When things go wrong: when and how to report an event to a UNF research integrity committee
After you have obtained IRB, IACUC and/or IBC approval for a research project, there is always a possibility problems will arise during study implementation that may need to be reported to the appropriate committee. Reporting can be done via the UNF research integrity unit within the Office of Research and Sponsored Programs. Depending on the type of project and the type of event, different information might be needed. Please see the information below to ensure you are up to date on both reporting requirements and procedures for submitting a report if necessary.
Adverse Event - this is a broad term for any unfavorable occurrence in a human subject, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom or disease, temporally associated with the subject’s participation in the research, whether considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms. Adverse events are not always reportable.
Unanticipated Problem Involving Risk- this includes any incident, experience or outcome that meets all of the following criteria:
- unanticipated (in terms of nature, severity or frequency) given (a) the research procedures that are described 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;
- related or possibly related to participation in the research (in this guidance document, 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 subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.
An unanticipated problem involving risk is usually an adverse event. However, an adverse event may not be an unanticipated problem involving risk. To determine whether an adverse event is an unanticipated problem, the following questions should be asked:
- Is the adverse event unanticipated?
- Is the adverse event related or possibly related to participation in the research?
- Does the adverse event suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized?
If the answer to all three bulleted questions is yes, then the adverse event is an unanticipated problem and must be reported. If an investigator determines that an event represents an unanticipated problem involving risk, the investigator must report it promptly to the IRB (45 CFR 46.103(b)(5)) by utilizing the Event Report Form that can be found on the UNF IRB Website or within the Forms and Templates Library in IRBNet. Please complete an Event Report Form and submit it for review though IRBNet. If the project was submitted and approved prior to IRBNet, please submit the Event Report Form to firstname.lastname@example.org. All event reports should be submitted within three business days of the event. However, if the event is severe or pertains to risk, the report should be submitted immediately or as soon as practicable.
In addition to reporting any unanticipated problems involving risks to subjects or others, the regulations also require prompt reporting of any serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB. Noncompliance can take many forms. However, the most common examples are as follows:
- Conducting human subject research without prior review and approval by the IRB. Please see the UNF IRB Standard Operating Procedures for more information about which projects require IRB review and approval prior to implementation. See also federal regulations 45 CFR 46.103(b)(5)
- Protocol deviation - any exception or divergence from an approved protocol (including changes to approved documents) that is not approved by the IRB prior to initiation or implementation. Protocol deviation may be major or minor depending on the deviation and/or the nature of the study and study populations. If either a protocol deviation or protocol exception occurs without prior IRB review and approval, the principal investigator is responsible for completing section II of the Event Report Form and submitting a copy to the UNF IRB for review within three business days when unanticipated problems involving increased risks to participants takes place. Any other unanticipated problem shall be reported to the IRB within one week of the investigator becoming aware of the problem. If applicable, the principal investigator is also responsible for reporting protocol violations to the study sponsor, and/or FDA.
If you have questions about whether your proposed activities constitute research involving human subjects that must be reviewed by the UNF IRB or if you are concerned that your activities may be a protocol deviation or other noncompliance, please contact a research integrity administrator to discuss your project. You can do so by calling (904) 620-2455 or e-mailing email@example.com.
Please complete an IACUC event form in the case of a serious adverse event or protocol deviation. An adverse event is any occurrence that has a negative impact on animal welfare (e.g., pain, distress or death of an animal) when the possibility of this occurrence was either not described in the IACUC protocol or unexpected in terms of magnitude, frequency, or scope. An IACUC protocol deviation is any departure from methods approved in an IACUC protocol. In an emergency, please contact at UNF’s veterinarian immediately. Due to extenuating circumstances, the event report form is not currently available on the UNF IACUC website at this time. In the meantime, to receive a copy of the event reporting form, please contact a research integrity staff by calling (904) 620-2455 or e-mailing firstname.lastname@example.org.
The following examples of reportable situations were taken from the NIH Guidance on reporting:
conditions that jeopardize the health or well-being of animals, including natural disasters, accidents and mechanical failures, resulting in actual harm or death to animals;
- conduct of animal-related activities without appropriate IACUC review and approval;
- failure to adhere to IACUC-approved protocols;
- implementation of any significant change to IACUC-approved protocols without prior approval;
- conduct of animal-related activities beyond the expiration date established by the IACUC (note that a complete review under IV.C is required at least once every three years);
- conduct of official IACUC business requiring a quorum in the absence of a quorum;
- conduct of official IACUC business when the IACUC Committee is improperly constituted;
- failure to correct deficiencies identified during the semiannual evaluation in a timely manner;
- chronic failure to provide space for animals in accordance with recommendations of the Guide unless the IACUC has approved a protocol-specific deviation from the Guide based on written scientific justification;
- participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained as required by IV.C.1.f;
- failure to monitor animals post-procedurally as necessary to ensure well-being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures);
- failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry);
- failure to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO 2);
- failure of animal care and use personnel to carry out veterinary orders (e.g., treatments); or
- IACUC suspension or other institutional intervention that results in the temporary or permanent interruption of an activity due to noncompliance with the Policy, Animal Welfare Act, the Guide, or the institution's Animal Welfare Assurance.
Examples of situations not normally required to be reported:
- death of animals that have reached the end of their natural life spans;
- death or failures of neonates to thrive when husbandry and veterinary medical oversight of dams and litters was appropriate;
- animal death or illness from spontaneous disease when appropriate quarantine, preventive medical, surveillance, diagnostic and therapeutic procedures were in place and followed;
- animal death or injuries related to manipulations that fall within parameters described in the IACUC-approved protocol; or
- infrequent incidents of drowning or near-drowning of rodents in cages when it is determined that the cause was water valves jammed with bedding (frequent problems of this nature, however, must be reported promptly along with corrective plans and schedules).
In the event of a medical emergency, please first seek appropriate immediate medical attention. IBC researchers must promptly report any significant problems pertaining to operating and implementation of containment practices and procedures, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the UNF IBC, Biological Safety Officer and other appropriate authorities. In some cases, events must be reported to the Office of Biotechnology Activities (e.g., adverse event pertaining to human gene transfer trial).
If there has been an accident on campus, please report the event by completing the UNF Environmental Health and Safety Accident form. Please follow-up that report by contacting the UNF IBC Biological Safety Officer Brandon Smith by calling (904) 620-1172 or e-mailing Brandon.email@example.com. Safety hazards can be submitted by completing a safety hazard report form. If you have questions about whether an event requires reporting, please contact Brandon via one of the above listed methods.