New York Codes, Rules and Regulations
Title 14 - DEPARTMENT OF MENTAL HYGIENE
Chapter XXI - OFFICE OF ALCOHOLISM AND SUBSTANCE ABUSE SERVICES
Part 815 - Patient Rights
Section 815.11 - Research subjects

Universal Citation: 14 NY Comp Codes Rules and Regs ยง 815.11

Current through Register Vol. 46, No. 39, September 25, 2024

(a) A person may participate only in research which does not conflict with their individual treatment / recovery plan. Participation as a "subject at risk" in any research project or activity shall not deprive any patient of the rights, privileges, and protections provided to all patients by this Part. "Subject at risk" means any individual who may be exposed to the possibility of injury, including physical, psychological or social injury, as a consequence of participation as a subject in any research, development or related activity which departs from the application of those established and accepted methods necessary to meet their needs or which increases the risks of daily life. The research project or activity must be approved by an independent institutional review board and the approval kept on file.

(b) Participation in any research project or activity and informed written consent.

(1) The informed written consent of a patient who participates as a subject at risk in any human subjects' research project shall be obtained in accordance with 45 Code of Federal Regulations Part 46.

(2) Prior to seeking consent required above, approval of any research placing human subjects at risk must be secured in accordance with 45 Code of Federal Regulations Part 46.

(3) Research projects which involve placing patients admitted to or enrolled in an addiction service at risk must be reported to the Office prior to initiation of the project.

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