Protocol and Consent Form Amendments

Investigators are required to inform the Institutional Review Board (IRB), in writing, of protocol changes prior to their implementation by submitting a Protocol Amendment form .  Investigators are permitted to take measures in order to eliminate apparent immediate hazards to subjects without prior IRB approval.  If such an event occurs, the Investigator must report the incident to the IRB within 5 working days.

Investigators are required to submit:

1. 12 copies of the Protocol Amendment form
2. 12 copies of the revised consent form, if amended (one copy with all changes and revisions highlighted)
3. 12 copies of amendment document (one copy with all changes and revisions highlighted) or new proposed document (may be new questionnaires, brochures, advertisements, etc)
4. 2 copies of supporting documentation (such as a revised protocol and investigator’s brochure with one copy with all changes and revisions flagged or highlighted)

Minor changes in previously approved research are reviewed by the IRB Chair and may be granted expedited approval under 45 CFR 46.110.  Minor changes include but are not limited to:

*Advertisements for recruiting study subjects

1. Administrative or informational changes
2. Additions or deletions of investigators or study coordinators
3. Corrections of grammatical or typographical errors
4. Changes leading to clarification of a protocol
5. Minimum charges in numbers of enrolled patients
6. Changes recommended by members of the IRB at an adjourned meeting during which the Chair or IRB has been designated to approve the changes by the expedited mechanism
7. Changes secondary to drug dispensation or software upgrades
8. Changes in the consent form to incorporate HIPAA language
9. Revisions that include changes to the protocol that may impact research participants but does not affect the risks to participants

*For advertisements that are taped broadcasts or videos, the IRB will review the final audio and/or video tape and request a copy of the final transcript.  If the advertisement will include a live interview or question/answer session, the IRB requests an outline of topics to be discussed prior to the broadcast and a tape or transcript of the session following the broadcast.

Significant changes in a protocol or changes that incorporate unanticipated added risks due to adverse events that involve increased risk to participants will undergo full IRB review and voting at a convened meeting.  Investigators must not use informed consent forms that do not include all known risks and side effects.  Therefore, new enrollment must be suspended pending full IRB review of the additional risk and approval of the revised consent documents.