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3.—(1) The 2000 Regulations are amended as follows.
(2) In regulation 2 (interpretation) in paragraph (1)—
(a)in the definition of “appropriate authority”, for “Secretary of State” substitute “the Commission for Healthcare, Audit and Inspection established under section 41 of the Health and Social Care (Community Health and Standards) Act 2003(1)”;
(b)after the definition of “equipment” insert the following definition—
““ethics committee” means:
an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004(2),
the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000(3), or
any other committee established to advise on the ethics of research investigations in human beings, and recognised for that purpose by or on behalf of the Secretary of State, the National Assembly for Wales or Scottish Ministers;”;
(c)the definition of “Local Research Ethics Committee” is omitted;
(d)in the definition of “practitioner”, for “medical practitioner, dental practitioner or other health professional” substitute “health care professional”;
(e)in the definition of “referrer”, for “medical practitioner, dental practitioner or other health professional” substitute “health care professional” and replace the full-stop with a semi-colon;
(f)after the definition of “referrer” insert the following definition—
““registered health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002.”.
(3) In regulation 6 (justification of individual medical exposures), in paragraph (1)(c), for “a Local Research Ethics Committee” substitute “an ethics committee”.
(4) In regulation 11 (training), in paragraph (4), after “record of” insert “all training undertaken by”.
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