Definitions

Definitions are from the January 2007 OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events, OHRP Guidance, http://www.hhs.gov/ohrp/policy/advevntguid.html.

What to Report to the IRB

Report any of the events listed below to the IRB within five (5) working days of the research staff having knowledge of the event. Reportable New Information must be submitted via the electronic system.

If you are unsure whether an event needs to be reported to the IRB or not, please contact your IRB coordinator for a consultation

1. Adverse events:  the term adverse event in general is used very broadly and includes any event meeting the following definition:
   • Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
2. Harm: Any harm experienced by a subject or other individual, which in the opinion of the investigator is unexpected and probably related to the research procedures. For Example: Serious adverse event (SAE) or unanticipated problem.

   • Serious Adverse Event (SAE):

     • Any adverse event that:
       • Results in death
       • Is life threatening, or places the participant at immediate risk of death from the event as it occurred
       • Requires or prolongs hospitalization
       • Causes persistent or significant disability or incapacity
       • Results in congenital anomalies or birth defects
       • Is another condition which investigators judge to represent significant hazards

   • Unanticipated Problem (UP):

   • Defined by DHHS 45 CFR part 46 as any incident, experience, or outcome that meets all of the following criteria:
     • unexpected, 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 study population;
     • 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);
     • suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
3. Risk: Information that indicates a new or increased risk or a new safety issue. For example: safety monitoring report, drug or device changes, interim analysis, or investigator finding.

4. Un-reviewed change: Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.

Report any of the events listed below to the IRB within ten (10) working days of the research staff having knowledge of the event. Reportable New Information must be submitted via the electronic system.

1. Non-compliance: Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance.
2. Audit: Audit, inspection, or inquiry by a federal agency or government agency.
3. Report: Written reports of study monitors.
4. Deviation (researcher error): Failure to follow the protocol due to the action or inaction of the investigator or research staff.
5. Confidentiality: Breach of confidentiality.
6. Incarceration: Incarceration of a subject in a study not approved by the IRB to involve prisoners.
7. Complaint: Complaint about a subject that cannot be resolved by the research team.
8. Suspension: Premature suspension or termination of the research by the sponsor, investigator, or institution.

The Office for Human Research Protections (OHRP) recognizes that it may be difficult to determine whether a particular incident, experience, or outcome is unexpected and whether it is related or possibly related to participation in the research.  OHRP notes that an incident, experience, or outcome that meets the three criteria above generally will warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others. Examples of corrective actions or substantive changes that might need to be considered in response to an unanticipated problem include: 

• changes to the research protocol initiated by the investigator prior to obtaining IRB approval to eliminate apparent immediate hazards to subjects;
• modification of inclusion or exclusion criteria to mitigate the newly identified risks;
• implementation of additional procedures for monitoring subjects;
• suspension of enrollment of new subjects;
• suspension of research procedures in currently enrolled subjects;
• modification of informed consent documents to include a description of newly recognized risks; and
• provision of additional information about newly recognized risks to previously enrolled subjects.

There are other types of incidents, experiences, and outcomes that occur during the conduct of human subjects research that represent unanticipated problems but are not considered adverse events.  For example, some unanticipated problems involve social or economic harm instead of the physical or psychological harm associated with adverse events.  In other cases, unanticipated problems place subjects or others at increased risk of harm, but no harm occurs.

Reporting New Information to the IRB

All reporting for new information, complaints and or concerns can be sent to the below contacts:

email: tamuk.irb@tamuk.edu

Phone: 361-593-2677

Phone: 361-593-4764

Ethics Point web reporting or phone number