IRB Review Process

Once your materials are submitted, your application will be sent out for review which will be conducted by one or more members of the Northwest IRB Committee. IRB review considers only whether the study meets the requirements for ethical research outlined by OHRP, not the quality of the research questions or methodologies. The number of reviewers, length of review time, and complexity of review will depend upon which application was submitted:

• Exempt IRB applications involving adult subjects are typically reviewed by one committee member; initial review is usually completed within one week of submission.
• Exempt IRB applications involving child subjects are typically reviewed by 2-3 committee members, at least one of which has expertise in research with children; initial review is usually completed within one week of submission.
• Expedited IRB applications are typically reviewed by 2-3 committee members and initial reviews are usually completed within 1-2 weeks of submission. The expedited review process does not vary based on subject age, though expedited projects with child subjects will include at least one member with expertise in research with children.
• Full IRB applications are reviewed and discussed by the full committee during a physical meeting (or, in extreme circumstances, a virtual meeting). This meeting requires attendance of at least 50% of committee members and must include a non-scientist IRB member in attendance. Full IRB reviews are usually completed within one month of submission.

IRB Decisions and Re-Submission

Once the Northwest IRB has reviewed your application, a decision will be made regarding whether your project can be approved in its current form. If your project is approved, you will be contacted through email by the chair of the Northwest IRB. The chair will provide you an IRB approval code and an approval letter signed by the chair and stating the terms of your approval.

It is common for reviewers to ask for revisions to your procedures or materials prior to granting approval. In these cases, the chair will contact you through email and explain any revisions to be made prior to approving your project for data collection. These changes can usually be made through a reply email with procedural questions answered and/or new versions of documents submitted.

In certain rare cases, a full IRB application may be denied by the IRB committee based on its high risk of subject harm. If you think your project may have a high chance of harming subjects and would like to discuss it, please contact the Northwest IRB (IRBNWMS@nwmissouri.edu) prior to submitting your application.

Protocol Changes After IRB Approval

Sometimes, unexpected issues or problems arise that require the protocols and procedures of a research project to be changed after the project has begun. It is important to understand that IRB approval is only granted to a project in the state that it was submitted and reviewed by the Northwest IRB committee. 

If any changes to protocol or procedures are made following IRB approval, the principal investigator must submit a Protocol Change Form   through the Northwest IRB email address (IRBNWMS@nwmissouri.edu). Once the form is submitted, it will be reviewed at same level at which the initial IRB application was reviewed. Note that some protocol changes may require your project to undergo an entirely new review if the protocol leads to higher subject risk or if your project no longer fits under the exempt or expedited category it was originally approved under.

When a decision is reached, the chair of the Northwest IRB will contact you through email notifying you of approval to continue with the new protocol or requesting changes to the protocol.

Data cannot be collected using updated protocols, procedures, or forms until IRB approval of the protocol change has been obtained. 

Common examples of protocol changes you might need to submit for approval include (but are not limited to):

• Adding new principal investigators, faculty advisors, or other researchers who will have access to participants and data.
• Adding new survey questions/questionnaires, or changing the wording or presentation of existing survey questions/questionnaires.
• Changing the location in which an in-person study will be conducted, or changing aspects of the location (e.g., allowing larger groups to participate than was originally planned).
• Changing the modality by which the project is conducted (e.g., an in-person study which needs to shift to online data collection procedures).
• Changes to procedures or materials due to unforeseen circumstances that have arisen during data collection (e.g., adding a procedure requiring subjects to turn their phones off prior to participation).
• Collecting additional subjects significantly beyond that planned in the original IRB application.

Continuing Review

After receiving initial approval, most projects do not require continuing review or notice of project completion unless a protocol change must be approved:

• Exempt projects do not require any further information following IRB approval unless a protocol change occurs.
• By default, expedited projects do not require further information following approval. However, the IRB may request continued review and status reports for expedited projects deemed in need of special oversight.
• Projects requiring a full review must undergo continued review.

If your project requires continued review, the review process will be outlined in the approval letter you receive for your project. To complete a continued review, you must submit an IRB Status Report   form within one year of the approval of your project. Keep in mind that the one year timeline is the maximum allowed for a continued review, and the Northwest IRB may determine and require continued review under a shorter timeline.

If your status report is not submitted within one year of approval, the IRB chair will contact you through email to request a status report. If one is not submitted within one week of email contact, the project will be closed and you will not be allowed further time for data collection without submitting a new IRB review application.