IRB Study Actions

DETERMINE whether IRB oversight is necessary

From the IRBManager Dashboard click: Does My Study Require IRB Oversight

This online self-test walks through decision trees to aid investigators in determining whether IRB oversight of their project is required.  Based on responses provided within this short form, investigators receive an automated response related to the need for IRB oversight.

See also Is IRB Approval Required? 

SUBMIT an application for new study

From the IRBManager Dashboard click: Submit an IRB Application for a NEW Study

• Select “Human Subjects Research Project” for a new study with human research subjects. This includes secondary use of identifiable private information/data/biospecimens in addition to research interactions/interventions with human subjects.
• Select “Creating/Maintaining a Recruitment Registry and/or a Data or Specimen Repository” to establish a standalone recruitment registry or data/specimen repository. Registries and Repositories require standalone protocols and cannot be embedded within a larger project application.
• Select “Request to Rely on an External 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.
  • For agreements in which Iowa State will serve as the reviewing IRB, please complete the relevant sections within the regular “Human Subjects Research Project” form.

See also Multisite Research & sIRB

• Select “Request for 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.

EXTEND IRB approval

The IRB requests periodic updates for all studies not requiring a formal continuing review (i.e. studies determined to be exempt and many studies reviewed under the updated 2018 Common Rule). Investigators are asked to complete a short series of questions that provide the IRB information on the study’s status. Studies that do not receive timely status updates are presumed complete (IRB oversight is no longer needed) and are administratively closed.

• To complete a status update and extend IRB approval, first locate the study in IRBManager. Under the “Actions” menu select “Start xForm” and choose “Study Status Check-In” then complete the short series of questions.

Detailed steps are outlined in the Researcher’s Guide to IRBManager.

AMEND the approved study

Amending an approved study encompasses Modifications, Renewal/Continuing Review, and Closures. The amendment process in IRBManager is designed to ensure investigators and the IRB always have a clear and current protocol that includes the relevant research plans at a given point in time. With each amendment, investigators create a COPY of the most recently approved protocol, then update the areas of the form to represent the proposed amendments. Historical iterations of approved forms are always accessible to investigators and the IRB.

The amendment process differs depending on whether the study has been previously reviewed in IRBManager or if it was last reviewed using the old, paper-based forms.

• To amend a study previously reviewed in IRBManager, investigators must locate the study and then “Copy for Amendment” using the most recent approved application. Detailed steps are outlined in the Researcher’s Guide to IRBManager.
• For studies that have only been submitted using paper applications (e.g., older exempt studies, preliminary determinations), basic protocol information (e.g., title, PI) is included in IRBManager, but investigators will need to manually enter protocol information.  See our IRBManager webpage  and the Researcher’s Guide to IRBManager for more information.

Note: If the study is currently under review (initial review or amendment) you must wait until review of that submission is complete before submitting another amendment. To request changes before the review is complete, please contact the IRB office to ask that the form under review be returned to you. A study undergoing review cannot be amended.

MODIFY the approved study

Begin the Amendment process by copying to amend the most recent approved application or through the Pre-IRBManager Amendment form (when applicable).

• Select “Modification” as the application type to seek approval for proposed changes to a study and/or add/remove study personnel.
• Identify “Modification Type(s)” (e.g., add personnel, change in funding, change in research procedures, change in risk) and within the “Modification Description” section include a summary of the proposed revisions.
• Update the application throughout to represent the research plan as you would like approval going forward. This may involve deleting procedures or materials that you are no longer using for the study and/or adding new information or materials. Historical copies of approved forms and materials will remain with the study.

Detailed process steps are outlined in the Researcher’s Guide to IRBManager.

If your study was deemed Exempt, see also: Modifications to Exempt Research

RENEW IRB approval via Continuing Review when required

Begin the Amendment process by copying to amend the most recent approval or through the Pre-IRBManager Amendment form (when applicable).

• Select “Continuing Review” to renew study approval.
• Select both “Continuing Review” and “Modification” to renew study approval AND seek approval for proposed changes to a study.

Detailed steps are outlined in the Researcher’s Guide to IRBManager.

See also: Continuing Review

CLOSE IRB oversight of the study

Begin the Amendment process by copying to amend the most recent approval or through the Pre-IRBManager Amendment form (when applicable).

• Select “Project Closure” to close-out IRB oversight of a study.

Detailed steps are outlined in the Researcher’s Guide to IRBManager.

See also: Study Closure

REPORT adverse events or unanticipated problems

Investigators must promptly report any serious adverse events or unanticipated problems related to the research to the IRB.  See also Reporting Adverse Events and Unanticipated Problems

• Locate the study in IRBManager. Under the “Actions” menu select “Start xForm” and choose “Adverse Events/Unanticipated Problems.”

Detailed steps are outlined in the Researcher’s Guide to IRBManager.