NRS 630.3735
Investigational drug, biological product or device: Conditions under which physician is authorized to prescribe or recommend
- contents of form for consent
- action not grounds for disciplinary action.
1.
A physician may prescribe or recommend an investigational drug, biological product or device to a patient if the physician has:(a)
Diagnosed the patient with a terminal condition;(b)
Discussed with the patient all available methods of treating the terminal condition that have been approved by the United States Food and Drug Administration and the patient and the physician have determined that no such method of treatment is adequate to treat the terminal condition of the patient; and(c)
Obtained informed, written consent to the use of the investigational drug, biological product or device from:(1)
The patient;(2)
If the patient is incompetent, the representative of the patient; or(3)
If the patient is less than 18 years of age, a parent or legal guardian of the patient.2.
An informed, written consent must be recorded on a form signed by the patient, or the representative or parent or legal guardian of the patient, as applicable, that contains:(a)
An explanation of all methods of treating the terminal condition of the patient that are currently approved by the United States Food and Drug Administration;(b)
A statement that the patient, or the representative or parent or legal guardian of the patient, as applicable, and the physician agree that no such method is likely to significantly prolong the life of the patient;(c)
Clear identification of the specific investigational drug, biological product or device proposed to treat the terminal condition of the patient;(d)
A description of the consequences of using the investigational drug, biological product or device, which must include, without limitation:(1)
A description of the best and worst possible outcomes;(2)
A realistic description of the most likely outcome, in the opinion of the physician; and(3)
A statement of the possibility that using the investigational drug, biological product or device may result in new, unanticipated, different or worse symptoms or the death of the patient occurring sooner than if the investigational drug, biological product or device is not used;(e)
A statement that a health insurer of the patient may not be required to pay for care or treatment of any condition resulting from the use of the investigational drug, biological product or device unless such care or treatment is specifically included in the policy of insurance covering the patient and that future benefits under the policy of insurance covering the patient may be affected by the patient’s use of the investigational drug, biological product or device; and(f)
A statement that the patient, or the representative or parent or legal guardian of the patient, as applicable, understands that the patient is liable for all costs resulting from the use of the investigational drug, biological product or device, including, without limitation, costs resulting from care or treatment of any condition resulting from the use of the investigational drug, biological product or device, and that such liability will be passed on to the estate of the patient upon the death of the patient.3.
A physician is not subject to disciplinary action for prescribing or recommending an investigational drug, biological product or device when authorized to do so pursuant to subsection 1.4.
As used in this section:(a)
“Investigational drug, biological product or device” has the meaning ascribed to it in NRS 454.690.(b)
“Terminal condition” has the meaning ascribed to it in NRS 454.690.
Source:
Section 630.3735 — Investigational drug, biological product or device: Conditions under which physician is authorized to prescribe or recommend; contents of form for consent; action not grounds for disciplinary action., https://www.leg.state.nv.us/NRS/NRS-630.html#NRS630Sec3735.