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Reporting Adverse Events, Complications or Complaints

All investigators conducting research with human subjects are required to report adverse events to the IRB in a timely fashion. For this purpose, adverse events are defined by IRB as "an undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy)." In non-medical research an adverse event can consist of an undesirable and unintended consequence of, or reaction to, procedures. In either case, if new information becomes available, as a result of an adverse event, the investigator is required to submit the new information for Committee review for possible inclusion in the consent form or additional deliberation by the IRB.

UCLA MEDICAL INSTITUTIONAL REVIEW BOARD POLICY FOR REPORTING BIOMEDICAL ADVERSE EVENTS

UCLA investigators who conduct human subject research are required to report adverse events to the UCLA Institutional Review Board (IRB).[1]  The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) require that institutions have “written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and federal departments or agencies, any unanticipated problems involving risks to subjects or others”.[2]

The IRB relies on the expertise of the UCLA investigator to make an assessment and to determine the relationship of the adverse event to the research activity (drug/device/procedure) and whether the event warrants a change to the protocol to minimize risks and/or the informed consent form to better inform subjects of the potential risks and procedures to minimize such risks.  Therefore, the reporting of adverse events is based upon the investigator’s assessment and whether the event involves a UCLA subject (Internal Adverse Event/Form HS-5) or a non-UCLA subject (External Adverse Event/Form HS-6). 

INTERNAL ADVERSE EVENTS

Reporting Requirements

An Internal adverse event is an event that occurs in a UCLA subject.  An adverse event that meets any of the following criteria must be reported to the IRB using the Form HS-5:

• The event is Serious or Unexpected, and Related to the research activity.

• If the event is Related, Expected or not Serious but in the opinion of the investigator the protocol and/or informed consent form requires modification.  Examples: identification of a “new trend” (adverse event occurring with greater frequency than anticipated) or a change in the risk/benefit ratio.

• All deaths regardless of relationship to the research activity.  For deaths that occur in drug studies, report any death that occurs within 30 days of the last dose of study drug administered to the subject.

Timeline for Reporting

• All deaths and life-threatening events must be reported within 2 working days after discovery. 
• Events that require protocol or informed consent form modification must be reported within 10 working days after discovery.
• All other events must be reported within 10 working days after discovery.

EXTERNAL ADVERSE EVENTS

An External adverse event is an event that occurs in a non-UCLA subject and is reported to the UCLA research team.  The most common example of an External adverse event is sponsor provided safety reports (i.e. MedWatch, IND Safety report).  An external event that meets any of the following criteria must be reported to the IRB:

• The event is Serious and Unexpected and Related to the research activity.

• For the same study conducted at UCLA, submit the event report using the Form HS-6 regardless of whether a change to the protocol and/or informed consent form is warranted.

• For a study not conducted at UCLA, submit only those event reports that require a change to your protocol and/or informed consent form.

• Events that require a protocol or informed consent form modification must be reported within 10 working days upon receipt from the study sponsor.

• All other events must be reported within 10 working days upon receipt from the study sponsor.

HOW TO SUBMIT AN ADVERSE EVENT FORM

• Use of the UCLA Adverse Event Report form is required (for Internal events use the HS-5 form, External events the HS-6 form). 

• Report one event per form. 

• Do not submit multiple safety reports (external events) on a single Adverse Event Report form.

• Incomplete forms will be returned to the investigator for completion.

• Attach pertinent supporting documents (i.e. MedWatch report, IND Safety report, hospitalization summary) to the HS-5 or HS-6 form.

• Provide a brief description/summary of the adverse event.  A reference to any attached documents (i.e. “see attached sponsor safety report”) does not replace the investigator’s description/summary and assessment.

PLEASE NOTE:  There are situations where a serious or unexpected adverse event requires an immediate change to a protocol in order to eliminate apparent immediate hazards to research subjects.  In these situations, the principal investigator may immediately implement a protocol change necessary to protect the welfare of the research subjects without an IRB approved amendment.  Investigators are required to notify the IRB in writing of the change, within 3 working days, and include a written description of the change and events which necessitated immediate implementation.  The investigator must indicate in the report whether a change to the protocol and/or informed consent is necessary.[3]

DEFINITIONS

• Adverse event: an undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention.[4]
• Serious adverse event: any event that may result in the following - death, a life threatening experience, a required or prolonged hospitalization, persistent or significant disability, congenital anomaly/birth defect and any event requiring intervention to prevent one of the outcomes previously listed.[5]
• Unexpected adverse event: an event when the specificity or severity is not consistent with the investigator brochure or general investigative plan.[6]
• Related adverse event: when there is a reasonable possibility that the adverse event is caused by the research activity (drug/device/procedure).[7]

Audits

The HSPC, the FDA, the OPRR, and the sponsor of a research activity, are empowered to conduct periodic random audits of an investigator’s protocol records. Investigators are required to keep copies of signed Consent Forms readily accessible for review. Since members of the OPRS are familiar with current regulations, their presence during an audit may help prevent unnecessary confusion during the auditing process.