Modification Review

After a protocol is approved, the investigator may find that it must be modified.  Possible reasons include:

• Preliminary results indicate that subject population, survey questions, etc., should be modified.
• Additional institutions (such as additional K-12 schools) have indicated willingness to participate.
• Original scope of research was too large and project must be scaled back.
• Preliminary interviews have generated new contacts or new questions and project is to be expanded.

In these cases, the investigator may submit a request for a modification review (see Forms and Templates).  In the request, the desired changed should be explained, as well as the reasons for making them. All revised IRB documents should be attached. For instance, if the recruiting information is being changed, the revised flyer, recruiting script or text should be submitted. Changes should be highlighted so that the IRB can compare the old and new documents. If the changes are substantive, or involve higher risk to the participants, a revised protocol which incorporates the changes should be generated and submitted.