IRB review and approval only applies to those project documents and procedures that were reviewed and approved. Any change in any document or procedure must have IRB review and approval before it can be implemented. The exception: when a change is immediately essential for the safety of subjects. And even in those cases, it 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 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. For more details on protocol amendment procedures, click here.
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 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 was last modified on June 10, 2015