"The development of an assent-based process for the inclusion of adults with impairments of capacity and/or communication in ethically-sound research"
Our project, ASSENT, is concerned with how adults with impairments of capacity and/or communication (AwICC) are included and considered within the ethical and governance frameworks in England and Wales.
The over-arching aim is to develop an ethically-sound, legally-robust strategy for including AwICC in research within the context of existing legislation. It is envisaged that the guidance will enhance the current Code of Practice of the Mental Capacity Act (MCA, 2005) and help to define a way through the complexities of working with AwICC, by recognising personal autonomy in all its gradations, and defining practical strategies and resources that serve to endorse their greater agency.
We will investigate current practice in the development and ethical review of research featuring AwICC as participants. Finally, drawing on our findings, we will develop guidance that recognises the interests and preferences of AwICC, identifies practical strategies and resources to support their involvement, and provides enhancements to the MCA Code of Practice within the context of existing legislation.
There are three key objectives that set out the intended impact for project ASSENT.
Objective 1. Recognition of and support for the agency and decision-making power of Adults with Impairments of Communication and/or Capacity (AwICC): conceptualisation, application and adoption of a continuum of decision-making that incorporates the spectrum of ability for self-determination. from informed consent/refusal (the decision made by a person deemed to have legal capacity), through degrees of engaged assent or dissent (the person’s active dis/agreement to something through a process of interaction), to passive dissent (lack of observable response or extreme passivity).
Objective 2.Enhancements to the MCA (2005) Code of Practice (CoP: DfCA, 2007): establishment of practical strategies for considering, seeking out and evidencing the wishes and preferences of AwICC (paragraph 11.29). In correspondence with the rights of AwICC as deifned above, the focus is on the pedagogical process whereby an individual who has impairments of communication and/or capacity actively engages with the options presented in relation to research participation.
Objective 3.Inclusion of AwICC in research: increased understanding of how to design research inclusively, such that a broader spectrum of the population is represented, ultimately leading to the development of rehabilitation interventions, medical treatments and psycho-social therapies that are relevant and proven for AwICC.
Project User Groups
Integral to our project are key stakeholder groups representing AwICC. We are working with representatives of the following groups: adults with learning disabilities; aphasia after stroke; traumatic brain injury; dementia; autistic spectrum conditions; mental health disorders through our Reference Group, which oversees the project, and a Working Group, which informs the development of project tools.