For health care: written informed consent required, in terms and language appropriate to the patient's condition and ability to understand, explaining plan of care, expected results, alternatives, the patient's general mental and physical condition, objectives of patient's treatment, reasons why particular treatment is considered. New Jersey Administrative Code 8:42-13.1b; N.J.Ad.C. 8:43G-4.1, N.J.Ad.C. 8:43G-5.2 (hospitals).
For experimental research: written informed consent required. N.J.St. 30:4-24.2 (mental institutions), N.J.St. 30:13-5 (nursing homes), N.J.St. 30:4-27.11d (short-term mental facilities), N.J.St. 26:2H-12.8 (hospitals), N.J.St. 30:6D-5 (facilities for developmentally disabled), N.J.Ad.C. 8:43A-16.2 (ambulatory care facilities), N.J.Ad.C. 8:43G-4.1 (hospitals), N.J.Ad.C. 8:42-13.1 (home health agencies), N.J.Ad.C. 8:42C-5.1 (hospice), N.J.Ad.C. 10:37-4.5 (mental health programs).
For medication by school for experimental purposes: written consent of parent/guardian and physician is required. N.J.St. 18A:6-1.1.
Hospital patients must be advised if the hospital proposes to engage in human research and have the right to refuse participation. N.J.St. 26:2H-12.8.
Informed consent required prior to treatment in a hospital, including description of procedure, significant risks, alternatives, duration of incapacitation, and significance of informed consent. N.J.St. 26:2H-12.8.
Informed consent required for medical treatment of inmates. N.J.Ad.C. 10A:16-2.19, N.J.Ad.C. 10A:16-5.1, N.J.Ad.C. 10A:31-13.28.
The conditions that must be met for informed consent are listed in N.J. St. 26:14-4.
New Jersey Statutes Annotated Currentness
Title 26. Health and Vital Statistics (Refs & Annos)
Chapter 14. Access to Medical Research
26:14-5. Consent by persons unable to give consent; surrogate consent
If an individual is unable to consent and does not express dissent or resistance to participation in research, 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 descending order of priority:
the guardian of the subject who has the authority to make health care decisions for the subject;
the health care representative of the subject pursuant to an advance directive for health care;
the spouse or civil union partner, as applicable, of the subject;
the domestic partner, as defined in section 3 of P.L.2003, c. 246 (C.26:8A-3), of the subject;
an adult son or daughter of the subject;
a custodial parent of the subject;
an adult brother or sister of the subject;
an adult grandchild of the subject;
an available adult relative with the closest degree of kinship to the subject.
A person who provides surrogate consent may not receive financial compensation for providing the consent.
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.
Notwithstanding a determination of incapacity, 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.
The requirement for obtaining informed consent for medical research does not apply to any research with respect to a person who is subject to a life-threatening emergency in accordance with the conditions in 21 C.F.R. �§50.24 and may be altered or waived in accordance with the conditions in 45 C.F.R. �§46.116(d). N.J.St. 26:14-5
The Access to Medical Research Act" (A-2379/S-1757) was signed into law in New Jersey on Jan. 14. The bill authorizes adult family members or health care representatives empowered by an advance directive for health care to make decisions concerning medical research for individuals with cognitive impairments, lack of capacity, or serious physical or behavioral conditions and life-threatening diseases. The law establishes a hierarchy for authorized informed consent: a guardian who has the authority to make health care decisions for the subject; the subjectâ??s health care representative under an advance directive for health care; the spouse or civil union partner; the domestic partner as defined by New Jersey law; an adult son or daughter; a custodial parent; an adult brother or sister; an adult grandchild; and an available adult relative with the closest degree of kinship to the subject. The law states that if a recognized treatment exists, the subject, guardian or authorized representative must be given the choice of the recognized treatment and the research protocol. Institutional review board and informed consent requirements also are detailed in the law.
Power of attorney. New Jersey Statutes 46:2B-8.2 (section should be interpreted as conveying authority to make medical decisions.) Matter of Peter by Johanning, 529 A2d 419 (N.J. 1987).
Guardian for mentally incompetent. N.J.St. 3B:12-57, N.J.St. 3B:12-69.
Guardian for minor. N.J.St. 3B:12-69. CEO of correctional institution, for juvenile inmates or for residents of mental institutions or who have developmental disabilities, where no parent or guardian is available. N.J.St. 30:4-7.1, N.J.St. 30:4-7.2. Medical guardian for prisoners. New Jersey Administrative Code 10A:16-5.4. Special medical guardian. N.J. R. Super. Tax Surr. Cts. Civ. R. 4:86-12.
Advance directive/health care representative. N.J.St. 26:2H-55, N.J.St. 26:2H-61, N.J.St. 26:2H-63.
Public guardian for elderly. N.J.St. 52:27G-26. Bureau of Guardian Services cannot consent to medical experimentation; matter must be referred to court. N.J.Ad.C. 10:45-5.2.
Genetic information is personal and should not be collected, retained or disclosed without the individual's authorization and informed consent, except for anonymous research where the person's identity will not be released. New Jersey Statutes 10:5-44, N.J.St. 10:5-45, N.J.St. 10:5-46, N.J.St. 10:5-47.
A DNA sample from a research subject shall be destroyed promptly upon completion of the project or the person's withdrawal from the study, unless otherwise directed by the person. NJ Stat. 10:5-46.
Any disclosure of genetic testing records shall include a notice that the information may not be further disclosed without written consent. N.J.St. 10:5-48.
Age of majority: 18 years. New Jersey Statutes 9:17B-4. Minors if married. N.J.St. 9:17A-1.
Health care facilities participating in experimental research involving residents must comply with HHS regulations. New Jersey Administrative Code 13:39-9.5.
No medical or pharmaceutical experiments or research shall be conducted with inmates or parolees of the Dept. of Corrections, except by court order or other legal process or for the inmate's own treatment needs. N.J.Ad.C. 10A:1-10.1, N.J.Ad.C. 10A:16-2.20.
Under a consensus agreement (http://www.state.nj.us/health/ccr/resourcebook/rb99k.htm), all insurers in the state, including those affiliated with the New Jersey Association of Health Plans, must cover all phases of cancer clinical trials run by NIH; NIH cooperative group or center; FDA; U.S. Department of Defense; or U.S. Department of Veterans Affairs.
Insurers will cover practitioner fees, laboratory expenses and expenses associated with hospitalization, administering of treatment and evaluation of the covered persons during the course of treatment or a condition associated with a complication of the underlying disease or treatment, which are consistent with usual and customary patterns and standards of care incurred whenever a covered person receives medical care associated with an approved cancer clinical trial. The insurer will cover charges for such items and services only if they would be covered for care and treatment in a situation other than an approved cancer clinical trial. The insurer provides coverage of routine patient costs for items and services furnished in connection with participation in the clinical trial. Insurers do not cover the cost of investigational drugs or devices, the cost of any non-health services that might be required for a covered person to receive the treatment or intervention, or the costs of managing the research, or any costs which would not be covered under the policy for treatments that are not experimental or investigational. The coverage applies to covered persons who are eligible to participate in an approved Phase 1-4 clinical trial. The insurer provides coverage for the clinical trial if the covered person's practitioner is participating in the clinical trial and has concluded that the covered person's participation would be appropriate; or the covered person provides medical and scientific information establishing that his or her participation in the clinical trial would be appropriate. The insurer will not deny a qualified Covered Person participation in an approved clinical trial with respect to the treatment of cancer or another life-threatening disease or condition. The insurer also will not deny or limit or impose additional conditions on the coverage of routine patient costs for items and services furnished in connection with participation in the clinical trial. Insurers also will not discriminate against covered persons on the basis of the individualâ??s participation in the clinical trial. N.J.A.C. T. 11:21
Under the regulations for Small Employer Health Benefit Plans, if a covered individual is participating in a National Cancer Institute sponsored clinical trial, the carrier will reduce benefits by 50 percent with respect to charges for such treatment of breast cancer which are not pre-approved by the carrier provided that benefits would otherwise be payable under the policy. N.J.A.C. 11:21
The state has specific procedures for the transfer of data and tissue samples from deceased infants or young children by medical examiners for Sudden Infant Death Syndrome research. N.J.St. 52:17B-88.11
Managed Care Organizations must permit participation in an approved clinical trial to a qualified enrollee and may not deny the enrollee participation in an approved clinical trial in which the enrollee is eligible to participate with respect to the treatment of his or her illness. Participation in clinical trials or the provision of investigational/experimental treatment is based on the referral of the treating physician to an internal review group that is not associated with the case or the referral center and, if denied, is then reviewed by a second, ad hoc group with a minimum of two experts in the field who are also not directly involved with the case. N.J.A.C. 10:74-3.3
Investigational drugs may be used by scientific experts provided the drug is labeled For investigational use only." New Jersey Statutes 24:6A-1. The storage/dispensing of investigational drugs in a health care facility shall be conducted by the pharmacist, cooperating with the principal investigator. New Jersey Administrative Code 13:39-9.5.
Hospital patients have a right to privacy and confidentiality of all records pertaining to treatment except as otherwise provided by law or third party payment contract. New Jersey Statutes 26:2H-12.8.
Patient records shall not be released to anyone outside the hospital without the patient's approval, except for statistical studies where the patient's identity is masked. New Jersey Administrative Code 8:43G-4.1.
Data and information pertaining to the diagnosis, treatment or health of any enrollee or applicant obtained from the individual or provider is confidential and may not be disclosed except to carry out the purposes of this Act or upon express consent of the enrollee or applicant. N.J.St. 26:2J-27.
Disclosure of certain patient information by organized delivery systems for research purposes permitted. N.J.P.L. 2001, Ch. 112.
Information related to the diagnosis, treatment or health, prospective enrollee or contract holder obtained by an organized delivery system may not be disclosed except with his/her express consent or for epidemiological and outcomes research when identities are protected, or with informed consent, for IRB-approved research. N.J.St. 17:48H-30.
Physicians who diagnose a person with HIV or AIDS shall report it within 24 hours to the Dept. of Health, including the physician's name and address, the patient's name, address, gender, race, and birth date, and the date of onset or date specimen was obtained. New Jersey Administrative Code 8:57-2.3; N.J.Ad.C. 8:57-2.2.
Any clinical lab which tests for AIDS or HIV must report positive tests to the Dept. of Health within five days, including the name and address of the lab, the name and address of the physician, and any identifying information available for the test subject. New Jersey Statutes 26:5C-6; N.J.Ad.C. 8:57-2.3, N.J.Ad.C. 8:57-2.2.
Any lab at which a sample tests positive for an STD must report it to the Dept. of Health within 72 hours, including the lab's name, address, and phone; the name, age, sex, and address of the test subject; the test performed; the date of testing; the test results; and the health care provider's name and address. N.J.Ad.C. 8:57-1.6.
Patient records regarding AIDS/HIV status or testing may be released only with the patient's written informed consent. Without consent, such records may be released only for IRB-approved scientific research provided the researchers shall not disclose the person's identity in any manner. N.J.St. 26:5C-8.
Minors can consent to medical care for venereal disease. Parents may be informed without minor's consent. Parental consent shall be obtained to release the HIV records of a minor under 12. N.J.St. 9:17A-4, N.J.St. 9:17A-5, N.J.St. 26:5C-13, N.J.St. 26:5C-5.
No current requirement.
