The purpose is to outline the policies and procedures for mandatory reporting to the Institutional Review Board (IRB) or Exempt Review Committee (ERC) concerning human research.
An adverse event is any untoward or unfavorable occurrence in a human subject, including any abnormal sign (e.g., abnormal physical exam or lab 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. It can encompass both physical and psychological harms. While it occurs mostly in the context of biomedical research, it can occur in the context of social and behavioral research. Adverse events that occur during clinical trials can be either internal or external.
A deviation is an inadvertent act by an investigator in which a research project is not followed exactly as proposed and approved.
An IND safety report (for an investigational new drug) is a type of adverse event report used in clinical trial studies. The Food & Drug Administration (FDA) requires trial sponsors to send it to the FDA and all investigators for any serious and unexpected adverse event taking place during the trial, regardless of the location of the event.
An unanticipated problem is any incident, experience, or outcome that meets all of the following criteria:
Status Report Policy
Approval of research is only valid for one year. Research investigators are required to submit a status report 6 months following approval for full and expedited projects. This is not required for exempt projects by the ERC. A report form may be found on our IRB Forms page. If the research has been completed at that point, the IRB will close the file. If the research continues beyond 6 months, but will end prior to the expiration, a second and final status report must be submitted to the IRB by the expiration date. If it is expected that the research will continue beyond the one year approval period, the Principal Investigator (PI) must apply for continuing review/renewal, allowing ample time for review so there is no lapse in approval. All research activities, including recruitment, enrollment, data collection and data analysis must cease as of the expiration date, unless the board approves a renewal. Studies are not considered closed until both data collection and analysis have been completed. Researchers must reapply if they have not completed analysis prior to the approval's expiration (See our Continuing Review policy).
Status Report Procedure (IRB Reviewed Projects Only)
- The IRB sends an automated email notice via its online management and submission system, IRBNet, to the PI and anyone granted “full” access in the system by the PI (e.g., faculty sponsor), 15 days prior the first status report’s due date.
- The PI submits the six-month status report via IRBNet (www.irbnet.org), indicating whether the project has been completed or is continuing.
- If completed, an IRB staff member closes the project’s file (See Closure or Withdrawal policy). If not yet complete, an IRB staff member determines if the project may continue or requires further review.
- If no further action is required, an IRB staff member acknowledges the submission in IRBNet by changing the status of the submission from “pending review” to “acknowledged.” An automated email message is sent the to the PI about this action.
- If further review is required, the IRB informs the PI through an official letter published via IRBNet. An automated email message is sent to the PI about this action.
If an investigator fails to submit a required status report, an IRB staff member will attempt contact with the Principal Investigator (PI) via e-mail or telephone. Continued failure to respond may result in suspension of research activities. Please see our failure to submit a status report procedure for further details.
Failure to Submit a Status Report
Deviation and Violation Reports
Deviation or Violation Report Policy
Research investigators are responsible for reporting to the IRB or ERC any instance of non-compliance with policies and procedures or the requirements or determinations of the IRB/ERC.
If inadvertently or intentionally, an approved research protocol is not followed exactly as proposed, the investigator must submit a Deviation/Violation report to the IRB or ERC within 10 business days of the incident. A report form may be found on our IRB Forms page.
Deviation or violation reports are acknowledged by the IRB or ERC within 3-5 business days.
Deviation or Violation Report Procedure
- The PI submits a deviation/violation report to the IRB or ERC via IRBNet at www.irbnet.org.
- For IRB projects, the Director of Human Participants Protection, the Assistant Vice President for Research, and the IRB Chairperson review the report. For ERC projects, the Director of Research Compliance and the Assistant Vice President for Research review the report. If necessary, the deviation/violation is reported to University and federal authorities.
- If the deviation/violation necessitates a minor revision to a previously approved study, the revision may be reviewed under the same procedure as the initial application, or in the case of a full initial review, under an expedited procedure.
- The IRB Chairperson (for the IRB) or the Director of Research Compliance publishes to IRBNet an acknowledgement letter within 3-5 business days of receipt of the report in IRBNet. The letter indicates either an action or no further action.
- If the report is serious or risks have increased, the report may be forwarded to the full board for review at a convened meeting.
Failure to Report Deviations or Violations
If the IRB or ERC Administrator discovers an unreported deviation or violation, s/he will attempt contact with the PI via e-mail or telephone. The PI will have one week to respond. Failure to respond may result in suspension of research activities. Please see our failure to report deviations or violations procedure.
Unanticipated Problems and Adverse Events
Unanticipated Problem and Adverse Event Policy
According to the US Office of Human Research Protections, an event or incident that meets the unanticipated problem criteria as defined above will most likely warrant substantive changes to the research protocol or informed consent document or process in order to ensure protection of the rights and safety of participants. Examples of corrective actions that may be required are:
changes to research protocol initiated by the PI prior to obtaining IRB approval, only to eliminate immediate hazards to subjects;
modification of inclusion/exclusion criteria to mitigate newly identified risks;
implementation of additional procedures for monitoring subjects;
suspension of enrollment of new subjects;
suspension of research procedures in currently enrolled subjects;
modification of informed consent documents to include a description of newly recognized risks; and
provision of additional information about newly recognized risks to previously enrolled subjects.
Assessment of whether an adverse event is an unanticipated problem includes:
Is the adverse event unexpected?
Is the adverse event related, or possibly related, to participation in the research?
Does the adverse event suggest that researched placed subjects or others at a greater risk of harm than was previously known or recognized?
If the answers to all three questions are YES, then the adverse event is an unanticipated problem and must be reported to the IRB/ERC.
An investigator is required to report to the IRB or ERC:
Research investigators must report all serious, internal adverse events, for example the death or serious injury of a research participant, regardless of relatedness or expectedness to study drug or interventions, immediately within 24 hours of the event to the Institutional Review Board (IRB) or ERC. Unanticipated Problems must be reported within 10 business days of the event. Unanticipated problem and adverse event reports are acknowledged by the IRB or ERC within 3-5 business days.
IND Safety Reports (Clinical Research)
An IND safety report does not always describe an event which meets the definition of an unanticipated problem. Often, however, clinical research sponsors send IND safety reports to investigators and instruct the investigators to submit them to the IRB. If a research investigator conducting a clinical trial receives a safety report from a clinical research sponsor, and the report qualifies as an unanticipated problem, the investigator must submit the safety report within 10 business days to the IRB. IND safety reports are acknowledged by the IRB within 3-5 business days.
Unanticipated Problem and Adverse Event Procedure
Approval of Research
Closure or Withdrawal
Suspension or Termination
7/19/2013 - Updated