Explanatory note

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.