University Human Subjects Review Committee (UHSRC)

Eastern Michigan University

University Human Subjects Review Committee (UHSRC)

EVENT REPORT FORM

Complete and submit this form to report the following: Unanticipated Problems involving risks to subjects, Adverse Events, protocol deviations, subject complaints, breaches of confidentiality, interim findings suggesting changes in risk to subjects, or any other unusual or reportable incident.

Events must be reported within 24 hours of discovery. If you cannot submit this form within 24 hours of discovery, contact the Office of Research Compliance at 734-487-3090 or

I. PROTOCOL INFORMATION

Date
Project Title
Principal Investigator
Department/School
Phone
Email
IF PRINCIPAL INVESTIGATOR IS A STUDENT:
EMU ID Number
Program and Status/Year
Faculty Sponsor
Faculty Sponsor Email

II. TYPE OF EVENT(check all that apply)

Death of a research subject: If the death is related or possibly related to the research study
Adverse Event[1]that is unanticipated: Unanticipated in terms of nature, severity, or frequency, related or possibly related, and suggest that there is an increased risk to subjects or others than was previously known
Unexpected Adverse Device Effect:Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the application (including supplemental documents), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of the subjects.This category applies to Investigational Devices.
Event or problem that is unanticipated: Unanticipated in terms of nature, severity, or frequency, related or possibly related, and suggest that there is an increased risk to subjects or others than was previously known.
Breach of Confidentiality
Suspension or termination of the research study by the Sponsor or other agency
Incarceration of a research subject enrolled into the study
Study Staff misconduct
Medication or laboratory error regardless of whether subjects experienced harm
Data Safety Monitoring Report/Interim Analysis/other oversight or monitoring committee report
New information that suggests that there are new or increased risks to subject or others
Complaint by a research subject or others that suggests that rights, welfare, or safety of a subject has been adversely affected.
Deviation: Any change/alteration to the UHSRC-approved protocol without prospective UHSRC approval.
Exception: This is a request for a one time, intentional change/alteration to the UHSRC-approved protocol that is approved by the UHSRCprior to implementation.
Other: (e.g. loss of study data, lapsed study approval, missing consent forms, etc.)

Provide a summary of the event(s) checked above. Do not include information that might identify a subject.

III. ASSESSMENT OF EVENT (do not complete if applying for an exception)

YES / NO
Is the event/information unexpected in terms of nature, severity or frequency given

the research procedures (that are described in the UHSRC-approved documents such as the protocol, consent form, etc.) and
the subject population being studied?

Is the event related or possibly related to a subject’s participation?
Does the event/information place the subjects or other at a greater risk of harm (including physical, psychological, economic, or social harm) or discomfort related to the research than was previously known or recognized?
In the opinion of the investigator, have the risks or potential benefits of this research changed as a result of this event?
Explain all “YES” responses:

IV. RE-CONSENTING OF ALEADY ENROLLED SUBJECTS

If the event could affect a subject’s willingness to continue taking part in the study, these subjects must be re-consented. Examples of when subjects may need to be re-consented: Change in study procedures, new risks identified, change in subject payment, etc. If subjects need to be re-consented, a new consent form/script must be submitted.
YES / NO
Could the event affect a subject’s willingness to continue taking part in this research study?

If “YES,” describe the process for re-consenting already-enrolled subjects below:

V. CORRECTIVE ACTION PLAN

Provide a summary of the Corrective Action Plan you will implement to address the reported event(s). If there is no Corrective Action Plan, provide justification. Note: the USHRC may require additional corrective actions.

VI. CERTIFICATION

By submitting this Event Form, you confirm that this application is complete and accurate, and that you will conduct this research in accordance with all applicable regulations, laws, and policies.

[1]Adverse Event: Any negative outcome experienced by the subject that has taken place during the course of a research project. Adverse Events include abnormal exam or lab findings, symptoms, or conditions temporally associated with the subject’s participation in the research, whether or notit is related to the subject’s participation in the research.