Adverse Event Reporting Requirements
- Not expected or anticipated + Directly related to research + Event is serious = Immediate Reporting (within 10 days)
- Expected + Directly related to research + Event is serious = Report during Continuing Review
- Expected + Not related to the research + Event is serious = Report during Continuing Review
- Expected + Related to the research + Event is not serious = Report during Continuing Review
Research-Related Event Reporting Requirements
- Refer to the WVU SOPs to report events to WVU OHRP and other required entities.
- Report events using the protocol submission system.
- Events for multi-site research where WVU is not the IRB of record must be reported.
Please see the chart for more information.
*Please Note: Suspected Unexpected Serious Adverse Reaction (SUSAR) reports are not required to be submitted to the WVU IRB unless the event involves, or potentially involves, a subject enrolled in a clinical trial under the purview of WVU IRB.
Examples of events that do not require reporting to the WVU IRB:
- Adverse device effects that are non-serious, anticipated, or unrelated;
- Adverse events or injuries that are non-serious, expected, or unrelated;
- Deaths not attributed to the research (e.g., from natural causes, accidents, or underlying disease) as long as the researchers have ruled out any connection between the study procedure and participants' death;
- IND safety reports from external sites not involving WVU research;
- Subject complaints that were resolved or complaints not involving risks.
- From the Protocol Actions Tab in your kc protocol, Request an Action.
- In the Available Actions list, show Notify IRB
- Select the action you wish to submit from the Submission Type Qualifier drop down menu. And choose from the Submission Type Qualifier field.
- Download and complete the appropriate form.
- Uploaded the form in the Attachment field by using the browse button. Provide a description and click Add.
- Attach any other relevant documents.
Research Event Definitions
A pattern of repeated actions or omissions to act that suggest a future likelihood of reoccurrence and that indicate a deficiency in the ability or willingness to comply with federal regulations or the policy, requirements, and determinations of the IRB governing human subject research. These actions can also compromise the scientific integrity of a study such that important conclusions can no longer be reached, and can suggest a likelihood that non-compliance will continue without intervention, or involves frequent instances of minor non-compliance. Continuing non-compliance may also include failure to respond to a request from the IRB to resolve an episode of non-compliance or a pattern of minor non-compliance.
A protocol deviation or violation occurs when there is a variance in a research study between the protocol and the activities being performed. Protocol deviations and violations may be minor or major.
A deviation that in the opinion of the PI is required to eliminate an apparent immediate hazard to a research subject or group of subjects. The researcher should proceed with the changes are needed to protect the safety and welfare of the subjects and may do so without prior IRB review. Following the Emergency Exception, the PI must report the exception as soon as possible after the site investigator learns of the event, and in all cases, within 10 days of the deviation.
Minor Protocol Deviations
Reported at the time of Continuing Review
- The deviation has no substantive effect on the risks or benefits to the individual research subject, AND
- The deviation has no substantive effect on the value of the data collected, AND
- The deviation did not result from willful or knowing misconduct on the part of the PI.
- DSMB Reports, interim analyses, or other reports, findings, or new information not altering the risk/benefit ratio of the research;
- Brochure updates not involving safety information;
- Protocol deviations or violations unlikely to recur or not involving the possibility of risks to subjects (or others);
- Problems or findings not involving risk (unless the investigator or research staff member believes the information could affect participants' willingness to continue in the research.
Major Protocol Deviations or Violations
Reported to the IRB as soon as possible after the site investigator learns of the event, and in all cases, within 10 days.
- The deviation has harmed or posed a significant risk of substantive harm to the individual research subject and increased the risk/benefit ratio, OR
- The deviation has compromised the scientific integrity of the data collected for the study, OR
- There is evidence of willful or knowing misconduct on the part of the investigator(s) or study staff, OR
- The investigator(s) or study staff demonstrated other serious or continuing noncompliance with federal, state or local research regulations.
- Adverse device effects that are serious, unanticipated, and related;
- Adverse events or injuries that are serious, unexpected, and related;
- Breaches of confidentiality involving potential risks;
- Data and Safety Monitoring Board (DSMB) reports, interim analyses, or other oversight committee/monitoring reports altering the risk/benefit profile;
- Events requiring reporting according to the protocol, sponsor, or funding agency;
- New information indicating an unexpected change in risks or potential benefits (e.g., literature/scientific reports or other published findings);
- Protocol deviations, violations, or other accidental or unintentional changes to the protocol or procedures possibly involving risks or with the potential to recur, even if no harm has actually occurred;
- Subject complaints indicating an unanticipated risk, or complaints that cannot be resolved by the research staff (see SOP 032: Complaints and Concerns);
- Unapproved changes made to the research to eliminate an apparent immediate hazard to the subject;
- Audit findings, inquiry, or written report by a federal agency (e.g., FDA Form 483);
- Suspension by the sponsor, investigator, institutional entity; or
- Other problems or findings (e.g., loss of study data or forms, a subject becomes a prisoner while participating in the research, etc.) that a researcher or research staff member believes could influence the safe conduct of the research.
An enrollment exception (waiver) is the sponsor’s prospective approval for the enrollment of a research subject that fails to meet currently approved protocol inclusion criteria, or falls under protocol exclusion criteria. Enrollment exceptions only apply to a single individual. Such requests should be rare and justified in terms of serving the best interests of the potential study participant and must be reported to the WVU IRB three working days in advance.
Any action or activity associated with the conduct or oversight of research involving human participants that fails to comply with either the research plan as approved by a designated IRB, or federal regulations or institutional policies governing human subject research. Non-compliance may be minor or sporadic or it may be serious or continuing. Note: Once a finding of non- compliance is proven, it must be categorized as serious, non-serious, or continuing.
Non-significant Risk Device (NSR)
An investigational device that does not pose a significant risk to human subjects.
An intentional or planned deviation from the protocol that should be considered justified in terms of serving in the best interest of the study subject. This type of exception (waiver) must be reported to the WVU IRB three working days in advance.
An event is related to a research procedures, if 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 current participants.
An event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
Serious Adverse Event
Any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria:
Following the Emergency Exception, the PI must report the exception to the WVU IRB within 10 days of the serious adverse event.
- results in death;
- is life-threatening (places the subject at immediate risk of death from the event as it occurred);
- is life-threatening (places the subject at immediate risk of death from the event as it occurred);
- requires inpatient hospitalization or prolongation of existing hospitalization;
- results in a persistent or significant disability/incapacity;
- results in a congenital anomaly/birth defect; or
- any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Failure to follow federal regulations and WVU HRPP SOPs or failure to follow the determinations of the WVU IRB and which, in the judgment of either the WVU IRB Chair or the convened IRB, increases risks to participants, decreases potential benefits, or compromises the integrity of the WVU Research Office. Research being conducted without prior IRB approval or participation of subjects in research activities without their prior consent (in studies where consent was not waived by the IRB) is considered serious noncompliance. A single instance of non-compliance may be determined by the WVU IRB to be serious non-compliance.
Significant Risk Device (SR Device)
Significant risk device is an investigational device that:
- is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
- is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject;
- is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
- otherwise presents a potential for serious risk to a subject.
Unanticipated Adverse Device Effect (UADE)
For studies of medical devices, the investigational device exemption regulations define an unanticipated adverse device effect as “any serious 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” (21 CFR 812.3(s)). UADE reporting applies to both significant and non-significant risk (NSR) device studies.
Unanticipated event is a broad term to include research related events that are unexpected.
Unanticipated Problems Involving Risk to Subjects or Others
An UPIRTSO is an unanticipated event involving risks to subjects or others, and includes any incident, experience, outcome, or new information that:
- Is unexpected or unanticipated at the time of its occurrence and is:
- Not previously described as a potential risk in the approved research protocol or consent document
- Not listed in the Investigator Brochure
- Not due to an underlying disease
- Occurring at an increased frequency or at an increased severity than expected
- Is related or possibly related to participation in the research, and
Indicates that subjects or others are at a greater risk of harm (including physical,
psychological, economic, or social harm) than was previously known or recognized.
Note: The event must meet all criteria to be considered a UPIRTSO.
The incident, experience or outcome is not expected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent documents; and the characteristics of the subject population being studied.