Investigators are responsible for prompt reporting to the IRB of “any unanticipated problems involving risks to subjects or others…” ([46.108(a)(4)(i)]. The IRB maintains responsibility for initial assessment of the risk/ benefit ratio in a research activity involving human participants. During the course of the project, investigators are required to promptly inform the IRB of any unanticipated negative effect or undesirable experience that is possibly, probably or definitely related to study procedure(s).
Although adverse events occur most commonly in the context of biomedical research, adverse events can occur in the context of social and behavioral research. Adverse events are not necessarily physical in nature; attention must be paid to psychological harm (such as depression, thoughts of suicide, etc), threats to privacy or participant safety. Events can occur which are unexpected and result in new circumstances that increased the risk of harm to subjects without directly harming them. The event may also present unanticipated risks to others (e.g., the sexual partners of the subjects, individuals the subject may come in contact with, family members, research personnel, etc.) in addition to the subjects.
In each case, while the event may not have caused any detectable harm or adverse effect to subjects or others they nevertheless represent unanticipated problems and should be promptly reported. The investigator must also include a description of any corrective actions that have been initiated in the conduct of the research to prevent a reoccurrence of the problem or to protect research participants from potential or further harm.
Only unexpected adverse events that are related to the research need to be reported. An event is “related to the research procedures” if in the opinion of the principal investigator, it was more likely than not to be caused by the research procedures or if it is more likely that not that the event affects the rights and welfare of current participants. If this relationship can be definitively ruled out, then the adverse event should not be reported to the IRB. If in doubt, it is best to err on the side of caution by contacting the ORPC at compliance@umbc.edu.
Reports of adverse events occurring on UMBC protocols should be submitted to the ORPC using the Kuali Protocols Portal within five (5) days of occurrence of any:
- actual unforeseen harmful or unfavorable occurrence to participants or others that relates to the research protocol (injuries, psychological events)
- unforeseen development that potentially increases the likelihood of harm to participants or others in the future
- problem involving data collection, data storage, privacy or confidentiality
- complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team
- protocol violation (meaning an accidental or unintentional change to an IRB approved protocol) that harmed participants or others or that indicates participants or others may be at increased risk of harm
The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating this report.
The IRB will determine if the study and/or consent form should be updated, and/or currently enrolled subjects should be informed of the new information to determine whether they wish to continue. If risks to subjects have changed such that the study must be stopped, all enrollment must cease and the research project placed on hold pending resolution by the IRB. Investigators will be notified of the appropriate changes to make for submission to the IRB for review and approval – usually submitted in the form of an amendment.. If the event is considered serious or life threatening, proper notification will be made by the principal investigator, via the IRB chair, to the UMBC Institutional Official and to all applicable Federal agencies.