§ 69.77.050 — Informed consent.

Washington § 69.77.050

• Jurisdiction: Washington
• Title 69: FOOD, DRUGS, COSMETICS, AND POISONS
• Ch. 69.77: INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES

Text

(1) Prior to treatment of the eligible patient with an investigational product, the treating physician shall obtain written informed consent, consistent with the requirements of RCW 7.70.060 (1), and signed by the eligible patient or, if the patient lacks the capacity to consent, his or her legally authorized representative.

(2) Information provided in order to obtain the informed consent must, to the extent possible, include the following:

(a) That the patient has been diagnosed with a serious or immediately life-threatening disease or condition and explains the currently approved products and treatments for the disease or condition from which the eligible patient suffers;

(b) That all currently approved and conventionally recognized treatments are unlikely to prolong the eligible patient's life;

(c) Clear identification of the investigational product that the eligible patient seeks to use;

(d) The potentially best and worst outcomes of using the investigational product and a realistic description of the most likely outcome. This description must include the possibility that new, unanticipated, different, or worse symptoms may result and that death could be hastened by the proposed treatment. The description must be based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the eligible patient's condition;

(e) That the eligible patient's health benefit plan is not obligated to pay for the investigational product or any harm caused to the eligible patient by the investigational product, unless otherwise specifically required to do so by law or contract, and that in order to receive the investigational product the patient may be required to pay the costs of administering the investigational product; and

(f) That the eligible patient is liable for all expenses consequent to the use of the investigational product, except as otherwise provided in the eligible patient's health benefit plan or a contract between the eligible patient and the manufacturer of the investigational product.

(3) The document must be signed and dated by the eligible patient's treating physician and witnessed in writing by at least one adult.

Legislative History

[2017 c 212 s 5.]