Submit a Deviation/Non-Compliance
- Planned Exceptions
- Deviating from the protocol but receiving IRB approval prior to doing so on a case by case basis.
- Failure to follow the protocol
- Failure to comply with regulations, laws, or policies
- Failure to follow the IRB approved protocol is considered a deviation. Minor deviations do not affect subject safety nor the integrity of the research data. Major deviations potentially affect subject safety, data integrity, or safety of others and as such would be considered an Unanticipated Problem (see Submit an Unanticipated Problem) and would need to be reported to the IRB within 5 days of discovery. Depending on what the research involves, the institution (UF, Shands, and/or VA) may be required to report major deviations that are unanticipated problems to appropriate federal agencies.
- Planned Exceptions
- Sometimes researchers know in advance that they want to deviate from their protocol. The most frequent example involves wanting to enroll a subject who does not meet inclusion/exclusion criteria. Most researchers realize they need the sponsor’s permission to enroll the subject but fail to realize they also need IRB approval before enrolling the subject. These deviations could be called “planned exceptions” and are really one time revisions or “case by case revisions” to their protocol. Enrolling a subject who does not meet inclusion/exclusion criteria without IRB approval is regulatory non-compliance and similar to conducting research without IRB approval.
- Non-compliance with regulations must also be reported to the IRB as an Unanticipated Problem within 5 days of discovery. Depending on what the research involves, the institution (UF, Shands, and/or VA) may be required to report regulatory non-compliance to appropriate federal agencies.
- Planned Exception
Receiving IRB approval in advance to deviate from the IRB approved protocol. Usually occurs on a case by case basis without officially revising the actual protocol. Examples include but are not necessarily limited to:
- Case by case exceptions to inclusion/exclusion criteria. Must be previously approved in writing by the sponsor (if applicable).
- Seriously altering study treatment treatment or testing for a single patient due to extenuating circumstances.
- Minor Deviation
Unapproved temporary change in previously approved research activities, implemented without IRB approval, which does not adversely affect subjects rights, welfare, safety, or willingness to continue participation. Examples include but are not limited to:
- Administering a survey a day later than described in the protocol,
- Not performing a test that isn’t required for diagnosis and treatment,
- Providing study related treatment within a brief period outside of the time frame described in the protocol (short enough not to adversely affect the treatment’s effectiveness or study results).
- Major Deviation
Unapproved temporary change in previously approved research activities, implemented without IRB approval, and potentially adversely affecting subjects rights, welfare, safety, or willingness to continue participation. Submit to IRB within 5 days of discovery. Examples include:
- study medication errors or variances including overdose, underdose, failure to administer treatment, or deviating from treatment in other manner without prior IRB approval
- failure to obtain study related diagnostic testing essential to patient evaluation within the described time frame
Conducting research without active IRB approval, implementing revisions without IRB approval (unless to protect patient safety, rights, or welfare), including enrolling subjects who do not meet enrollment criteria, failing to obtain Informed Consent when required, and otherwise conducting research activities not approved by the IRB. Submit to IRB within 5 days of discovery. Examples include but are not limited to:
- Implementing a revision without IRB approval,
- Starting a study (even simple studies like retrospective chart reviews) without IRB approval,
- Enrolling more subjects than the IRB approved for the study,
- Enrolling a subject who does not meet inclusion/exclusion criteria without prior IRB approval,
- Failure to obtain/document Informed Consent before enrolling a subject,
Unanticipated Problem Involving Risks to Subjects or Others within 5 days of discovery.
Adverse events and deviations may be specific kinds of unanticipated problems (UPR). Examples include:
- Three subjects enrolled in a phase I trial of a study drug all experience organ failure that was not previously associated with the drug or the patient’s underlying condition, and requires hospitalization to treat. This is clearly an adverse event for each of these three subjects, and the event is (a) unexpected (wasn’t previously associated with the condition or drug), (b) related or possibly related to the study, and (c) suggests an increase in risk to others (if the drug is administered to others with the condition they might suffer similar organ failure). As such this adverse event is ALSO an unanticipated problem. Please note: you only need to submit this as an Adverse Event, because as such it is a specific kind of UPR.
- A subject is administered the incorrect dose of study medication, even if there is no immediate indication of harm to the subject. This deviation from the protocol is obviously an unexpected event that is directly related to the study and suggests an increase in risk to subjects (either increased likelihood of side effects or decreased efficacy, depending on the error). As such this deviation is ALSO an unanticipated problem.
The UPR form is most likely to be used for events that are not subject specific. Among the examples that fit this are: loss of a computer with identifiable research information on it; interim findings by a DSMB or similar body that the risks of the research indicate the study should end early; contamination of drug processing equipment; etc.