The level of IRB review primarily depends on the potential risks to the subjects involved in the research. As the potential risks to subjects increases, so too does the level of review required by the IRB. All levels of review are processed through eIRB (the electronic application system); however, applications for exempt projects are less detailed. In the case of student projects, all applications are routed through a mentor/advisor for approval. The three levels of review and procedures for approval for each are as follows:
(No submission deadline)
Exempt review categories [pdf] are defined in the Federal regulations governing research involving human subjects.
Research involving prisoners does not qualify for exemption, and research involving other vulnerable subject populations, including children, may not qualify for exemption.
The investigator selects the level of review s/he believes is appropriate; however, the IRB determines if the study qualifies for exemption. The investigator is notified through eIRB if there are questions or issues that need to be addressed prior to approval. Upon approval, the IRB will issue formal letter of approval, which will be uploaded to eIRB. Exempt studies do not require a stamped and dated consent form.
Once the exemption is granted, no further action or oversight by the Institutional Review Board is required, as long as the study includes only exempt activities. Substantive changes to the study may require further review to determine if the exemption still is appropriate. The IRB should be consulted prior to making changes in the study procedures or subject population.
(No submission deadline)
Research that falls into categories [pdf] designated as minimal risk qualifies for Expedited review.
The eIRB application requires that the investigator select the expedited review category (ies) that best describe his/her research. The IRB will make the final determination as to the appropriate level of review. During the review process, the investigator likely will be asked to answer questions and/or clarify portions of the application/research protocol. This dialogue between the IRB and investigator is conducted through eIRB. Once the IRB staff completes the administrative review, the application is forwarded to the IRB Chair, or to his designee, for final review and approval. Upon approval by the IRB Chair or designee, the investigator will receive notification through eIRB. A formal letter of approval and a stamped version of the consent form will be uploaded to eIRB.
In most cases, approval for minimal risk research will remain in effect for one year. Prior to expiration of approval, a “Continuing Review” application must be submitted in order to renew the IRB approval. Changes to the protocol or consent document(s) must be submitted to the IRB for review and approval.
Full Board Review
Research studies that do not qualify for exempt or expedited review must be reviewed at a convened meeting of the IRB. Applications undergo the same process as for expedited review and involve a preliminary review by the IRB staff prior to being submitted the Committee for review. Upon review at a convened meeting, the investigator will be informed of the IRB’s decision as follows:
Approved: If the study is approved as submitted, the investigator will receive a notice through eIRB. The formal approval letter and stamped consent documents will be uploaded to eIRB.
Approved with Contingencies: The study will receive final approval once non-substantive issues related to research procedures are clarified and/or specified revisions to the consent documents are made. This decision will be conveyed to the investigator through eIRB.
Upon receiving the investigator’s response, the IRB’s Designated Reviewer will verify that all requested modifications have been addressed appropriately. The designated reviewer may approve the application on behalf of the IRB, or refer it back to the full committee.
Tabled: The IRB determines that the research protocol or consent document(s) require major revision or there are questions related to risks to the subject participation. The investigator must submit revised materials and supporting documentation for consideration at a convened meeting. The investigator is encouraged to attend the ensuing meeting to answer questions.
Disapproved: A study is disapproved if the IRB determines that the risks to subject welfare are not justified by the potential benefits of conducting the research. The investigator may appeal the decision of the IRB. The IRB or a subcommittee of the IRB will consider (either in person or in writing) such appeals. Upon consideration of the appeal, the decision may stand (disapproved) or, if appropriate, the decision may be to approve as resubmitted, or approve after required modifications. Approval of a previously disapproved study may only be given at a convened meeting of the IRB. There is no avenue of appeal beyond the IRB.
Other Pertinent Reviews
Continuing Review (pertains only to Expedited and Full Board Reviews)
Studies reviewed by the IRB may be approved for up to one-year. In order to maintain IRB approval, the investigator must complete the Continuing Review application in eIRB and submit it in sufficient time for review/approval prior to the expiration date. It is strongly encouraged that Continuing Review applications be submitted at least one month prior to the study’s expiration date. The Principal Investigator, Co-Investigator, and Study Coordinator (if applicable) will receive email notifications 60 and 30 days prior to the IRB expiration date as a reminder that the study is due for Continuing Review. If changes are proposed to the study protocol or to any of the approved documents, the investigator must complete a separate Amendment application prior to completing the Continuing Review application.
Note: There are no provisions to cover lapsed periods between IRB approvals; therefore, there should be no study activities (e.g. enrollment, intervention, data collection) involving human subjects during any lapse in IRB approval.
Amendments (pertains to all review categories)
Changes to approved projects must be submitted to the IRB. The IRB must review and approve the changes before the investigator can proceed with the protocol.
According to 46 CFR Part 46, to be considered "reportable" (required to be submitted to the IRB) an event must be considered to be an Unanticipated Problem, which means that the event must be:
- Unexpected (in nature, severity or frequency)
- Related or possibly related to participation in the research, and
- Suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized.
Protocol Deviation is any departure from the procedures as specified in the IRB approved protocol. Protocol deviations are unplanned and unintentional events. Protocol deviations have the potential to place participants at risk and also can undermine the scientific integrity of the study. The Principal Investigator must complete and submit a Reportable Event application in eIRB for all protocol deviations that occur during the course of a study immediately upon discovering them and no later than 10 working days following the discovery. The Principal Investigator also reports all protocol deviations to the sponsor, if applicable, following the sponsor's requirements.
Other Reportable Events include such things as DSMB reports, FDA/Government Sponsor Monitoring or Audit Reports, follow-up reports for previously submitted Reportable Events, and internal monitoring/audit reports.