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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.). IRBManager will route completed applications to Supervising Investigators for review and signature. The application will be routed by IRBManager to all personnel who are Faculty and Professional and Scientific Staff to indicate whether or not they have a financial conflict of interest. Applications must also be reviewed and signed by the Department Chair of the PI or Supervising Investigator.
IRB applications undergo a pre-review process to ensure that all materials and information needed for review are included and to determine the review status of the study (i.e., exempt review status, eligible for expedited review procedures, or requires review by the full committee). The terms exempt and expedited refer to categories of research established in the federal regulations, which do not require review by the full committee. At ISU, the IRB Co-chairs conduct expedited reviews; exemption can be granted by the IRB Co-chairs or the IRB Administrators.
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 measures.
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.
Type of Review
Minimum Time to Allow for Review
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 the continuing review date and other important information. Also, please note that the IRB-stamped informed consent document should be used when enrolling study participants.
Any change to non-exempt research must be reviewed and approved by the IRB prior to implementation of the change, as stated in the approval letter. The only exception to this requirement is when the change is necessary to eliminate apparent immediate hazards to participants. Modification to an approved project may be submitted by amending the protocol in IRBManager.
Modifications include, but are not limited to:
- any changes in study procedures;
- changes in research personnel (see explanation below);
- changes to the project title;
- requests to increase the number of participants;
- changes in funding sources;
- changes in how you are recruiting or following participants;
- new or revised advertisements, flyers, or recruitment materials;
- changes to informed consent documents, surveys, questionnaires, correspondence with potential or current participants;
- the addition of new measures, stimuli, surveys, interview questions, etc.;
- changes in confidentiality or privacy protections;
- changes to inclusion or exclusion criteria.
Minor modifications are changes to 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-investigator(s), and/or funding sources; addition or modification of procedures that fall into one of the categories eligible for expedited review; most wording clarifications to consent documents or recruitment materials, etc. These minor modifications may be approved by the Co-chair alone, using the expedited review procedures. More extensive modifications may require full board review. In either case, revisions or clarifications may be required.
Modifications to exempt research need prior IRB approval only under certain circumstances. Information about these circumstances can be found here.
Changes in research personnel, including a change in Principal Investigator may be submitted by amending the application in IRBManager. All research personnel must have completed the appropriate CITI human subjects protection training course before the application may be submitted.
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.