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 the IRB with any questions or concerns

515-271-DIRB (3472)
irb@drake.edu

University News
October 31, 2014
A retired U.S. diplomat and United Nations peacekeeper will discuss the UN’s role in peacekeeping on Nov. 6.
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