N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-11.3

Current through Register Vol. 46, No. 45, November 2, 2024

Section 52-11.3 - Informed consent

(a) Nontransplant anatomic banks that recover bodies, body segments, organs or tissues from deceased donors, including whole body acquisition services, shall obtain documented informed consent to the donation from a person authorized to consent to such donation in accordance with Public Health Law, section 4301, or, for recoveries outside New York State, applicable statutes in the state where the nontransplant anatomic parts were recovered.

(b) Nontransplant anatomic banks that recover body segments, organs or tissues from living donors shall obtain documented informed consent from the donors.

(c) If specific direction is not provided in the consent document, it shall be presumed that whole bodies, body segments, and other nontransplant anatomic parts have been donated to entities authorized to receive the bodies of deceased persons pursuant to subdivision (1) of Public Health Law section 4211 and in accordance with the priorities established therein. Such entities may transfer or authorize the transfer of whole bodies, body segments and other nontransplant anatomic parts to other donees specified in subdivisions (1) and (2) of Public Health Law section 4302 for purposes of:

(1) medical or dental education;

(2) medical or dental research; and/or

(3) the advancement of medical or dental science, therapy or transplantation.

(d) The documentation of informed consent to a donation shall identify the donee, indicate whether the gift is of the whole body or is limited to specified identifiable body segments, organs or tissues, and clearly specify the authorized uses of such donated body, body segments, organs, and/or tissues. Consent obtained by telephone shall be electronically recorded or documented in writing by the nontransplant anatomic bank. Electronically recorded telephone consent shall be put in the form of written documentation of consent for donation prior to using whole bodies, body segments, organs and tissues in education and/or research.

(e) Except as provided in subdivision (c) of this section, no nontransplant anatomic bank shall use or transfer bodies, body segments or other nontransplant anatomic parts for any purpose not specified in the consent.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-11.3