Abstract
The voluntary consent of the human subject is absolutely essential. (Nuremberg Code, 1948)
Durham University hosted its first AREC regional workshop on 16 April 2012. The workshop was designed to consider the concept of informed consent, why it is valued by research ethics committees, how it might be achieved with different participant populations, and whether it is always necessary (or desirable). It was targeted at researchers from all disciplines and aimed to increase understanding of and stimulate discussion around this fundamental ethical principle.
The workshop was chaired by David Anderson-Ford (immediate past AREC Chair) and Lorna Carter (AREC Council member), and delegates were welcomed to the University by Professor Tom McLeish, Pro-Vice-Chancellor (Research) (Durham University). Delegates travelled from across the UK and represented research ethics committees, researchers and research officers from both higher education and the NHS.
Dr Andrew Rawnsley (Teesside University) set the context for the day with ‘Consent and permissions in the context of research integrity’. Having outlined the relevant history and definitions Dr Rawnsley considered issues of covert research; proportionality; attitudes towards ethics review and consent; the relationship between integrity and compliance; and integrity as fundamental to the full research lifecycle.
This was complemented by a practical session from Dr Alasdair MacSween (Teesside University and Chair of the NRES Committee North East – County Durham & Tees Valley) in ‘Consent in practice – what do REC members look for in Health and Social Care applications?’. Dr MacSween urged applicants to clearly demonstrate that appropriate methods would be adopted to enable a participant to give informed consent, and highlighted NRES guidance as a comprehensive resource for both researchers and research ethics committee members.
Dr Nicole Westmarland and Dr Julia Downes (Durham University) opened the first thematic session, ‘Tensions between consent and confidentiality when undertaking research with victims of abuse’. Considerations included the concept of participants as moral agents; whether this particular group should be offered special treatment and unique protection; the importance of ensuring that participants understood the limits of confidentiality; and the challenges posed by the traditional verifications of consent.
In the afternoon Dr Tina Cook (University of Northumbria) identified the moral and methodological justifications for including research participants with learning difficulties and emphasized the need to avoid assumptions and adopt non-standard methods (in this case collaborative, repetitive and recursive discussions) to communicate successfully, and ensure understanding of, a research project in ‘“Knowing what you are in for”: issues about informed consent for people with learning difficulties’.
Delegates were next challenged by Professor Priscilla Alderson (Institute of Education, University of London) to consider the youngest age at which an individual could give consent, and the criteria for such a decision, in the opening to ‘Consent and “assent” of minors’. This led to a discussion regarding research with (as opposed to on or in) children including the concepts of assent and proxy consent, and the risks of broad-brush application of Directive 2001/20/EC consent requirements within UK research.
Professor Bob Simpson (Durham University) closed the thematic sessions with ‘The challenges of seeking informed consent in developing country contexts: some examples’. The session considered the transposition of Western principles to another culture, including the realities of medical paternalism (patiency over agency) and familism (heteronomy over autonomy), and demonstrated that the classic bioethical model was not naturally compatible with the developing world perspective. Professor Simpson concluded with the need to develop new languages – beyond informed consent – to meet ethical objectives.
Following the informative and stimulating sessions the day concluded with a summary panel discussion revisiting the theme of the workshop: Do you really need to ask? The concept of individual autonomy, and the language of informed consent, provided the key areas of debate between speakers and delegates alike, and areas of general consensus included the importance of truth and contextual information sharing (however this may be accomplished). Our speakers broadly concluded that, in a research context, you really do need to ask, but how and who is a matter of ongoing ethical and legal debate.