§ 121.6 - Organ procurement.

§ 121.6 Organ procurement.

The suitability of organs donated for transplantation shall be determined as follows:

(a) Tests. An OPTN member procuring an organ shall assure that laboratory tests and clinical examinations of potential organ donors are performed to determine any contraindications for donor acceptance, in accordance with policies established by the OPTN.

(b) HIV.

(1) Organs from individuals infected with human immunodeficiency virus (HIV) may be transplanted only into individuals who -

(i) Are infected with HIV before receiving such organ(s); and

(ii)

(A) Are participating in clinical research approved by an institutional review board, as defined in 45 CFR part 46, under the research criteria published by the Secretary under subsection (a) of section 377E of the Public Health Service Act, as amended; or

(B) The Secretary has published, through appropriate procedures, a determination under section 377E(c) of the Public Health Service Act, as amended, that participation in such clinical research, as a requirement for transplants of organs from individuals infected with HIV, is no longer warranted.

(2) Except as provided in paragraph (b)(3) of this section, the OPTN shall adopt and use standards of quality with respect to organs from individuals infected with HIV to the extent the Secretary determines necessary to allow the conduct of research in accordance with the criteria described in paragraph (b)(1)(ii)(A) of this section.

(3) If the Secretary has determined under paragraph (b)(1)(ii)(B) of this section that participation in clinical research is no longer warranted as a requirement for transplants of organs from individuals infected with HIV, the OPTN shall adopt and use standards of quality with respect to organs from individuals infected with HIV as directed by the Secretary, consistent with 42 U.S.C. 274, and in a way that ensures the changes will not reduce the safety of organ transplantation.

(c) Acceptance criteria. Transplant programs shall establish criteria for organ acceptance, and shall provide such criteria to the OPTN and the OPOs with which they are affiliated.

[63 FR 16332, Apr. 2, 1998, as amended at 64 FR 56659, Oct. 20, 1999; 80 FR 26467, May 8, 2015]