ACCORD

ACCORD will explore the complex ethical and legal uncertainties surrounding research involving adults with impaired capacity to consent and develop implementable behaviourally-informed interventions to improve inclusion.

Background

A global ageing population brings rising prevalence of conditions affecting decisional capacity. Research is essential in order to improve evidence -based care for these populations who often have the most complex care needs. Yet adults lacking capacity to consent are frequently excluded from research due to the complex ethico-legal issues involved. Consent-based exclusion affects the generalisability of results and leads to inequalities in care.

In our previous work, as part of the CONSULT research programme, we explored the barriers and facilitators to conducting research involving adults with impaired capacity to consent. We identified a ‘knowledge gap’ for researchers and others, which led us to develop tools to help researchers design trials involving adults with impaired capacity to consent (INCLUDE Impaired Capacity to Consent Framework), evidence-informed training to provide them with knowledge about the legal, ethical and methodological issues they need to consider (CONSULT Training) and made recommendations for designing more inclusive consent processes (OPTIMISE recommendations). We also developed and evaluated a decision support intervention for family members involved in making ‘proxy’ consent decisions on behalf of someone who lacks capacity to consent (CONSULT SWAT). However, these barriers are driven by much more fundamental ethical and legal uncertainties about including people in research who are unable to protect themselves through consent.

Building on these solid foundations, a new, bolder, and more imaginative approach is now needed. Uncovering the ethico-legal issues that limit inclusion of this population in research is a key first step, ahead of establishing the behaviours that need to change in terms of who needs to do what differently and when, and then developing multiple, layered, complex interventions to address the barriers at scale across individual, organisational and systems levels. Behavioural science seeks to explore how and why people behave as they do. It is increasingly being used to understand and address challenges in clinical trials, such as recruiter bias, but has yet to be applied to the ethico-legal complexities that limit inclusion.

In order to understand and address the barriers to including adults lacking capacity in research, the ACCORD project (Addressing consent-based challenges to improve inclusivity in research) will address the following questions:

1) What are the ethico-legal issues that limit the inclusion of adults lacking capacity to consent and what contextual and intersectional factors affect this?

2) How are these issues navigated by those involved in designing, approving, and conducting research?

3) How can the barriers to inclusion be effectively addressed at an individual, organisational and/or systems level?

Project design

This sequential mixed-methods project, spanning diverse research populations and contexts, will be conducted in collaboration with multiple stakeholders across three work packages (WP):

1) Exploring implementation of the ethical and legal frameworks governing research involving adults who lack capacity to consent

A documentary analysis of relevant studies and ethics applications, mapped against the relevant legal frameworks, will explore how the ethical and legal frameworks governing research involving adults lacking capacity are implemented in a broad range of studies (WP1a). In parallel, vignette-based focus groups and semi structured interviews will explore researchers, practitioners, and members of research governance organisations’ views and attitudes towards the challenges encountered when implementing the legal frameworks (WP1b). Ethnographic observations of REC meetings will explore members’ deliberation and decision-making when implementing the legal frameworks (WP1c).

2)  Developing conceptual understanding of the key ethico-legal issues that act as barriers to inclusion

A prioritisation exercise with stakeholders will identify the most significant barriers to address and the behavioural determinants that will lead to change (WP2a). For each priority issue we will develop a conceptual framework through combining a scoping review of the literature with data from WP1 (WP2b).

3) Co-design interventions to target the barriers to inclusion

The findings from the previous work packages will then be used to develop and implement behaviourally informed and co-designed interventions to address the ethico-legal issues that limit inclusion. To do this, we will form co-design groups, develop a series of interventions to target individual/organisational/systems level barriers using equity-guided questions, and then pilot and refine plans for implementing the interventions.