Modification Application

The Modification application must describe the modification(s) requested, including reasons for the change, whether the modification will increase or decrease the risk of harm to the subject, and whether the consent form requires modification.

Modification applications must be approved by the IRB before any changes are implemented. For sponsored research or multi-center studies, changes should be submitted no later than 30 days after receipt from study sponsors and collaborators.

When proposing changes to an existing study, it is important to consider whether the changes may warrant submission of a new protocol rather than a modification. It is a misconception that adding a modification to an existing study will be easier and faster than submitting a new application. The IRB must examine any modification application using the same review criteria and standards as it would for a new submission. A modification application that results in an overly long protocol with many inconsistencies and/or the inclusion of information and documents that are no longer relevant can be confusing to reviewers and create issues with regulatory determinations. In many cases, a new application that is current and consistent will be easier to review and faster to approve.

Modification Application Requirements

Researchers requesting changes, modifications, and addendums to a currently approved research protocol must submit a completed modification application. In addition to the modification application, any forms or documents that are impacted by these changes must all be updated.

For example, if a study that did not previously provide participant compensation is now going to provide compensation, a modification application must be submitted describing the change, the New Study Application form must be updated to describe the compensation, and the informed consent document must be updated to describe the compensation.

The Principal Investigator is responsible for the overall conduct of the research, including submission of all IRB application forms. While individual tasks, such as completing the application forms, may be delegated to research team members, the information submitted is the responsibility of the PI.

Exempt Research

For studies that have received an “Exempt” determination, not all changes require a modification application.  Only substantive changes to the study must be reviewed by the IRB to ensure the study still qualifies for exempt status in light of the change(s).  Substantive changes include, but are not limited to the following:

• Changes that increase the risk to participants or change the risk:benefit ratio of the study
• Changes that affect a participant’s willingness to participate in the study
• Changes to study procedures or study components that are not covered by the Exemption Category
• Changes to the study sponsor
• Changes to the targeted participant population
• Changes to the stamped consent document(s)

ALL research team changes (addition or removal of investigators or study personnel) require a modification even though it is not a substantial change to the research itself.  A modification is required as the institution is required to confirm education, training and potential conflicts of interest for all research team members.