Reportable Event Definitions

Definitions

Adverse Event: An unfavorable medical occurrence, which may include abnormal signs (for example, abnormal physical exam or laboratory finding), symptoms, or disease, temporally associated with, but not necessarily considered related to, the subject’s participation in the research study.   Not all Adverse Events meet IRB reporting requirements.

Continuing Non-compliance: Non-compliance that has been previously reported or a pattern of ongoing Non-compliance that, in the judgment of the IRB, significantly adversely affects the safety, rights or welfare of human research subjects or significantly compromises the quality or integrity of the research data (i.e., negatively impacts the ability to draw conclusions from the study data).

External Adverse Event: An Adverse Event that occurs at a site external to the authority of the University IRB and is reported to the University or UPMC investigator.

Internal Adverse Event: An Adverse Event that occurs at a site that falls directly under the authority of the University IRB.

Non-compliance: Failure on the part of the Principal Investigator or any member of the study team to follow the terms of IRB approved protocol or to abide by applicable laws or regulations, or HRP policies. This includes protocol deviations. 

Incidents of Non-compliance on the part of research participants which do not meet the definition of Serious or Continuing Non-compliance do not need to be reported to the IRB.

Possibly Related to the Research Intervention:  In the opinion of the Principal Investigator, there is a reasonable possibility that the incident, experience, new information or outcome may have been caused by the procedures involved in the research. 

Probably Related to the Research Intervention:  In the opinion of the Principal Investigator, the incident, experience, new information or outcome more likely than not was caused by the procedures involved in the research.

Serious Non-compliance:   Non-compliance that, in the judgment of the IRB, significantly adversely affects the safety, rights or welfare of human research subjects, or significantly compromises the quality or integrity of the research data (i.e., negatively impacts the ability to draw conclusions from the study data). Examples of Non-compliance that are considered to meet the definition of Serious Non-compliance include, but are not limited to:

1. Performing non-exempt human subject research without obtaining prospective IRB approval.
2. Implementing substantial modifications to a research study without obtaining prospective IRB approval.
3. Failing to obtain research subjects’ informed consent as required by the IRB approved study application.
4. Failing to adhere to IRB-approved study application where subject safety or the quality or integrity of the research data may be significantly and negatively impacted.   
5. Failing to comply with federal, state, or local regulations governing human subject protections (this includes activities of the IRB and/or HRP staff).

Unanticipated: Unforeseeable at the time of its occurrence. 

Unanticipated Problem Involving Risk to Human Subjects or Others: Any accident, experience, new information or outcome that meets all of the following criteria:

1. Unexpected in terms of nature, severity, or frequency;
2. Related, or possibly related, to a subject’s participation in the research;
3. Places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Unanticipated Adverse Device Effect: Any serious adverse effect on health or safety, life-threatening problem, or death cause by, or associated with, a device that was not previously identified in nature, severity or frequency 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. 

Unexpected Adverse Event: An Adverse Event that was not previously identified in nature, severity, or frequency in the investigator’s brochure, sponsor protocol or current IRB-approved research protocol or informed consent document, taking into account the characteristics of the subject population being studied.

Management and Reporting of Unanticipated Problems Involving Risks to Human Subjects and Others and Reportable Non-compliance

It is the policy of the IRB to:

• Require the reporting of Adverse Events and Unanticipated Events that meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others.
• Require reporting of Non-compliance that meet the definition of Serious Non-compliance and/or Continuing Non-compliance. 
• Review reports of Reportable New Information and determine which constitute Serious Non-compliance, Continuing Non-compliance and/or an Unanticipated Problem Involving Risk to Human Subjects or Others
• Fulfill reporting requirements to the appropriate entities (institutional officials, federal departments, or agencies)

5/14/2021