All activities that meet the definition of both research and human subject must be approved by an IRB before being performed unless the research has been determined to be exempt. Investigators uncertain whether an activity represents human research are advised to seek guidance from the Office of Responsible Research Practices (ORRP).
There are three internal Ohio State institutional review boards. The committees, including volunteers from Ohio State and the surrounding community, are responsible for protecting the rights, welfare, dignity and privacy of human research participants. The IRBs have the authority to:
- require modifications to secure approval,
- monitor, or
- suspend and/or terminate all research involving human participants.
The submission process has several steps and investigators should plan to allow sufficient time for the process before beginning the research. The principal investigator is responsible for submitting all studies in Buck-IRB by logging in with Ohio State credentials. A system profile can be updated at any time at go.osu.edu/orregister. Buck-IRB is an electronic submission smart form that dynamically adapts to user responses, activating additional questions and/or pages as questions are answered.
It is not possible to print the entire application form prior to completion. To assist researchers, the Office of Responsible Research Practices (ORRP) has created PDFs containing the text and conditional logic of each submission form so that investigators or research staff may preview the application questions without entering the electronic system. Review Buck-IRB system tips such as user guides, training and technical contacts through the Office of Research knowledge base.
Requests for department chair and co-investigator signatures will be routed automatically by email following submission. ORRP will pre-review the application to verify the following:
- Required materials are included and signed.
- All study team members meet human subjects research education requirements.
- All individuals involved in the conduct of the research submit a conflict of interest disclosure.
- Review by required ancillary committees, as applicable, is complete and documented.
If an application is incomplete or clarifications are required, the principal investigator (PI) and additional contacts are notified by ORRP. If no response is received within 90 days, the PI is notified that the submission will be withdrawn.
Note: Buck-IRB continuing review, annual status report, amendment, and/or final status report applications cannot be submitted concurrently for the same study. For example, if an amendment is currently in process, it must either be approved or withdrawn and deleted before the option to initiate any other submission type will appear in Buck-IRB. Event reports and personnel change requests may be submitted at any time.
Application Review Process
The IRB review process and time vary depending on the level of review required.
Research proposals are directed to the most appropriate IRB for review based on the type of research proposed and its funding source. Full committee review studies are reviewed by the IRB committee at a convened meeting, while expedited studies are reviewed by a small number of IRB reviewers outside of a convened meeting. Research exempt from IRB review may undergo administrative review by ORRP unless the IRB requires that a study undergo continuing review via expedited procedure.
IRB Review Outcomes
To approve research, the IRBs must determine that the research meets the regulatory criteria for approval. Research that has been approved by the IRB may be subject to further review and approval by other institutional committees; however, no one may approve human subjects research and authorize it to proceed that has not been approved by the IRB.
The convened IRBs may make one of the following decisions:
- modifications required
IRB expedited reviewers may make one of the following decisions:
- modifications required (to secure approval)
When an expedited reviewer cannot approve or require modifications to the study, the research will be referred for review by the convened IRB. Research can be deferred or disapproved only by the convened IRB.
Appeals/Requests for Reconsideration
Investigators may appeal an IRB decision by submitting a request addressed to the appropriate IRB chair to IRBinfo@osu.edu, including a reason for the appeal and any information and materials supporting the request. Appeals must be made within 30 days of investigator notification of the IRB decision in question. Investigators may attend the IRB meeting at which this review will occur.
Frequency of IRB Review
The IRBs may approve research for a period of up to one year. The IRBs will require continuing review at intervals appropriate to the degree of risk, but not less than once per year. Investigators should allow adequate time before the expiration date for review of the research and for resolution of any modifications that may be required prior to its re-approval. Approval must be obtained before the end of the current approval period. If approval expires, the research must stop unless the IRB finds that it is in the best interests of individual participants to continue participating in the research. Enrollment of new participants cannot occur after the expiration of IRB approval. Reminders are sent to assist researchers in meeting continuing review requirements. Protocol expiration dates can also be checked in the Study Team Lookup tool.
Preliminary Determination Letter
If a sponsor requests proof of IRB approval or exemption, but the project involving human subjects has not been developed or relies on additional phases that do not involve human subjects research activities, ORRP staff may be able to provide a preliminary determination letter to partially satisfy the sponsor’s requirements. The preliminary determination letter will outline the project scope and activities and cite applicable regulations/policies. The letter will require investigators to return to ORRP for an official exempt determination or IRB approval before any human subjects research activities can occur (including recruitment, pilot testing, etc.).
Email ORRPDeterminations@osu.edu to request a preliminary determination letter and include the following:
- Information regarding the nature of the request including a copy of any sponsor communications or requirements. This will help ORRP staff determine if such a letter is acceptable and, if so, the type of letter required.
- The timeline for the phases/activities that do not involve human subjects research activities.
- The project title and investigator information.
- Sufficient materials to allow a determination to be made (the research protocol, grant, and any other already developed materials).
Once materials are received, ORRP will review and provide a determination, or will request for additional information by email within three business days.