Ethical medical research relies on the principle of informed consent. However, obtaining valid consent can be difficult in certain situations. For instance, some individuals may find themselves unable to provide consent due to sudden impairing medical conditions like strokes or conditions that cause a gradual loss of capacity, such as dementia. Additionally, individuals with profound learning disabilities may also face difficulties in giving informed consent.
The exclusion of individuals who lack the ability to consent from participating in research has raised concerns. This exclusion can result in a lack of evidence-based care for populations already experiencing significant health disparities. In other words, by not including these vulnerable groups in research, healthcare providers may lack the necessary data to tailor their treatments and interventions to address the specific needs and challenges faced by these individuals.
Balancing the ethical imperative of informed consent with the inclusion of vulnerable populations in research is crucial. Special considerations and alternative consent procedures may be necessary to ensure that those who lack mental capacity can still be represented in research studies in an ethical and respectful manner. This approach would enable researchers to gather valuable data and ultimately contribute to improved healthcare outcomes for all, regardless of their cognitive abilities.
Over the past decade there have been advances in including individuals with impaired capacity to consent, but many challenges still remain, including complexities of legislative frameworks and concern about surrogate decision making. You can read more about this in Victoria Shepherd’s paper Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.
In England and Wales, the Mental Health Capacity Act 2005 provides a comprehensive framework for decision making on behalf of people with impaired capacity to consent. In Scotland, a similar framework is provided by the Adults with Incapacity Act 2000. In Northern Ireland – the Mental Capacity Act 2016.