Events to be Reported

 

The following events must be promptly reported (within 10 days) using xForm 109 in IRBManager:

  • An unexpected harmful or unfavorable occurrence to participants or others that possibly relates to the research protocol (injuries, side events, psychological events, dosing errors)
  • A serious adverse event or problem that are unexpected and probably related to the research procedures, interventions, or treatment
  • An unforeseen development that potentially increases the likelihood of harm to subjects or others
  • Any new information that indicates a change to the risks, safety, or benefits of the research
  • Any deviation from the protocol taken without IRB approval to eliminate apparent immediate hazard to a research participant
  • Any problem reflecting a deficiency that substantially compromises the effectiveness of the institution’s human research protection or human research oversight programs


The following are examples of events that require prompt reporting:


  • A local subject death possibly related to the research.
  • Incarceration of a subject for research not previously approved to enroll prisoners.
  • Sponsor imposed suspension of research.
  • A publication from another study that shows the risks, or potential benefits, of your study may be different than what was initially considered by the IRB
  • A data and safety monitoring report that indicates the frequency or magnitude of harm or benefits may be different than what was initially considered by the IRB.
  • A black box warning (or VA PBM Safety Alert) for any drug or device used in your research study
  •  A problem involving data storage, privacy, or confidentiality.
  • An accidental or unintentional change to the IRB-approved procedures that increases the potential for harm to subjects or others.
  • For VA studies, the VA requires immediate reporting of the loss, unauthorized use, disclosure, transmission, removal, theft, or destruction of VA research-related PHI or confidential information stored on portable media such as laptops or personal computers.

For VA studies, the following apply to a local research death that is both unanticipated and related to the research:

VA personnel, including WOC and IPA appointees, must ensure oral notification of the Institutional Review Board (IRB) immediately upon becoming aware of any local research death that is both unanticipated and related to the research. The IRB must alert ORO by e-mail or telephone within 2 business days after receiving
such notification and provide relevant information as requested. The VA facility Director and the ACOS/R&D must receive concurrent notification.

VA personnel, including WOC and IPA appointees, must ensure written notification of the IRB within 5 business days of becoming aware of the death.

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