unanticipated/serious problems procedure and form background: in accordance with 45 cfr 46.103 (b)(5), “institutions engaged in human s
Unanticipated/Serious Problems Procedure and Form
In accordance with 45 CFR 46.103 (b)(5), “Institutions engaged in
human subjects’ research conducted or supported by HHS must have
written procedures for ensuring prompt reporting to the IRB,
appropriate institutional officials, and any supporting department or
agency head of any unanticipated problem involving risks to subjects
“For research covered by an assurance approved for federalwide use by
OHRP, HHS regulations at 45 CFR 46.103(a) require that institutions
promptly report any unanticipated problems to OHRP.”
This procedure has been established to fulfill the above requirements.
In its January 2007 guidance document, The Office of Human Research
Protections (OHRP) considers unanticipated problems, in general, to
include any incident, experience, or outcome that meets all of the
unexpected (in terms of nature, severity, or frequency) given (a)
the research procedures that are 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;
related or possibly related to participation in the research (in
the guidance document, 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.
Note: Some problems in research are serious but anticipated, while
others are unanticipated and may or may not be serious. The scope of
this procedure covers all unanticipated problems, whether they are
serious or not, and all serious anticipated problems. A serious
problem shall be deemed as one that is harmful, life threatening or
fatal to the participant or others.
If an unanticipated problem or serious anticipated problem should
occur, please take the following action:
The first duty of the investigator is the safety and care of the
research participant. Attend to her/his needs.
The investigator should consider whether any more participants
should be used in the research and consider immediately stopping
the study until the investigator, with the help of the Human
Subjects Committee or others investigates the occurrence and
possibly adds procedures to deal with the unanticipated problem.
If the problem is serious (harmful, fatal or life threatening),
report the event either orally or in writing to the Research
Compliance Coordinator within three days.
For all problems, document and provide a written report to the
Human Subjects Committee in ten working days using the
Unanticipated/Serious Problem Reporting Form.
Consult with SDSU’s insurance and risk management officials as
The Chair or her/his designee will review the report to follow up
and take appropriate action. This action may include:
Additional follow up with the investigator
Committee review of the report
Consultation with the Institutional Official* to coordinate
reporting to the Office of Human Research Protections
If reporting to OHRP is determined to be required, such reporting will
take place no later than 30 days following the incident.
In addition to halting a study, OHRP provides other examples of
corrective actions or substantive changes that might need to be
considered in response to an unanticipated problem. They include:
changes to the research protocol initiated by the investigator
prior to obtaining IRB approval to eliminate apparent immediate
hazards to subjects;
modification of inclusion or exclusion criteria to mitigate the
newly identified risks;
implementation of additional procedures for monitoring subjects;
modification of informed consent documents to include a
description of newly recognized risks; and
provision of additional information about newly recognized risks
to previously enrolled subjects.
*The designated Institutional Official at this time is Dr. Kevin
Kephart, Vice President for Research and Dean of the Graduate College.
Department of Health and Human Services (HHS) Office for Human
Research Protections (OHRP) Guidance on Reviewing and Reporting
Unanticipated Problems Involving Risks to Subjects or Others and
Adverse Events January 15, 2007
Investigator Unanticipated/Serious Problem
Faculty Advisor (if applicable): Phone #:
Title of Study:
IRB Approval #:
Date participant enrolled into the study:
Date of problem:
Description of unanticipated or serious problem:
(Use as much space as needed or separate sheets to thoroughly describe
Please answer the following:
Was this problem unanticipated given (a) the risks and research
methodology described in the protocol and (b) the characteristics of
the subject population being studied?
Was this problem directly related or probably/possibly related to
participation in the research?
Does this problem suggest that the research places subjects or others
at a greater risk of harm than originally anticipated? No Yes
If you answered ‘No’ to this question, please justify your response:
Revision to Protocol or consent required: No Yes
If revisions are required please provide one revised copy of the
protocol and/or consent indicating the revisions by highlighting or
underlining the changes.
Will revision require information that will affect all research
Yes; if yes, have the research subjects been informed? Please provide
Investigator signature Date
H UMAN SUBJECTS USE:
Unanticipated/serious problem report form reviewed by:
Submit report to full committee
Write to investigator with concerns
Discussed with investigator – Nor further action required
File with protocol – No further action required