Full Board 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.  At MSU, review by the convened IRB is called “full review” and are reviewed at convened IRB meetings. More information about full review is available on the Full Review Process webpage.

Requests for an initial full board submission 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 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).
    3. HRP-541 - Template - Involvement of Prisoners in a Research Project
      1. Complete when prisoners are involved in a study.
      2. Upload HRP-541 (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.

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)

    • HRP-540 - Template - ICH-GCP - For Investigators (use when ICH-GCP will be applicable to the study)

    • HRP-541 - Template - Involvement of Prisoners in a Research Project (use when prisoners are involved in a study)

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 8-3, Full Board Review Procedure and 8-5, Initial Review.

How to Submit