Findings, declarations relative to causes of deaths, sudden deaths.

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26:6B-14 Findings, declarations relative to causes of deaths, sudden deaths.

14. a. The Legislature finds and declares that: advances in genetics, biochemistry, and other areas of medical research have yielded, and continue to yield, new information about the specific causes of death and sudden death, including in the areas of sudden infant death syndrome and sudden, unexpected death in epilepsy (SUDEP); and it is in the public interest to accelerate research efforts to identify actual causes of death. The Legislature further finds and declares that there is a need to enhance awareness among medical examiners with respect to various diseases and types of death, and there is value to be had in establishing awareness programs that would address knowledge deficiencies in this area.

b. The Chief State Medical Examiner shall establish a Research Oversight Committee to assist in developing and reviewing the research protocols required by this section. The committee shall include five members, as follows: the Chief State Medical Examiner; the commissioner; a person with expertise in ethics, who may also be a member of the department's Institutional Review Board; an attorney; and an epidemiologist.

c. The Chief State Medical Examiner, in consultation with the commissioner and the Research Oversight Committee established pursuant to this section, shall establish, and periodically revise as necessary, protocols for participation by medical examiners in research activities concerning deaths, including, but not limited to, the deaths of children three years of age and younger, and sudden, unexpected deaths in epilepsy. The research shall include all autopsies in which the suspected cause of death is not considered a violent death that is subject to the provisions of subsection a. of section 10 of this act.

(1) The research protocols developed pursuant to this section shall authorize the Chief State Medical Examiner, Deputy Chief State Medical Examiner, county or intercounty medical examiner, or other authorized person to take and transfer tissue samples to an approved research project prior to obtaining the ordinary consent necessary to engage in such taking and transfer, but the research project shall not be permitted to use the tissue before appropriate consent is obtained.

(2) Notwithstanding the provisions of this section to the contrary, the protocols developed pursuant to this section shall provide that no tissue sample shall be taken from a deceased person who has objected, or from a deceased minor whose parent or legal guardian has objected, to an autopsy because it is contrary to the religious beliefs of the decedent in accordance with the provisions of this act.

(3) The protocols developed pursuant to this section shall stipulate, at a minimum, that:

(a) the research project is to first be approved by the institutional review board of the facility at which the research is to be conducted, and then by the Research Oversight Committee established pursuant to this section, and finally by the Institutional Review Board of the department; except that, if a research project is submitted by the department, the final review of the project is to be conducted by an independent review board;

(b) the research project is to delineate the information, other than the tissue sample, that will be required from the investigation of the death;

(c) the research project is to develop a plan for the release by the Chief State Medical Examiner or county or intercounty medical examiner, as applicable, of a decedent's tissue, as well as the obtaining of written consent for the use of the tissue and the decedent's other identifying information;

(d) the research project is to develop a plan that provides for the disposal of a decedent's tissue in the event that consent is not obtained for use of the tissue, and for disposal of the decedent's tissue upon completion of the research in those cases in which consent is obtained; and further, which incorporates accepted procedures for disposal of surgical biopsies and biohazardous materials, and procedures to inform the deceased's family members, as well as the Research Oversight Committee, of the disposal plan;

(e) the research project is to reimburse the Chief State Medical Examiner, Deputy Chief State Medical Examiner, county or intercounty medical examiner, or other authorized person participating in the research for any reasonable costs incurred in taking, storing, and providing tissue samples for the project; and estimated costs subject to reimbursement are to be reviewed and approved by the Chief State Medical Examiner;

(f) the research project is to provide the Chief State Medical Examiner and the Research Oversight Committee with periodic updates on the status of the project; and

(g) the Research Oversight Committee may terminate a research project that is not in compliance with either the provisions of this subsection or the provisions of the proposal for that research project that was approved pursuant thereto.

(4) Upon receiving notification from the research project that the research project has obtained written consent for the use of tissue samples and identifying information, the Chief State Medical Examiner, Deputy Chief State Medical Examiner, county or intercounty medical examiner, or other authorized person, as applicable, shall provide the research project with copies of the autopsy reports and any reports generated by the Chief State Medical Examiner, Deputy Chief State Medical Examiner, or county or intercounty medical examiner concerning the subject of the research.

(5) The information and tissue samples provided to the research project by the Chief State Medical Examiner, Deputy Chief State Medical Examiner, county or intercounty medical examiner, or other authorized person, shall be used by the research project only for the purposes approved by the Research Oversight Committee and as specified in the protocol, and shall not otherwise be divulged or made public so as to disclose the identity of any person to whom they relate. The information provided to the research project shall not be considered a public or government record pursuant to P.L.1963, c.73 (C.47:1A-1 et seq.) or P.L.2001, c.404 (C.47:1A-5 et al.).

(6) The Research Oversight Committee shall oversee each research project approved pursuant to this subsection.

d. The Chief State Medical Examiner, in consultation with the commissioner and the State Board of Medical Examiners, shall, as deemed appropriate, establish awareness programs to educate medical examiners in the State about various types of death, including, but not limited to, sudden infant death syndrome, and sudden, unexpected deaths in epilepsy.

L.2018, c.62, s.14.


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