S1757 2R

An Act concerning informed consent for medical research and supplementing Title 26 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. This act shall be known and may be cited as the "Access to Medical Research Act."

2. The Legislature finds and declares that:

a. Access to the latest treatments developed through medical research is essential to provide the citizens of this State with the best health care services available;

b. The advancement of the scientific understanding of health, behavior, disease, and treatment is a vital endeavor for the benefit of humankind;

c. Ground-breaking research is currently being conducted in New Jersey by a wide variety of health professionals in the diagnosis, intervention and monitoring of all aspects of health and medical care; and

d. All research involving human participants, regardless of the setting, must be conducted with profound respect for their health, safety, and dignity.

3. The provisions of this act shall apply to medical research ²on persons with cognitive impairments, lack of capacity, or serious physical or behavioral conditions and life-threatening diseases² that²[:]² is approved and monitored by an institutional review board that holds an assurance with the United States Department of Health and Human Services²[; and relates to the cognitive impairment, lack of capacity, or serious physical or behavioral conditions and life-threatening diseases of research participants] and either:

a. offers the prospect of direct benefit to the individual subject, provided that the institutional review board has determined that the risk is justified by the anticipated benefits to the subject and that the relation of the anticipated benefit to the risk is at least as favorable to the subject as that presented by available alternative approaches. If a currently recognized treatment exists, the subject or his guardian or authorized representative, as applicable, shall be presented with the choice of the recognized treatment and the research protocol; or

b. does not offer the prospect of direct benefit to the individual subject, provided that the institutional review board has determined that it: (1) is likely to yield generalizable knowledge about the subject's disorder or condition; (2) by its very nature cannot be conducted without the participation of decisionally incapacitated persons as subjects; and (3) involves no more than a minor increase over minimal risk.

For purposes of this section, “minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests².

4. As used in this act, “informed consent” means the authorization given pursuant to this act to participate in medical research performed on a subject after each of the following conditions have been satisfied:

a. The subject or his guardian, or authorized representative as provided in section 5 of this act, as applicable, is informed both verbally and within the written consent form, in nontechnical terms and in a language in which the subject or the subject’s guardian or authorized representative is fluent, of the following facts ²[of the proposed medical research, which might influence the decision to participate in the research, including, but not limited to]that include²:

(1) an explanation of the procedures to be followed in the research and any drugs or devices to be utilized, including the purposes of the procedures, drugs, or devices²and, when applicable, the use of placebo controls and the process by which persons will be assigned to control groups²;

(2) a description of any attendant discomfort and ²reasonably foreseeable² risks to the subject ²[to be reasonably expected]²;

(3) an explanation of any ²potential direct² benefits to the subject ²[to be]. If no such direct benefits are² reasonably expected, ²[if applicable] that fact should be made clear²;

(4) a disclosure of any appropriate alternative procedures, drugs

or devices that might be advantageous to the subject, and their relative risks and benefits;

(5) an estimate of the expected duration of the research procedure or study;

(6) an offer to answer any inquiries concerning the research or the procedures involved ²and an explanation of whom to contact for answers to pertinent questions about the research and the research subject’s rights, and whom to contact in the event of a research-related injury²;

(7) an instruction to the subject or his guardian or authorized representative, as applicable, that he is free to withdraw his prior consent to the medical experiment and discontinue participation in the research at any time, without prejudice to the subject;

(8) the name, institutional affiliation, if any, and address of the person or persons actually performing and primarily responsible for the conduct of the research;

(9) the name of the sponsor or funding source, if any, or manufacturer if the research involves a drug or device, and the organization, if any, under whose general aegis the research is being conducted;

(10) the name, address, and phone number of an impartial third party, not associated with the research, to whom the subject may address complaints about the research ²and the contact information for the institutional review board connected with the research²; and

(11) the material financial stake or interest, if any, that the investigator or research institution has in the ²[outcome of the]² research. For purposes of this section, “material” means $10,000 or more in securities or other assets valued at the date of disclosure, or in relevant cumulative salary or other income, regardless of when it is earned or expected to be earned or as otherwise determined by the research institution.

b. The subject or his guardian or authorized representative, as applicable, has signed and dated a written consent form.

c. The written consent form is signed and dated by ²[any] a² person ²[other than] , who is not² the subject ²[or],² his guardian or authorized representative, or the researcher, and² who can attest that the requirements for informed consent to the medical research have been satisfied.

d. Consent is given voluntarily and freely by the subject or his guardian or authorized representative without the intervention of ²[any element of]² force, fraud, deceit, duress, coercion or undue influence.

5. a. For purposes of obtaining informed consent required for medical research ²[in a non-emergency room environment]², 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) ²[the health care representative of the subject pursuant to an advance directive for health care;

(2)]² the guardian of the subject who has the authority to make health care decisions for the subject;

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

(3) the spouse ¹or civil union partner, as applicable,¹ 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. ²[For purposes of obtaining informed consent required for medical research in an emergency room environment, 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 who is any of the following persons, in the following descending order of priority:

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

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

(3) the spouse ¹or civil union partner, as applicable,¹ 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.] 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.²

c. For the purposes of ²[subsections a. and b. of]² 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 ²[exercise substituted judgment, and base] make² 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, ²or if the instructions or wishes do not clearly indicate what decision should be made,² he shall make the decision in accordance with the subject’s ²[best interests. In determining the subject’s best interests, the authorized representative shall consider the subject’s]² 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 ²[that benefits] with respect to² 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 ²[apply to an adult in a terminal condition who executes] override² an advance directive for health care ²[directing the withholding or withdrawal of life-sustaining procedures] executed² pursuant to P.L.1991, c.201 (C.26:2H-53 et seq.).

6. This act shall take effect immediately.