As defined in policies on Amendments (c.f. Section 11), Principal Investigators are required to obtain IRB approval for changes in studies. Although such changes/amendments are usually permanent and affect all or most study participants, there may be occasions when the Principal Investigator wishes to make a temporary change in a protocol or a change that pertains only to one or a few participants. These temporary or limited changes are defined as "study exceptions".
Examples of "study exceptions" may include:
a) Enrollment of a study participant who does not meet the eligibility criteria, such as whose age slightly exceeds the age criterion
b) Changing the dose of a study medication
c) Changing a visit date
d) Adding an extra visit or omitting a visit
All study exceptions must receive IRB approval prior to initiation and must be listed in the ensuing continuing report. Submission and review of study exceptions shall follow the policies defined for submission and review of Amendments. Whether expedited review by the IRB Chair or designee or by the convened IRB, the review deliberation shall take into account all relevant materials as well as a determination as to whether the exception falls either within the specified guidelines of the approved protocol or is specifically approved by the sponsor. The review shall also be based on a determination as to whether the exception can affect the well-being of subjects (either favorably or adversely).
When submitting a request to the HSRO for IRB approval of a study exception, the Principal Investigator should include such information as:
a) What are the limitations of the exception
b) Why the exception is the best choice for the subject
c) How the exception differs from the approved protocol
d) Whether the trial sponsor (if any) approves the exception
e) Whether the data collected as a result of the exception will be analyzed in a manner different from that of other data
f) Whether the exception changes the risk/benefit
g) Whether or not an amendment to the study is intended to follow
If an exception is required in an emergency for a life-threatening situation before IRB approval can be obtained, the Principal Investigator may implement the changes but must notify the IRB of such changes in writing within ten (10) working days of the occurrence. This notification must be submitted in the eProst amendment form if the changes will apply to the entire study or via a Notification if the changes are limited to one or a few participants. In either case, the submission must explain why the exception was necessary to eliminate immediate hazards to human subjects [45 CFR 45.103(b)(4)(iii), 21 CFR 56.108(a)(3) and (4).