Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB- POL006   

DEFINITIONS

Unanticipated problems involving risks to subjects or others includes any incident, experience, or outcome that is:

• 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 documents; and (b) the characteristics of the subject population being studied;
• Related or possibly related to participation in the research (possibly related means there is some likelihood in the judgment of a reasonable investigator 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.

Adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory findings), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subjects’ participation in research. Adverse events encompass both physical and psychological harms.

Serious adverse event is any adverse event temporally associated with the subject's participation in research that meets any of the following criteria:

• Results in death.
• 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 or birth defect.
• 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 (examples of such events include allergic bronchospasm requiring intensive treatment in the emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse).

This definition includes serious adverse drug or biological experience and unanticipated adverse device experiences under FDA regulations.

POLICY STATEMENT

UAB policy requires that unanticipated problems involving risks to research subjects or others be promptly reported to the IRB, the Institutional Official, the sponsor, and appropriate federal agencies. The term “others” includes investigators, research staff, or other individuals affected by the research project. Some adverse events will qualify as “unanticipated problems.” Only the IRB can determine whether a problem including an adverse event will qualify as an unanticipated problem. Therefore, the Principal Investigator will report to the IRB any problems listed in Attachment A to this policy as soon as possible but in all cases within the time frame listed in Attachment A.

The IRB and OIRB will develop procedures to receive and evaluate the information it requires in a timely fashion. Whenever the IRB determines an unanticipated problem alters the risk of the research, it shall report promptly its determination and actions to the principal investigator and the Institutional Official. The Institutional Official is responsible for promptly reporting the IRB findings to the sponsor and applicable federal agencies. (See also PRO106 Procedure to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others.)

ATTACHMENT TO POL006:  LIST OF PROBLEMS INVESTIGATORS MUST REPORT TO THE IRB AND ENSURE RESEARCH STAFF ARE FOLLOWING THE REPORTING REQUIREMENTS

As soon as possible but in all cases within 5 working days, the Principal Investigator must report to the IRB:

• Any changes to the protocol that were taken to eliminate apparent hazards to a research participant.
• Any deviations from the investigational plan of an investigational device investigation to protect the life or physical well-being of a subject in an emergency.
• Any emergency use of an FDA regulated test article or Humanitarian Use Device prior to IRB approval.
• Any serious adverse event, related or possible related to the research regardless of whether the event occurred at a UAB performance site or non-UAB site.

As soon as possible but in all cases within 10 working days the Principal Investigator must report to the IRB:

• Any adverse event occurring at a performance site under UAB IRB oversight which in the opinion of the principal investigator is both unexpected and related or possibly related to the research.
• Information that indicates a change to the risks or potential benefits of the research. For example:
  • An interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different from those initially presented to the IRB.
  • A paper is published from another study that shows the risks or potential benefits of your research might be different from those initially presented to the IRB.
• A breach of confidentiality.
• Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol.
• Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research subject.
• Incarceration of a subject in a protocol not approved to enroll prisoners.
• Event that requires prompt reporting to the sponsor.
• Sponsor imposed suspension for risk.
• Complaint of a subject when the complaint indicates unexpected risks or cannot be resolved by the research team.
• Protocol violation (meaning an accidental or unintentional change to the IRB approved protocol) that harmed subjects or others or that indicates subjects or others may be at increased risk of harm.
• Safety monitoring reports and DSMB reports from the Sponsor.

At the time of continuing review the Principal Investigator must report to the IRB the following:

• Summary of all adverse events at performance sites under UAB IRB oversight;
• Summary of all reported problems to the UAB IRB including serious adverse events;
• Most current safety monitoring or DSMB report from Sponsor, if any.