The Human Subjects Office will be providing IRB metrics information on quarterly and annual basis. This is in an effort to better provide the UI research community with an inside look at the three Institutional Review Boards processes. Information can be found on a variety of topics on this page. Content will include, but not limited to, IRB processing times, total number of applications reviews, types of application reviews, and who are our biggest contributers of research projects.
How many active projects are there at the University of Iowa?
An active project is a project that is considered "open" at The University of Iowa. The HawkIRB system currently recognizes the following stages in the life of a project:
- Pending – A project has been submitted to the Human Subjects Office (HSO) and is currently under review by the HSO and/or the IRB. It has not received a formal IRB determination or IRB approval.
- Withdrawn - A project that was withdrawn from the HawkIRB system prior to IRB approval.
- Disapproved - A project which was reviewed by the IRB and not granted IRB approval.
- Open - A project that has obtained IRB review and approval. Research related activities can begin or are underway.
- Closed - A project status which indicates all research related activities have ended.
Projects can be categorized in one of three ways:
- Exempt review
- Expedited review
- Full Board review
Additional information on each type of review can be found in the UI Investigator’s Guide. This Chart will provide you with a historical look at the total number of active protocols as reported to the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
How many changes occur to a research protocol during the life of the research?
2012 reporting indicated over 3246 active projects occurring with University of Iowa researchers. While those numbers give an overall picture of the research activity, there are frequent changes that occur during the lifetime of a research project. Projects may require modifications or annual reviews to be reviewed and approved by the IRB. The below chart will provide a historical look at just how many form submission are reviewed in the Human Subjects Office and by the IRB. A form submission can be defined as:
- A new project application
- Modification to the current IRB approved protocol
- An annual review (Continuing review)
- A modification + Continuing review
How are the projects reviewed by the IRB?
Depending on the type of form submitted, there are various steps to the review process. Projects fit into either Expedite and Exempt review or Full Board review based on the level of risk associated with each study. The IRB Review Process flowchart (below) is a snapshot of how projects are reviewed by the HSO and IRB. The Other Committee Review chart explains the committees outside the IRB that must have their approvals either before IRB approval or prior to release of the project.
For research projects that are greater than minimal risk, full board review at a convened IRB meeting is required. Here is a historical look at how many convened IRB meetings were held as well as how many agenda items were reviewed at every meeting.
How long does it take for IRB review to be completed?
Review the below charts for more information on average times to approval and the number of studies released. The charts are broken down by the type of application (New, Modification, Modification / Continuing Review, and Continuing Review) as well as the type of review (Full Board, Expedited, and Exempt). Additional data will be posted after the close of calendary year 2014