Virginia Code 54.1-3442.2: Eligibility for expanded access to investigational drugs, biological products, and devices; written, informed consent to treatment
A. A person shall be eligible for expanded access to investigational drugs, biological products, or devices if:
Terms Used In Virginia Code 54.1-3442.2
- Biological product: means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings. See Virginia Code 54.1-3401
- Device: means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals. See Virginia Code 54.1-3401
- Drug: means (i) articles or substances recognized in the official United States Pharmacopoeia National Formulary or official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them; (ii) articles or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; (iii) articles or substances, other than food, intended to affect the structure or any function of the body of man or animals; (iv) articles or substances intended for use as a component of any article specified in clause (i), (ii), or (iii); or (v) a biological product. See Virginia Code 54.1-3401
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
- Person: means both the plural and singular, as the case demands, and includes an individual, partnership, corporation, association, governmental agency, trust, or other institution or entity. See Virginia Code 54.1-3401
- Terminal condition: means a condition caused by injury, disease, or illness from which, to a reasonable degree of medical probability, a patient cannot recover and (i) the patient's death is imminent or (ii) the patient is in a persistent vegetative state. See Virginia Code 54.1-3442.1
- Treating physician: means a physician who is providing or has previously provided medical treatment or evaluation to and has or previously had an ongoing treatment relationship with the person. See Virginia Code 54.1-3442.1
- Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
1. He has a terminal condition, attested to by his treating physician and confirmed by a second physician not previously involved in the treatment of the person who has conducted an independent examination of the person;
2. He has, in consultation with his treating physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration and the treating physician has determined that no reasonable opportunity exists for him to participate in an ongoing clinical trial for his terminal condition;
3. The potential benefits of use of the investigational drug, biological product, or device to treat his terminal condition are greater than the potential risks of the use of the investigational drug, biological product, or device to treat his terminal condition;
4. He has received a recommendation from his treating physician for use of an investigational drug, biological product, or device for treatment of his terminal condition; and
5. He or, if he is incapable of making an informed decision, his legally authorized representative has given written informed consent to use of the investigational drug, biological product, or device for treatment of his terminal condition or, if the person is a minor or lacks capacity to provide informed consent, his parent or legal guardian has given written informed consent to the use of the investigational drug, biological product, or device for treatment of his terminal condition.
Documentation indicating that the person meets the criteria for eligibility for expanded access to investigational drugs, biological products, or devices shall be provided by the person’s treating physician and shall be included in the person’s medical record.
B. Written informed consent to use of an investigational drug, biological product, or device shall include:
1. An explanation of the currently approved products and treatments for the person’s terminal condition;
2. A statement that the person has, in consultation with his treating physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration and the treating physician has determined that no reasonable opportunity exists for the person to participate in an ongoing clinical trial for his terminal condition;
3. An explanation of the specific investigational drug, biological product, or device proposed for treatment of the person’s terminal condition;
4. A description of possible outcomes resulting from use of the investigational drug, biological product, or device to treat the person’s terminal condition, including a statement that new, unanticipated, different, or worse symptoms might result from and death could be hastened by the proposed treatment, based on the treating physician’s knowledge of the proposed treatment in conjunction with an awareness of the person’s terminal condition;
5. A statement that the person may be required to pay any costs associated with use of the investigational drug, biological product, or device; and
6. A statement that the person or, if the person is a minor or lacks capacity to provide informed consent, his parent or legal guardian consents to the use of the investigational drug, biological product, or device for treatment of his terminal condition.