Amendments and Updates

Any change in any IRB approved document or procedure must have IRB review and approval before that change can be implemented.  The exception: when a change is 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 approval of the needed change in the 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 or Annual 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 Pearl IRB staff.

Please forward redlined and clean versions of the documents that are to be changed to the IRB Coordinator.

A determination will be made within 3 days.