2016 South Dakota Codified Laws
Title 34 - PUBLIC HEALTH AND SAFETY
Chapter 51 - Investigational Treatments
§ 34-51-3 Written, informed consent.

34-51-3. Written, informed consent. For purposes of this chapter, the term, written, informed consent, consists of a signed writing executed by the patient, parent, or legal guardian, if the patient is a minor, or substitute informed consent from an appointed guardian, an attorney-in-fact, or a person with authority pursuant to chapter 34-12C, if the patient is incapacitated as defined in § 34-12C-1, and attested to by the treating physician, that:

(1) Explains the currently approved products and treatments for the disease or condition from which the patient suffers;

(2) Attests to the fact that the patient concurs with his or her treating physician that no current United States Food and Drug Administration approved treatment would likely prolong the patient's life;

(3) Clearly identifies the specific proposed investigational drug, biological product, or device that the patient is seeking to use;

(4) Describes the potential outcomes of using investigational drug, biological product, or device. The description shall include any possibility of worsening symptoms and death hastened by the treatment;

(5) Contains a statement that the patient's health insurance carrier is not obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product, or device;

(6) Makes clear that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment with the investigational drug, biological product, or device and that care may be reinstated if this treatment ends and patient meets hospice eligibility requirements; and

(7) Makes clear that the patient understands that he or she is liable for all expense consequent to the use of the investigational drug, biological product, or device.
Source: SL 2015, ch 188, § 3.