Unanticipated Problems and Reportable Events

Unanticipated problems as defined below must promptly be reported the IRB to meet federal regulations. Even though the Office for Human Research Protection (OHRP) does not define an unanticipated problem, OHRP considers the following as described below, to be an unanticipated problem involving risk to a subject or others (e.g. the sexual partners of subjects, individuals the subject may come into contact with, family members, research personnel, etc.). Events where a subject is directly harmed are defined as adverse events. Although adverse events occur most commonly in the context of biomedical research, adverse events can occur in the context of social and behavioral research. The term Unanticipated Problems is used to ensure that research teams identify events that may not encompass biomedical terms. ONLY unanticipated adverse events that are related to the research need to be reported to the IRB. Unanticipated problems are considered in general, to include any incident, experience, or outcome that meets all of the following criteria as stated in guidance provided by OHRP:

  1. unexpected (in terms of nature, severity, or frequency) in (a) the research procedures in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
  2. related or possibly related to participation in the research;

    Related means an event is related in the opinion of the investigator and/or/in conjunction with a faculty mentor, it was more likely than not to be caused by the research procedures or if it is more likely than not that the event affects the rights and welfare of the current participants.

    Possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research;

    and

  3. 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.

Examples of Unanticipated Problems to Be Reported

  • The loss of a digital storage device, such as laptops, smartphones, iPads, USB keys, etc. with stored identifiable research data.
  • Incarceration of a participant in a research study that has not been approved or reviewed to include prisoners.
  • Change to a protocol taken without prior IRB review to eliminate apparent immediate harm/hazard to a research participant.
  • Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team.
  • Protocol violation (meaning an accidental or unintentional change to the IRB approved protocol) that harmed participants or others; or that indicates participants or others may be at an increased risk of harm and affects the integrity of the research.
  • Adverse events which pose risk to subjects (which include serious adverse events such as death; dismemberment; permanent disability, etc. and in the opinion of the Investigator and/or in conjunction with the Faculty Mentor/Dissertation Chair are both unexpected and related or possibly related to the research.
  • An unexpected event related to the research that exposes individuals other than the research subjects (e.g. investigators, research assistants, students, the public, etc.) to potential risk.
  • If the project is sponsored, an event that requires prompt reporting to the sponsor.
  • If the sponsor imposes a suspension on the study due to risk.
  • If the Investigator/Faculty Mentor determines that an adverse event is not an unanticipated problem but is later notified by the sponsor/research monitoring entity that they have determined the event to be an unanticipated problem, the Investigator must promptly report the event to the Human Research Compliance Manager (HRCM).

The HRCM must be notified of the event as soon as it occurs via e-mail (dicciann@fdu.edu). A written report (see Unanticipated Problems and Reportable Events Form) summarizing the event must be submitted within 24 hours of the event via e-mail to dicciann@fdu.edu. At the discretion of the HRCM and/or in conjunction with the Grants and Sponsored Projects Executive Director, if additional review is necessary, the HRCM will forward the event report to the IRB Chair, Vice Chair and/or member(s) of the IRB with appropriate expertise to review the event. Updated information on the status of the event occurrence and if applicable, the participant/participants harmed, must be provided to the HRCM by the Investigator/Faculty Mentors within five (5) business days of the occurrence of the event. Any additional information that the Principal Investigator receives on the event and/or resolution of the event, must be provided within ten (10) business days of the event. If the event has not been resolved within ten business days, the Principal Investigator and/or if applicable, Faculty Mentor must keep the HRCM apprised until the event is resolved.

Unanticipated problems/adverse events where the risk is more than minimal, will be reviewed at a convened IRB meeting.

If the IRB considers the event to be an unanticipated problem, the IRB will consider the following actions:

  • Require modifications to the project, consent form language changes/process.
  • Providing additional information to the current/past participants.
  • Requiring current participants to be re-consented.
  • Alteration to the frequency of the continuing review.
  • Requiring additional training of the Investigator and/or the study staff.
  • Termination or suspension of the research.
  • Referral for action to other organization entities such as Risk Management, General Counsel, Institutional Official, etc.
  • Other actions appropriate to the local context of the situation.

All determinations and any/all requirements for continuing, placing on hold or stopping the research will be reported to the primary investigator in writing.

All incidents, experiences, or outcomes determined to be unanticipated problems involving risk to subjects or others will be reported to the Executive Director for Research and Grants, Sponsored Projects, the Chair of the School of the research study project, Department Director (if applicable) and the Institutional Official within 1 month. The HRCM and IRB Chair are responsible for the reporting of events, incidents, or outcomes to OHRP, if the project is federally funded, and, if applicable, the supporting HHS agency head (or designee). For multicenter studies only events occurring at the FDU site will be reported by the HRCM and IRB Chair in conjunction with the Executive Director of Grants and Sponsored Projects and only if a central monitoring agency has not been designated for this purpose. The Institutional Official will be notified as well.

Reporting Instructions

  • Contact the Human Research Compliance Manager via e-mail at dicciann@fdu.edu.
  • Complete the Unanticipated Problems and Reportable Events form via e-mail as soon as the HRCM is notified of the event. This should be completed via e-mail within 24 hours.
  • Complete the form (link to the form, form attached to the e-mail) and ensure to append any additional information about the occurrence/event.
  • This form MUST be updated, if this event is not resolved or ongoing, as new information is obtained about the event.
  • Please ensure your research project documentation file includes a copy of all information including communication of the event, reports to the IRB, sponsor, and any other parties necessary to resolve this event.