Submission and Review

Submitting Applications

IRB Applications

All IRB applications are completed and submitted electronically through our online system OneAegis (IRBManager).  OneAegis can be accessed through single-sign-on (SSO), or by clicking here.

The IRB application form is configured to support multiple types of submissions.

Initiate a new application for:

• New human subjects research projects
• Establishing a data repository or recruitment registry – a standalone recruitment registry or data/specimen repository. Registries and repositories require standalone protocols and cannot be embedded within an application for a larger project.
• A Preliminary IRB Determination – for a funded project that lacks definite plans for the involvement of human subjects because time is needed after funds are awarded to develop the final protocol and related study materials. A Preliminary IRB Determination is often requested to meet Just-In-Time requirements.
• Request to rely on an external (non-ISU) IRB — for studies involving collaboration between researchers at ISU and another institution, where the other Institution’s IRB will assume oversight responsibilities for both sites. If Iowa State will serve as reviewing IRB, please complete the relevant sections within a regular “Human Subjects Research Project” form.

An amendment is needed for the following actions associated with approved research:

• Modifications (guidance for non-exempt and exempt research)
• Continuing Review (guidance)
• Closing the study (guidance)

See OneAegis (IRBManager) How-To Guide for instructional guidance for initiating various types of forms.

Exempt Review Wizard

The Exempt Review Wizard is an online form in the IRB’s online system (OneAegis, formerly IRBManager). The Wizard automates certification of exemption for certain types of research.  Please review the following document’s information about eligibility, using the Wizard, and the automated review process.

Step-by-step instructions are available here.

Reporting Adverse Events or Unanticipated Problems

Serious adverse events or unanticipated problems involving risk to participants or others are reported through a form in OneAegis (IRBManager).  See related IRB guidance for detailed reporting requirements and timelines.

Incidents that pose an immediate risk of serious harm to participants or others must be reported immediately to IRB@iastate.edu or by phone (staff directory).

OneAegis (formerly called IRBManager)

OneAegis is the electronic system for IRB application submission and management of IRB-related study records. OneAegis was formerly called IRBManager—the system itself has not changed.

OneAegis supports an online IRB application and review process with conditioned questions, automated CITI training verification for study personnel, electronic signatures and routing, and email notifications for actions needed. It also allows for collaboration between researchers when completing the IRB application, as well as collaboration with the IRB office during IRB review. All IRB-related study materials and records are contained within the application and the online study record.

OneAegis How-To Guide

Review Process & Timelines

IRB applications undergo a pre-review process to ensure that all materials and information needed for review are included and to determine the level of review necessary for the study (i.e., exempt review, expedited review, or review by the full committee). The terms exempt and expedited refer to categories of research that do not require review by the full committee. At ISU, expedited reviews are conducted by IRB Chair(s) or designated IRB members.  Exempt reviews are conducted by qualified IRB staff.

Following IRB approval, the approved application, the IRB-stamped supporting documents, and the IRB approval letter are available to the PI and Supervising Investigator (SI) in OneAegis (IRBManager). PIs/SIs should read the approval letter carefully as it contains important information. Also, the IRB-stamped informed consent document should be used when enrolling study participants.

Timelines

Review timelines depend on three primary factors:

1. Review volume – IRB review load is typically highest mid-semester.
2. Application quality – clear, complete, and internally consistent applications require much less communication between the PI and IRB staff, and therefore, less review time.
3. Project complexity – complex, novel, or risky research typically requires more review time.  In some instances, consultation with outside experts, legal counsel, or other campus departments is needed. Those processes take extra time.

PIs are advised to submit their applications well in advance of the proposed start date or the continuing review date of the study. Although a review often takes less time than shown in the table below, it’s wise to allow for the longer time frame, especially during peak periods such as the middle of fall and spring semesters.

IRB Meeting Schedule/Application Submission Deadlines

IRB meetings are normally held on the first and third Tuesdays of each month, including over the summer.*  Completed applications must be submitted two full weeks in advance of the meeting.  The two-week period is needed to prepare applications for the board and ensure IRB members have sufficient time for review.

Please note: The application due date applies only to applications to be reviewed by the convened IRB.  Applications for exempt research or research that will be reviewed by a designated IRB member (i.e., “expedited review”) do not have submission deadlines; instead, these applications are placed in a queue for review in the order received.

*Changes in this schedule sometimes occur due to members’ absences, particularly during the summer and breaks or near University holidays.

IRB Approval Criteria

Federal regulations established the following criteria that must be satisfied for the IRB to approve non-exempt research.  IRB application questions are designed to obtain the information reviewers need to assess whether project plans align with these criteria.

Risks to subjects are minimized – sound scientific design, no unnecessary procedures, adequate plans to prevent harm (when possible), researchers are qualified, etc.

Risks are reasonable in relation to anticipated benefits of the research – in other words, there must be adequate scientific justification for exposing research participants to any risks associated with the study.

Subject selection is equitable – participant selection should be justified by the research question(s); not solely due to ease of access (particularly if they may be vulnerable).

The research plan includes adequate provisions to protect the privacy of subjects and to maintain confidentiality of the data collected – the IRB considers both privacy and confidentiality at all parts of the study (recruitment, during data collection, security of the data, when reporting results or sharing data, etc.).

Informed consent will be obtained from each participant prior to their inclusion in the study and in accordance with regulatory requirements, unless waived by the IRB.

Informed consent will be documented (by handwritten or electronic signature), unless this requirement is waived by the IRB.  If the documentation requirement is waived, the IRB may require written information to be provided to research participants.

When appropriate, additional safeguards are in place to protect the rights and welfare of subjects who may be vulnerable to coercion or undue influence (children, educationally or economically disadvantaged, individuals with impaired decision-making capacity, prisoners, students or employees—in some cases).

When appropriate (i.e., clinical trials, high risk research, etc.), the research plan includes adequate provisions for monitoring the data collected to ensure the safety of subjects.