Project Life Cycle
I have a determination, now what?
Once the IRB has made a determination about your research, the first thing to do is go to IRBNet to download the determination letter. If a project is determined to be EXEMPT, you can begin you research, and you will not need to submit continuing review or amendments for that research. The only submissions that would need to be made would be amendments where significant changes are made to the research and the determination needs to be reconsidered or if an unanticipated problems occurs. If a project is determined to be EXPEDITED or FULL BOARD, you will make several submissions to the IRB over the course of the conduct of the research. These submissions include amendments when changes need to be made, continuing review or closure submitted 30 days before date of IRB approval expiration, and reportable events. See below for more information about these submissions. Always make sure that you read and understand the determination letter and follow the decisions of the IRB.
Prior to implementing a change to a non-exempt study, an amendment must be submitted to and approved by the IRB. Examples include adding or revising questionnaires or other study procedures, changes in study location or population, adding/removing project team members, changes in recruitment, compensation, etc. Amendments to exempt studies only need to be submitted if the proposed change disallows the study to remain exempt (contact the OIRB for guidance). An Amendment Application must be completed and submitted with any new or revised documents using track changes or a similar method to highlight the changes made. If the amendment is solely adding or removing project team members, the project team amendment application can be submitted instead of the standard amendment application, along with current CITI training certificates and a revised project team form. Amendments are submitted as a new package within the existing IRBNet project and a version trail should be created for each revised document. For further guidance, please see the IRBNet submission instructions for creating a new package.
Federally funded research must be reviewed by the IRB no less than once per year. Some faculty research reviewed under Equivalent Protections may qualify for continuing review every two years. A Continuing Review Application and applicable paperwork as outlined in the IRB Submission Checklist (e.g. abstracts and publications that occurred within the last approval period, the last signed consent form with participant identifiers redacted, protocol deviations if appropriate, etc.) must be submitted no later than 30 days prior to the expiration date to allow adequate time for IRB review. Researchers may remove project team members and update HSR trainings at the time of continuing review as part of the continuing review package. IRBNet sends automated email reminders of continuing review at 60- and 30-days prior to expiration of IRB approval.
Please note continuing review and amendments may not be submitted at the same time. Continuing reviews are submitted as new packages within the existing IRBNet project.
Protocol Deviations Report
A protocol deviations report is completed over the course of the approval period when protocol deviations occur and is reported to the IRB at the time of continuing review or closure, if any deviations occurred. This report documents minor deviations that caused no harm to participants, such as enrollment of participants using an unstamped consent form, lack of researcher signature on the consent, over enrollment in a minimal risk study, etc. For more information, please see SOP 405 “Reporting of Protocol Deviations.”
An unanticipated problem is a significant complication or other unfavorable occurrence that is related or possibly related to research participation, is not anticipated at the time of protocol review and arises in or following the conduct of research. Unanticipated problems may occur with the participants or others. Adverse events are harms that occur to research participants or project team members. They range from minor to severe and may be anticipated or unanticipated. An event report must be submitted to the IRB within 7 calendar days of discovery of an unanticipated problem or adverse event occurring during the research. Additional reporting requirements to federal agencies, study sponsors, risk management, legal counsel, police authorities or other entities may also be required. Event reports are submitted as new packages in the existing project in IRBNet.For more information, please see SOP 401 “Reporting and Review of Events Involving Risks to Participants or Others.”
Examples of reportable events include:
- injury, disability, hospitalization, life-threatening experience, death, unexpected side-effects, aggressive or unusual behavior;
- harm or damage to the safety, rights, or welfare of research participants, research staff, or others;
- any complaint of a participant that indicates an unanticipated risk or which cannot be resolved by the research staff;
- breach of privacy, confidentiality or data security that caused harm or increased the risk of harm;
- loss or destruction of study data not in accordance with IRB approved procedures.
The PI and/or the IRB may close approved protocols under certain circumstances. The PI is responsible for promptly closing out an IRB approved project when:
- all research activities including analysis of identifiable data and reporting are complete;
- the PI never initiated the study;
- participant enrollment is closed, all data collection is complete and the only remaining activity is analysis of de-identified data with no identifying links or codes;
- the PI plans to leave the University and intends to continue the research activities at another institution;
- a student researcher leaves the University without notifying the IRB.
The study cannot be closed if the study:
- is still collecting data from participants;
- is analyzing identifiable data (including data with codes or links to identifiers).
To submit a closure request, the PI or student researcher will submit a Closure Application and other documents as outlined in the IRB Submission Checklist as a new package within the existing IRBNet project. Note that closure requests are not required for studies granted exemption.
Post Approval Monitoring (PAM)
Researcher interactions with the IRB are not limited to submitting paperwork for review. Once a project is approved, it is under IRB oversight as long as participant interactions continue, identifiers exist, and the project is not closed. The post approval monitoring (PAM) program has two goals: 1) ensure ongoing monitoring and compliance of active projects and 2) serve as a training opportunity for researchers as they conduct their research. To assist researchers with establishing their projects and monitor them over time, Monitoring and Compliance (MAC) tools are available on the OIRB website. Additionally, the IRB may contact the researcher in order to assess the project in real time through a full assessment, self-assessment, consent document review, consent process review, or other activity.