Treatment and Compensation for Injury
Statement: Background and UCSF Policy
| Since 1978, both DHHS and FDA
have required an additional element of consent regarding treatment
and compensation for injury resulting from participation in
research. The current regulations for consent forms require: |
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"For research involving more
than minimal risk, an explanation as to whether any compensation
and an explanation as to whether any medical treatments are
available if injury occurs and, if so, what they consist of, or [emphasis
added] where further information may be obtained." |
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Standard Wording
In 1979, the President of the University
of California issued a University policy on treatment and
compensation for injury (see next page for complete policy).
The UCSF Committee on Human Research, in consultation with
Legal Counsel, formulated a standard statement (which was
updated in 1985) to describe this policy. An alternate version
of the statement, to be used when a sponsoring company or
another institution with a similar policy is involved, was
also formulated. The CHR requires that the following
standard wording be used on all consent forms for studies
involving more than minimal risk:
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"If you are injured as a result
of being in this study, treatment will be available. The costs
of such treatment may be covered by the University of California
[or by the study sponsor, (which should be identified by name)],
depending on a number of factors. The University [and the study
sponsor] does [do] not normally provide any other form of compensation
for injury. For further information about this, you may call
the office of the Committee on Human Research at (415) 476-1814." |
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| The exact wording required for
studies being conducted at the VAMC is as follows: |
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If you are injured as a result
of being in this study, treatment will be available. If you
are eligible for veteran's benefits, the costs of such treatment
will be covered by the Department of Veterans Affairs. If not,
the costs of such treatment may be covered by the Department
of Veterans Affairs or the University of California, [or the
study sponsor, (which should be identified by name)], depending
on a number of factors. The Department of Veterans Affairs
and the University [and the study sponsor] do not normally
provide any other form of compensation for injury. For further
information about this, you may call the V.A. District Counsel
at (415) 750-2288 or the office of the UCSF Committee on Human
Research at (415) 476-1814. |
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| The references to the sponsor's
provision of compensation should be inserted only if they accurately
reflect the sponsor's policy. If there is a distinctly different
policy (e.g., the sponsor will cover the costs of
research-related injuries, or the sponsor has no provision
whatsoever for compensation) this may be stated in a brief
but separate paragraph following the UCSF statement.
Industry Sponsors
Sponsoring companies often
request that their own wording be used for the
treatment and compensation for injury policy
statement or that minor changes be made in the
UC statement. Such requests cannot be
honored. The wording of the statement was formulated
with the advice of legal counsel with the intent
of adhering to the requirements of the federal
regulation, and conveying the basic, necessary
information to the subject.
Industry sponsor's have three, and
only three, options regarding the discussion
of treatment and compensation for injury in
the consent form. First, the sponsor may include
their name in the UCSF statement as written
above. Second, the sponsor may remain silent
on this point in which case all reference to
the sponsor should be omitted from the above
statement. Third, a brief paragraph (one or
two sentences) may be added below and separate
from the UCSF statement to explain the
sponsor's policy. However, any description
of the sponsor's policy must state what the
sponsor will cover, not what it will
not cover. As a further limitation, the sponsor's
statement may not make reference to third party
carriers, government programs, or lost wages. No
other changes may be made to the UCSF statement.
The CHR office is not in the
position to negotiate indemnification agreements.
This occurs through the Clinical Contracts Unit
(476-0833) at the time of contract negotiations.
University of California
Policy on Treatment and Compensation for Injury
in Research
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1.
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The University of California
will provide to any injured subject any and all medical treatment
reasonably necessary for any injury or illness which a human
subject suffers as a direct result of participation in an authorized
University activity covered by University policy on the protection
of human subjects in research, or reimburse the subject for
the costs of such treatment, except when the injury or illness
is a consequence of a medical research procedure which is designed
to benefit the subject directly. |
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2. |
The obligation of the University
undertaken in paragraph 1 shall be subject to the following
conditions: |
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a. It must be demonstrated that the injury resulted directly
from participation in the specified activity.
b. Written notification of any such injury is to be given
to the University by the human subject within a reasonable
time after discovery.
c. Any claim for reimbursement is to be supported by appropriate
documentation.
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3. |
It is the preference of the
University that the medical treatment available under this
policy be provided at a University of California medical facility.
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4.
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Chancellors and other chief
administrators, as appropriate, shall designate an individual
or office as a contact for inquiries about implementation of
this policy. |
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| Discussion
As its name indicates, there are two
major aspects of this policy: (1) treatment for injury,
and (2) compensation for injury. These two must be clearly
distinguished in considering the University policy and
the UCSF statement regarding that policy.
Appropriate treatment should be available
to any subject injured as a result of participating in
a research project. Treatment should be considered a moral
obligation rather than any admission of liability. Consent
forms should indicate within the Risks section the nature
of available treatment for any possible serious side effects.
Several factors must be considered in
applying the University compensation policy. These factors
include the following:
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1. |
The nature of the alleged injury; |
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2. |
The extent to which the research
procedure was designed to benefit the subject; |
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3. |
Whether the research procedure
was the direct cause of the alleged injury; |
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4. |
The nature of the compensation
being sought (Note that the University policy does not address
costs other than those for medical treatment of the injury); |
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5. |
Other policies for compensation
for injury from cooperating institutions or study sponsors;
and, Sources of funds available to cover the costs of treatment. |
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Implementation
Reports of Injury: All incidents of alleged
injury must be reported to the CHR, either on the UCSF Research
Subject Injury Report form (see Adverse
Effects and Incident Reporting), or as a letter containing
the same information. Minor incidents of anticipated side
effects may be reported at the time of annual renewal or
at termination of the study if it is not to be continued;
all others must be reported immediately.
Requests for Compensation: Request for
clarification as to whether the alleged injury is compensable
under the University policy and how it will be compensated
should be directed to the CHR office or to UCSF Medical Center
Risk Management at 415-353-1842. A preliminary determination
will
be made, and
the matter will then be referred to the Executive Vice Chancellor,
Research.
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