Office of Research and Innovation
University of Louisville
Louisville, Ky. 40202
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Studies often require modifications to the study team, study procedures, study documents and/or consent form(s) after initial IRB approval. Before any change can be made to the approved research plan, an amendment request must be approved by the IRB (*unless there is a need to eliminate an immediate hazard facing the participants as outlined in 45 CFR 46.108 and 21 CFR 56.108.) The IRB amendment forms in iRIS are used to submit changes to the IRB for review; each one is specific to the type of change requested.
Noncompliance with these regulations, and/or UofL IRB policies and procedures, during the conduct of a research study results in a protocol violation, must be reported to the IRB by using the IRB Deviation/Violation/Misc. form as outlined on the Report a Study Event page.
*If approved research is changed to eliminate an apparent immediate hazard(s) to the subject, the investigator is required to notify the IRB of the change(s) promptly (within five (5) business days). The IRB will review to determine if the change(s) instituted were consistent with the subject’s continued welfare.
There are several amendment types found in iRIS: Request Application, Protocol, or Document Change, Request Personnel Change Only, Submit Safety Data or Risks Update-Investigator’s Brochure or DSMB Report, and Request Enrollment Closure, Study Closure, or PI Request for Hold.
The amendment’s review path (e.g. full board, expedited, administrative) depends on the nature and level of the change. Substantive changes to a project previously reviewed by the full board most likely will require full board approval also and are subject to the IRB committee meeting dates. Minor amendments may be reviewed via an expedited or administrative (i.e. IRB staff) process. Examples of minor amendments include but are not limited to (all amendment reviews are at the discretion of the IRB and HSPP staff):
For more information about amendments and types of review, visit Chapter 7.9 of the policy manual.
For exempt projects, amendments are only required for substantive changes that impact or alter the criteria used to make the initial exempt determination (e.g., focus of the research or changes in activities). Personnel amendments must be submitted to the IRB to add/remove research personnel from your study team.
Below is a list of tips to avoid common issues the IRB encounters when reviewing amendments.
Personnel Changes: in the amendment description text box, list the names of the individuals you are adding or removing.
Consent/Document/Application Change: in the amendment description text box, describe the changes being requested. Include any pertinent information that the IRB should know as they review the requested changes.
Study Closure/Enrollment Closure/PI Request to Hold:
When the amendment changes the scope or goal of the study, includes a new analysis plan, or a new study population, an amendment may no longer be appropriate. In these cases, the IRB may require a new study to be submitted for review rather than changing an existing study. If you have questions, contact the HSPP office.