IRB Amendment Process

A principal investigator may not implement any changes to an approved study (including to the protocol or informed consent document) without prior IRB review and approval, unless the change is necessary to eliminate apparent immediate hazards to the subjects.

IRB Amendment

An IRB Amendment is an online form completed in U-M's eResearch Regulatory Management (eRRM) system that provides a description of changes to an approved human subjects study. The amendment has two parts:

• Coversheet - used to identify the reason for the amendment and the IRB application sections to be changed
• Amendment workspace - used to edit the application sections and study documentation to reflect the requested changes

An amendment can be initiated in eRRM by any study team member listed on the approved application. Based on the information in the coversheet, eRRM creates the amendment by copying the approved application and opening that copy for editing. Once the system creates the amendment, you can access it via the amendment workspace to update the study and submit it for IRB review. Don't delete any previously approved text or documents in the application. See References & Resources below for instructions.

Only the UM Principal Investigator on the approved application can submit the amendment in eRRM for review. Only one amendment can be in process at a time for a study.

Amendment Requirements & IRB Review

For projects that were approved via expedited or full board reivew, you are required to submit an amendment for IRB approval for any proposed change to the:

• Study team members
• Study protocol or procedures
• Study documentation (e.g., informed consent, recruitment materials, survey instruments)

The amendment's review path (e.g., full board, expedited, administrative) depends on the nature and level of the change. Substantive changes to a project previously reviewed by the full board most likely will require full board approval also and are subject to the IRB submission deadlines and committee meeting dates. Minor amendments (defined in the HRPP Operations Manual, Part 3, Section III C 3) may be reviewed via an expedited or administrative (i.e., IRB staff) process. Examples of minor amendments include but are not limited to:

• Addition or deletion of study team members
• Addition of procedures that do not increase risk
• Removal of procedures which would result in reduced risk to subjects
• Addition of non-senstive survey or interview questions
• Document changes that do not modify the intent of the content (e.g., typographical error corrections, improvements for clarity)
• Addition of, or changes to, recruitment materials or recruitment strategies

For exempt projects amendments are required only for sustantive changes that impact or alter the criteria used to make the initial exempt determination. For example, a request to change a survey project's protocol from the collection of anonymous data (which qualifies for an exempt #2 determination) to the collection of sensitive data linked to personal identifiers would require the submission of an amendment for IRB review.

Once the IRB approves an amendment, the information, protocol, and documentation in the amendment becomes the record of the approved study.