Reportable Problems

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. Others, in "research subjects or others," includes investigators, research staff, or other individuals affected by the research project.

In accord with that policy, the IRB has published a list of problems (below) that investigators must report to the IRB. The Principal Investigator must report the problems listed to the IRB within the timeframes indicated. The IRB may request further information as necessary and will determine whether any research project that has been associated with unexpected serious harm to the participants must be terminated.

Investigators are responsible for meeting all reporting requirements that apply to their projects. For example, investigators have reporting responsibilities to sponsors of FDA-regulated research. Investigators serving as sponsors of FDA-regulated research have additional reporting responsibilities (see FDA-Regulated Research).

Investigator Reports to the IRB

Adverse events and safety reports that require prompt reporting should be submitted to the IRB using the Problem Report form. If the event being reported leads to a change in the informed consent document, see "Changes in the Informed Consent Document" in Revisions & Amendments.

Within 5 Working Days

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

• Any changes to the protocol that were taken to eliminate an apparent hazard to a participant in an emergency.
• Any deviations from the investigational plan for an investigational device taken to protect the life or physical well-being of a participant in an emergency.
• Any emergency use of an FDA-regulated test article or Humanitarian Use Device prior to IRB approval.

Within 10 Working Days

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

• Any adverse event occurring at a performance site under UAB IRB oversight that, 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 the 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 enrolled 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 (i.e., 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

Along with the Investigator's Progress Report and other materials described in the section on Continuing Review & Approval, the investigator must report to the IRB:

• Summary on the Problem Summary Sheet of all adverse events at performance sites under UAB IRB oversight.
• Summary on the Problem Summary Sheet of all problems reported to the UAB IRB, including serious adverse events.
• Safety monitoring or DSMB reports received from sponsor and not previously forwarded to the IRB, if any. The investigator will be notified in writing if the IRB requires that all such reports be submitted for continuing review.

IRB & Institutional Reporting

If the IRB determines that a reported event constitutes an unanticipated problem that alters the risk of the research, it promptly reports its determination and actions to the investigator and the Institutional Official. The Institutional Official, in turn, is responsible for promptly reporting the IRB findings to the sponsor and applicable federal agencies.

Definitions Related to Research-Related Problems

The "correct" terminology for an event can vary because different agencies use different terms. For example, a "serious adverse drug experience" under FDA regulations may or may not be an "unanticipated problem involving risks to subjects or others" under DHHS regulations. To help investigators plan their strategies for reporting, this section defines these terms in relation to UAB requirements. Unanticipated problems involving risks to research subjects or others includes any incident, experience, or outcome that meets all of the criteria below:

1. Is unexpected in terms of nature, severity, or frequency given
   1. the research procedures that are described in the protocol-related documents, such as the IRB-approved Human Subjects Protocol and informed consent documents; and
   2. the characteristics of the subject population being studied; and
2. Is 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
3. 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 (includes serious adverse drug or biological experience and unanticipated adverse device experiences under FDA regulations) 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/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 include allergic bronchospasm requiring intensive treatment in the emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, and the development of drug dependency or drug abuse.

Forms

• Problem Report
• Problem Summary Sheet