Reporting New Information / Events
What needs to be reported to the IRB?
All reports of new risk information, unanticipated problems, adverse events, non-compliance, audits and monitoring reports are now submitted in the electronic system. New information falls into four categories:
- Events, problems or information that require prompt reporting to the IRB
- Events or information that can be submitted at the time of Continuing Review
- Events or informaiton that is submitted only to the sponsor or other parties as specified in the protocol
- Requests from KUMC investigators for prospective approval of an exception to the IRB-approved study protocol
Detailed instructions are presented in the Reportable Events Instructions document (01/2019). For specific types of reports, additional information may be needed as described below.
When reporting Adverse Events to the IRB, please consult the instructions document referenced above. Complete the submission in eIRB and also upload this Reportable Adverse Events Form found on the forms and template page.
NOTE: Additional documentation is needed when reporting external adverse events in multi-center trials. Please include
- The sponsor's determination that the event is an unanticipated problem, along with the sponsor's action plan to address the problem, or
- Documentation that the sponsor approves changes to the study (if the local PI has determined the event represents an unanticipated problem)
External Reports without this documentation may be returned without review.
Documentation of all incidents of non-compliance, both reportable and non-reportable, must be maintained by the study team throughout the life of the study.
Prompt reporting (within 5 working days of the study team's awareness) is ALWAYS required in the circumstances below. Reports should be submitted as a Report of New Information in the eIRB system, utilizing the Non-Compliance Reporting Form found on the forms and template page:
- Failure to obtain informed consent or re-consent when required by the IRB
- Modifying the protocol without IRB approval, except to avoid immediate hazard to subjects
- Conducting the research prior to IRB approval, during an IRB suspension or after IRB approval expires.
Additionally, prompt reporting is required for other non-compliance when the principal investigator (PI) determines the non-compliance meets at least one of the following criteria:
- Causes harm or increases the risk of harm;
- Adversely affects the rights and welfare of the participants; OR
- Undermines the scientific integrity of the data
The documentation of non-compliance, including the PI assessment of reportability can utilize the Non-Compliance Reporting Form, Non-Compliance Summary Log (as found on the forms and template page) or other means supplied by the sponsor or developed by individual study teams, provided the ALL of the follow items are documented:
- Protocol IRB#
- PI name
- Subject ID
- Date of incident
- How and when incident was discovered
- Description of incident
- Did the incident cause harm or increase risk of harm?
- Did the incident adversely affect the rights and welfare of the participant?
- Did the incident undermine the scientific integrity of the data?
- Corrective and Preventive Action
- Documentation of IRB reportability assessment by the PI (this can be in the form of signature and date, email correspondence or other written means of documentation).
One-time Exception Requests
KUMC investigators may request prospective approval of a one-time exception to the IRB-approved study protocol. These planned, non-emergent exceptions may include, for example: exceptions to eligibility criteria, exceptions to the form or manner of obtaining informed consent, use of out-of-window test results, and exceptions to the administration or use of an investigational product. Investigators must provide their rationale and demonstrate there is no negative impact to subject safety or data integrity. Requests for studies with external sponsors must include the sponsor's approval for the exception. The Exception Request Form can be found on the Forms and Template page under the Reportable Events section.
One-time requests are made by filing a Report of New Information in the eIRB system; however, if the investigator is planning a permanent change to the protocol, this must be submitted in eIRB as a Modification.
Note: these types of exceptions must be approved by the IRB in advance. Please allow at least one business day for IRB review. At the time of submission, please also send an email to IRBhelp@kumc.edu to help ensure prompt review.