All research studies involving human subjects that are FDA regulated are always reviewed by Full Review.
Every research application begins with a complete submission to the Office of Research Compliance.
The Office of Research Compliance staff works closely with the Principal Investigator to prepare the required IRB documents for IRB review.
An IRB application called: Clinical Studies Involving Human Subjects form
Informed Consent form
Assent Document (if minor subjects will be included)
Data Collection Instrument
Letter of Permission or IRB approval from Off-Site Institution/Off-Site Research Agreement
Sponsor Protocol/Master Protocol
Once the application is determined to be complete, it is formally accepted by the Office of Research Compliance. This is the starting point for the IRB review process.
The Compliance Coordinator forwards the application to the IRB Chair for assignment of two primary reviewers to evaluate the application, discuss concerns with the Principal Investigator, and serve as advocates during the Full Review.
In addition, upon receipt of all required paperwork, the Compliance Coordinator logs the IRB submission, scans the materials and enters application into InfoEd (the Office’s electronic data management system), assigns an application number, reviews it for completeness, notifies the assigned primary reviewers, and places the application on the agenda for the next IRB meeting. All information or revision requests by the Primary Reviewers are sent to the principal investigator through e-mail and copied to the Office, including notes of oral communications. When the application is brought before the committee, the Primary Reviewers serve as advocates for the Principal Investigator. All IRB Board Members have access to the application and communications between the Primary Reviewers and the Principal Investigator via InfoEd prior to the meeting. When IRB‘s review is completed, the Compliance Coordinator notifies the Principal Investigator in writing of the application’s status.
The IRB conducts continuing review of all research, funded or unfunded, approved thorough the Full Review procedures in accordance with the policies and procedures outlined in Federal Regulation 21 CFR 50, 56, 312 and 812 at intervals appropriate to the degree of risk, but not less than once per year for the life of the project. No study continues beyond the one-year approval without IRB review. Applications approved by Full Review are reviewed for continuation by Full Review.
It is the Principal Investigator's responsibility to secure continuing approval. The Principal Investigator must allow adequate time for the process. Principal Investigators are reminded at one and two month intervals by the Office to seek continuing review. Requests are placed on the Continuing Review form. Principal Investigators who fail to obtain continuing approval are notified by the Office (by telephone, email, and letter) that their investigation has been terminated and that subjects are no longer allowed to participate in the investigation (except for a medical emergency).
Continuing review information submitted to the IRB should include information such as: the number of subjects entered into the research study; a summary description of subject experiences (benefits, adverse reactions); numbers of withdrawals from the research; reasons for withdrawals; the research results obtained thus far; a current risk-benefit assessment based on study results; and any new information since the IRB's last review, identifying any new information or unanticipated risks discovered since the previous IRB review.
If the Principal Investigator, during the course of conducting the research, needs to revise the application (e.g., makes changes to the informed consent form or conduct of the study, survey instruments used, or number and nature of subjects), the Principal Investigator must notify the Office and seek approval prior to making any changes. The Compliance Coordinator will notify the original Primary Reviewers and they will determine the need and degree of additional review needed for approval.
The Principal Investigator must submit in writing any intended changes of the study to the Office using the, Request for Modification/Amendment form. The Principal Investigator is reminded that no changes can be implemented until the Chair and/or the Committee approves the changes, and that failure to do so may result in the application’s suspension and/or termination. Note: For investigations initially approved by Full Review, changes that alter the degree of risk to the subjects require Full Review.
Review of IRB Actions
As a part of the Full Review procedures, the IRB has the authority to approve, request revision and modification, or disapprove the proposed research activity.
The application is approved with or without IRB required changes.
Request Revision and Modification
When an application is not approved during Full Review because problems are identified in the application, the application is considered to be in need of revision or modification. When problems fall into either of two categories, i.e.,: 1) 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, or 2) the informed consent forms(s) or the research design is in need of minor revision, then approval may be given at the next convened meeting, after the Principal Investigator rewrites the application, informed consent form, or submits to the Chair a written response to the IRB's questions and concerns. For applications with a high degree of risk, the IRB may request that a Principal Investigator resubmit the revised application for Full Review.
The IRB can disapprove a proposed application and shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. A research activity may be disapproved only after a Full Review has been conducted.
Suspension or Termination of Research
The IRB has the authority to suspend or terminate previously approved research that is not conducted in accordance with the IRB's requirements, other institutional and federal requirements, or has been associated with any serious harm to subjects. Concerns regarding the conduct of research are to be reported to the Chair of the IRB by any individual having such knowledge. Any suspension or termination of research must include a statement of the reason for the IRB's action and written notification of the IRB’s decision must be provided promptly to the Principal Investigator. The Office of Grants and Contracts will be notified of the IRB’s action in the case of a sponsored project.
Serious and Unanticipated Adverse Event Reporting
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. Further, 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 committee to make a recommendation.
Adverse Events 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 approved 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.
Final Report Form
The IRB requires Principal Investigators conducting approved research to submit in writing notification of the completion of their project to the Office. Written notification shall be provided within 30 days of completion or the termination of all research activity for a study.