IRB Incident Report - University of Western States

All incidents of injury or other adverse events experienced by the participant must be reported by the principal investigator to the Institutional Review Board within 48 hours after the event.

Section A: General Information

Project title:(Required)

Principal investigator (PI):(Required)

Email:(Required)

Co-principal investigator(s):

Co-investigator(s):

Other key personnel:

Section B: Incident Information

Name(s) of individuals involved:(Required)

Location of incident:(Required)

Date(s) of incident:(Required)

Incident involved:(Required)

Treatment

Procedure

Other

Severity of incident:(Required)

Please first review the Explanations of Type of Incident/Adverse Event page to determine the answer to this question.

Mild

Moderate

Severe

Serious

Was the incident expected or unexpected?(Required)

Please first review the Explanations of Type of Incident/Adverse Event page to determine the answer to this question.

Expected

Unexpected

Relatedness of Event to Research Participation(Required)

Unrelated

Unlikely

Possible

Probable

Definite

Describe the incident in detail:(Required)

Was the incident an anticipated risk described in the IRB application of informed consent documents?(Required)

Yes

In your judgement, was the event caused/related by the procedures stated in the protocol?(Required)

Not related

Possibly related

Not enough information available to make a judgement

If “related” or “possibly related” to the research, explain what procedures are in place to minimize the risk of this event.(Required)

Section C: Incident Information

Please provide any additional information related to this incident that may be helpful.(Required)

Gather all appropriate signatures.

Upon receipt and approval of the IRB Incident Report Form, you and any other members of your study team will receive a request via SignNow to confirm the details within the form.

1. Mild Expected

▪ Transient of minimal symptoms

▪ No change in activity level

▪ No therapy, or only symptomatic therapy, required

2. Mild Unexpected

▪ Transient of minimal symptoms

▪ No change in activity level

▪ No therapy, or only symptomatic therapy, required

Relatedness of Event to Research Participation

Unrelated (A)

Unlikely (B)

Possible (C)

Probable (D)

Definite (E)

3. Moderate Expected

▪ Symptomatic

▪ Moderate change in activity level

▪ Specific therapy required

Relatedness of Event to Research Participation

Unrelated (A)

Unlikely (B)

Possible (C)

Probable (D)

Definite (E)

4. Moderate Unexpected

▪ Symptomatic

▪ Moderate change in activity level

▪ Specific therapy required

Relatedness of Event to Research Participation

Unrelated (A)

Unlikely (B)

Possible (C)

Probable (D)

Definite (E)

5. Severe Expected

▪ Incapacitating = >24 hours of any of the following:

▪ Loss of work

▪ Bed rest

▪ Decreased social activities

Relatedness of Event to Research Participation

Unrelated (A)

Unlikely (B)

Possible (C)

Probable (D)

Definite (E)

6. Severe Unexpected

▪ Incapacitating = >24 hours of any of the following:

▪ Loss of work

▪ Bed rest

▪ Decreased social activities

Relatedness of Event to Research Participation

Unrelated (A)

Unlikely (B)

Possible (C)

Probable (D)

Definite (E)

7. Serious Expected

▪ Life threatening or results in death

▪ Requires in-patient hospitalization

▪ Results in persistent or significant disability

▪ Congenital anomaly or birth defect

Relatedness of Event to Research Participation

Unrelated (A)

Unlikely (B)

Possible (C)

Probable (D)

Definite (E)

8. Serious Unexpected

▪ Life threatening or results in death

▪ Requires in-patient hospitalization

▪ Results in persistent or significant disability

▪ Congenital anomaly or birth defect

Relatedness of Event to Research Participation

Unrelated (A)

Unlikely (B)

Possible (C)

Probable (D)

Definite (E)

9. Unanticipated Problems

▪ Unintentional change to IRB-approved protocol that involves risk or has potential to recur

▪ Deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard

▪ Publication in the literature, safety monitoring report including Data and Safety Monitoring Reports, interim result or other finding that indicates an unexpected change to the risk/benefit ratio of the research

▪ Breach of confidentiality

▪ Any complaint of a subject that indicates an unanticipated risk or that cannot be resolved by the research staff

Relatedness of Event to Research Participation

Unrelated (A)

Unlikely (B)

Possible (C)

Probable (D)

Definite (E)

*Expected: Disclosed in Consent Form or part of an underlying disease

*Unexpected: More serious than expected or not disclosed in Consent Form

Please select the type of incident/adverse event below.

(Example: If the event was moderate, unexpected, and unrelated to treatment, you would check box 4A) All incidents/events are reported to the IRB. Incidents/events that fall between 6C through 9E (shaded dark gray) must be reported to the IRB immediately.