Statutory Instruments
mental capacity, england
Made
21st October 2006
Laid before Parliament
27th October 2006
Coming into force
for the purpose mentioned in regulation 1(1)(a)
1st February 2007
for all other purposes
1st April 2007
The Secretary of State for Health makes the following Regulations, in exercise of the powers conferred upon her by sections 30(4) and 30(6)(a) of the Mental Capacity Act 2005(1).
1.—(1) These Regulations may be cited as the Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 2006 and shall come into force on—
(a)1 February 2007 for the purpose of enabling applications for approval in relation to research to be made to, and determined by, an appropriate body,
(b)1 April 2007 for all other purposes.
(2) These Regulations apply in relation to the carrying out of research in England.
2. In relation to a research project referred to in sections 30, 31 and 32 of the Mental Capacity Act 2005, the appropriate body is a committee—
(a)established to advise on, or on matters which include, the ethics of intrusive research in relation to people who lack capacity to consent to it; and
(b)recognised for that purpose by the Secretary of State.
Signed by authority of the Secretary of State for Health
Rosie Winterton
Minister of State
Department of Health
21st October 2006
(This note is not part of the Regulations)
These Regulations are made under section 30(4) of the Mental Capacity Act 2005 (“the Act”)(c.9) and define ‘appropriate body’ for the purposes of sections 30 to 32 of that Act. Section 30(1) of that Act provides that certain research carried out on or in relation to a person without capacity is unlawful unless it is carried out as part of a project which is approved by an appropriate body and satisfies further requirements specified in the Act.
Regulation 1 provides that these Regulations apply in relation to research carried out in England. Regulation 1 further provides for the Regulations to come into force on 1 February 2007 for the purposes of enabling applications for ethical approval of research to be made and determined under the Act and on 1 April 2007 for all other purposes.
Regulation 2 defines an appropriate body as a committee which is established to advise on, or on matters which include, the ethics of intrusive research in relation to people who lack capacity to consent to it and which is recognised for that purpose by the Secretary of State.
A Regulatory Impact Assessment was prepared for the Mental Capacity Act 2005 and a copy has been placed in the library of each House of Parliament. Copies are published on the Department of Health’s website (www.dh.gov.uk) and can be obtained from Room 604, Wellington House, Waterloo Road, London, SE1 8UG.