Issues that Must be Reported to the IBC

All issues reported to the IBC will be acknowledged by email, with any further follow-up noted, if known.

Adverse Events

An adverse event is defined by NIH as any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.

Any faculty member who is part of an approved IBC proposal is responsible for reporting an adverse event that has not yet been reported. Written notification must be promptly sent to both the IBC email (ibc@up.edu) and the Environmental Health and Safety Officer’s email (ehs@up.edu) summarizing the adverse event. Adverse events must be reported within 24 hours of occurrence.

Adverse events may result in required modifications, suspension, or termination of the IBC approved protocol.

Serious Adverse Events

Serious Adverse Event (SAE) are defined by the NIH as any adverse event that:

• Results in death;
• Is life threatening, or places the participant at immediate risk of death from the event as it occurred;
• Requires or prolongs hospitalization;
• Causes persistent or significant disability or incapacity;
• Is another condition which investigators judge to represent significant hazards.

Serious Adverse Events must be reported to Campus Safety by telephone (503.943.4444) immediately following occurrence and must be reported to the IBC email (ibc@up.edu), Environmental Health and Safety Officer (ehs@up.edu), and the Office of the Provost (provost@up.edu) via email within eight hours of occurrence. If a Serious Adverse Event occurs, research under the IBC protocol must be suspended until revised protocols are developed and approved by the IBC.

Eliminating an Immediate Hazard

Any immediate hazards that present a threat to life or physical safety, such as those that could result in a serious adverse event, should be immediately reported to Environmental Health & Safety (ehs@up.edu) and Campus Safety (503.943.4444). Research personnel must coordinate with Environmental Health and Safety to work with appropriate campus and emergency services personnel. The IBC must be notified of the hazard in writing, within 24 hours. Written notification must be sent to the IBC email ibc@up.edu                                                          

Unanticipated Problems

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

• Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the IBC approved protocol and informed consent document.
• Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).
• Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Every member of the research team is responsible for reporting an unanticipated problem not previously addressed in the research proposal. Written notification must be promptly sent to both the IBC email (ibc@up.edu) and Environmental Health and Safety (ehs@up.edu) summarizing the unanticipated problem.

Unanticipated problems with a study may result in required modifications, suspension, or termination of the IBC approved protocol.

Noncompliance

Noncompliance is defined as failure to adhere to UP IBC policy and NIH policy as well as the protocols outlined in the research personnel’s accepted research proposal. This includes failure to submit a yearly protocol review.

Failure to adhere to NIH and IBC regulations will be documented in IBC records. Serious or continuing noncompliance is reported to the Provost’s office, Environmental Health and Safety, and the academic supervisor. The third failure to follow UP IBC policy constitutes continuing noncompliance.

Noncompliance that results in harm to research personnel constitutes serious noncompliance. Three incidents of serious failures to adhere to the NIH and University’s IBC regulations, three incidents of continuing noncompliance, or a combination of three incidents of  serious and continuing noncompliance will result in prohibition from conducting research that would require IBC approval while a UP employee.

Prior failures to adhere to NIH and IBC policies will result in more frequent continuing review.

Every member of the research team is responsible for reporting when an IBC approved protocol is not  being followed. Written notification must be sent within 24 hours to both the IBC email (ibc@up.edu) and Environmental Health and Safety (ehs@up.edu) summarizing how the approved protocol is not being followed, or the individual can fill out the IBC Compliance Reporting Form.

When a noncompliance report is filed the Environmental Health and Safety Officer and Chair of the IBC work with appropriate campus personnel to address the safety concern.

Noncompliance Appeals

Researchers may appeal consequences for noncompliance by submitting a written appeal to the IBC and Provost. All appeals for noncompliance are presented to the Provost’s Council for review. The Provost will communicate, in writing, the decision of the Provost’s Council.