Modifications

Any proposed change to an approved non-exempt research study must be reviewed and approved by the IRB prior to implementation of the change, with certain limited exceptions to eliminate a hazard to subjects. Examples of changes include revising the informed consent document, adding recruitment materials, adding a new subject population, or adding a new research site.  

This means that the project, as approved by the IRB, must be followed. It is recommended that investigators consider this requirement when submitting an application to the IRB and build flexibility into their research project.

However, when an immediate change in a research protocol is necessary to eliminate a hazard to subjects, the proposed change need not be reviewed by the IRB prior to its implementation. In such situations, however, investigators must report the change in protocol to the IRB immediately thereafter. See the HRPP Manual 9-5, Unapproved Change in Protocol for policies and procedures.

Requests for Modification are made through the ClickTM Research Compliance System.

How to Submit

  1. In Click, open the Study to modify and select "Create Modification/CR."
  2. For the submission type, select Modification. NOTE: if you also would like to renew the study, select Modification and Continuing Review. See the Continuing Review page for information about the continuing review process.
  3. Select the Modification scope (type of modification).
    1. Study team member information - select if you need to modify your study team. Please note this does not include the Principal Investigator. If you need to modify the Principal Investigator, select Other parts of the study.
    2. Other parts of the study - select to modify any SmartForm page, other than Study Team.
  4. Complete the Modification Review SmartForm page.
  5. Complete and upload the following templates as appropriate:
    1. HRP-510 - Template - Legacy Protocol
      1. Complete for studies that have been transferred from the MSU IRB Online System to Click at the time of first modification or continuing review.
      2. Upload HRP-510 (Basic Information SmartForm page).
    2. HRP-529 - Template - Change in Principal Investigator Document
      1. Complete when requesting a change in Principal Investigator).
      2. Upload HRP-529 (Supporting Documents SmartForm page).
    3. HRP-530 - Template - Add or Remove Individuals to FDA Projects Conducted Under an IND or IDE
      1. Complete when adding or removing individuals to FDA projects conducted under an IND or IDE.
      2. Upload HRP-530 (Modifications SmartForm page).
    4. HRP-537 - Template - Use of Protected Health Information Application
      1. Complete when the study adds the involvement of HIPAA Protected Health Information, for any covered entity.
      2. Upload HRP-537 (MSU Additional Information SmartForm page).
    5. HRP-540 - Template - ICH-GCP - For Investigators
      1. Complete when ICH-GCP is added and 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 (Additional Information SmartForm page).
    6. HRP-541 - Template - Involvement of Prisoners in a Research Project
      1. Complete when prisoners involvement is added to a study.
      2. Upload HRP-541 (MSU Additional Information SmartForm page).
  6. Make the needed changes to the SmartForm pages and upload new or revised documents as appropriate.
  7. Submit the Modification.

Click Templates

  • As Appropriate:
    • HRP-510 - Template - Legacy Protocol (use for studies that have been transferred from the MSU IRB Online System to Click at the time of first modification or continuing review)
    • HRP-529 - Template - Change in Principal Investigator Document (Use when requesting a change in Principal Investigator)
    • HRP-530 - Template - Add or Remove Individuals to FDA Projects Conducted Under an IND or IDE (use when adding or removing individuals to FDA projects conducted under an IND or IDE)
    • 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 Complete the Transfer of Legacy Non-Exempt Study to Click: At the Time of First Modification or Continuing Review (use for studies that have been transferred from the MSU IRB Online System to Click at the time of first modification or continuing review) 

Available at the Click Quick Guides & Videos page.

More Information

For more information, visit HRPP Manual 8-6, Revisions to an Approved Project.

How to Submit