Any deviations or adverse events that occur during research need to be submitted to OneAegis).

• Deviations sometimes happen in research
• Submit deviations or adverse events to the IRB by completing the Adverse Event & Incident Reporting Form within regulatory timeframe for event
• Implement corrective actions
• Implement preventative actions

What are Adverse Events?

Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding,) symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice.)
 
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.

What are Unanticipated Problems?

1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
2. Related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

The Office for Human Research Protections (OHRP) notes that an incident, experience, or outcome that meets the three criteria above generally will warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others.

What are Deviations?

A deviation is generally defined as an incident which does not impact subject safety, compromise the integrity of study data and/or affect a subject’s willingness to continue participation in a study.