Review of IRB Actions
The review of all research studies involving human subjects occur in one of the three methods: Exempt (from further) Review, Expedited Review, and Full Board (Convened) Review. FDA regulated research involving human subjects is always reviewed by the full review board.
Applications which, in accordance with federal regulations, do not require Expedited or Convened Review are determined Exempt (from further) Review. As part of the Expedited and Convened Review procedures, the IRB has the authority to approve, request revision and modification, or disapprove the proposed research activity.
Review Determinations
Approval
The Institutional Review Board may approve a proposed research application with or without IRB required changes. Once approved, the Principal Investigator will receive an email containing a protocol approval letter which includes the approval date, expiration date, and any changes the IRB requires (if applicable).
Request Revision and Modification
If the IRB identifies problems within a proposed research application during a Convened Review, the application may be deferred and its status considered in need of revision or modification. Problems resulting in this IRB determination fall under one of two categories:
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The Principal Investigator needs to clarify an aspect of the study, provide additional information, or discuss in greater detail the potential risks and benefits the study presents
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Minor changes need to be made to the informed consent document(s) or the research design
If an application is deferred for one of the above reasons, approval may be given after the Principal Investigator rewrites the application, rewrites the informed consent, or submits to the Chair a written response to the IRB’s questions and concerns. The Chair may then ask IRB members with expertise in area of concern, ask the Primary Reviewers for their recommendation, or forward the application to the committee for Convened Review. For applications with a high degree of risk, the IRB may request that the Principal Investigator resubmit the revised application for Convened Review.
Disapproval
The IRB can disapprove a proposed application if the risks to the subjects outweigh the benefit or value of the knowledge gained and shall include in its written notification a statement of the reasons for its decision and provide the investigator an opportunity to respond in person or in writing. Disapproval of a research activity occurs only after the Convened Review of the application.
Suspension or Termination of Research
The IRB has the authority to suspend or terminate research not in accordance with the IRB's requirements, other institutional and federal requirements, or has been associated with any serious harm to subjects. The IRB Chair receives all concerns regarding the conduct of research. Any suspension or termination of research must include a statement of the IRB's action and the Chair must report the IRB's decision promptly to the Principal Investigator, funding agency, and regulatory agencies. The Office of Grants and Contracts receives a notification of termination/suspension letter from the IRB if the project had sponsorship.
Closure or Withdrawal
The status of a terminated study is determined closed by the IRB. The IRB may also close expired protocols and acknowledge the closure or withdrawal of a study by the Principal Investigator.
IRB Acknowledgement
The Institutional Review Board must stay informed of all research activities conducted under an approved protocol. Some protocol submissions, however, must only be acknowledged by the board.
Adverse Event Reports
The IRB has no authority to approve, require modifications, or disapprove unanticipated harmful incidents experienced by a subject involved in a multi-center project. Once the Principal Investigator receives notification of adverse events of subjects from other multi-centered research sites, the Principal Investigators submits the report to the IRB. The Primary Reviewers of the IRB who initially reviewed the application, review the reports and inform the IRB at the next convened meeting of their findings. The IRB acknowledges the receipt and review of the forms at the next scheduled IRB meeting.
Serious and Unanticipated Adverse Events Reports
If a subject participating in an approved research study at one of our study sites experiences an unanticipated harmful incident, the Principal Investigator must complete an adverse event form to report the incident within 24 hours of the initial discovery. Adverse events include any incident or event that results in harm whether psychological, physical, or if it puts the participant at more than minimal risk. The researcher must report any incident where there is a clear cause and effect relationship that the subject suffered harm. Furthermore, the researcher must also report any incident where there is a possibility that the subject suffered harm because of their participation in the research study. The Primary Reviewers of the IRB, who initially approved the application, review the reports and inform the IRB at the next convened meeting of their findings to allow the IRB to make a recommendation.
