IRB Levels of Review

Initial reviews must be conducted by the IRBs at convened meetings, except where expedited review procedures are permitted. Federal regulations outline several 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. When writing your protocol, ensure all the following regulatory requirements have been considered:

• Risks to participants are minimized.
• Risks to participants are reasonable in relation to anticipated benefits.
• 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 appropriate, adequate provision is 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 appropriate, there are additional safeguards included to protect vulnerable populations participating in a study.

Materials Reviewed

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, etc.
• complete research protocol
•  investigator’s brochure, as applicable
• questionnaires, when longer or more detailed than those normally reviewed by all IRB members
• relevant grant application or funding proposal, as applicable
• all other information provided by the investigator
• DHHS-approved sample informed consent document, as applicable
• Complete DHHS-approved protocol, as applicable

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

The Buck-IRB continuing review application will become available in the study workspace 90 days prior to study expiration. Investigators should plan to meet continuing review requirements before the expiration date so that research may continue. A lapse in approval may be evaluated as noncompliance. Under certain conditions, continuing review of research previously approved by the convened IRB may receive expedited or administrative review.

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
• minor document revisions

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 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 implemented, except as necessary to eliminate apparent immediate hazards to subjects.

Review procedures

Minor changes that pose no more than minimal risk to subjects are approved by expedited review. Amendments involving more than minor changes are approved by convened IRB.

Changes to approved research initiated without IRB approval that are made to eliminate apparent immediate hazards to subjects may represent unanticipated problems involving risks to subjects or others and should be promptly reported as described by the HRPP policy Event Reporting – Unanticipated Problems Involving Risks to Subjects or Others, Adverse Events, and Other Problems. Such changes will be reviewed by the convened IRB to determine whether the change is consistent with ensuring the continued welfare of 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

When research has been completed and investigators are no longer interacting with participants and accessing identifiable information and/or biospecimens, a final study report (FSR) must be submitted via Buck-IRB to close the study. The FSR is a brief application confirmed by ORRP through an administrative review. The report may be completed at any time during the review period.