Please see our Exempt FAQ page (last question) to learn more about post approval reporting requirements on exempt studies. The question and answers below are applicable to Expedited and Full Board studies.

Yes. On an annual basis, the investigator must submit an “Annual Update Form” to keep the IRB informed on the current project status. See our Annual Reviews SOP for additional information.

The Annual Update Form is auto generated when you receive your reminder, approximately 60 days prior to the expiration date, and must be accessed under “Open Saved IRB Project” section of eCompliance. Please submit the form prior to the deadline found within the reminder notice to keep your study active or to close it.

Yes. An “Amendment Form” must be submitted to the IRB for review and approval prior to initiating any changes to your study. The one exception would be changes initiated to eliminate apparent immediate hazards to the participant prior to IRB approval, the change must be submitted to the IRB as soon as possible as an Amendment with justification. This is the only time a change can be initiated prior to IRB approval and not be classified as noncompliance.

The Amendment form is found under “IRB Forms” in eCompliance. The level of review that will occur will depend on the overall review level of the study and whether the changes are considered administrative, minor, or major. There is no deadline to submit administrative or minor changes, but major changes to full board studies must be submitted by the 25th of the month to be reviewed at the next board meeting. If you are making changes to currently approved documents (protocol, consents, recruitment materials, surveys, etc.), you will need to upload a tracked changes or highlighted version in addition to the revised clean version in Attached Files. When uploading the clean version, be sure to use the Replace File button to indicate the File ID of the approved file you are replacing.

  • Administrative changes are reviewed internally within the office. These include, but are not limited to:
    • Personnel changes (except for PI changes)
    • Changes to improve the clarity of statements or to correct typographical errors provided the requested changes do not alter the content or intent of the statement/document. 
    • Title change that does not change the overall purpose of the study.
    • Data safety monitoring reports allowing the research to continue as approved with no concerns noted.
  • Minor changes are reviewed at the expedited level and are defined as changes which do not involve procedures that increase risk more than minimally or add procedures that would make the protocol ineligible for initial review using the expedited procedure. These include but are not limited to:
    • Request inclusion of activities that fall under the categories of allowable expedited review set forth in 45 CFR 46.110.
    • Changes to minimal risk projects that remain minimal risk with the proposed changes. 
    • Changes to greater than minimal risk projects, which do not alter the risk/benefit ratio (a sponsor memo/protocol update documenting no changes to the risk/benefit ratio will be taken into consideration).
    • Changes to the anticipated enrollment number greater than 20%.
  • Major changes are those that do not meet the criteria set forth in the expedited categories and may involve an increased risk or decreased potential benefit. Major changes are reviewed by the full board, and may include, but are not limited to:
    • Increase in the amount of blood drawn
    • Safety issues
    • Extension of the study duration
    • Multiple changes in the study design
    • New software in devices
    • Additional arm added to the study
    • Additional population added to the study (including vulnerable populations)
    • Increase in the medication dose
    • Increase in infusion rate
    • Increase in radiation exposure

See the MU IRB Amendment SOP for additional information.

Adverse events typically do not need to be reported to the IRB. If the adverse event was expected and fits within the foreseeable/anticipated risks described in the IRB application, protocol, and consent, it is likely not reportable. The nature, rate of occurrence, and severity would be in line with expectations. Also, adverse events that are caused by an underlying health condition not related to the study or its procedures are not reportable to the IRB. Certain adverse events may need to be reported to a sponsor, clinical research organization acting on behalf of the sponsor, or another entity, but the IRB does not need to be notified. When in doubt, consult the PI and/or IRB. 

If the PI determines an adverse event resulted in an unanticipated problem, that’s when it needs to be reported to the IRB. Unanticipated problems are (1) unexpected, (2) related or possibly related to the research, AND (3) suggest the research places subjects or others at greater risk of harm than was previously known or recognized. The adverse event, as determined by the PI or qualified and delegated research staff, can make the determination whether it meets the 3 criteria of an unanticipated problem. Documentation of this assessment should be included in the study binder. If it meets all, it is reportable to the IRB. Final determinations whether the adverse event resulted in an unanticipated problem are made by the convened board. Most unanticipated problems are reportable within 5 business days on the Event Report found within eCompliance under “IRB Forms,” but some require quicker reporting as outlined in the Unanticipated Problems SOP (i.e. deaths).

Examples of unanticipated problems can be found in the OHRP Guidance on Reviewing and Reporting Unanticipated Risks to Subjects or Others and Adverse Events (page 22). Please see our Unanticipated Problems SOP for additional examples (page 3).

Yes. All noncompliance is reportable to the IRB but the timing of reporting depends on the type of noncompliance. When in doubt, consult the PI and/or IRB. If the noncompliance is considered major (see definition below), it must be reported within 5 business days on the “Event Report”. If it is not considered major, then you will be responsible for keeping track of those events throughout the year and report them on your Annual Update. 

Major noncompliance are deviations that caused harm or have the potential to cause harm to research subjects or others, and have or may have affected subject’s rights, safety, and/or welfare. Examples include but are not limited to:

  • A deviation resulting in an unanticipated problem (see below).
  • Enrollment of an ineligible subject causing potential for harm.
  • A subject withdrawn from a study because of potential harm caused by a deviation.
  • Breach of privacy and/or confidentiality.
  • Failure to appropriately obtain informed consent and/or HIPAA Authorization. 
  • Deviations impacting the scientific integrity of the study.
  • Exceptions to an investigational product’s administration plan. This would include missed dosing or dosing errors for drug studies.
  • Missing safety labs, procedures, or tests.
  • Human subject research conducted without IRB review or approval.
  • Implemented a substantive change(s) without prior IRB approval (unless noted below regarding emergency deviations).

All incidences of noncompliance that could potentially be serous or continuing noncompliance will be presented to at a convened board meeting for a vote to determine whether the noncompliance meets the definition of serious and/or continuing. 

Please see our Noncompliance SOP for additional information. Please contact the IRB office if you are unsure whether it needs to be reported as major noncompliance.

Yes. Complete a “Monitoring Report Form” in eCompliance to submit all local monitoring reports from the sponsor. The report is required to be submitted within one week of receipt. See our Post Approval Monitoring Process SOP for more information. If the sponsor identified major noncompliance during the visit, you would need to submit the Event Report in addition to the Monitoring Report Form.

Yes. When the study is complete, an “Annual Update Form” or the “Completion Report” must be submitted to close the study. A project may be closed when the activities are limited to data analysis AND all data have been completely de-identified.