26:14-5 Obtaining surrogate informed consent; conditions.

5. a. For purposes of obtaining informed consent required for medical research, if a person who may be the subject of the research is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from an authorized representative with reasonable knowledge of the subject, who shall include any of the following persons, in the following descending order of priority:

(1) the guardian of the subject who has the authority to make health care decisions for the subject;

(2) the health care representative of the subject pursuant to an advance directive for health care;

(3) the spouse or civil union partner, as applicable, of the subject;

(4) the domestic partner, as defined in section 3 of P.L.2003, c.246 (C.26:8A-3), of the subject;

(5) an adult son or daughter of the subject;

(6) a custodial parent of the subject;

(7) an adult brother or sister of the subject;

(8) an adult grandchild of the subject;

(9) an available adult relative with the closest degree of kinship to the subject.

b. For purposes of this section, inability to consent shall mean that a subject is unable to consent if he is unable to voluntarily reason, understand, and appreciate the nature and consequences of proposed health research interventions, including the subject's diagnosis and prognosis, the burdens, benefits, and risks of, and alternatives to, any such research, and to reach an informed decision.

All adults are presumed to have the ability to consent unless determined otherwise pursuant to this section or other provisions of State law.

A determination that a subject is unable to consent, as well as the extent of his incapacity and the likelihood that he will regain decision-making capacity, shall be made by an attending physician with no connection to the proposed research and shall be made to a reasonable degree of medical certainty.

A determination of incapacity shall promptly be given to the subject and to at least one person at the highest level reasonably available on the list of surrogates contained in subsection a. of this section.

Notwithstanding a determination of incapacity made pursuant to this section, a subject's objection to a determination of incapacity or objection to the proposed research intervention shall be binding, unless a court of competent jurisdiction determines that the subject lacks decision-making capacity.

c. For the purposes of this section:

(1) when there are two or more available persons who may give surrogate informed consent and who are in the same order of priority, if any of those persons expresses dissent as to the participation of the person in the research, consent shall not be considered as having been given; and

(2) when there are two or more available persons who are in different orders of priority, refusal to consent by a person who is a higher priority authorized representative shall not be superseded by the consent of a person who is a lower priority authorized representative.

d. An authorized representative described in this section shall make decisions about participation in accordance with the subject's individual health care instructions, if any, and other wishes, to the extent known to the authorized representative. If the authorized representative does not have knowledge of any health care instructions or other wishes of the subject, or if the instructions or wishes do not clearly indicate what decision should be made, he shall make the decision in accordance with the subject's personal values and his best estimation of what the subject would have chosen if he were capable of making a decision.

e. The requirement for obtaining informed consent for medical research pursuant to this act shall not apply to any medical research with respect to a person who is subject to a life-threatening emergency in accordance with the conditions set forth in 21 C.F.R.s.50.24.

f. The requirements for obtaining informed consent for medical research pursuant to this act may be altered or waived in accordance with the conditions set forth in 45 C.F.R.s.46.116(d).

g. A person who provides surrogate consent pursuant to this section may not receive financial compensation for providing the consent.

h. Except as otherwise provided by law, the provisions of this section shall not override an advance directive for health care executed pursuant to P.L.1991, c.201 (C.26:2H-53 et seq.).

L.2007, c.316, s.5.