IRB submission/review process

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 U.S. Office for Human Research Protections' (OHRP) Human Subject Regulations decision charts or contact the MU IRB office for guidance. This determination form can be completed prior to taking the IRB training discussed in Step 2.

If you know your activity is human subject research requiring IRB review, start and submit an "IRB application" under "IRB forms" in eCompliance. The IRB application is the main form for all exempt, expedited and full board research.

See "Step 2: eCompliance account access & IRB training" below before starting the IRB application.

If you plan to use an external IRB and want to request MU to rely on that IRB, follow Scenario 2 at the bottom of our Single IRB and reliance procedures page.

Funding priority or request for MU to be the single IRB (sIRB)

If you have funding urgency or a need to find out if MU IRB will serve as the sIRB for a multisite study, submit the "Initial Request for MU to be the IRB of Record Form" under "IRB forms" in eCompliance. This should provide you with documentation needed in these situations and allow time to work on preparing a complete application to the IRB.

Transferring projects to MU 

If you transferred to MU and you need to transfer the IRB of record to MU, you may start with completing the "IRB application" under "IRB forms" in eCompliance. The IRB application is the main form for all exempt, expedited and full board research.

If you transferred to MU, but the IRB oversight should remain at another institution, the MU IRB can choose to rely on the other IRB. Follow these steps:

1. For an exempt study: Submit the "Collaborative Exempt Notification Form" (as long as your role in the study is still covered under their exemption). No formal reliance agreement will be put in place, but this will allow MU to track collaborative exempt research activities covered under another IRB.
2. For an expedited or full board study: Submit the "Initial Reliance Request Form" in eCompliance to request to rely on the other IRB. Follow Scenario 2 at the bottom of our Single IRB and reliance procedures page.

1. Log into eCompliance using your university credentials to establish your account.
2. Select the "Institutional Review Board" module.
3. Select “IRB Training” under the “Prerequisites” column.
4. Review the Collaborative Institutional Training Initiative (CITI) Program training instructions.
5. Sign into the CITI Program using your university credentials.
6. All investigators must complete the Basic Human Subject Research course. Training is active for three years. Renewal is required if you continue to conduct human subjects research.
7. If you are conducting a clinical study, you must also complete the Good Clinical Practice course. Renewal is required after three years if you continue to conduct human subjects research.
8. If you have completed CITI Program IRB training at another institution, you can complete the affiliation instructions to get credit for required modules at MU. See the CITI affiliation instructions for more information.
9. Everyone on your research team must complete all required training before submitting an IRB application to conduct human subjects research.

1. Log into eCompliance.
2. From the IRB dashboard, choose IRB forms under the Submission to IRB heading (middle column).
3. 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.
   • 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 sIRB for a multisite protocol.
   • Emergency use of a test article: Submitted for emergency use of an FDA-regulated test article.
   • Humanitarian use device (HUD): Submitted for HUD requests only.
4. Complete the application to the best of your ability. Upload support documentation to the attached files section. Access consent and protocol templates and review our Informed consent FAQ.
5. The IRB application requires a two-step process for submission.
   • Student applications require an advisor to be listed and will prompt an email approval. See our Student researcher page for more information.
   • All principal investigators (PIs) must complete the PI assurance form received via email after you hit submit.
6. Submission receipts and additional requests will be sent by email. 

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 It is necessary to continuously monitor your email.

• Exempt studies are reviewed administratively unless they require limited IRB review or approval of a HIPAA waiver request. See our exempt FAQ page.
• Expedited studies are reviewed by at least one board member. Please monitor email for any required changes. See our expedited/full board FAQ page.
• 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. See our expedited/full board FAQ page.

If additional information is needed, we will return your application to you, via email, for corrections. Make sure to follow the instructions in the email. Required edits related to the form itself (Application, Amendment, or Annual Update) will be indicated within the form in eCompliance (see our Researcher Resources page for instructions). Required edits to attached files will be listed within the e-mail you receive. Resubmit when all corrections have been made.

Additionally, some studies require consultant or ancillary reviews that will occur concurrently with our review.

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 Please monitor your email regularly to avoid delays in the review process.

1. 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.
2. Make sure you understand your reporting responsibilities. You are required to promptly report deviations, problems, amendments, annual updates and closures.
3. An "Annual Update Form" is generated 60 days before your study’s expiration date. You will complete it in eCompliance.

See our exempt FAQ page or our expedited/full board FAQ page for more information on post-approval requirements.

The "Annual Update Form" can be used to close a study when all activities have concluded.

You must fill out a "Completion/Withdrawal Report" within eCompliance instead of waiting for the "Annual Update Form" to generate for studies that end with the following conditions:

• If your study was never conducted.
• If you are closing your study prematurely.
• If you are now only analyzing de-identified data.

You must retain records according to the following guidelines (see our data collection/storage best practices FAQ page):

• 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.