AARHPP

Unanticipated Problems

What is an unanticipated problem involving risks to participants or others (UPs)?

  • UPs are defined as: any incident, experience or outcome that meets all of the following criteria:
    • Unexpected (unforeseen by the researcher or the research participant) given the research procedures and the subject population being studied; and
    • Related or probably related to participation in the research, or if the event or problem probably or definitely affects the safety, rights and welfare of current participants; and
    • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.
  • An unexpected adverse event is any adverse event occurring in one or more subjects participating in a research protocol whose nature, severity, or frequency is not consistent with either:
    • The unknown or foreseeable risk of adverse events associated with the procedures involved in the research that are described in the protocol related-documents, such as: the IRB-approved research protocol, applicable investigator brochure, the current IRB-approved informed consent document, and/or other relevant sources of information, such as product labeling and package inserts; or
    • The expected natural progression of any underlying disease or condition of the subject(s) experiencing the adverse event.
  • A related adverse event is:
    • An adverse event that, in the opinion of the principal investigator, was more likely than not related to the investigational agent(s) or intervention. It is the responsibility of the University of Utah Principal Investigator to make the initial determination of a relationship between an adverse event (either internal or external) and any investigational agent(s), intervention, or research study procedure.

What is the University of Utah IRB's policy regarding the reporting of research events?

  • It is the policy of the University of Utah IRB to require researchers to submit reports on events that may represent unanticipated problems involving risks to participants and others (UPs) including unexpected, related adverse events. Adverse events that may also be unanticipated problems must be promptly reported using the ERICA Report Form application.
  • The Investigator will be asked to determine if the adverse event is an unanticipated problem in the ERICA Report Form application. Please be advised that adverse events which do not meet the IRB's definition of an Unanticipated Problem (UP) should not be promptly reported to the IRB using the Report Form application. Report Forms will be automatically withdrawn and will not be reviewed by the IRB if the investigator indicates that the adverse event does not satisfy the definition of a UP.

What does "prompt" reporting mean?

  • Prompt reporting means that the report must be submitted as soon as possible after the PI learns of the event, but in all cases within 10 working days. The deadline for reporting begins at the time the investigator learns of the event. If the report is submitted late, a written explanation of its tardiness must accompany the report.

What are the consequences for late reporting

  • Researchers are required to submit the report as soon as possible after the PI learns of the event, but in all cases within 10 working days. Late reports may be reviewed for non-compliance.

What needs to be promptly reported?

  • Unanticipated problems involving risks to participants or others (see above definition) including but not limited to:
    • Unanticipated Problems (UPs)
    • A breach of confidentiality or privacy that involves real or potential risk (e.g. unauthorized use of disclosure of protected health information.)
    • Unanticipated adverse device effects (UADE), which are defined as "any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death, was not previously identified in a nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects" (21 CFR 812.3(s)).
    • New information indicating a change to the risks or benefits of the research including but not limited to:
      • DSMB summary reports that indicate that frequency or magnitude of harms or benefits may be different than initially presented to the IRB;
      • A publication that shows that the risks or potential benefits or the research may be different than initially presented to the IRB;
      • Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol;
      • Incarceration of a participant in a protocol not approved to enroll prisoners;
      • Complaints from participants or others involved in the research that indicate unexpected risks or cannot be resolved by the research team;
      • Warning or determination letters issued by any funding agency or regulatory body including Office of Human Research Protections (OHRP), Department of Health and Human Services (DHHS), Food and Drug Administration (FDA);
      • Protocol Deviations if:
        • Intended to eliminate apparent immediate hazard to a research participant (such as changing the dose of a medication due to possible toxicity), or
        • Harmful (caused possible harm to participants or others, or places them at increased risk of harm - including physical, psychological, economic, or social harm, such as a breach of confidentiality), or
        • Possible serious or continued noncompliance (such as a deviation that has happened previously and is now being repeated).

Why do these events/problems need to be reported?

  • The above events/problems may be unanticipated problems involving risks to participants and others. The IRB will review the events to identify and report any unanticipated problems involving risks to participants and others as required by federal regulations.

How is a report created and submitted to the IRB?

  • To report and adverse event, log on to ERICA, select the study in questions, click on the "AE" tab, and follow the instructions on that form. All events/problems may be reported through the AE form, the form will be re-named in the future to clearly indicate reporting of all events regardless of whether they are "adverse events."

Where can I find more information?