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.
Amending an Existing Protocol
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.
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.
To determine what types of changes require submission prior to initiation, see IRB SOP: Amendment to Approved IRB Protocol. If an amendment submission is necessary, the following is requested:
- Exempt or Registration Project (by FLEX review) – For projects previously determined to qualify for exempt or registration, investigators should first determine if the project appears to continue to qualify for exemption or registration by using the Exempt and Registration Project Worksheets found on the IRB website.
- If the project continues to qualify for exemption or registration, an amendment should be prepared using the Amendment Submission Form and submit to the IRB.
- If the project no longer appears to qualify for exemption or registration, a New Protocol Submission Form and applicable protocol materials will need to be prepared and submitted to the IRB for review.
- Expedited and Full Review – Projects previously determined to require expedited or full review, must submit an Amendment Submission Form for any changes to previously approved research. The IRB must determine that all approval criteria specified in the federal regulation continue to be satisfied. If all criteria are satisfied, the IRB will issue an approval for the proposed changes.
Requests for amendments to previously determined/approved research must be reviewed separately from Continuing Review and Progress Report submissions.
For further information regarding changes to approved research please see the IRB Investigator Manual and the IRB SOP: Amendment to Approved IRB Protocol.
If you have further questions, please contact the IRB Office.
Continuing Review and Progress Reporting for Human Subjects Research
At the time of initial review, a protocol is granted an approval period. 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 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. All research activities must be stopped beyond the expiration date unless it affects the welfare o f thee participants. If human subject research activities have concluded, the PI must properly close the protocol as detailed in Project Closures.
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 to the IRB in a timely manner. The IRB requires continued review requests to be submitted at least 45 days prior to the protocol’s expiration date.
Continued approval must be requested as follows:
- Exempt, Registration Project (by FLEX review) and Expedited (without continuing review requirement) – Protocols previously determined/approved by exempt, registration project by FLEX review and expedited without continuing review requirement, must submit a Progress Report Submission Form and a revised project end date will need to be provided. The IRB will review the protocol to verify the project’s progress and determine that the protocol continues to qualify for exemption or registration. A revised expiration date will be issued.
- Expedited and Full Review – Projects previously determined to require expedited with continuing review or full review, must submit a Continuing Review Submission Form. The IRB must conduct a continuing review of the protocol annually, at minimum, and determine that all the approved criteria specified in the federal regulations continue to be satisfied. If approved, the IRB will issue continued approval with a new expiration date.
Requests for continuous reviews/progress reports must be reviewed separately from other proposed changes to previously approved research (i.e., amendments).
For more information on Continuing Reviews and Progress Reporting please see IRB Investigator Manual and the IRB SOP: Continuing Review and Progress Reporting of IRB Approved Protocol.
If you have further questions, please contact the IRB Office.
Closure of IRB-Approved Protocol
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’s expiration date.
Human subjects research activities are completed when the research team as completed:
- Obtaining data through intervention or interaction with subjects; and/or
- Obtaining/using identifiable private information about the subjects (i.e., data has been stripped of any identifiers and any code keys linking the data to the participants has been destroyed).
A Closure Submission Form 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.
For additional information regarding Protocol Closure please see IRB Investigator Manual and the IRB SOP: Closure of IRB Approved Protocol.
Reportable Events Requiring notification to the IRB
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.
Researchers should contact the IRB Office immediately upon discovery of an unanticipated problem or event involving risks to subjects or others.
If the reportable even does not involve unanticipated problems or adverse events involving risks to participants or to others, the PI must submit the reportable even at the time of discovery or at the time of submission of a progress report, continuing review or protocol closure.
For additional information regarding Reportable Events please see IRB Investigator Manual and the IRB SOP: Requirements for Reporting to the IRB for detailed information.
If you have further questions, please contact the IRB Office.