Exemptions

The regulations for the protection of human subjects define categories of “exemptions.” This means that if the involvement of human subjects will only be in one or more of the exempt categories, the research activities are exempt from the regulations. For studies that may be eligible for exemption if a limited IRB determination is made, the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB will also be assigned to make the limited IRB review determination. More information about exemptions is available on the Exempt Process webpage.

At MSU, the investigator may not make the determination of exempt status; the MSU IRB staff, chair, or committee members make the exempt determination.

Requests for an exempt determination are made through the Click(TM) Research Compliance System.

How to Submit

  1. Complete the HRP-503 - Template - Protocol.
  2. Create and complete a New Study in Click.
  3. Upload the HRP-503 template (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 instruments, surveys, variables, consent form(s) to the appropriate SmartForm pages. You do not need to upload recruitment materials for exempt studies.
  6. Submit the New Study.

For detailed instructions, see the Quick Guides.

Click Templates

  • Required:HRP-503 - Template - Protocol
  • As Appropriate: HRP-537 - Template - Use of Protected Health Information Application (use when the study involves HIPAA Protected Health Information, for any covered entity)

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 8-1, Exemptions.

How to Submit