – SAVE after each section to avoid losing your work.
- Click Submit at the top; click through all final prompts to finalize.
- See Forms and Applications for expected turnaround timelines. Any IRB feedback or revision requests will come through the TOPAZ system via email.
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.
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?