All modifications to currently approved research are required to have IRB review and approval before implementation. An Amendment/Revision Request Form must be submitted to the IRB outlining each specific change. All revisions to a consent form must be submitted to the IRB, including those not resulting from an amendment (e.g., increase in compensation, an addendum, additional safety information, etc.).
An amendment/revision may require full Committee review if the modification is significant and affects the risks and benefits to research subjects. Changes in the risks and benefits to subjects may require modifications to the consent form and re-obtaining consent.
When a study is approved by the IRB, the IRB assigns an approval period. Investigators may request modifications/changes to the study during that period, within limitation. Approval of a modification does not alter the date of the study's approval period. Changes to a study may not be implemented until approved by the IRB.
Please contact an Office of Research Affairs staff member at 614-546-4325 or email@example.com with questions about modifying an approved study.
When changing investigators, the current principle investigator must submit an Amendment/Revision Form indicating the change in responsibility and a letter from the new investigator accepting responsibility for the research. Changes in investigators may qualify for expedited review.
Once the IRB has received your Amendment/Revision/Modification Request, the IRB has the following options:
When the modification is approved, the request form, signed by the Chairperson, will be returned to the investigator.
Examples of minor changes to a protocol include but are not limited to:
Examples of significant changes to a protocol may include, but are not limited to: