Amendments and Modifications to a Research Project

Can a Protocol be modified after IRB approval?

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IRB review and approval only applies to those specific project documents and procedures that were reviewed and approved.  Any change in any document or procedure must have IRB review and approval before that change can be implemented.  The exception: when a change is immediately essential for the safety of subjects.  And even in those cases, the modification must still be reported as soon as possible afterwards to the IRB for a needed change in protocol and/or consent form.

Many modifications entail minimal risk adjustments to a protocol and/or consent form and can be made on an Expedited basis (via the IRB Chair).  Some examples are: format changes, correcting spelling errors, adding key personnel, minor changes to questionnaires, recruiting ad changes, and so forth.  Other, more substantive changes, especially those that may alter the risk-benefit ratio, may require Full Board review and approval.   In all cases, except where noted above regarding subject safety, any changes to any protocol document or procedure must first be approved by the IRB before they can be implemented.  

Note that these modification requirements also apply to EXEMPT category projects.  Any change in a project approved as Exempt category must be reviewed beforehand by OReC staff.

This OReC review is essential to determine if the change has altered the level of review and whether or not IRB review might be involved as a result of the modification.  As usual, contact OReC personnel if you have any questions.

This page last updated 08th Oct 2013