INSTITUTIONAL REVIEW BOARD (IRB)

Report of Adverse Eventsor Unanticipated Problems

Submit thisform to the Office for Responsible Research to promptly report

1. any serious adverse event that is related to the research; or

2. any event that meets the definition of an unanticipated problem.

For more information about reporting requirements, please see the document entitled “Reporting Adverse Events and Unanticipated Problems” available on the IRB Guidance & Education web page.

GENERAL INFORMATION

IRB ID: / Principal Investigator:
Project Title:
Date of Incident: / Today’s Date:
Participant ID:
Participant enrolled by an ISU Investigator
Participant enrolled by a non-ISU Investigator
  1. Please describe the incident (e.g., a narrative of what happened, including any symptoms, diagnosis, contact with participant, etc.).
  1. Was the incident unexpected (e.g., not described in the investigator’s brochure, IRB application, or the informed consent document)?

Yes / No
  1. Was the incident serious? (Check all that apply.)

Resulted in death

Life threatening

Required inpatient hospitalization or prolongation of existing hospitalization

Resulted in a persistent or significant disability/incapacity

Resulted in a congenital anomaly/birth defect

Based upon appropriate medical judgment, may jeopardize the individual’s

health and may require medical or surgical intervention to prevent one of the

other outcomes listed above

Resulted in a breach of confidentiality that is damaging to the participant’s

rights, employment, financial standing, or reputation

  1. Is the incident related or possibly related to the study?

Definitely related

Probably related/likely

Possibly related

Probably not related/unlikely

Definitely not related

Unknown

  1. Does the incident suggest that participants or others may be at greater risk of harm than was previously known?

Yes (Submit a modification form to describe the new risks and procedures to minimize the risks.)

No

  1. Describe any treatment to the participant.
  1. Should the informed consent document or study protocol be revised based on this incident?

Yes (Submit a modification form to describe the proposed revisions to the protocol and/or

informed consent document.)

No

  1. Is it necessary to inform participants who have already enrolled in the study?

Yes (Submit a modification form to describe the proposed plan for informing participants.)

No

______/ ______
Signature of Principal Investigator / Date
______/ ______
Signature of Supervising Faculty Member
(if applicable) / Date

Office for Responsible Research Page 1 of 2

Revised 02/04/10