1. Understanding the Mental Capacity Act David Neal Head of Policy, NRES

2. Content Core principles Scope of research provisions Approval criteria for “intrusive research” under section 30 Procedures and transitional issues Loss of capacity during the project Sources of further information and advice

3. Core principles People must be assumed to have capacity unless established otherwise Individuals should be helped to make their own decisions Assessment of capacity depends on the decision to be taken at a particular time Recognition that people move in and out of capacity Statutory “best interests” checklist: –Respect wishes, feelings, beliefs, values & written advance statements –All acts must be the least restrictive of a person’s rights and freedom of action

4. Scope of research provisions The Act applies in England and Wales only. The research provisions (sections 30-34) apply to any “intrusive research” involving participants who cannot consent due to physical or mental incapacity. Includes research in social care and other fields as well as NHS research. CTIMPs specifically excluded as separate provision is made in the Clinical Trial Regulations.

5. The research provisions Sections 30-33 provide lawful authority for intrusive research to be carried out involving people without capacity s.30 – Intrusive research s.31 – Requirements for approval s.32 – Consulting carers etc. s.33 – Additional safeguards Section 34 makes transitional provisions relating to loss of capacity in research started before 1 October 2007 Section 42(4) – duty to have regard to Code of Practice

6. Section 30 Intrusive research involving a person who lacks capacity is unlawful unless it is approved by an “appropriate body”. “Appropriate body” to be specified in Regulations.

7. What is “intrusive research”? Research is intrusive if it is of a kind that would be unlawful if it was carried out “on or in relation to a person who had capacity to consent to it, but without their consent”. Includes “non-interventional” research such as observations where consent is legally required. Covers health, social care and potentially other types of research (but CTIMPS excluded).

8. Is consent legally required? Consent is not a legal requirement – and so MCA does not apply - where research involves only: –Non-identifiable data –“Existing holding” of tissue (prior to 1 September 2006) –Non-identifiable tissue from the living –Processing of identifiable data with approval of Patient Information Advisory Group (PIAG)

9. What is an appropriate body? Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 2006 and parallel regulations for Wales Appropriate body is a REC recognised by the Secretary of State or Welsh Ministers. All NHS RECs in England and Wales are recognised. Plans for a national Social Care REC with MCA recognition. University ethics committees are not recognised.

10. Section 31 – approval criteria 1. Research must be connected with an impairing condition affecting P or its treatment. 2. Research of equal effectiveness cannot be carried out if confined to participants with capacity. 3. (a) Research must have the potential to benefit P without imposing a disproportionate burden, or (b) Provide knowledge of the causes or treatment of others with same condition, and involve negligible risk to P, not interfere significantly with freedom of action or privacy, or be unduly invasive or restrictive. 4. Arrangements are in place to comply with s.32 and 33.

11. Section 32 – consulting carers Researcher must seek advice from a carer or another person (“consultee”) on whether P should take part and what P’s wishes and feelings would be. The consultee gives advice not consent. Under the MCA there is no “consent” representing the presumed will of the participant in law.

12. Consulting carers (2) Researcher must take reasonable steps to identify a personal consultee. A “personal consultee” means a person who is (a) engaged in caring for P (not professionally or for payment) or is interested in his/her welfare, and (b) is prepared to be consulted. If no personal consultee can be found, the researcher may consult a nominated consultee, i.e. a person independent of the project appointed in accordance with DH guidance.

13. Consulting carers (3) Consultee must be given information about the project and advise on what P’s wishes and feelings would be. Advice of consultee must be respected. If consultee so advises, P must not take part and, if already taking part, must be withdrawn unless withdrawal of treatment would involve significant risk to P’s health. In an emergency, P may be treated with agreement of a doctor who is not connected with the project, or in accordance with a procedure agreed by the REC.

14. Section 33 – additional safeguards 1.Nothing must be done to which P appears to object unless it is to protect him from harm, or reduce or prevent pain or discomfort. 2.If P indicates he/she wishes to be withdrawn, this must be done without delay unless there would be a significant risk to health. 3.Any advance statement by P must be respected. 4. Interests of P must be assumed to outweigh those of science and society.

15. s.30-33 – approval process All new projects allocated to flagged RECs via CAS. Existing ethically approved projects have until 1 October 2008 to comply. Projects planning to continue beyond 1 October 2008 may opt to submit either a “Supplementary Application” to the main REC or a new application to a flagged REC. Research conducted in England/Wales and Scotland require separate approvals.

16. Approval process (2) New applications – full application including the new Part B Section 7. “Supplementary applications” - Notice of Amendment, plus supplementary form MCA1 and revised study documentation. 60 day clock both for new and supplementary applications. Additional statement in opinion letters.

17. Loss of capacity in research starting after 1 October 2007 Key principle: consent does not generally endure loss of capacity in common law Intrusive research following loss of capacity either requires specific consent in advance or section 30 MCA approval

18. Loss of capacity - options 1.Withdraw participant, destroy or anonymise data/tissue – no further implications 2.Withdraw participant, retain identifiable data/tissue already collected – requires specific advance consent anticipating loss of capacity 3.Participant remains in study, undergoes further intrusive research – requires section 30 approval.

19. Section 34 – loss of capacity in existing research Section 34 makes transitional provisions for existing projects involving people with capacity who later lose it Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2006 The Regulations apply where (a) The project started before 1 October 2007, and (b) P consents to take part in the project before 31 March 2008 but loses capacity before the end of the project Section 34 approval makes it lawful to continue to use tissue or data taken with consent before loss of capacity.

20. Section 34 – approval criteria Protocol must be approved by a REC. Researcher must seek advice from a consultee about participant’s presumed wishes and feelings. P’s tissue/data must be withdrawn if consultee so advises or if P indicates he wishes research to be discontinued. Do not have to actively monitor capacity – it may be assumed (refers back to core principles). S.34 approval only allows for continued use of tissue/data already collected. Subsequent intrusive research would require s.30 approval.

21. Section 34 – approval process Researcher submits Notice of Amendment to the main REC for the study with supplementary form MCA2, revised protocol and information sheet for consultee 35 day clock Additional statement in opinion letters

22. MCA and children Where children cannot consent due to immaturity – parental consent applies under common law Where children aged 12 or over would normally be able to give Gillick consent but cannot consent due to an impairing condition – MCA applies, requires section 30 approval, parents are consulted but do not give consent

23. Sources of guidance (1) Key reading in MCA Code of Practice: Chapter 2Core principles Chapter 3Helping people make decisions Chapter 4Assessing capacity Chapter 11Research

24. Sources of guidance (2) Suite of guidance to be published shortly by DH: Appointment of consultees under s.32 Scope of the research provisions, consent and loss of capacity MCA and children

25. Sources of guidance (3) Information and guidance on NRES website: Section 12 of SOPs Guidance on applying for MCA approval Summary of s.30/34 approval criteria Links to the Act and Code of Practice http://www.nres.npsa.nhs.uk/recs/guidance/guidance.htm#awi

26. Thanks for listening – questions welcome David Neal Head of Policy, NRES david.neal@nationalres.org.uk www.nres.npsa.nhs.uk