Amending an Approved IRB Study
Modifications to expedited and full board studies must be submitted for IRB approval prior to implementing changes of any kind. Many modifications to exempt studies may be done without prior approval, but be sure to review the specific criteria to ensure a change is permissible.
Modifying Studies in RAMS-IRB – All Study Types
Changes to studies in RAMS-IRB can be initiated by starting an Amendment activity in the system. Modify the research plan accordingly and upload revised documents to the study workspace.
Please see the RAMS-IRB Submission System guide for details on submitting an Amendment.
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 pre-approval, however.
Types of Changes Requiring IRB Review
- Change in principal investigator
- Any change that increases the risk to the participant
- Addition of children, wards of the state, or prisoner participants
- Changes in survey or interview questions (addition or deletion of questions or wording) that change the level of risk or adds questions related to sexual activity, abuse, past or present illicit drug use, illegal activities, questions reasonably expected to provoke psychological anxiety, or would make participants vulnerable, or subject them to financial, psychological or medical risk
- Changes that impact the category of exemption or add additional exemption categories
- Changes that add procedures or activities not covered by the exempt category(ies) under which the study was originally determined to be exempt
- Changes requiring additional participant identifiers that could impact the exempt category or determination
- Change in inclusion dates for retrospective record reviews if the new date is after the original approval date for the exempt study. (ex: The approval date for the study is 9/24/10 and the original inclusion dates were 01/01/08-06/30/10. This could be changed to 01/01/06 to 09/24/10 but not to end on 09/25/10 or later.)
- Addition of a new recruitment strategy
- Increase in the planned compensation to participants
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.
Maintaining Approval and 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)
- Unanticipated problems
- Continuing reviews
- Study closure.
A copy of ALL submissions must be provided to ORSP via IRBIntake@vcu.edu, as well as to WIRB. WIRB will send continuing review reminder notices to principal investigators. Please pay close attention to the reminders. WIRB strictly enforces deadlines.
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.