Modification Request Protocols

When any revisions to an approved research protocol, written consent form and/or advertisement for participant recruitment is desired, the investigator must submit in writing to the FUIRB a modification request and a new Form A. The modification request must be on department letterhead and include a description of the original study in enough detail to allow FUIRB to evaluate the requested change(s) and should explain the changes and the rationale for change(s). A brief summary of findings from the study should be included in the request. A revised copy of the pertinent documents (e.g. consent form and/or advertisement) must also be submitted with the change(s) italicized or underlines.

Modifications to approved protocols may not be initiated until FUIRB approval has been obtained, except where necessary to eliminate apparent immediate hazards to the subjects.

An expedited process may review minor revisions, which reflect administrative changes or do not increase the risk of the participants. An example of minor modifications would be a change in the title of the research project. Those modifications, which are not deemed as minor, will require full-board review.

A letter sent to the investigator and recorded in the FUIRB files may acknowledge non-substantive (administrative) changes to approved protocols.