Amending an Approved IRB Study

Amending Exempt Research

Most modifications to exempt research may be done at the discretion of the principal investigator without prior IRB approval. Some changes do require IRB approval before being implemented. For a list of changes that must be submitted to the IRB for review and approval, see the Conditions of Approval attached to your initial exemption letter from the IRB or refer to WPP VIII-5.

Amending Expedited Research

All proposed changes to expedited research must be submitted for IRB review and approval prior to initiating the change.

Amending Full Board Research

All proposed changes to full board research must be submitted for IRB review and approval prior to initiating the change. Some types of minor changes to full board studies may be reviewed in an expedited fashion by a single reviewer. This determination is made by the IRB reviewer, not the principal investigator.

Submitting an Amendment in RAMS-IRB

  • Login to RAMS-IRB and open the workspace for the study needing an amendment
  • Click the “New Amendment” button
  • Fill out the amendment cover sheet and then modify the smartform. Upload redline and clean copies of any revised documents to the study workspace.

Please see the RAMS-IRB Submission System guide for details on submitting an Amendment.

Ongoing Submissions for Western IRB Approved Research

Once an initial submission is approved by WIRB, the Principal Investigator is responsible for directly submitting all future submissions to WIRB including changes in research (amendments).

A copy of ALL submissions must be provided to ORSP via IRBIntake@vcu.edu, as well as to WIRB.

Be aware that WIRB updates its submission forms as much as twice yearly to improve the review of research and protection of human subjects. When preparing to submit research for review, be sure to use the most current versions of WIRB submission forms by referring directly to the WIRB forms site.