Obtaining clinical informed consent is both an ethical and legal requirement before invasive medical or surgical procedures. In research, informed consent must be sought and secured before enrolling a participant in a study.
The concept of informed consent is founded on the ethical principle of respect for persons. As outlined in the Belmont Report, ‘respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished capacity are entitled to protection.’ The first conviction emphasises that individuals must be provided with sufficient information to make an informed decision, that they fully understand the information shared, and that they are capable of making and communicating a voluntary choice. The second conviction highlights that, when individuals lack the capacity to make decisions for themselves, they should either be excluded from participation or have an authorised representative provide consent on their behalf.
Barriers to Patient Understanding
Informed consent typically involves a discussion between clinician and patient, followed by the signing of a consent document. However, these processes often fail to achieve adequate patient understanding. Researchers have identified barriers to comprehension that fall into two categories: patient-centred and process-centred.
Patient-centred barriers include factors such as age, limited education, language barriers, poor health literacy, and the impact of illness. Process-centred issues, on the other hand, highlight structural challenges, such as insufficient time allocated to discussing the procedure, addressing patient questions, and aiding decision-making.
Illness Can Be a Patient-Centred Barrier
Illness itself can impair a patient’s ability to fully understand the information provided during the informed consent process. The physiological and psychological impacts of illness may reduce a person’s willingness or capacity to engage with or retain complex medical information.
Another complicating factor is the potential confusion between enrolment in a clinical trial and receiving medical treatment. Many patients trust their physicians to recommend the best treatment and may perceive enrolment in a study as a direct treatment recommendation. For patients with conditions such as cancer, clinical trial enrolment may even appear to be their last hope for effective treatment, leading them to overestimate the potential benefits of participation.
Addressing Gaps in Understanding
The core elements of informed consent include information on risks, benefits, alternatives, and general knowledge about the procedure. However, research suggests that the focus is disproportionately placed on procedural risks, with far less emphasis on the other key elements.
A recent review revealed that only one-fifth of studies assessed patient comprehension of all four elements, pointing to a physician-centred approach that prioritises malpractice risk reduction over patient autonomy. Additionally, sociodemographic factors such as language proficiency, education, and health literacy are rarely addressed, leaving gaps in the understanding of how informed consent processes affect vulnerable populations.
Step Towards Patient-Centred Informed Consent
To improve patient comprehension, particularly for vulnerable groups, further research and standardisation are needed. Some authors suggest developing specific quality standards for informed consent, including:
1. Defining adequate patient comprehension across all four key elements of informed consent.
2. Creating validated tools to routinely measure patient understanding.
3. Using clear, culturally and linguistically appropriate materials to address language barriers, limited education, and poor health literacy.
4. Incorporating interactive elements into the consent process, as these have been shown to enhance understanding more effectively than non-interactive methods.
Globally, informed consent practices are shifting towards a more patient-centred approach and continue to evolve. However, there is still no unified international guideline for clinical informed consent comparable to the ethical frameworks governing human research. Bridging these gaps is essential to ensure all patients, particularly those from vulnerable groups, can make informed decisions about their care.
Conclusion
The informed consent process must evolve to prioritise patient understanding and autonomy. Efforts to standardize practices and address barriers will ultimately foster greater trust and fairness in clinical care and research.
Veronique Ropion, MD
Director of Business Strategy & Corporate Communication
Sources:
– Glaser J. et al. Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Med Decis Making. 2020 February ; 40(2): 119–143. doi:10.1177/0272989X19896348.
– Hewlett S. Consent to clinical research Adequately voluntary or substantially influenced? J Med Ethics 22:232- 237, 1996.
– Taylor H.A.. Barriers to informed consent. Seminars in Ontology Nursing, Vol 15, No 2 (May), 1999: pp 89-95.
