During the course of a research study, Unanticipated Problems Involving Risk to Subjects or Others (UPIRSOs) and Non-compliance may occur and need to be reported to the IRB. The guidance contained here is intended to help ensure that the reporting and review of these events occur in a timely, meaningful way so that research participants can be protected from avoidable harms.
Who can submit Reportable New Information?
- Investigators are required to inform the IRB of the occurrence of the events below in non-exempt research studies.
- Study Team members may also submit reportable new information to the IRB. For example, a research coordinator might allege that an investigator is conducting research that was never submitted to the IRB.
- IRB staff may also initiate Reportable New Information submissions upon receipt of a complaint from the research community or a research participant.
- Non-compliance: Failure to follow the regulations, requirements and/or determinations of the IRB.
- Serious Non-compliance: Non-Compliance that adversely affects the rights or welfare of subjects.
- Continuing Non-compliance: A pattern of Non-Compliance that suggests the likelihood that, without intervention, instances of Non-Compliance will recur, a repeated unwillingness to comply, or a persistent lack of knowledge of how to comply.
- UPIRSO: Any information, including any incident, experience, or outcome that meets ALL of the following conditions:
- is unexpected (in terms of nature, severity, or frequency) given the procedures described in the research protocol documents (e.g., the IRB-approved research protocol and informed consent document) and the characteristics of the human subject population being studied;
- is related or possibly related to participation in the research ("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
- suggests that the research places human subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.
What must be reported to the IRB?
The following events are reported as a Reportable New Information and/or a Modification submission in eIRB+:
- Risk: Information that indicates a new or increased risk, or a safety issue. For example:
- New information (e.g., an interim analysis, safety monitoring report, publication in the literature, sponsor report, or investigator finding) indicates an increase in the frequency or magnitude of a previously known risk or uncovers a new risk.
- An investigator brochure, package insert, or device labeling is revised to indicate an increase in the frequency or magnitude of a previously known risk, or to describe a new risk.
- Withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol.
- Protocol violation that harmed subjects or others or that indicates subjects or others might be at increased risk of harm.
- Complaint of a subject that indicates subjects or others might be at increased risk of harm or at risk of a new harm.
- Any changes significantly affecting the conduct of the research.
- Harm/Death: Any harm (including death) experienced by an NU subject or other individual(s) that, in the opinion of the investigator, is unexpected and at least probably related to the research procedures.
- A harm is “unexpected” when its specificity or severity is inconsistent with risk information previously reviewed and approved by the IRB in terms of nature, severity, frequency, and characteristics of the study population.
- A harm is “probably related” to the research procedures if, in the opinion of the investigator, the research procedures more likely than not caused the harm.
- Non-compliance: Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB that causes harm, increases the risk of harm, adversely affects the rights or welfare of participants or undermines the scientific integrity of the data, or an allegation of such non-compliance.
- Audit: Audit, inspection, or inquiry by a federal agency and any resulting reports (e.g., FDA Form 483)
- Reports: Only certain written reports of study monitors must be reported. Prompt reporting (within 5 days) is required for monitoring reports for which the industry sponsor determines the findings could affect the safety of participants or influence the conduct of the study.
- Researcher Error: Failure to follow the protocol due to the action or inaction of the investigator or research staff.
- Confidentiality: Breach of confidentiality.
- Unreviewed Change: Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
- Incarceration: Incarceration of a subject in a study not approved by the IRB to involve prisoners.
- Complaint: Complaint of a subject that cannot be resolved by the research team.
- Suspension: Premature suspension or termination of the research by the sponsor, investigator, or institution.
- Unanticipated Adverse Device Effect: 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 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.
Information that does not fit into one of the categories above does not need to be submitted.