Adverse Events
and Effects
Compensation
in Clinical Trials
It is the position
of the University
of Washington that
subjects and their
third party payers
or governmental programs
should not be held
accountable for the
costs of treating
adverse effects incurred
as a result of taking
part in clinical
trials sponsored
by commercial companies.
The terms of the
agreement under which
the trial is conducted
shall determine whether
the sponsor or the
University of Washington
is financially responsible
for the treatment
of adverse effects.
With rare exception,
the agreement will
specify that the
University will hold
the sponsor harmless
from adverse effects
resulting from the
negligence of University
employees, including
failure to adhere
to the protocol,
while the sponsor
will hold the University
harmless from adverse
effects resulting
from the prescribed
use of the test article
or protocol. It is
possible, though
unusual, that both
University negligence
and sponsor negligence
could concurrently
cause adverse effect,
in which both parties
share financial responsibility.
The consent form
should include information
that physical injuries
to the subject that
are a direct result
of study procedures
will be treated at
no cost to the subject.
Wherever possible,
the consent form
should state that
the sponsor is the
responsible party.
For example:
If you
have a physical injury
as a direct result
of this study, we
will treat you or
refer you for treatment.
The X company, the
sponsor of this study,
will pay for this
treatment.
In cases in which
the sponsor refuses
to be named, acceptable
wording is as follows:
If you
have a physical injury
as a direct result
of this study, we
will treat you or
refer you for treatment.
The treatment will
be given at no cost
to you.
Adverse Event
Reporting
It is the responsibility
of researchers at the
University of Washington
to report injuries to
human subjects and problems
involving the conduct
of research. The following
information is provided
to assist researchers
and others in determining
which events to report
and how to report them.
- Adverse Events:
what and how to report.
All serious or unexpected adverse effects
and deaths associated with a research
activity conducted by a University researcher
must be reported immediately to the Human
Subjects Review Committee. Adverse effects
which occur no more frequently than expected and which
are described in the consent form need
not be reported, unless they result in
death. If there is a question, researchers
are urged to err on the side of over-reporting.
Within twenty-four (24) hours after
the researcher learns that an adverse
event has occurred, it should be
reported by telephone to the Human
Subjects Division ((206) 543-0098).
The researcher will be instructed
to complete an Serious Adverse Event Report Form - 12/01/04 (doc) 34 kb form for submission
to the Human Subjects Division. It
must be accompanied by a copy of
the consent form signed by the injured
subject, and should also be accompanied
by any other relevant information
(autopsy reports when available,
hospital incident reports, reports
to the U.S. Food and Drug Administration
(FDA) and to study sponsors).
The report will be reviewed by
the Human Subjects Division staff,
who will refer it to the appropriate
Human Subjects Review Committee,
and notify the Office of Risk Management.
Depending on the nature of the report,
no action may be taken, the consent
form may be revised, study procedures
may be modified, or approval of the
study may be suspended, pending further
inquiry.
Reports of adverse effects which
occur at another site of a multi-site
study should be forwarded to the
Human Subjects Review Committee that
reviewed the study. The researcher
should complete an adverse event
report, attaching any material received
from the central study office or
coordinating center or study sponsor.
- What and how to
report.
Any problems involving the conduct of
the study or subject participation (including
recruitment, consent, screening and termination)
should be reported immediately. For example,
if a subject complains about any aspect
of his or her treatment as a study subject,
this should be reported and the subject
should be referred for assistance to
the Human Subjects Division (206) 543-0098).
Any deviations from approved protocols
should be reported. For example,
if a subject is inadvertently enrolled
in a study before informed consent
has been given, or if a subject is
given a higher or lower dose of an
investigational or other material
than is described in the approved
Human Subjects Review Committee application,
these should be reported.
- Reporting incidents
related to other
research activities:
All research activities involving humans
are reviewed by the Human Subjects Review
Committee at least annually. Since additional
monitoring activities are limited, we
must rely on subjects, study personnel,
staff, faculty and students to report
possible misconduct that relates to research
activities involving humans. Such misconduct
might include carrying out research without
Human Subjects Review Committee approval,
improper recruitment of subjects, or
undue influence on prospective subjects
to participate. Such incidents should
be reported in writing to the Human Subjects
Division and will be handled in accord
with University of Washington policy
on scientific misconduct.
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