Research and adults without capacity

For more information, see Sheather J. The Mental Capacity Act 2005. Clin Ethics 2006; 1:33–6. The Act and its accompanying Code of Practice contain further advice and information on assessing capacity

For Scotland, see the Adults with Incapacity (Scotland) Act 2000. There is no specific legislation dealing with adults without capacity and medical research in Northern Ireland

s 2(5) and s 1(2), respectively

s 2(4)

s 2(1)

s 3(1)

We will consider best interests further in our FMF in volume 5(4) of this journal. For an ethical discussion, see Slowther A. Determining best interests in patients who lack capacity to decide for themselves. Clin Ethics 2007; 2:19–21

Medicines for Human Use (Clinical Trials) Regulations, SI 2004/ 1031

National Research Ethics Service (NRES), Standard Operating Procedures for Research Ethics Committees, version 4.0, April 2009, para. 3. See http://www.nres.npsa.nhs.uk/news-and-publications/publications/standard-operating-procedures/ (last checked 30 April 2010)

Regulation 12(3)(a). For further information on ethics committees, see Regulations 5-16 and Schedules 2-4, as amended

Regulation 12(3)(b). See further Regulations 12 and 17-27, as amended

Schedule 1, Part 1, paragraph 2

Regulation 15(7)

Regulation 15(5)(h)

s 30(3)

s 30(2)

Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 2006, SI 2006/2810

See http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalas-sets/@dh/@en/documents/digitalasset/dh_4058609.pdf (last checked 30 April 2010). A new edition of this is expected following consultations during 2009

Department of Health, ‘The Mental Capacity Act and research’ (2009): See http://www.dh.gov.uk/en/SocialCare/Deliveringadultsocialcare/MentalCapacity/MentalCapacityAct2005/DH_078789 (last checked 30 April 2010)

NRES. See http://www.nres.npsa.nhs.uk/ (last checked 30 April 2010)

An ‘impairing condition’ is ‘a condition which is (or may be) attributable to, or which causes or contributes to (or may cause or contribute to), the impairment of, or disturbance in the functioning of, the mind or brain’, s 31(3)

s 32(3)

See s 32(8)-(10)

In England, Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007, SI 2007/679

s 42(4); Department for Constitutional Affairs, Mental Capacity Act Code of Practice (2007)

Biggs H. Healthcare Research Ethics and Law - Regulation, Review and Responsibility. Oxford: Routledge Cavendish, 2009:137

Department for Constitutional Affairs. Mental Capacity Act Code of Practice (2007) See http://www.dca.gov.uk/legal-policy/mentalcapacity/mca-cp.pdf

Department of Health, ‘The Mental Capacity Act and research’ (2009): http://www.dh.gov.uk/en/SocialCare/Deliveringadultsocialcare/MentalCapacity/MentalCapacityAct2005/DH_078789

Department of Health Scientific Development and Bioethics Branch. Guidance on Nominating a Consultee for Research Involving Adults Who Lack Capacity (2008) See http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_083133.pdf

Healthcare Biggs H. Research Ethics and Law - Regulation Review and Responsibility. Oxford: Routledge Cavendish, 2009