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 previously approved protocol, a request must be submitted through the SharePoint site. When logging into SharePoint, you will be prompted for your Portal username and password (NOTE: if accessing the site from an off-campus computer, add "@twu.edu" to your username). Once the SharePoint site has been accessed, press the "NEW" button to initiate the request and follow the instructions on the form. Click here to view a template of this form. Note that only one modification should be pending at any given time, the SharePoint site will override previous modifications submitted that have not been processed.
Please note to attach 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 expedited. However, more substantial changes may require that the change be reviewed by more than one member, especially on full-committee review studies.
page last updated 4/22/2014 9:47 AM