Formal Modification Requests for an existing study judged to be Expedited or Full-Board are required.
Studies previously judged to be Exempt do not need subsequent Modification Requests -- unless the desired changes to the protocol would alter the risk to human participants in the research to such an extent that the study would no longer be Exempt. If you are uncertain about this, please email the IRB Office with your questions or to schedule a consult.
The IRB must review and approve any changes in the approved research for an Expedited or Full-Board study before implementation of these changes -- except when they are necessary to eliminate apparent immediate hazards to subjects.
You may modify your protocol at any time during the approval period. Modifications of Full-Board protocols that significantly alter the risk level or significantly change a project’s goals or methodology may require review and approval by the full board at the monthly meeting.
We will post here when Modification Requests become available through OneAegis. In the meantime, please continue to download the traditional form and email it to the IRB.
Download the current form: IRB Modification Request
Under new federal regulations that were rolled out in March 2019, you no longer need to submit a continuing review application for ongoing (open enrollment or continuing data collection) minimal risk studies. This specifically impacts Expedited studies.
Instead, the OneAegis system will send you a notification email at the end of the initial approval period. This email will contain a brief survey to determine the current status of your project for records compliance.
If you have concluded all data collection and interaction with participants, and you will be analyzing data only, please see "Downgrade to Exempt" below.
If your study was a Full-Board protocol, the OneAegis system will send you a notification email within a month of your study's approval expiration date. This email will contain information regarding appropriate steps for continuing review and approval.
If you have concluded all data collection (i.e., you are no longer interacting with participants) and, for the project in question, you will henceforth conduct data analysis only, you may request to have your study reclassified as Exempt. Once it is reclassified, IRB oversight is no longer required.
We will post here when Requests to Downgrade to Exempt become available through OneAegis. In the meantime, please continue to download the traditional form and email it to the IRB.
Download the current form: Downgrade to Exempt Application
You should submit a Closeout Report when you will no longer interact with participants and have concluded your study. You should also submit a Closeout Report if 1) you never initiated the study, and no enrollment took place; and/or 2) you will leave SU without requesting a change in PI.
A Closeout Report is required by Federal regulations for all studies approved by the IRB.
After study closure, you may not contact study subjects for further data collection without consulting with the IRB about re-opening the study.
If a student PI graduates and does not submit a report, a Closeout Report must be completed by the Faculty Adviser.
We will post here when Closeout Reports become available through OneAegis. In the meantime, please continue to download the traditional form and email it to the IRB.
Download the current form: IRB Closeout Report form
You must submit an Unanticipated Problem–Adverse Event report if an unexpected (in nature, severity, or frequency) incident, experience, or outcome occurs related or possibly related to research procedures, and that places subjects or others at greater risk of harm than previously realized or anticipated.
For more information, read the IRB Adverse Event/Unanticipated Problem Policy.
An unanticipated problem may warrant corrective actions in the research protocol or the informed consent process/document to ensure the safety, welfare, or rights of participants.
Do not attempt to use OneAegis to report these events, as many of them may be time-sensitive.
Required Timeframe for Reporting Unanticipated Problems–Adverse Events
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Investigator Must Report the Following |
Reporting Timeframe |
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Identification of an unsafe research environment. |
Immediately by phone, when it represents a significant departure from the approved protocol and/or if it affects the welfare or safety of participants. |
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Threats of harm to participants or others related to their participation in the research. |
Immediately by phone. |
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Change to the protocol made without prior IRB review to eliminate an apparent immediate hazard to participants. |
Immediately by phone. |
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Deaths |
Within 24 hours, if subject currently in protocol. Otherwise, within 60 days of investigator’s notification of death. |
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The above instances should be immediately reported to the IRB, key site personnel, and any other authorities overseeing or involved in the research protocol. |
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Breach of confidentiality. |
Within 3 days of discovery. |
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Any harm experienced by the participant that, in the opinion of the investigator, is both unexpected and likely caused by research procedures. |
Within 7 days of occurrence, or within 7 days of a reported occurrence to the PI by participants. |
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Any other problem that the investigator considers to be unanticipated, and indicates that participants or others are at increased risk of harm. |
Within 7 days. |
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Incarceration of a participant in a protocol not approved to enroll prisoners. |
Within 10 days. |
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Newly discovered information that indicates a change in the risk/benefit ratio. |
Within 10 days of discovery. |
Download the current form: IRB Unanticipated Problem/Adverse Event Report Form