What to do if something goes wrong – Reporting Requirements

If you have found that you did not follow the approved IRB protocol, you should complete a protocol deviation report in iRIS. Instructions on completing the Protocol Deviation form are available in the HELP menu within iRIS.

The protocol deviation application should include information on the specific incident and how it was handled. If any changes to the consent form, application, or protocol need to be made as a result of the protocol deviation, an amendment should be submitted.

For more information, please see section 20.7 of the IRB Manual.

Some examples of times when the protocol deviation form should be completed:

  • You enroll more participants than were approved in the application
  • You find that one participant was out of the age range approved by the IRB
  • There was a discrepancy in the informed consent process
  • An unapproved recruitment method is inadvertently used

Unanticipated problems must be disclosed to the IRB from the Unanticipated Problem form in iRIS.  The application should include a detailed account of the occurrence and the outcome. If the event highlights any changes that need to be made to the consent form, application, or protocol, an amendment should be submitted.

An Unanticipated Problem is an indecent, experience, or outcome that meets ALL of the following criteria:

  1. Unexpected (in terms of nature, severity, or frequency)
  2. Related or possibly related to participation in the research
  3. Suggests that the research places subjects or others at greater risk of harm that was previously known or recognized

Only events meeting the definition of unanticipated problems must be disclosed to the IRB.  The IRB will review the Unanticipated Problem application and determine if an unanticipated problem did, in fact, occur and if reporting is necessary to OHRP or the FDA.
For more information about Unanticipated Problems please see section 21 of the IRB Manual or the Guidance from the Department of Health and Human Services.

Within seven business days of knowledge of the deviation or unanticipated events, the Principal Investigator (PI) is asked to submit the Unanticipated Event Form to the IRB Compliance Office. Anticipated events (anticipated events described in the risks section of the consent form) are to be reported in the annual continuing review application.
The consequences will vary greatly based on the severity of the event and how it is handled. Some examples of possible actions by the IRB for unanticipated events are below.

  1. Accept the actions taken by the PI to report and resolve the incident
  2. Notify and re-consent current participants when information about the unanticipated problem might affect their willingness to continue to take part in the research
  3. Alter the continuing review schedule
  4. Peer review monitoring
  5. Approve with explicit changes, such as notification of previous subjects or modification of consent and/or protocol
  6. Suspension of some or all research activities
  7. Terminate the study for cause

Some examples of possible actions by the IRB for non-compliance are below:

  1. informal counseling
  2. action plan for resolving non-compliance
  3. audit(s) of active protocols
  4. subjects previously enrolled in the study contacted and provided with additional information and/or re-consented
  5. frequent review of compliance
  6. suspension of research protocol
  7. termination of research protocol
  8. letter(s) of reprimand
  9. suspension of sponsored research grant account
  10. notification of current participants when such information might relate to participants’ willingness to continue to take part in the research
  11. prohibit collected data from being used for publication
  12. report of non-compliance to Vice President for Research and other University administrators, the sponsor, and/or government agencies
  13. disqualification of Principal Investigator from conducting research involving human subjects at the University
  14. embargo of publications
  15. referral of the Claim to the Vice President for Research for investigation