IRB Protocol Amendment Instructions

Instructions for the Completion of the “Request to Amend an IRB Protocol” Form

In accordance with 45 CFR 46.103(b)(4) changes to an IRB protocol or its related consent document must be approved by the IRB prior to implementation except where necessary to eliminate apparent immediate hazards to participants.

To request a change in your protocol or consent form, please submit the Request to Amend an IRB Protocol form. Answer all questions.

  • The revised protocol, consent form, and/or survey instruments should be sent electronically to , with changes highlighted. Include the IRB protocol number in the subject line of your e-mail.
  • If you are adding a study site, you may need to provide additional documentation, depending on the type of site. If you are adding a research site at another university, an approval letter from that institution’s IRB must be submitted. Research conducted at public schools or other institutions without IRBs requires a letter of permission from the school district or other official. See IRB Research in Schools and Other Organizations Policy for further details.
  • If you are adding additional personnel, all must be CITI-certified before the amendment will be approved. Please note that it is not necessary to send CITI certificates; the IRB staff has access to all UM CITI training records.
  • Does your proposed change increase the risks to subjects? If so, your department chair’s email is required.
  • Details of your request and a justification for all changes should be provided in question 3.

Amendments are reviewed as they are received and, according to the level of risk to subjects, may be reviewed by one reviewer or by the entire Board. You will be notified by email when the amendment has been approved and you may then begin your research. The new consent form, should one be required, will be stamped with the IRB approval stamp and sent to you by email. Discard any previously approved consent forms.

If you have any questions, please do not hesitate to contact the IRB staff at