An unanticipated problem is an occurrence that is a) unexpected in terms of nature, severity, or frequency based on the IRB approved study protocol and the subject population being studied; b) is related or possibly related to participation in the research study; and c) suggests that subjects or others are at a greater risk of harm (including physical, psychological, economic, or social) than was previously known or recognized. All three conditions must be met in order for an occurrence to be considered an unanticipated problem. Simply put, an unanticipated problem results in an increased risk of harm to study participants, whether or not any participants actually experience harm as a result.
Researchers must report all unanticipated problems to the IRB as soon as possible by submitting an Unanticipated Problem / Adverse Event Report form. This form is available under the "IRB Forms" tab of this website. The IRB will review the occurrence within one week and determine appropriate action. All unanticipated problems will be reported to the Provost within five (5) days following the IRB review and to any relevant Federal, state, or regulatory agencies within thirty (30) days.
An adverse event is an unfavorable medical occurrence (psychological or physical harm), including a sign, symptom, or disease, temporally associated with participation in the research, whether or not it might be related to a subject’s participation in the research study. Adverse events result in actual harm to individual participants. If an adverse event meets the criteria of an unanticipated problem, then the event must also be reported to the IRB as noted above.
It is important to note that not all adverse events are unanticipated problems. In fact, adverse events in research are often anticipated, such as harm that occurs as an expected risk of participation. Adverse events may also encompass harm that is unrelated to study participation, such as disease progression in subjects with baseline health conditions. Adverse events that are anticipated or unrelated to study participation typically do not need to be reported to the IRB; however, if the adverse event suggests that study participants may be at greater risk for harm than previously expected or if the adverse event is serious and related to study participation, then the adverse event must be reported to the IRB.
Non-compliance is any deviation from the IRB approved study protocol, IRB policies or requirements, or any laws or regulations. If non-compliance compromises the rights and welfare of study participants or compromises the integrity or interpretability of the data collected from them, then the non-compliance is considered promptly reportable non-compliance (PRNC) and must be reported to the IRB as soon as possible.
Examples of PRNC include, but are not limited to, the following:
Upon notification, the IRB will review the PRNC within one week and determine appropriate action. Such action may lead up to suspension or revocation of study approval. If the PRNC constitutes an unanticipated problem, the IRB will follow the procedures noted above. If the PRNC is particularly serious, suggests a pattern of non-compliance, or results in suspension or revocation of study approval, the IRB is required to notify all relevant Federal and state agencies.
Researchers are encouraged to contact the IRB for any questions related to unanticipated problems, adverse events, or non-compliance, or if assistance with reporting is needed.
Researchers must inform the IRB for any of the following changes by submitting a Study Amendment Application Form:
Proposed changes must be approved by the IRB before they may be implemented by the investigators unless there is a possibility of immediate harm to study subjects. In the latter case, the change will be temporary pending IRB approval. Submit the completed Study Amendment Application Form to email@example.com.
Continuing Review is a reevaluation of an approved study conducted at least once a year, as mandated by federal regulations. Continuing review is required so long as the study is ongoing, that is, until research-related interactions and interventions with human subjects or the obtaining and analysis of identifiable private information described in the IRB-approved research plan have been completed.
This review allows the IRB to monitor the progress of the study and ensure that it continues to meet the requirements for approval.
Researchers must provide the following information in the continuing review process:
Email a copy of the completed, signed Continuing Review Form to firstname.lastname@example.org.
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