Research investigators shall be responsible for submitting for IRB review all amendments, addenda, supplements or other changes to previously approved projects along with a copy of the original protocol when:
The research project proposes to involve or to change the involvement of human subjects and the involvement is significantly different from that which was originally approved by the IRB
The informed consent document is materially modified from that which was originally approved by the IRB
The Principal Investigator wishes to add or change any study personnel
Principal Investigators must check with the IRB to determine if modifications are material.
Submission Requirements
The Principal Investigator shall submit as attachments to an email message toIRB@drake.edu:
A letter that summarizes the changes and indicates their location in the protocol and/or informed consent document
An electronic copy of the revised protocol and informed consent document. Any changes in the language of the informed consent must be noted
A clean copy of the revised informed consent document (to be dated by the IRB upon approval)