The Project

Regulatory committees are a feature of all NHS research in the UK. Their remit is “to protect the dignity, rights, safety and well-being of all actual or potential research participants” (Dept Health 2001). Institutional Review Boards in the US and Canada have a similar role and have similarly been subject to scrutiny in their operation in terms of membership, consistency of decisions-making and adherence to legislation (Nicholls et al. 2015; Lai et al. 2006; McDonald et al. 2009; Trace and Kolstoe 2017).

RECs review projects both on the ethics of a study and its design (Trace and Kolstoe 2018). Approved designs are modelled on assumptions derived from clinical trials and biomedical experimentation and even research in populations with specific needs is expected to follow a similar, albeit adapted, format (Murphy and Dingwall 2007; Hedgecoe 2008). My work has previously challenged ideas of ‘gold-standard’ trial methods and measures (Russell et al. 2018).

A standard question in REC applications is; ‘does the research involve prisoners, children or vulnerable adults?’ Vulnerability, here, operationally applies to all people with a learning disability, not just those who lack capacity (Crow et al. 2006). While there is a move away from conceptions of vulnerability in policy (e.g. Care Act 2014), in research ethics the concept is still used (McDonald et al. 2009; Lai et al. 2006) undoubtable influenced by the history of people with learning disabilities subjected to unethical research, including research without their consent (Freedman 2001; McDonald, Keys, and Henry 2008).

When a participant is deemed ‘vulnerable’ or their capacity is under scrutiny, confirmation of their informed consent appears to be even more important. Rather than enhancing equality this means they are subject to greater scrutiny than those individuals deemed not to be vulnerable and the onus is on the researcher to ensure consent is informed.

The Mental Capacity Act provided much needed definitions and clarifications of practice. It has, however, been contested for promoting one form of individual rational autonomy and is now being challenged to reconceptualise the legal individual in light of the social model of disability and the Convention on the Rights of Persons with Disabilities (CRPD)(Series 2015; UN 2006).

The HRA guidance based upon the Mental Capacity Act suggests guidelines for researchers when making capacity decisions in elation to consent. However, in practice, each individual expresses capacity differently and in the field researchers base heir decisions on a complex social interaction that combines judgements of capacity, communication, coercion and ideas of how ‘informed’ consent needs to be. Socio-legal guidance on research practices does not engage with the complexity of this interaction and researchers are left to negotiate the process using their own ethical criteria.

The ASSENT study has begun looking at the guidance offered to researchers when recruiting people with a learning disability. However, the study’s socio-legal perspective and choice of interviews for data collection have meant that it is unable to take an insider perspective on research recruitment or REC decision making. The exploration of Pre-submission “procedural ethics” leaves “ethics in practice” un-interrogated, yet enacted daily by researchers working in the field(Guillemin and Gillam 2004).

Discussions of vulnerability immediately juxtapose autonomy. Often research recruitment is conceptualised as a dyadic relationship between researcher and subject of research and permissions are predicated on the interaction of the two individuals. However, when an individual consents to research they rarely do so without considering other actors, often a network of factors and individuals who will be affected and may have their own opinion on participation. Yet legalistic guidance still draws upon the idea of the individual, capacitous autonomous agent (Weston 2019; Owen et al. 2009), critiqued in philosophy (through the Essex Autonomy Project), critical disability studies and feminist scholarship (Mackenzie
2014; Clough 2014; O'Shea 2012).

Critical disability scholars have called for recognition of relational autonomy as a legitimate aspect of many people’s lives (Mackenzie 2014). While legal frameworks require a person to be able to weigh up risk and benefit before making a choice, they often problematize the involvement of supporters/carers. It is typically only those people whose capacity is under scrutiny that are encouraged to explain their reasoning and prove their autonomy (Fisher 2003; Morris, Niederbuhl, and Mahr 1993; Björnsdóttir, Stefánsdóttir, and Stefánsdóttir 2015).