Modifications

Researchers are required to promptly report proposed changes in research activities to the IRB. Such changes often include, but are not limited to, changes in the research team, addition of a data collection site, changes in the instrument used or data collection procedures, or changes in the criteria for subject inclusion / exclusion. It is important to note that the investigator must receive approval from the IRB for the requested modification PRIOR to this this change being implemented. 

In order to modify a Legacy study (a study submitted prior to the Cayuse implementation), email the completed Modification Request Form to irb@twu.edu with the PIs name, campus, and protocol number in the subject line. For studies submitted through Cayuse, a modification submission should be initiated in the Cayuse system. This document contains more detailed instructions for Cayuse Modification Submission.

Please include any documents necessary for the modification including revised consent forms, agency approval letters if adding a site, revised testing instruments, and/or training certificates for new research team members. Once received, the request will be reviewed by the IRB Chair or another member of the IRB. Most modifications are considered to be minor and will be processed within one to two weeks of receipt. However, more substantial changes may require that the change be reviewed by more than one member, especially on full-committee review studies.