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.

The following must be included in an expedited modification request:

1 original and 2 copies of the Modification Request Form, noting where and what changes have been made to any study materials within the body of the Narrative Summary,

1 original and 2 copies of all revised study materials, i.e. protocol and consent documents, advertisements, form 1572,

3 copies of the currently approved study materials for comparison with proposed changes,

If adding study personnel, 3 copies of each person's CITI and HIPAA training certificates.

The following must be included in a full board modification request, collated into 1 original packet, and 15 packets including the currently approved study materials and requested revised study materials:

1 original and 15 copies of the Modification Request Form, noting where and what changes have been made to any study materials within the body of the Narrative Summary,

1 original and 15 copies of all revised study materials, i.e. protocol and consent documents, advertisements, form 1572,

16 copies of the currently approved study materials for comparison with proposed changes,

If adding study personnel, 16 copies of each person's CITI and HIPAA training certificates.

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.