Reporting Adverse Events

An adverse event is an event that occurs during the course of the research protocol that causes or increases the risk of physical or psychological harm to the research volunteer, or results in a loss of privacy and/or confidentiality to the research volunteer or others.

Investigators are encouraged to contact HAP if they have a question about whether or not an adverse event requires a report. We will attempt to maintain confidentiality until a formal adverse event report is filed; however, we are required to follow-up on any indication that a serious or significant adverse event has occurred.

Serioues Adverse Event Report form in Word

Adverse events may be:

  • Anticipated: An adverse event that is reasonably expected in nature, severity, and frequency, and is included in the protocol and consent form as a possible risk of participating in the research
  • Unanticipated: An adverse event whose nature, severity, or frequency was not identified in the protocol and consent form as a possible risk of participating in the research.
  • Related: Only adverse events that are caused by or affect the study design or procedures of the research need to be reported to Human and Animal Protections.

Adverse events may be:

  • Serious: adverse events defined by 21 CFR 312.32, including death, a life-threatening adverse experience, hospitalization or prolongation of hospitalization, a persistent or significant disability or incapacity, or a congenital abnormality/birth defect. Serious adverse events must be reported to HAP as soon as possible for the protection of the research volunteer, but at least within 5 working days and may need to be reported to the federal Office for Human Research Protections (OHRP).
     
  • Significant: adverse events not specified by federal code; however, events that SFSU considers grave, requiring immediate attention. These would include e.g., a psychotic or schizophrenic break not requiring hospitalization; a suicide attempt that does not result in hospitalization; suicide threat; a serious breach of confidentiality or privacy of research volunteers or others by the researcher or focus group members that results in or could result in, e.g., deportation, arrest, expulsion, suspension, loss of job, loss of family support; loss of laptop with private, identifiable information about research volunteers. Significant adverse events must be reported to HAP as soon as possible for the protection of the volunteer, but at least within 5 working days.
     
  • Minor: Minor adverse events should be reported to HAP only if they result in a modification of the protocol to mitigate and/or detail this event.

Reporting adverse events:

  • Serious and Significant adverse events must be reported to HAP as soon as possible for the protection of the research volunteer, but within at least 5 working days using the Serious/Significant Adverse Event Report Form (Word). This form must be completed and signed by the Principal Investigator, although an electronic notification from the PI is acceptable with a signed, hard-copy follow-up. The report will include actions taken to mitigate the current adverse event and to avoid the adverse event in the future, if appropriate. A copy of the current informed consent document and any other supporting documentation must be included for review. This event will usually trigger a modification of the protocol and related documents. All resulting modifications to the protocol must be approved by the IRB.
     
  • Minor adverse events that require reporting should be reported on the Minor Adverse Event Report Form to HAP in a timely manner.

Review of adverse events:

Adverse events are reviewed by the Institutional Review Board (IRB) Chair to determine level and relatedness of the event. Possible consequences are listed below.

  • Serious/significant adverse event:
    If it is determined by the IRB Chair that the adverse event is related to the research and is serious or significant, the event is reported to the IRB. The IRB Chair may: suspend or terminate the research immediately, followed by IRB involvement; or report his/her findings at the next scheduled meeting of the IRB for their input; or call an emergency meeting of the IRB to discuss the matter. If the IRB determines that the research volunteer may be placed at an immediate risk, the IRB also has the authority to suspend or terminate approval of a protocol, requiring the immediate cessation of data collection from research volunteers.
    The Adverse Event Report is sent to the Institutional Official (Associate Vice-President of Research and Sponsored Programs) or the Dean of Graduate Studies for students with the IRB's acceptance or their recommendations for any action needed beyond the mitigation proposed by the researcher. Serious adverse events may need to be reported to OHRP, sponsors, and/or the FDA, as required. These reports must include the actions the institution is taking or plans to take.
  • Minor adverse event:
    Minor adverse events are reviewed by HAP to assure that protocol modifications are initiated, if necessary.

Possible outcomes following an adverse event:

  • Serious/significant adverse event:
    Possible actions that may be taken may include: acceptance of the mitigations proposed; revise the protocol; revise the informed consent; suspend research volunteer enrollment; inform enrolled research volunteers of the adverse event; requirement for additional information to be provided to past and current research volunteers; requirement that current research volunteers re-consent to participation; monitoring of the research by HAP; reduction of approval period to less than one year; suspension or termination of the research; confiscation of the data.
     
  • Minor adverse event:
    Continued occurrence of minor adverse events may trigger a report to the Institutional Official (or the Dean of Graduate Studies for students) for further action.

All investigators will be notified in writing of all actions that the committee, the IRB Chair, and/or HAP have taken.