Reporting Problems

Unanticipated Risks

Research, like most human enterprises, does not always go as planned. Unexpected events occur and problems arise. The IRB is primarily concerned with increases in the risk of harm to research participants.

Unanticipated risks fall into two general categories:

  1. Risks resulting from study procedures that were not expected when the research was designed.
  2. Errors that result in risk, such as the loss or theft of identifiable sensitive information.

Investigators should inform the IRB if either of the above events occurs.

Investigators should also inform the IRB if other researchers have identified unanticipated risks in similar contemporaneous studies.

Generally, a study with unanticipated risks will be stopped while the investigator and the IRB review possible responses and consider changes to the protocol. Changes to the protocol resulted from the review would have to be approved by the IRB before the study could be resumed.

Protocol Deviations

Investigators should also let the IRB know if errors are made and protocols are not carried out as approved, for example, if a research assistant fails to use the most recently approved version of the consent form. Protocol deviations need to be reported to the IRBĀ as soon as they are identified so needed remedies can be devised. If you have a deviation to report, please fill out the Protocol Deviation Form and email it to campusirb@duke.edu.