Amendments
Description
The Amendment 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.
Amendments 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 an amendment. It is a misconception that adding an amendment to an existing study will be easier and faster than submitting a new application. OPRS and the IRB must examine any amendment using the same review criteria and standards as a new submission. An amendment that results in an overly long application 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 which is current and consistent will be easier to review and faster to approve.* (*From University of Oregon IRB)
Amendment Application Submission Requirements
Investigators requesting changes, modifications, and addendums to a currently approved research protocol must submit a completed amendment application. In addition to the amendment form, 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, an amendment form 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 may be delegated to research team members, including completion of the application forms, the information submitted is the responsibility of the PI.
Exempt Research
For studies that have received an “Exempt” determination, not all changes require an amendment application. Please review Researcher Guidance for Exempt Research for details.