Statutory Instruments
MEDICAL PROFESSION
Made
14th November 1989
Laid before Parliament
15th November 1989
Coming into force
1st April 1990
In exercise of powers conferred by section 2(2) of the Human Organ Transplants Act 1989(1) and of all other powers enabling me in that behalf, I hereby make the following Regulations:
1.-(1) These Regulations may be cited as the Human Organ Transplants (Establishment of Relationship) Regulations 1989 and shall come into force on 1st April 1990.
(2) In these Regulations-“
"donor" means a living person from whom an organ is proposed to be removed which is intended to be transplanted into another person and "recipient" means the person into whom the organ is intended to be transplanted;
"tester" means a person approved by the Secretary of State to carry out the tests described in regulation 2 of these Regulations.
2.-(1) The means by which the fact of a genetic relationship is to be established for the purposes of section 2 of the Human Organ Transplants Act 1989 are the carrying out by a tester of the appropriate tests described in paragraph (2) of this regulation.
(2) The tester shall carry out on the donor and the recipient and on such relatives of each as appear to the tester to be necessary-“
(a)tests for the antigenic products of the Human Major Histocompatibility system HLA-A, HLA-B and HLA-DR, using conventional serological techniques, and
(b)tests to establish HLA-DR beta and HLA-DQ beta gene restriction fragment length polymorphisms, and
(c)where the tests in the preceding sub-paragraphs do not establish a genetic relationship between the donor and the recipient, tests to establish DNA polymorphisms, using at least 2 multi-locus gene probes, and
(d)where the tests in the preceding sub-paragraphs do not establish a genetic relationship between the donor and the recipient, further tests to establish DNA polymorphisms, using at least 5 single locus polymorphic probes.
Kenneth Clarke
One of Her Majesty's Principal Secretaries of State
14th November 1989
(This note is not part of the Regulations)
These Regulations provide that the genetic relationship between proposed living donors of human organs and proposed recipients is to be established in each case by persons approved for that purpose by the Secretary of State using tests specified in the Regulations.