Amendments & Clarifications

Federal regulations require IRB’s to review and approve changes to approved studies prior to their implementation. In rare cases, changes might be implemented prior to IRB approval if the changes are necessary in order to eliminate immediate hazards to subjects. If a change is necessary in order to eliminate immediate hazards to subjects, investigators should contact the IRB immediately if possible.

However, for all other changes, investigators should seek IRB approval prior to implementing changes.

Any changes/alterations that occur prior to IRB approval are considered to be deviations and require  reporting to the IRB. See the Deviation Policy for more information.

Changes to Expedited/Full Board Studies

Changes to studies reviewed by expedited review or at a convened IRB meeting should be submitted on an Amendment Form. Changes to staff are completed on a Staff Amendment Form. All forms can be found on the Forms page.

In addition, investigators should submit any documents that require revisions as a result of the amendment (e.g. consent form, IRB application, recruitment flyers, etc.).

For changes to your IRB application:

Be sure to highlight/shade or use track changes to indicate where the changes have been made. You should also note where the change has been made within the body of your amendment form.

For changes to your study documents:

Be sure to submit a highlighted/marked version of the documents. You can either shade, use strike-through, or use track changes to highlight where the changes have been made. The IRB will create a clean version of the document using the submitted marked version if it is in a Word format.

However, if you are submitting a marked PDF or PowerPoint, we ask that you also submit a clean version of the revised document.

Changes to Exempt Studies

Changes to exempt studies should be submitted on a Clarification Form, which can be found on the the Office of Research Compliance’s Forms page. If applicable, investigators should update the IRB application to reflect the new changes.

For changes to your IRB application:

Be sure to highlight/shade or use track changes to indicate where the changes have been made. You should also note where the change has been made within the body of your amendment form.

Please note, the IRB does not require investigators to send updates about staff changes on Exempt studies.

Amendment Examples (not exhaustive)

  • Changes in study staff. Study staff amendments are not required for Exempt studies
  • Revisions to the Inclusion/Exclusion criteria
  • Revisions to questions being asked in a study survey
  • Changes in the time frame for a study assessment
  • Changes in the contact information on the recruitment materials
  • Changes in the method of obtaining informed consent
  • Addition of new study location
  • Increase in the number of subjects being enrolled etc.
  • Removal of a study questionnaire/instrument

Amendment Review

Minor changes that pose no more than minimal risk can typically be reviewed via expedited procedures. This means that the amendment will be reviewed in the office by an IRB member.  However, if the change is more significant and is greater than minimal risk, the amendment will need to be reviewed at a convened IRB meeting.

The approval of the amendment does not alter the dates of the study’s overall approval period.

When is an Amendment Really a New Study?

If the proposed amendment includes changes to two or more of the following criteria, the IRB would consider this to be a new study and the investigator would need to submit a new study application.

  • Study population
  • Study procedures
  • Study purpose