ORIO Guidance: Accidents and Incidents
Accidents or incidents that have an impact on the research must be reported to the IRBMED. When the study is affected in a way that intrudes upon the science of the study because procedures cannot be done or data is lost, that information needs to be reported.
Accidents/Incidents Involving Study Subjects:
Report to the IRBMED any accident/incident that involves, but did not harm a subject, or others, only if the accident/incident is definitely, probably, or possibly related to the research intervention. (If a subject or others experiences physical or psychological harm, report the incident as an AE).
Example:
- Subject is involved in a no-injury auto accident returning home just after a research procedure involving several blood-draws and glucose infusions.
Accidents/Incidents Involving Study Data Or Specimens
Report to the IRBMED any event that harms or destroys the study data or specimens to the degree that the information cannot be restored.
Examples:
- Destruction of electronic data by a computer virus or paper documents by fire.
- Specimen storage is compromised (e.g. the freezer containing tissue samples collected for the study fails before specimens have been analyzed).
- A sub-investigator leaves UM, takes the data, and refuses to return it.
- Discovery that a researcher or staff member has falsified data.
Accidents/Incidents Involving Study Facility
Report to the IRBMED any event that harms or destroys the study facility to the degree that the study is significantly interrupted or must be discontinued.
Example:
- A fire or tornado closes the facility during the week necessary tests were to be performed and no alternate facility was available.
