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Research Ethics & Mental Capacity Act
- Janet Wisely (6 September 2007)
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There is a need for greater awareness of and training on the Mental Capacity Act (MCA) 2005 within the National Health Service (NHS).
- Jude N Chukwuma, Shuja Reagu, Chisolum I Chukwuma (5 October 2007)
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Janet Wisely, Director National Research Ethics Service
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Reid & Menon have highlighted the implications of the Mental Capacity Act 2005 which will come into force on 1 October 2007. As they pointed out, the National Research Ethics Service (NRES) is providing guidance for conducting research in incapacitated subjects (available at www.nres.npsa.nhs.uk) While Reid & Menon have encouraged NRES to include advice on the Data Protection Act 1998, it should be noted that the Department of Health is leading on providing further guidelines on the scope of the Act’s research provisions and how they relate to other legislation, especially patient data. NRES is working closely with the Department on this. Where a research participant lacks capacity to give consent to “intrusive research”, the Mental Capacity Act sets out particular approval criteria and requirements to consult with carers. Intrusive research includes any research involving the processing of identifiable data from participants lacking capacity. The approval criteria are explained in detail in the Act’s Code of Practice (issued in April 2007 by the Lord Chancellor and available at www.dca.gov.uk). The Act provides that such research has to be approved by an appropriate body, i.e. a NHS Research Ethics Committee in England or Wales. The guidance issued by NRES in June was designed mainly to describe the arrangements for researchers to access ethical review under the Act; it complemented guidance in the Code of Practice and elsewhere on the interpretation of the Act. As well as providing information to researchers both through guidelines and as part of the research ethical approval process, NRES has also provided a significant amount of training on the Mental Capacity Act to the members of Research Ethics Committees with further workshops planned. This training will be incorporated into the ongoing training provided to committees by NRES. As the Act covers a wide range of research, NRES acknowledges that there will inevitably be many specific enquiries such as that raised by Reid & Menon. For that reason, NRES endeavours to be easily accessible to specific inquiries or concerns. We therefore encourage Reid and Menon to contact us directly; we are more than happy to help and advise on such issues. Researchers can contact NRES through the queries line by emailing queries@nationalres.org.uk. The UK Clinical Research Collaboration (UKCRC) Regulatory Governance and Advice Service is another source of assistance and may be contacted using the website www.ukcrc-rgadvice.org. Janet Wisely
Competing interests: None declared |
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Jude N Chukwuma, Honorary Clinical Research Fellow School of Medicine, Swansea University, Shuja Reagu, Chisolum I Chukwuma
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The MCA 2005 (and its code of Practice) came into full force in England and Wales on October 1st 2007. The Act introduces a new Criminal Offence of ill-treatment or wilful neglect of people who lack capacity. It is crucial for individual staff members to have an appropriate level of understanding of the Act and it principles, and be able to work within its Code of Practice as appropriate. We are surprised by the poor media coverage at this crucial time of full implementation of the Act. In July 2007, barely three months before the full implementation of the Act, we undertook a survey of the awareness and training needs for the MCA 2005 within a National Health Service Trust in the United Kingdom. The aim of the survey was to gain an insight into staff members’ perceived level of preparedness and confidence for the implementation of the Act and its Code of Practice. Its objectives were to raise awareness, identify information gaps and further training needs. Our methods included a 12-item self-rated questionnaire which was administered to a stratified sample of staff working in the NHS Trust: the strata included staff working in Rehabilitation, Old age and Learning Disability Psychiatry. This population was selected by the trust’s MCA 2005 Steering Committee on the understanding that they were more likely to encounter the more vulnerable patient population in the course of their daily work. A total of 90 questionnaires were sent out, and 59 responses were received (response rate of 66%) The results revealed that only 48 of the 59 respondents (81%) reported that they were aware of the MCA 2005; 11 of the 59 respondents (19%) reported lack of awareness. 21 of 59 respondents (37%) were not aware of the date the Act was to come into force. Only 13 of 59 respondents (22%) said that they had undergone training to familiarise themselves with the Act. Common comments from respondents who had attended the available training included that training sessions were “boring” and “not tailored to individual professional needs”. Overall only 8 of the 59 respondents (13%) felt prepared and confident to implement the Act within their practice. However, more than half of the respondents (58%) had arranged further training. In terms of acts amounting to a Criminal Offence within the MCA 2005, 25% of respondents said they ‘did not know’ while 10% mentioned wilful neglect, only 25% correctly included ill treatment and wilful neglect. This survey identified the need for increased awareness, training and follow up training, in order to improve competence, confidence and preparedness of staff for the implementation of the MCA 2005 It also identified a need to tailor training to individual professional needs. It went on to recommend strategies to facilitate these identified needs including that awareness and training information may be attached to payslips, training may be part of new staff induction programme, need for follow up training to improve competence and confidence, need for compulsory attendance at training, and need to tailor training to individual professional needs. Competing interests: None declared |
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