Any change in a human subject research protocol or in the informed consent document during the period of IRB approval must be submitted immediately in writing to the IRB for review and approval.  An investigator cannot initiate the procedures/changes stated in the amendment until appropriate IRB approval has been obtained, except those actions taken for patient safety.  These may be retrospectively reviewed by the IRB within five (5) business days.  An amendment to the protocol does not change the IRB expiration date for the protocol or consent document.

Amendments or changes to a protocol will be reviewed by the IRB Chairman or Administrative Director to determine if they are minor or major.  Minor changes to the protocol or consent form may be approved by expedited review.  Minor changes are those that have no substantive effect upon an approved protocol or reduce the protocol risk already approved by the IRB.  Major changes are changes that may increase the research population’s risk or are of questionable risk or benefit and must be reviewed by the full IRB board

The investigator must forward a memo to the IRB office outlining the change(s) with a copy of the new protocol with the modifications included.  If there are changes to the informed consent document, two copies must be submitted with a cover letter.  One copy of the informed consent must be marked (either bold or underline) to indicate the changes and a second copy is a “clean” revised copy of the consent document.

A letter of approval of the modifications or changes will be sent to the investigator along with an approved, stamped copy of the consent form document if changes were required.

The IRB imposes a fee for amendments that require full IRB board review.  A fee up to $500.00 will be determined depending upon the type and volume of changes required by the amendment.  There is no fee for amendments that do not require full IRB board review