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07th March 2016

Raising the Standard: Informed Consent & The Social Services & Wellbeing (2014) Act

I have written extensively on the Social Services and Well-being (Wales) Act, 2014 in recent months, much remains to explore. As it is being implemented from April this year we will soon find out how it works in practice. However, the issue that has attracted me this week is the impact that the legislation has upon informed consent practice. I am struck by how the level of consent is rising in the health and social care field, whilst remaining at a lower level in the world of clinical research. It's the same principle – informed consent – but implemented very differently, from my point of view.

Clinical Guidelines for Consent

The existing clinical guidelines re: informed consent appear to operate at a higher level of 'enactment' than that which is publicly visible within clinical research. According to NHS choices “for consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision.” Although this consent is within the context of consent for treatment, it provides a benchmark for the concept of informed consent. The 3 ingredients are voluntary (offered freely), informed (given information) and capacity (ability to process the information).

In the context of social care a model for obtaining informed consent is emerging in the light of recent legislation. This model appears even more rigorous than that which occurs in clinical trial recruitment. Both the Care Act (2014) in England, and the Social Services and Well-being (Wales) Act, (2014) mandate a 'super-high' level of engagement, active consultation, planning and participation of those receiving social care and support. Although the basic principles of informed consent appear the same the practice appears wholly different.

Does It Matter?

It is right and proper that services should be involving service users as actively as possible, and this is certainly a central tenet of the new Welsh and English care legislation. Such a move should safeguard all citizens’ rights to services that they are actively willing to engage with in full knowledge about what is going on and in active partnership. In this way consent is transformed into control and collaboration.

In the clinical research world things look a bit stuck in the mid-late 20th century. Informed consent exists and perhaps is done well in places, even in the majority of trials but there is evidence to suggest that there are compliance issues with best practice and possibly some deeply ingrained resistance to change. My evidence for this is the clinical research trials where things have gone wrong.

Too Risky?

That is not to say that all harm can be negated within a clinical trial, but surely we should be adopting best possible practice and affording trial subjects the same level of consent and engagement that is given to people receiving care and support?

*All information is correct at the time of publishing

Nic Bowler

Welsh Care and Social Services Inspectorate Specialist

Dr Nicholas Bowler is a researcher and consultant to government-level [Welsh Government Review of Secure Services, 2009] – specialising in QA/compliance focused projects. He has interests in clinically relevant training, service development and research. He enjoys working with clients to support them in identifying problems and initiating projects to improve practice.

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