Revise/Amend Your Research
You may not implement any changes, no matter how minor, to the research that has been submitted to the IRB UNLESS:
- You submit the changes/revisions/amendments to the IRB AND receive IRB approval PRIOR to implementing the changes, or
- You need to implement the changes in order to protect subject safety, in which case you may implement the changes immediately. However, you must report these changes and that they were implemented prior to IRB approval within 5 days.
- A completed copy of our Project Revision form signed by the Principal Investigator. Please read and follow all of the directions on this form. Some of the directions on the form are visible only in Hidden Text – text that you can see on the computer but will not print. Be sure to turn the Hidden Text on – each form contains directions on how to do so.
- A copy of the altered pages with any new information (insertions/additions) underlined and any removed information (deletions) struck-out. Doing this helps the IRB review the changes more quickly – the reviewer can easily see what you have added and/or removed.
- Click here to learn how Microsoft Word will automatically underline insertions and strike-out deletions for you (“track changes”).
- If you are altering one of our forms you may need to unlock the document before you “track the changes”. Click here to learn how to unprotect / unlock our forms
- Clean copies: If the Informed Consent was changed, you must submit an entire clean copy of the document (with all the changes fully implemented – no underline or strike-out showing). For all other documents (Introductory Questionnaire, Protocol, Advertisements, etc) you only need to attach a clean copy of the affected pages.
You should familiarize yourself with all of our submission requirements. Review the instructions on our Forms Page and Submitting Paperwork to the IRB page (including Submission Acceptability Standards).
When working with our forms or other electronic protocol documents, you should save each with a name that identifies the file with this particular study and date that you submit this form. For example, let’s pretend our study is called “Use of drug xxx in patients with condition yyy”. You might name your files: xxx-IQ-062206, xxx-prot-062206, xxx-icf-062206, etc. Rather than using the drug name you could also use a sponsor protocol number, IRB number, etc. Naming files in this manner can be particularly useful (1) when searching for files on your computer, and (2) keeping track of different versions of the documents as they are revised. Thus, if I were submitting a revision to my protocol and Informed Consent form for this project I could create the following new files:
- xxx-rev-060407 (my revision memo),
- xxx- prot-060407tc (revised protocol with track changes)
- xxx-prot-060407 (clean copy of the revised protocol, to be used after it’s approved and serves as the basis for any future changes)
- xxx-icf-060407tc (revised Informed Consent form with track changes)
- xxx-icf-060407 (clean copy of the revised Informed Consent form, to be used as the basis for any future changes)