Determination of Human Subject Research

Not all activities with humans meet the definition of human subject research and as such, do not need to be reviewed by the IRB. IRB review is required when the activity meets the definition of research and /or clinical investigator involving human subjects. Individuals should contact the MSU IRB office with any questions regarding whether an activity constitutes research and/or a clinical investigation involving human subjects. Requests for a determination of human subject research are made through the Click^TM Research Compliance System.

How to Submit

1. Complete the HRP-512 - Template - Determination of Human Subject Research.
2. Create and complete a New Study in Click.
3. Upload HRP-512 (Basic Information SmartForm page).
4.  Complete additional template, as appropriate:
   1. HRP-537 - Template - Use of Protected Health Information Application
      1. Complete when the study involves HIPAA Protected Health Information, for any covered entity.
      2. Upload HRP-537 (MSU Additional Information SmartForm page).
5. Upload any variables.
6. Submit the New Study.

For detailed instructions, see the Quick Guides.

Click Templates

• Required: HRP-512 - Template - Determination of Human Subject Research
• As Appropriate: HRP-537 - Template - Use of Protected Health Information Application

Available at the Click Templates page.

Click Quick Guides

• How to Create, Save and Edit an Initial Study
• How to Submit an Initial Study
• Completing the Initial Study - SmartForm Pages

Available at the Click Quick Guides & Videos page.

More Information

For more information, visit HRPP Manual 4-3, Determination of Human Subject Research.