Protocol Modifications

Investigators are responsible for reporting any changes to the protocol to the IRB before the changes are instituted. These can include adding or removing study personnel, adding or revising study advertisements, updating FDA form 1572s, sponsor protocol amendments and revisions to investigator brochures, modifications to the consent and assent documents, etc.

Changes which are not substantive and do not affect the risk to benefit ratio for subjects may qualify for expedited review.

Changes that are substantive and affect the risk to benefit ratio for subjects must be reviewed by the full board.

The same modification request form is used for both expedited and full board reviews. A notice of receipt is sent to the principal investigator identifying missing items and, for full board modifications, indicating the meeting date when the modification will be reviewed.

Expedited modification requests are assigned to reviewers on a rolling basis. Modification requests which require full board review are assigned to a full board meeting based upon date and time of submission to the IRB office.

Following review, your modification will receive one of the following status determinations: Approved, Approvable pending re-review by the chair or his/her designee, Approvable pending re-review by the subcommittee, or Approvable pending re-review by the full board.