Amend a Study
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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.
Instructions for how to submit these amendment forms can be found here [PDF]. A video tutorial on how to submit a form in iRIS can be found here.
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 [PDF]. 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):
- Addition or deletion of study team members (not principal investigator changes)
- Addition of procedures that do not increase risk
- Addition of non-sensitive survey or interview questions
- Document changes that do not modify the intent of the content (e.g., typographical error corrections, improvements for clarity)
For more information about amendments and types of review, visit the Policy Manual/Guides page.
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.
- Ensure new study personnel have complete all personnel requirements.
- For principal investigator (PI) changes, consent forms and study documents must be updated to include the PI change.
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.
- The requested changes must be addressed across all applicable study documents and/or the IRB applications.
- If an updated IRB application is required, ensure it’s selected in 1.4 of the amendment form and the revised application is attached in 1.9 of the amendment form.
- For protocol revisions, include a summary of changes [docx]. This is a cumulative document that outlines changes over the life of the study protocol.
- If the amendment changes require revisions to study documents:
- use the “tracked changes” feature in Microsoft Word to update the documents. This allows the IRB to see what changes have been made. Attach the tracked copy to the amendment form.
- also attach a “clean” version of the updated document (that does not include tracking). This will be the version that the IRB approves when the amendment is approved.
- ensure changes are made on the current approved version of the document.
Study Closure/Enrollment Closure/PI Request to Hold:
- If the study is sponsored, attach the sponsors notification of enrollment or study closure.
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.