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

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University News
May 20, 2015
Drake’s College of Business and Public Administration held its Graduate Student of the Year awards ceremony at West End Architectural Salvage on May 7, 2015. The college recognized four graduate students and one faculty member at the event.
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