Transcript Unanticipated problems

Unanticipated problems
Melody Lin, Ph.D.
December,12. 2012
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Unanticipated problems involving risk
to participants or others
• Is unexpected
• Is related or possibly related to participation in
the research, and
• Indicates that subjects or others are at a
greater risk of harm (physical, psychological,
economic, or social harm) than was previously
known or recognized.
Unexpected
• The incident, experience or outcome is not
expected (in terms of nature, severity, or
frequency) i.e. the IRB-approved protocol and
informed consent documents; and the
characteristics of the subject population being
studied;
Related
• There is a reasonable possibility that the
incident, experience, or outcome may have
been caused by the procedures involved in the
research.
Or others
• UAE expose individual other than subject. i.e.
PI, research assistant, student or pubic.
Examples of unanticipated problems
involving risk to subjects or others
• A researcher
– survey questions trigger an intensely negative psychological
reaction in some subjects. The response is unforeseen and the
possibility of such a reaction was not included in the research
plan.
– loses a laptop with individual identifiable subject information
– accidentally injures an child during a child development
assessment
• A research assistant is physically threatened while doing an
interview in the home of a subject
• Sexually explicit material part of an internet survey for
adults is inadvertently released on a publically available
website
Reporting Unanticipated Problems to
the IRB
• Each institution
– will have policies on what constitutes “prompt”
reporting. Researchers should check with their local
IRB to determine reporting standards.
– should determine which individual(s) or office(s) is
responsible for determining whether an event is in
fact an unanticipated problem involving risk to
subjects or others.
• Researchers should develop a clear process for
promptly detecting possible unanticipated
problems involving risk to subjects or others
promptly, and reporting them to their IRB.
Other reporting requirements
Researchers should be prepared to report any of the following to their
IRB:
• Any information that indicates a change to the risks or potential
benefits of the research.
• Changes to the research plan made without prior IRB review to
eliminate an apparent immediate hazard to a subject.
• Complaints from subjects that cannot be resolved by the research
team.
• Incarceration of a subject in a study not approved to enroll
prisoners.
• Protocol deviations that affect risk to a subject.
• Unexpected breaches of confidentiality.
• Unexpected and related adverse events.
When providing a report to the IRB,
researchers should provide
• A description of the problem in lay language
understandable to the non-scientific members
of the IRB.
• Suggested changes to the research, if any.
• Suggested changes to the information
disclosed in the consent process, if any