01/09
IRB Office
Sterry 406
(208)495-5334
Fax (208) 459-5204
UNANTICIPATED PROBLEM REPORT FORM
Federal regulations require that the IRB be informed of any “unanticipated problems involving risk to research participants or others”
[45 CFR 46.103(b)(5)]. OHRP considered unanticipated problems, in general, to include any incident, experience, or outcome that
meets all of the following criteria:
(1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the described
in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the
characteristics of the subject population being studied;
(2) 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); and
(3) suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic,
or social harm) than was previously known or recognized.
The Project Director must notify the IRB of any incident, experience, or outcome that meets these definitions as soon as s/he
is made aware of it.
Name of Project Director (“PD”):
Name of Faculty Sponsor (if PD is
a Student):
Project Title:
(Use the exact title of the project.)
IRB #
Name of contact person:
Email:
(If different from PD)
BRIEFLY DESCRIBE THE INCIDENT, EXPERIENCE, OR OUTCOME
Attach additional pages or supplementary information as necessary. Include date of event, date of discovery, action taken to-date to address the event,
whether the participant remains in the study, and whether the sponsor has been notified (as applicable).
In the judgment of the Project Director (and Faculty Sponsor if applicable):
Is the specificity, nature, severity, or incidence of this event consistent with any information previously reviewed
and approved by the IRB? (If yes, attach a copy of the applicable page(s) previously provided to HRPO with the
information highlighted)
Using the criteria outlined above, answer the following questions.
Was this event unexpected at the time of its occurrence?
Yes
No
Yes
No
Was this event related or possibly related to the research?
Yes
No
Did this event suggest that research participants or others are at a greater risk of harm than was previously
known or recognized? Consider physical, psychological, economic, and social harm.
Yes
No
Should the consent document be revised? (If yes, submit a revised consent with this form for IRB review.)
Should research procedures (protocol) be revised? (If yes, submit a revised protocol with this form for IRB review.)
Yes
Yes
No
No
Should currently enrolled participants be notified? (If yes, submit a letter or script with this form for IRB review.)
Yes
No
Statement of PD and Faculty Sponsor (if applicable): I/we have personally reviewed this report and agree with the above assessment.
Signature(s) of Project Director (and Faculty Sponsor if applicable)
After review of the information
described in this report, I
recommend:
Signature of IRB reviewer:
Date
For IRB use only
No action required. This event does not represent an unanticipated problem involving risks to participants or others.
Referral to convened IRB for review.
Date:
Download

unanticipated problem report form