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 participant, or results in a loss of privacy and/or confidentiality to the research participant or others.

Investigators are encouraged to contact the IRB 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.

Link to Serious 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 the Office for the Protection of Human and Animal Subjects.

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 the IRB as soon as possible for the protection of the participant, 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 CSUEB 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 subjects 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 participants;. Significant adverse events must be reported to the IRB as soon as possible for the protection of the participant, but at least within 5 working days.
  • Minor: Minor adverse events should be reported to the IRB 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 the IRB as soon as possible for the protection of the participant, 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 the IRB in a timely manner.

Review of adverse events:

Adverse events are reviewed by the 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 Chair may: suspend or terminate the research immediately, or report his/her findings to the board for their input; or call an emergency meeting of the board to discuss the matter. If the IRB determines that the research participant may be placed at an immediate risk, the board may suspend or terminate approval of a protocol, requiring the immediate cessation of data collection from research participants. 

    The Adverse Event Report is sent to the Institutional Official (Associate Vice-President of Research and Sponsored Programs) with the board’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 the IRB 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 participant enrollment; inform enrolled participants of the adverse event; requirement for additional information to be provided to past and current participants; requirement that current participants re-consent to participation; monitoring of the research by the IRB; 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 for further action.

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

 

OHRP VIDEO - reviewing and reporting unanticipated problems and adverse events:

The U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP) has made available an educational video that discusses reviewing and reporting unanticipated problems and adverse events; it can be assessed at:  http://videocast.nih.gov/ram/ohrp_carome.ram 
(If a hyperlink does not work, paste the entire URL into your browser to access the video.) 

The video is approximately 20-25 minutes in length. An institution may reproduce or share these materials for educational purposes and may wish to consider incorporating the materials in their training programs.

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