Bridging The Gap – Can Advance Research Planning Help Address Some Of The Challenges Of Research With Adults With Impaired Capacity To Consent?

Bridging The Gap – Can Advance Research Planning Help Address Some Of The Challenges Of Research With Adults With Impaired Capacity To Consent?

In order to include people in research who are unable to provide their own consent to participate, someone close to them is approached to help make a decision on their behalf. This is usually a family member or close friend, but it might be a person who cares for them in a professional capacity if it is not possible to involve family members or friends. They are asked to act as a ‘consultee’ or ‘legal representative’ and to decide whether the person they are representing should participate in the study or not based on what, in their opinion, the person’s wishes and feelings would be about taking part.

Challenges of research involving adults with impaired capacity to consent

Previous research has found that people rarely discuss their preferences about research. Family members find it hard to make a decision about research, and many experience an emotional and decisional burden as a result. This leads to concerns that proxy decisions about research may not sufficiently reflect peoples’ wishes and preferences. It also contributes to the ethical and practical challenges encountered when conducting research involving people with impaired capacity to consent, which results in adults lacking capacity frequently being excluded from research.

The gap between decisions about care and research

When it comes to decisions about care and treatment, there is an increasing focus on encouraging people to engage in advance care planning – a process which gives people the opportunity to plan their future care and support, including medical treatment, while they have the capacity to do so. This doesn’t currently extend to decisions about participating in research. People are also encouraged to consider making legal arrangements to appoint someone to make decisions on their behalf such as through a Lasting Power of Attorney. However, this also does not cover decisions about research, despite moves towards research being embedded in routine care.

There is a gap between the processes for planning what care we want to receive in the future and who we wish to be involved in making care decisions on our behalf, and the current legal arrangements for research which do not provide a mechanism for expressing our research preferences in advance. It is left until we no longer have capacity, at which point others are appointed as consultees or legal representatives on our behalf and they have to retrospectively determine what our wishes and feelings might be. At least that is the situation in the UK ……

Advance planning for research: the story in other countries

Other countries have established processes for planning ahead for research participation. Including Canada where it was introduced several decades ago, and Australia which in 2007 implemented a formal process for researchers to discuss and document views on future research participation with participants who anticipate periods of cognitive impairment. Recently, there have been moves to integrate processes into European legal frameworks, including Germany which requires a directive to be in place for people lacking capacity to consent to be included in some types of research.

Back in 2009 the Nuffield Council on Bioethics recommended that research is needed on the feasibility of developing a non-binding advance statement on research participation which could influence decisions on research participation after loss of capacity, and that serious consideration be given to explicitly extending Lasting Power of Attorney arrangements to include decisions over research. However, there are still no such arrangements in the UK.

Changes to policy and practice in the UK that enables advance research planning arrangements could support consultees and legal representatives to make preference-based decisions, reduce the burden they experience when acting as proxy, and ensure that people with capacity-affecting conditions have equitable opportunities to participate in and benefit from research.

Addressing the gap through the CONSULT-ADVANCE Study

As part of the larger CONSULT project exploring issues around research involving adults with impaired capacity to consent, the CONSULT-ADVANCE Study is exploring the views of people with personal experience of capacity-affecting conditions, and researchers and other professionals, about advance research planning.

We are conducting two online surveys (one survey with members of the public and one with researchers and other professionals) followed by interviews with both public and professional stakeholders.  We will use the findings to plan future research and to develop an Advance Research Planning intervention.

If you would like to share your views on this topic, please get in touch.

Contact: Vicky Shepherd