Once your application is received, the IRB staff will work with you to ensure submissions are complete, accurate and in alignment with federal regulations. If changes are needed, you will be notified via email that your application has been returned outlining the necessary edits.
When your projects is ready to be approved, you will receive an approval email from eCompliance with a link to the IRB approval letter. Do not initiate your research until you receive this documentation.
Read the approval letter thoroughly for expectations moving forward.
Access the attached files section in eCompliance to obtain the most recently reviewed/approved documents for use.
Expedited/full board studies will have IRB approval stamps in the footer of the consent/assent forms. Use the stamped versions only.
Exempt study consents are not stamped by our office. Use the highlighted green copy.
Approved documents will be highlighted in green.
Record retention/data storage
Maintain all research records in a secure, confidential manner. Research information should be kept on approved MU devices and locations. You should work directly with your advisor to maintain records in an area/location that is readily accessible for IRB or other inspections.
Do not store research information on a personal laptop that is not approved by your departmental IT.
Research records must be maintained at MU for a period of seven years following the completion of the study. If you leave the institution, you may take copies of the records with departmental permission, but originals must be maintained at MU.
Amendments/changes
Prior to implementing any changes to your approved study, an Amendment Form must be submitted and approved.
Amendment forms are located under IRB Forms in eCompliance where the application was started.
Changes may include; wording changes on a survey, adding a recruitment site or letter, adding or removing a survey, etc.
If new documents are submitted for IRB approval, for example consent documents, be sure to pull the most recently approved documents to use in your research study. All approved documents are marked green, and older documents are marked replaced and should no longer be used after the amendment approval date.
Personnel/investigator changes
Use the Personnel Change Form under IRB Forms in eCompliance to let us know when investigators are being removed or MU investigators are being added to your study. New investigators must complete CITI training. If you want to add non-MU investigators to the study, submit the amendment.
Continuing review – annual updates
Most studies are approved for 12 months. Do not let your study expire. Complete the Annual Update Form when you are notified by the IRB that it is coming due and prior to the expiration date. Annual updates can be found under Open Saved IRB Project in eCompliance.
Deviations – noncompliance
Complete the Event Report Form in eCompliance to report events (multiple events can be submitted on one form).
This includes major deviations (noncompliance).
This includes unanticipated problems (events that are unexpected, related or possibly related to the research and suggests the research places subjects or others at a greater risk of harm than was previously known or recognized).
This includes any unresolvable complaints.
This form must be submitted within five business days of becoming aware of the event.
Study closure
Studies can be closed when all interactions and interventions are complete and all data have been de-identified. When the study is complete and before you graduate, please be sure to close your study with the IRB. Do not leave it to your advisor to do it for you. They may lack the important details about the study to close it properly. Maintain all study documents for seven years following the completion of the study (when the IRB application is closed) according to the Record Retention SOP.
Submit an Annual Update Form, if it has been requested by the IRB, or a Completion Report if the annual update is not due soon.