Initial review is conducted by the IRBs at convened meetings or through the expedited review procedure. Federal regulations outline the criteria that must be satisfied for the IRB to approve research.
To ensure an effective review by the IRB, a full description of the planned research (i.e., a research protocol or proposal) must be submitted at the time of initial review. A research protocol provides information such as the study objectives, background, a detailed plan for conducting the research, and a discussion of how the research findings will be analyzed. For most research, informed consent must be obtained and documented using a written form approved by the IRB and signed by the participant or the participant’s legally authorized representative. The consent provides key information regarding the research (unless a waiver is appropriate).
The study must address all the following regulatory requirements:
- Risks to participants are minimized.
- Risks to participants are reasonable in relation to anticipated benefits, if any.
- Selection of participants is equitable.
- Informed consent is sought, obtained, and appropriately documented for each prospective participant or the participant’s legally authorized representative.
- When applicable, adequate provisions are in place for monitoring the data collected to ensure the safety of participants.
- There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
- When applicable, there are additional safeguards in place to protect vulnerable populations participating in the study.
At the initial review, all IRB members will receive and review the following materials:
- Buck-IRB initial review application
- consent form(s), assent form(s) and permission form(s), and verbal script(s), including translated documents, as applicable
- recruitment materials, as applicable, including advertisements intended to be seen or heard by potential participants
- study instruments such as questionnaires, surveys, data collection forms, etc.
- complete research protocol
- investigator’s brochure, as applicable
- relevant grant application or funding proposal, as applicable
- all other information provided by the investigator
The Office of Responsible Research Practices (ORRP) will provide a pre-review of the submitted protocol before notifying IRB members of review assignments. Expedited reviewer(s) will receive all information that the convened IRB would have received. The IRB chair or one or more experienced IRB members designated by the chair will perform an in-depth review using the same criteria for approval as the convened IRB except expedited review procedures are used to approve this limited class of research activities. Refer to the Expedited and Administrative Review Procedures policy to:
- learn which research qualifies
- understand the process and procedures
- distinguish which types of research qualify for administrative review
Research must undergo IRB review at intervals appropriate to the degree of risk, but not less than once per year. IRB review must be performed at a convened IRB meeting unless the research meets the criteria for expedited review. At the time of both initial and continuing review, the IRB must ensure that the criteria to approve research are satisfied, including determinations regarding risks, potential benefits, informed consent, and safeguards for participants. At continuing review, the IRB must review research progress and any new information pertinent to the Board’s decision to re-approve the research.
IRB approval must be obtained before the end of the current approval period to avoid lapse. If approval expires, the research must stop unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research. Enrollment of new subjects 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.
The Buck-IRB continuing review application will become available in the study workspace 90 days prior to study expiration. Investigators will provide all applicable information required in the Buck-IRB continuing review application. The following changes to the research may be requested at the time of continuing review:
- change in principal investigator
- addition or removal of Ohio State co-investigators and key personnel
- increase or reduction in the number of Ohio State-approved participants
- change in sponsor information, such as the addition of new funding, provided such changes do not alter the conduct of the research as described in the approved protocol
Investigators may need to upload the following, as applicable:
- multi-site study reports and/or study summaries issued since the previous IRB review
- Data Safety & Monitoring Committee reports issued since the previous IRB review
- documents being revised with the continuing review submission - the investigators should provide a revised version of the document(s) being modified with proposed changes underlined (or "tracked changes") within the document(s), as well as a version in which proposed changes have been incorporated (“clean” copy) within the document(s)
Annual Status Report
Under certain conditions, the requirements for continuing IRB review can be satisfied by completing a brief annual status report. The abbreviated annual status report is limited to questions regarding study changes over the previous year and current study status. The types of studies eligible for submission of an annual status report are described in HRPP policy Expedited and Administrative Review Procedures.
Proposed changes in research activities (amendments), including changes to the protocol or informed consent process, must be reviewed and approved by the IRB before implementation, except as necessary to eliminate apparent immediate hazards to participants. Minor changes that pose no more than minimal risk to participants can be reviewed using the expedited procedure. Amendments involving more than minor changes will be reviewed by the convened IRB.
Investigators may not implement research changes until final IRB approval is received. In certain circumstances, changes may be made to approved research without IRB approval to eliminate apparent immediate hazards to participants. The investigator must provide a rationale for all proposed changes and submit the application in Buck-IRB. Investigators will upload the following information, as applicable:
- revised version of the document(s) being modified with proposed changes underlined (or tracked changes) within the document(s)
- revised version of the document(s) being modified with proposed changes incorporated (clean copy) within the document(s)
- clean version of newly proposed document(s) being added
Personnel Amendment (Personnel change request)
Proposed personnel changes are used only when adding or removing Ohio State students or paid employees, and when removing external collaborators. No document updates can take place during personnel change request submissions.
Events requiring prompt reporting by investigators and research staff may involve physical, psychological, social, legal or economic harm and can be submitted at any time.
Final Study Report
Principal investigators are responsible for notifying the IRB when a study is completed or is being closed. It is important to note that all research activities involving participants, including data analysis with individually identifiable or coded private information, must be complete to terminate IRB approval for a study. The Final Study Report is a brief application confirmed by ORRP staff through an administrative review. The report may be completed at any time during the review period.