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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
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eProst User Guide
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Western IRB (WIRB)
About the HSRO

Basic Folder Information

11.5 Study Exceptions

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

April 4, 2006

Revised: February 13, 2012


11.5 Study Exceptions

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).

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