Review Process/Timelines

Follow These Steps to Assure Proper IRB Approval

How to Apply for IRB Approval

To seek IRB approval, complete an IRB Application in IRBManager. Before applying, identify the individual who will serve as Principal Investigator.  The individual must be eligible to serve as PI.  In some cases, a Supervising Investigator must agree to supervise the research (e.g., projects led by students, post-docs, etc.).   Completed applications must be reviewed and signed by the Principal Investigator, Supervising Investigator (when applicable), and Chair of the department overseeing the research before submission to the IRB.  Additionally, all study personnel who are ISU Faculty or Professional and Scientific Staff must indicate whether they have a financial conflict of interest.

IRBManager automatically routes completed applications for signature and conflict of interest verification, and notifies (via email) the individual(s) who need to take action.

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.

The IRB full committee generally meets twice a month to review and approve proposals. A current meeting schedule along with due dates for submission can be found here. Materials to be reviewed at a full committee meeting must be submitted two full weeks in advance of the meeting to allow time for pre-review. Following pre-review, proposals will be scheduled for review on the next available meeting agenda (i.e., one that isn’t already full). However, not all submissions are reviewed by the full committee; many can be reviewed through exempt or expedited procedures.

Due to the number of protocols reviewed by the IRB, 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.

Approval

Following IRB approval, the approved application, the IRB-stamped supporting documents, and the IRB approval letter are available to the PI and Supervising Investigator in IRBManager. Please read the approval letter carefully as it contains important information. Also, please note that the IRB-stamped informed consent document should be used when enrolling study participants.

Modifications

After approval, researchers must carefully follow the approved protocol.  If changes are needed, an amendment for modification may be submitted in IRBManager.

A modification is any change from the IRB-approved protocol.  Examples include, but are not limited to:

• changes to study procedures;
• adding or removing research personnel (see explanation below);
• revising the project title;
• changes in funding source(s);
• changes to recruitment plans and methods;
• new or revised advertisements, flyers, or other recruitment materials;
• increasing the number of participants;
• changes to inclusion or exclusion criteria;
• changes to the informed consent process or informed consent form(s);
• new or revised measures, stimuli, surveys, interview questions, etc.;
• changes in confidentiality or privacy protections.

IMPORTANT:  Any modification to non-exempt research must receive IRB approval prior to implementation, unless the modification is necessary to eliminate an immediate hazard to participants.

Minor modifications are changes to non-exempt research projects or materials that pose no additional risk to participants and no significant ethical concerns.  Examples of minor modifications include changes in title, co-investigators or research assistants, and/or funding sources; addition or modification of procedures that are eligible for expedited review; most wording clarifications to consent documents or recruitment materials, etc.  Minor modifications typically do not require review by the full-committee—instead, these submissions are reviewed by IRB Chair(s) or designated IRB members.

Modifications to exempt research need prior IRB approval only under certain circumstances. Information about these circumstances can be found here.

Changes in principal investigator, supervising investigator, or any research personnel require prior approval for both exempt and non-exempt research.   All research personnel must have completed the appropriate CITI human subjects protection training course before the amendment for modification may be submitted.

Continuing Review

IRBs are required to regularly review approved research to ensure human subjects protections remain appropriate over the life of the study.  This process is called “continuing review.”  Continuing review of non-exempt research is required at intervals appropriate to the degree of risk.  Intervals are established by the IRB, and vary depending on level of risk to participants, whether the project requires review by the convened IRB, and whether the project is federally funded or FDA-regulated.  Under the 2018 Common Rule, continuing review is typically not required for research approved via “expedited procedures” (review by an IRB Chair on behalf of the convened IRB) or research that has progressed to the point that remaining activities are limited to data analysis.  Such research may undergo an abbreviated status check every three years.  See the IRB guidance Continuing Review for more information.

For research that requires continuing review, the IRB approval letter indicates the IRB approval expiration date.  It is the principal investigator’s responsibility to submit an application in sufficient time (at least three to four weeks prior to expiration) to permit review prior to the expiration date.  As a courtesy, reminders will be sent in advance of the expiration date.  If continuing review is not completed prior to the expiration date, IRB approval will lapse.  No human subjects research activity may take place after the expiration date and until IRB approval is reestablished, unless continuation is necessary to prevent harm to subjects.  Human subjects research activity includes recruitment and enrollment of participants, data collection, and/or use of identifiable research data.  Instances where continuation is needed to prevent harm must be reported to IRB@iastate.edu for consideration by an IRB Chair.