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Human Subjects Research

Policy for Reporting Adverse Events and Unanticipated Problems

An adverse event is defined as: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (the event can be physical and/or psychological)

An unanticipated problem is defined as any incident, experience, or outcome that meets all three of the following criteria:

  1. Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents and the characteristics of the subject population being studied
  2. Related or possibly related to participation in the research (there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research)
  3. Suggests that the research places subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized

The primary investigator of research approved for the use of human subjects is responsible for reporting any adverse events or unanticipated problems to the Office of Research Compliance (753-8588, researchcompliance@niu.edu) as soon as possible, but no later than 7 days after first becoming aware of the problem. The principal investigator must independently begin initiation of any measures necessary to ensure subject safety while preparing and submitting the required reports.

The report must contain sufficient information for the IRB to make an assessment of risk. The IRB may request additional information from the PI, which should be provided within one business week, or sooner if specified by the IRB.

Event reports will be reviewed by one or more IRB members, typically the Chair or Vice-Chair or member designated by the Chair. Upon receiving a report of an unanticipated problem or adverse event, the IRB reviewer(s) may take one or more of the following actions:

  1. Acknowledge the report, with no changes to the informed consent and/or protocol necessary
  2. Request additional information
  3. Request changes to the informed consent and/or protocol in response to the report
  4. Approve changes to the informed consent and/or protocol submitted by the PI in response to the report as long as these modifications are minor changes.
  5. Refer the report to the next convened IRB meeting
  6. The research study may be temporarily suspended and/or the research study procedures discontinued/terminated. The IRB has the authority to suspend or terminate its approval of a study. When practical, such action will be taken by vote of the members at a convened IRB meeting. In the case of an emergency, in order to protect the safety of the study subject(s) the IRB Chair or a Vice-Chair may suspend enrollment and/or any portion of a study without waiting for a convened meeting of the IRB; however, the Chair or a Vice-Chair may not terminate the study. In such cases, the IRB Chair (or Vice-Chair, as appropriate) will notify the IRB members of the suspension at the next regularly scheduled meetings of the IRB.

A suspension/termination may be appropriate for any of the following reasons:

  1. Unexpected death or serious harm to a study subject.
  2. Unanticipated problems involving serious harm or risk of serious harm to a study subject, such as known or suspected contamination of a study drug.
  3. Failure of the Principal Investigator to provide information requested by the IRB.
  4. Known or potential non-compliance of the Principal Investigator and/or a research team member with human subject regulations or the requirements or determinations of the IRB.
  5. Other circumstances that, in the judgment of the IRB, the IRB Chair, or a Vice-Chair necessitate suspension/termination to protect study subjects from harm.

In all cases, in a timely manner the IRB Chair or Vice-Chair will inform the Principal Investigator in writing of the suspension/termination. The letter to the Principal Investigator must state the reason for the suspension/termination. In cases of immediate, significant risk to human subjects, the IRB Chair or designee may communicate the suspension/termination orally while written materials are prepared. In the case of a suspension, the letter is to specify whether the suspension applies only to the enrollment of new subjects, or also requires the cessation of all study procedures on subjects who have already been enrolled.

In the case of a termination, no new subjects may be enrolled and all study activities involving enrolled subjects must cease. Exceptions may be made by the Chair or Vice-Chair in circumstances where subjects are receiving intervention that cannot be discontinued for safety reasons. These potential instances will be reviewed on a case-by-case basis. The IRB Chair or Vice-Chair will immediately notify the Institutional Officials and the Research Compliance Coordinator of the suspension or termination.