If you already know your activity is human subject research, submit an IRB Application under "IRB Forms" in eCompliance.
If you are unsure whether your activity is considered human subject research, then you would submit the Human Subject Research Determination Form in eCompliance located under “IRB Forms” on the IRB dashboard. Additionally, you can review the Human Subject Regulations decision charts.
Non-human subject research includes:
- De-identified analysis of secondary information or biospecimens.
- Quality improvement projects.
- Scholarly or journalistic activities.
- Publicly available information or biospecimens with no restrictions.
- Public health surveillance activities.
- Log into eCompliance using your university credentials to establish your account.
- Select the Institutional Review Board module.
- Select “IRB Training” under the “prerequisites” column.
- Review the Collaborative Institutional Training Initiative (CITI) Program training instructions.
- Sign into the CITI Program using your university credentials.
- You must complete the Basic Human Subject Research course. Training is active for three years; renewal is required if you continue to conduct research.
- If you are conducting clinical trials, you must also complete the Good Clinical Practice course. Renewal is required after three years if you continue to conduct research.
- If you have completed CITI training at another institution, you can complete the affiliation instructions to get credit for required modules at MU. See the CITI Program training instructions for more information.
- Everyone on your research team must complete all required training before submitting an IRB application.
- From the IRB Dashboard, choose IRB Forms under the Submission to IRB heading.
- Choose the appropriate IRB form.
- IRB application: For all local exempt, expedited and full-board projects.
- Initial Reliance Request Form: For studies relying on an external IRB.
- Emergency Use of a Test Article: Submitted for emergency use of an FDA-regulated test article.
- Humanitarian Use Device: Submitted for HUD requests only.
- Initial Request for MU to be the IRB of Record: Submitted when you require documentation for a sponsor study submission and/or you are requesting MU IRB to be the IRB of Record for a multi-site protocol.
- Complete the application to the best of your ability. Upload support documentation to the attached files section. Access consent and protocol templates.
- Some forms require a two step process for submission. Failure to complete the two step process will prevent the IRB from reviewing the study.
- Student applications require an adviser to be listed and will prompt an email approval.
- All Principal Investigators must complete a PI Assurance Form.
- Submission receipts and additional requests will be sent by email.
- Exempt studies are reviewed administratively unless they require limited IRB review or approval of a HIPAA waiver request.
- Expedited studies are reviewed by at least one board member. Please monitor email for any required changes.
- Full board studies must be submitted by the 25th of the month. The full board meets on the second Wednesday of the following month to review submissions. It is important to address any concerns or new deadlines communicated to you before the meeting.
If additional information is needed, we will return your application to you for corrections. Make sure to follow the instructions in the email. Resubmit when all corrections have been made.
Additionally, some studies require consultant or ancillary reviews that will occur concurrently with our review.
Please monitor your email regularly to avoid delays in the review process.
- Review your approval letter to ensure there are no restrictions required by the MU IRB.
- If the study is set to “Active - Open to Enrollment,” you are approved to move forward with your study.
- If the study is set to “Not Yet Open to Enrollment,” you may need to supply more information before the study can commence.
- Make sure you understand your reporting responsibilities. You are required to promptly report deviations, problems, amendments, annual updates and closures.
- An Annual Update Form is generated 60 days before your study’s expiration date. You will complete it in eCompliance.
The Annual Update Form can be used to close a study when all activities have concluded.
For studies that end with the following conditions, you must fill out a Completion/Withdrawal report within eCompliance:
- Closing your study before the Annual Update Form is generated.
- If your study was never conducted.
- Closing a study prematurely.
- If you are now only analyzing de-identified data.
You must retain records according to the following guidelines:
- The University of Missouri System Collected Rules and Regulations require you to maintain original research records for seven years after the completion of the study.
- If the study is sponsored and the sponsor requires a longer retention period, you must retain your records for the longer period.
- If there are other contracts or agreements in place outlining record retention, you must follow the negotiated terms.