Expedited Initial Submission

If an activity is a non-exempt human subject research study and/or clinical investigation, the project is subject to the regulations for the protection of humans involved in research and/or clinical investigation. The human research regulations require review by the convened IRB, unless the research qualifies for expedited review. A research study that is determined to meet one or more of the expedited categories (both HHS and FDA) and is no more than minimal risk can undergo expedited review.

Projects that qualify for expedited review can be reviewed and approved by the IRB chair or by one or more experienced reviewers designated by the chair from among members of the IRB. This means that the project does not need to be reviewed by the convened IRB to receive approval and can be approved between convened IRB meetings. Expedited projects ARE still subject to the regulations for the protection of humans involved in research. More information about expedited review is available on the Expedited Process webpage.

Requests for initial expedited review are made through the ClickTM 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 (Basic Information SmartForm page).
  4. Complete any additional templates, 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).
    2. HRP-540 - Template - ICH-GCP - For Investigators
      1. Complete when ICH-GCP will be applicable to the study; you are typically notified by the Compliance office when this template needs to be completed.
      2. Upload HRP-540 (MSU Additional Information SmartForm page).
  5. Upload documents such as consent form(s), parental permission/child assent, surveys, instruments, variables, recruitment materials, debriefing forms, translations, investigator brochures, package inserts, data safety monitoring plan, etc. See HRPP Manual 8-5, Initial Review for a complete list.
  6. Submit the New Study.

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)
    • HRP-540 - Template - ICH-GCP - For Investigators (use when ICH-GCP will be applicable to the study) - You are typically notified by the Compliance office when to complete this template

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 8-2, Expedited Review Procedure and 8-5, Initial Review.

How to Submit