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Maintaining :: Unexpected events :: Definitions

Definitions

The following three categories define undesirable research events. These definitions are important to understanding what needs to be reported to the IRB-SBS and OHRP.

Unexpected Event

An unexpected event is an event that is not listed as a risk in the protocol and/or consent forms or was not previously documented at the intensity/frequency observed in your study population. The unexpected event also places the participant in greater risk than was previously known or recognized. For example, as a researcher in a typical school, you are interviewing children about a math test.  During one of the interviews, the student tells you that his dad abuses him when he does poorly in school. Abuse is not a topic that you intended to cover in your study and the possibility of talking to students about abuse was not listed as a risk in your protocol.  However, you are obligated to report child abuse (for more information on reporting abuse see Abuse) and this is an unexpected event that changes the level of risk to the participant.

Adverse Event

An adverse event is any “undesirable and unintended, although not necessarily unexpected, effect of the research occurring in human subjects as a result of (a) the interventions and interactions used in the research; or (b) the collection of identifiable private information under the research” (Adapted from the 1993 OPRR IRB Guidebook). In other words, a participant is harmed as a result of participating in the study but the harm was described as a possibility in the protocol. For example, your study involves clinically depressed participants with a high suicidal rating. After attending intervention therapy as part of the study, one of the participants later in the evening reports a suicide attempt. This event was described as a risk in the protocol and in the consent form.

Serious Adverse Event: The potential harm for most studies fits in a scale of severity as related to probability. For example, the risks for a study measuring one’s happiness after exercising (low-impact moderate jogging) might include fatigue and soreness. Depending on the athleticism of the participants, the probability may be high for this adverse event to occur, though for normal, healthy adults this would not be considered a severe adverse event. A serious adverse event would be an event where the probability is not high for the event to occur and it resulted in harm to the participant. Continuing with the exercise example, one of the participants trips while performing the exercise and sprains an ankle, resulting in the need for medical assistance. Although the event is serious, it is still within the defined levels of risk outlined in the protocol.  However, if five of the fifteen participants receive the same injury, the frequency of the event changes the probability predicted in the protocol. The protocol should be reviewed to determine if the procedures need to be altered to better protect participants (i.e. select another jogging route) and if participants need to be better informed about the study (i.e. increased risk for injury, advice for safe jogging).

Adverse Event Related or Possibly Related to the study: It is easy to develop examples where an adverse event is clearly related to a study. However, it is not always clear that an injury or harm is directly related to a study and may require your best assessment of the situation. If you have questions about a potential situation, please contact our office. We would be happy to provide consultation.

Noncompliance Event

Noncompliance and more specifically, a "protocol violation," results from any change or departure from the study design or procedures of a research project that is not approved by the IRB-SBS prior to its implementation.  Also, a protocol violation is thought to be any departure from established code of ethical conduct from the researcher's professional organization, or from applicable local, state, national and/or international regulations, policies and procedures.  For example, a data recording procedure is not followed properly and confidential data about a participant is accidentally published on a website, or a laptop is stolen with participants’ social security numbers and home addresses, putting the participants at risk for identity theft. The act may be an unexpected problem or misfortune, a careless act or mistake, or a deliberate act against what the Board recommended.

In addition, failure to properly maintain a protocol is also considered a noncompliance event. For example, letting a protocol lapse without submitting a continuation request or modifying a protocol and failing to notify our office of the change are considered noncompliance events. Repeated disregard for maintaining a protocol is a serious noncompliance event. It is important that you keep accurate records and an updated protocol in order to maintain compliance with the IRB-SBS and federal regulations. If the study is complete, don't let it lapse but submit a Study Closure form instead.

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