WEST VIRGINIA CODE











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WVC 5 - 16 B- 6 B

§5-16B-6b. Definitions.

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

program;

(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

include:

(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

trial.





Note: WV Code updated with legislation passed through the 2015 Regular Session

The WV Code Online is an unofficial copy of the annotated WV Code, provided as a convenience. It has NOT been edited for publication, and is not in any way official or authoritative.