After receiving your initial IRB determination or approval your research may require additional submissions to the IRB for review to ensure compliance with institutional policy and regulations.<\/p>\n
Any changes to previously approved research generally require additional review by the IRB. These may include changes in study personnel, study design, recruitment, methods, questions or procedures etc. Approval for the changes must be obtained prior to starting new research activities. For example, a new investigator added to the study cannot start any study activities until their addition is approved by the IRB.<\/p>\n
If you must make a change to an approved protocol to eliminate immediate potential hazards to participants, you may do so without prior approval. If you make a change to eliminate potential hazards, contact the IRB, as soon as possible and within no less than 5 business days after the change was implemented.<\/p>\n
To determine what types of changes require submission prior to initiation, see IRB SOP: Amendment to Approved IRB Protocol<\/a>. If an amendment submission is necessary, the following is requested:<\/p>\n Requests for amendments to previously determined\/approved research must be reviewed separately from Continuing Review and Progress Report submissions.<\/p>\n For further information regarding changes to approved research please see the IRB Investigator Manual<\/a> and the IRB SOP: Amendment to Approved IRB Protocol<\/a>.<\/p>\n If you have further questions, please contact the IRB Office<\/a>.<\/p>\n At the time of initial review, a protocol is granted an approval period.\u00a0 For determinations\/approvals that do not require a continuing review the expiration date is determined by the protocol end date listed at the time of submission. For\u00a0 all other approvals the approval period is usually for 1 year. The Principal Investigator (PI) is responsible for submitting and maintaining approval prior to continuing human subjects research activities beyond the expiration date.\u00a0 All research activities must be stopped beyond the\u00a0 expiration date unless it affects the welfare of the participants.<\/strong> If human subject research activities have concluded, the PI must properly close the protocol as detailed in Project Closures.<\/p>\n To request continued approval and obtain continued approval prior to the expiration date, the PI must complete and submit a Continuing Review Submission Form or a Progress Report Submission Form<\/a> to the IRB in a timely manner. The IRB requires continued review requests to be submitted at least 45 days prior<\/strong> to the protocol\u2019s expiration date.<\/p>\n Continued approval must be requested as follows:<\/p>\n Requests for continuous reviews\/progress reports must be reviewed separately from other proposed changes to previously approved research (i.e., amendments).<\/p>\n For more information on Continuing Reviews and Progress Reporting please see IRB Investigator Manual<\/a> and the IRB SOP: Continuing Review and Progress Reporting of IRB Approved Protocol<\/a>.<\/p>\n If you have further questions, please contact the IRB Office<\/a>.<\/p>\n All IRB protocols reviewed and determined\/approved by Registration Project by FLEX review, Exempt, Expedited and Full review must be closed once human subject research activities conclude and prior to the project\u2019s expiration date.<\/p>\n Human subjects research activities are completed when the research team as completed:<\/strong><\/p>\n A Closure Submission Form<\/a> needs to be submitted to request closure by the IRB. The IRB will conduct a review of the submission and verify the protocol is eligible for closure based on the status of reported activities. Notification of the determination will be provided to the investigator.<\/p>\n For additional information regarding Protocol Closure please see IRB Investigator Manual<\/a> and the IRB SOP: Closure of IRB Approved Protocol<\/a>.<\/p>\n Use the Reportable Event Submission Form to report unanticipated problems or adverse events involving risks to participants or to others. If the event, problem or information meets the immediate reporting criteria, the Principal Investigator must submit the reportable event within 5 business days of becoming aware of the occurrence.<\/p>\n Researchers should contact the IRB Office immediately upon discovery of an unanticipated problem or event involving risks to subjects or others.<\/p>\n If the reportable event does not involve unanticipated problems or adverse events involving risks to participants or to others, the PI must submit the reportable event at the time of discovery or at the time of submission of a progress report, continuing review or protocol closure.<\/p>\n For additional information regarding Reportable Events please see IRB Investigator Manual<\/a> and the IRB SOP: Requirements for Reporting to the IRB<\/a>\u00a0 for detailed information.<\/p>\n\n
Continuing Review and Progress Reporting for Human Subjects Research<\/h2>\n
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Closure of IRB-Approved Protocol<\/h2>\n
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Reportable Events Requiring notification to the IRB<\/h2>\n