Addenda and Amendments

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 to IRB@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)
• A copy of any revised advertising material
• A copy of any other relevant documentation

Please contact IRB staff with any questions or concerns
515-271-2850
irb@drake.edu