WEST VIRGINIA CODE
WVC 5 - 16 B- 6 B
For purposes of section six-a of this article:
(a) A "clinical trial" is a study that determines whether new
drugs, treatments or medical procedures are safe and effective on
humans. To determine the efficacy of experimental drugs,
treatments or procedures, a study is conducted in four phases
including the following:
Phase II: The experimental drug or treatment is given to, or
a procedure is performed on, a larger group of people to further
measure its effectiveness and safety.
Phase III: Further research is conducted to confirm the
effectiveness of the drug, treatment or procedure, to monitor the
side effects, to compare commonly used treatments and to collect
information on safe use.
Phase IV: After the drug, treatment or medical procedure is
marketed, investigators continue testing to determine the effects
on various populations and to determine whether there are side
effects associated with long-term use.
(b) "Cooperative group" means a formal network of facilities
that collaborate on research projects and have an established
NIH-approved peer review program operating within the group.
(c) "Cooperative group" includes:
(1) The national cancer institute clinical cooperative group;
(2) The national cancer institute community clinical oncology
(3) The AIDS clinical trial group; and
(4) The community programs for clinical research in AIDS.
(d) "FDA" means the federal food and drug administration.
(e) "Life-threatening condition" means that the member has a
terminal condition or illness that according to current diagnosis
has a high probability of death within two years, even with
treatment with an existing generally accepted treatment protocol.
(f) "Member" means a policyholder, subscriber, insured,
certificate holder or a covered dependent of a policyholder,
subscriber, insured or certificate holder.
(g) "Multiple project assurance contract" means a contract
between an institution and the federal department of health and
human services that defines the relationship of the institution to
the federal department of health and human services and sets out
the responsibilities of the institution and the procedures that
will be used by the institution to protect human subjects.
(h) "NIH" means the national institutes of health.
(i) "Patient cost" means the routine costs of a medically
necessary health care service that is incurred by a member as a
result of the treatment being provided pursuant to the protocols of
the clinical trial. Routine costs of a clinical trial include all
items or services that are otherwise generally available to
beneficiaries of the insurance policies. "Patient cost" does not
(1) The cost of the investigational drug or device;
(2) The cost of nonhealth care services that a patient may be
required to receive as a result of the treatment being provided to
the member for purposes of the clinical trial;
(3) Services customarily provided by the research sponsor free
of charge for any participant in the trial;
(4) Costs associated with managing the research associated
with the clinical trial including, but not limited to, services
furnished to satisfy data collection and analysis needs that are
not used in the direct clinical management of the participant; or
(5) Costs that would not be covered under the participant's
policy, plan, or contract for noninvestigational treatments;
(6) Adverse events during treatment are divided into those
that reflect the natural history of the disease, or its
progression, and those that are unique in the experimental
treatment. Costs for the former are the responsibility of the
payor as provided in section two of this article, and costs for the
later are the responsibility of the sponsor. The sponsor shall
hold harmless any payor for any losses and injuries sustained by
any member as a result of his or her participation in the clinical
Note: WV Code updated with legislation passed through the 2015 Regular Session
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