Lost Voices in Research: Exposing the Gaps in the Mental Capacity Act 2005

Abstract

Despite laudable intentions, since its inception, the Mental Capacity Act 2005 of England and Wales (MCA) has proved to be a controversial piece of legislation. The majority of legal scholarship has concentrated on the problems created by the Act in relation to the treatment of incapacitated patients. However, there is an additional and somewhat unexplored dimension to the MCA, that of research. We argue here that the research provisions of the MCA are poorly drafted and do not provide an appropriate balance between protection and empowerment. We also assert that contrasting obligations and expectations are placed on different parties in the approval process, which creates a blurred sense of responsibility and a potential chilling effect.

Inclusion under the Mental Capacity Act (2005): A review of research policy guidance and governance structures in England and Wales

“…Protection of individual rights under the law through the relevant governance procedures formed the major content of the research guidance and the CoP (2007), consistent with previous work by Heywood and colleagues 22 . The CoP (2007) elaborated on the MCA (2005) principles by considering ‘research value’ as critical to the protection of incapacitous individuals, and as justification for their involvement in research.…”

“…Conversely, empowerment was addressed infrequently within the research guidance and the CoP (2007), which is consistent with comments from the House of Lords select committee 2 . In accordance with the legal test for capacity, the research guidance adopted a binary approach to mental capacity assessment, whereby a person was either assessed to have capacity or not 21,22,29,30 . However, fluctuations in capacity and how these affect an individual's eligibility to participate in research requires consideration 21,22,29,30 .…”

“…In accordance with the legal test for capacity, the research guidance adopted a binary approach to mental capacity assessment, whereby a person was either assessed to have capacity or not 21,22,29,30 . However, fluctuations in capacity and how these affect an individual's eligibility to participate in research requires consideration 21,22,29,30 . Although the need for accommodations was recognized, detail into how they might serve the principles of determining and supporting an individual's capacity and communication was not provided 22 .…”

“…However, fluctuations in capacity and how these affect an individual's eligibility to participate in research requires consideration 21,22,29,30 . Although the need for accommodations was recognized, detail into how they might serve the principles of determining and supporting an individual's capacity and communication was not provided 22 . Thus, the idea of joining efforts with others in order to achieve understanding, which is consistent with empowerment theory, 35 was largely neglected.…”

“…For example, paragraph 11.29 of the CoP (2007) stipulates that the patient's wishes and feelings must be considered regardless of their capacity for deciding about their own research participation. In the context of research, the MCA (2005) has been criticized for lacking an appropriate balance between protection from exploitation and empowerment, with emphasis placed on the former 22 . Indeed, the MCA post‐legislative scrutiny criticized the implementation of the Act in care contexts, noting a culture of protection and paternalism amongst professionals working with people who may lack capacity 23 .…”