(1) Right 7 set out in clause 2 of the Schedule of the principal regulations is amended by revoking subclause (10), and substituting the following subclause:
“(10) No body part or bodily substance removed or obtained in the course of a health care procedure may be stored, preserved, or used otherwise than—“(a) with the informed consent of the consumer; or“(b) for the purposes of research that has received the approval of an ethics committee; or“(c) for the purposes of 1 or more of the following activities, being activities that are each undertaken to assure or improve the quality of services:—“(i) a professionally recognised quality assurance programme:“(ii) an external audit of services:“(iii) an external evaluation of services.”
“(10) No body part or bodily substance removed or obtained in the course of a health care procedure may be stored, preserved, or used otherwise than—
“(a) with the informed consent of the consumer; or
“(b) for the purposes of research that has received the approval of an ethics committee; or
“(c) for the purposes of 1 or more of the following activities, being activities that are each undertaken to assure or improve the quality of services:—
“(i) a professionally recognised quality assurance programme:
“(ii) an external audit of services:
“(iii) an external evaluation of services.”
(2) Clause 4 of the Schedule of the principal regulations is amended by inserting, after the definition of duties, the following definition:
“ethics committee means an ethics committee—“(a) established by, or appointed under, an enactment; or“(b) approved by the Director-General of Health”.
“ethics committee means an ethics committee—
“(a) established by, or appointed under, an enactment; or
“(b) approved by the Director-General of Health”.