Expedited Review

If an activity is a non-exempt human subject research study and/or clinical investigation, the study 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.

New Study Submission

To apply for approval of an expedited research study, the investigator submits a New Study for review to the IRB through the ClickTM Research Compliance System. See the What & How to Submit - Expedited Initial Submission for more information about the submission process.

An IRB coordinator will be assigned to the submission. The IRB coordinator conducts a pre-review (e.g. checks for completeness, whether ancillary reviews are needed, if additional requirements apply, review the informed consent).

After the pre-review is complete, an IRB member will review the submitted application to determine if the study qualifies for expedited review and if so, whether the criteria for IRB approval have been met. Reviewer comments may be generated if clarification or explanations are needed.

The IRB member may approve the study all criteria necessary for approval have been met. Expedited approvals do not require convened IRB review. The approved version of the consent form(s) and the approval letter will be available through Click. Please note that an MSU IRB Approval Letter must be received before any human subject research may begin.

Continuing Renewed Approval

For research subject to the revised Common Rule, unless the IRB determines otherwise, continuing renewed approval is not required for:

  • Research eligible for expedited review;
  • Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
    • Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
    • Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

Modifications, reportable events (e.g. unanticipated problems involving risks to subjects or others, noncompliance) and study closure must still be submitted to the IRB, even if the study does not require continuing renewed approval.

Please note that studies that were approved prior to implementation of the revised Common Rule and have not been transitioned to the revised Common Rule require continuing renewed approval. Studies regulated by the U.S. Department of Justice or the U.S. Food and Drug Administration also require annual continuing renewed approval.

If continuing renewed approval is required, IRB approval is valid until the expiration date listed on the MSU IRB Approval Letter.  If the research continues to involve human subjects, you must submit a Continuing Review request at least one month before expiration. Visit the How to Submit a Continuing Review page for more information.

Modifications

Any proposed change or modification with certain limited exceptions discussed below must be reviewed and approved by the IRB prior to implementation of the change. Please submit a Modification request to have the changes reviewed.  If changes are made at the time of continuing review, please submit a Modification and Continuing Review request. Visit the How to Submit a Modification page for more information.

Immediate Change to Eliminate a Hazard

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. Please visit the Reportable Events page for more information, including timelines.

Reportable Events

Certain events require reporting to the IRB. These include:

  • Potential unanticipated problems that may involve risks to subjects or others
  • Potential noncompliance
  • Subject complaints
  • Protocol deviations or violations
  • Unapproved change in protocol to eliminate a hazard to subjects
  • Premature suspension or termination of research
  • Audit or inspection by a federal or state agency
  • New potential conflict of interest of a study team member
  • Written reports of study monitors
  • Emergency use of investigational drugs or devices
  • Any activities or circumstances that affect the rights and welfare of research subjects
  • Any information that could increase the risk to subjects

Please report new information through the project’s workspace and contact the IRB office with any urgent events. Please visit the Reportable Events page for more information, including timelines.

Prisoner Research

If a human subject involved in ongoing research becomes a prisoner during the course of the study and the relevant research proposal was not reviewed and approved by the IRB in accordance with the requirements for research involving prisoners under subpart C of 45 CFR part 46, the investigator must promptly notify the IRB. Please visit the Reportable Events page for more information, including timelines.

Site Visits

The MSU HRPP Compliance office conducts post approval site visits for certain IRB approved projects. If the project is selected for a site visit, you will be contacted by the HRPP Compliance office to schedule the site visit. For more information, see the Site Visits page.

Consent, Parental Permission, or Assent Form(s)

  • Use of IRB Approved Form: Investigators must use the form(s) approved by the IRB and must typically use the form with the IRB watermark.
  • Copy Provided to Subjects: A copy of the form(s) must be provided to the individual signing the form. In some instances, that individual must be provided with a copy of the signed form (e.g. projects following ICH-GCP E6 requirements). Assent forms should be provided as required by the IRB.

Closure

If the research activities no longer involve human subjects, please submit a Continuing Review request, through which project closure may be requested. Human subject research activities are complete if data collection is complete and there is no further interaction or intervention with human subjects, and analysis of identifiable private information or identifiable biospecimens is complete. Visit the How to Submit a Closure page for more information.

More Information

See the HRPP Manual 8-2, Expedited Review and 8-5, Initial Review for a more detailed description of the expedited review process.

Review Process