Expedited and Full Board Review

Expedited review applies to research activities that present no more than minimal risk to human subjects, as determined by the IRB, and involve only procedures listed in one or more of the first 7 expedited categories defined on the OHRP website (categories 8 and 9 only pertain to continuing reviews of full board studies.) These categories are defined by OHRP and followed by the IRB.  

• The categories in this list apply regardless of the age of subjects, except as noted.  

• The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, UNLESS reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.  

• It can also be used for full board studies that have an amendment with a minor change.   

  • A minor change is defined as those which do not involve procedures that increase risk more than minimally or add procedures that would not fit an expedited category.   

The study is screened by the IRB office to ensure completeness. When complete, the study is assigned to at least one IRB member for review.  Continuously monitor your email from IRB staff during the review process. It is very common to receive emails requiring clarifications and/or corrections.  

For questions whether your study is expedited, please contact the IRB office. The MU IRB reserves the right to take any study full board even when expedited criteria are met. You will be informed if a study requires full board review.  

Expedited studies can be submitted at any time. There are no IRB deadlines, however, if a study is not able to remain at an expedited review level and the board moves it to a full board review, there is a deadline of the 25th of each month. The turnaround time for complete submissions is 10-14 days. It is important to monitor your email for changes and/or clarifications and follow the instructions for resubmission. Expedited studies, including resubmissions, are reviewed in the order in which it is received. An approval email with an attached letter will be sent when approved. Review the letter because it contains important study information and post-approval IRB requirements.  

Full board applications and amendments must be submitted by the 25th of each month. The meeting is held the second Wednesday of the following month. The submission is reviewed before the board meeting for board readiness. It is very important to monitor your email for any changes or clarifications before the meeting to avoid the submission being pulled from the agenda.  

It is common for incomplete applications to be submitted for full board review. The deadline is often met, but the application is missing important information needed for full board review. If the application is incomplete and must be returned, it may not give enough time for the board to review the application resulting in a deferral at the board meeting. It is important not to focus so much on the deadline but the completeness of the application, as submissions of incomplete applications may result in additional delays.  

Greater than minimal risk studies, and minimal risk studies that do not fall into any of the exempt or expedited categories, are reviewed by the full board.   

Some annual updates require re-review at the meeting, so pay attention to deadlines included in the annual reminder emails you receive.  

The IRB application asks questions which apply to most studies. For studies involving certain populations, products, or other items that have additional regulatory or institutional requirements, a subform will either automatically populate based on an answer you gave or populate based on a selection you made to the end of the application with a list of possible subforms.   

Examples include, children, cognitively impaired adults, drugs/biologics, medical devices, etc. If you forget to populate a subform, the IRB staff will return the application for you to complete following their screening.  

• Protocol: See our Biomedical and SBE protocol templates on our Researcher Resources page  

  • All expedited and full board studies require a protocol unless the study only involves secondary, identifiable information with no subject interaction or intervention. You should use our protocol templates unless you have a sponsor provided protocol to submit.   

  • Drug/Device Brochures – Package Inserts, Drug or device brochure, FDA Approval Documents. See our Drugs/Other Products FAQs for additional guidance.  

  • Supporting documents (letters of support, coverage analysis or waiver, etc.)   

• Any document that will be presented to subjects must be submitted for review  

  • Consent and Assent Forms (with HIPAA Authorization, when applicable). See our Expedited and Full Board templates on our Researcher Resources page as well as our Informed Consent FAQs. 

  • Recruitment materials: (for example, flyers, scripts, emails, ads, postings). See our Recruitment FAQs. 

  • Survey and/or Interview Questions (in general, anything the subject will see, do, hear, or read for the research)   

• Any document the IRB requests.  

Some studies may involve ancillary reviews and/or expert consultations. The IRB review will focus mainly on IRB regulations, and the Human Research Protection Program review component will include ensuring institutional requirements are met before opening a study to enrollment by involving certain persons or committees. Examples include investigational pharmacy, radiation safety, biosafety, conflicts of interest, etc.  

Please see our Initial Review SOPs for more information.  

Here are the most common mistakes per section that we see on submitted applications:  

Basic Project Information:  

• Not providing enough detail on the question, “Provide a description of your study, including research objectives.”  

  • Research objectives and goals should be included in the answer. In other words, explain the research question(s) you are trying to answer and what steps will you take to try and answer those questions. Specifically, and most importantly, we need to know what you are asking subjects to do as participants in the research. Describe all the activities involving subjects' participation in detail.  

• Sponsor Information  

  • Accidentally entering a sponsor twice: duplications can be deleted in eCompliance using the edit/delete button to the far right.  

  • Be specific with the sponsor in the drop-down list. For example, list a specific department instead of just University of Missouri-Columbia.  

  • After adding the sponsor from the drop-down list, be sure to select the type as well. This is often missed. Also, consider if federal sponsor is also DHHS and mark both.  

  • A sponsor should be added if a proposal has been submitted and/or funding is likely. It can always be removed if not received.  

• Protocol  

  • For investigator-initiated protocols, be sure to keep the version number/date the same when you resubmit any requested changes (prior to approval). It needs to match what is in the IRB application fields for the protocol information. It should stay version 1 until your study is approved. If you make changes to an approved protocol later with an amendment, then you will change it to version 2.  

Subject Recruitment:  

• Not checking the right target population or checking it unnecessarily.   

  • For example, you should only check “Employees” if you are truly targeting employees, not if employees just happen to be in your subject population.   

  • Many investigators forget to check “Employees” when they are using a recruitment panel. Remember, subjects are being paid by these recruitment panels and therefore are employees.  

• See Recruitment FAQs for additional tips.    

Subject Consent:    

• Be sure to leave the footer blank to leave room for the IRB stamp, once approved.  

• Make sure the signature section isn’t cut off and split between two pages. The entire signature section should appear on the same page.  

• See Informed Consent FAQs for additional tips.  

Risks and Benefits:  

• It’s common with minimal risk applications to see investigators say that the project involves “no risk.” There’s almost always at least a risk of loss of confidentiality. It’s better to say the study involves “minimal risk,” rather than no risk.  

• It’s common to see investigators overstate the benefits of participating in a study. If there’s a possibility that the subject will receive “no direct benefit,” please state so. In general, possible benefits should be stated using the word “may” instead of the word “will,” unless it is a guaranteed benefit.  

Confidentiality and Security:    

• Not checking yes on the question, “Will any web/electronic software/applications be utilized for such purposes as recruiting subjects, completing questionnaires/surveys, conducting interviews/focus groups, or processing/storing data?” If you are recording/analyzing identifiers and/or data electronically, this should be marked yes. It’s rare for a study not to use an electronic application of some sort.  

• Not marking all identifiers accessed or collected. When a HIPAA waiver is also submitted, those should mostly align when it comes to identifiers marked.  

Costs Associated with Research:    

• Not uploading documentation related to a coverage analysis, when needed, whether it is a waiver or final coverage analysis.  

• When there’s standard of care costs associated with a study, be sure to mark yes instead of no. This question sets up the rest of the section and is often returned for marking this incorrectly.  

Subforms:    

• Not marking an applicable subform. Please review the entire list and mark applicable subforms while completing the subform with detailed information.  

When your project status is set to Not Yet Open to Enrollment, this means you cannot enroll participants in your study until the contingencies outlined in your approval letter have been met, and you receive a new, revised approval letter with an Active-Open to Enrollment status. It is very important to read your approval letter for any enrollment hold placed on your study.  

Most common contingencies include:  

• SPA Proposal Number (external funding) or MoCode  
  • The proposal number can be located on your PSRS and Grant Award Summary (GAS) that you receive from OSPA. Your grants & contract specialist in your department/division should also be able to assist you in locating this number. If you need further assistance, please call the IRB at (573) 882-0611.  
  • The “Requested Identification Numbers/Information Form” should be utilized to  provide Clinicaltrials.gov number, MoCode, proposal number, or Study Short Name if it was not previously provided on an approved study.  
• IDS Approval
  • Amendments only if changing drugs, administration, dosage, etc. affecting IDS review/approval
• Coverage analysis or coverage analysis waiver
• MU Athlete Committee approval
• Data Use Agreement (possibly other agreements) – final, signed copy
• IRB-required Site Initiation Visit  (not sponsor SIV)
• Active IBC protocol for human biospecimens - before biospecimen collection/work

IRB fees apply for industry sponsored studies, for profit, private sponsors, multi-site studies where MU is engaged in research, and administrative one-time reviews on reliance studies. If you would like a consultation, please fill out our “Initial Request for MU to be the IRB of Record Form."

Please see our IRB Fees page to learn if your study will be charged a fee.  

In addition to the below, please see our Investigator Reporting Requirements FAQs.

• On an annual basis, the investigator must submit an “Annual Update Form” to keep the IRB informed on the current project status, including enrollment, funding, consent, and unanticipated problems/noncompliance information. See our Annual Reviews of Research SOP for additional information.  

  • This form is auto generated when you receive your reminder and can be accessed under the “Open Saved IRB Project” section of eCompliance. 

• 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.  

• An “Amendment Form” must be submitted to the IRB for review and approval prior to initiating changes to your study. The level of review will depend on the overall review level of the study and whether the changes are considered administrative, minor, or major. Please upload clean and tracked versions of any documents being revised with an amendment. Also, be sure to indicate the Replacement File ID number when uploading the clean version. See the MU IRB Amendment SOP for additional information.

  • Personnel changes can be made on the “Personnel Change Form” instead of the Amendment unless it is a PI change.  

• “Event Reports” should be submitted to report events (multiple events can be submitted on one form), including major deviations (non-compliance) or unanticipated problems (events that are unexpected, related or possibly related to the research, AND suggests the research places subjects or others at greater risk of harm than was previously know or recognized).  

  • This form must be submitted within 5 business days of becoming aware of the event. Some events require faster reporting (i.e. Deaths related to a study). See our Unanticipated Problems SOP and Noncompliance SOP for additional information.  

• Complete a “Monitoring Report” 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.