Imagine suddenly finding yourself in a fast-paced hospital environment – maybe after a traumatic injury, sudden illness or a frightening diagnosis. You are overwhelmed and confused, trying to make sense of your surroundings. Amidst the countless machines and medical staff, you are handed a dense, technical form full of scientific and legal jargon asking you to participate in a research study. You are in no state to truly comprehend or weigh the risks and alternatives to what is being presented but, in that moment, your signature is meant to represent informed consent.
In research and medical treatment, patients often are expected to make major decisions under time constraints when they are already distraught. Knowing this, it is the responsibility of health-care practitioners, and the medical system itself, to ensure patients are prepared to make these decisions.
In informed consent, a patient voluntarily agrees to a proposed medical treatment, intervention or to research participation after being made aware of the purpose, benefits, risks, alternatives and possible outcomes. Typically, it is obtained by a researcher and concludes with a signature on a form. While informed consent is legally and ethically mandated in both medical treatment and clinical research, our focus primarily is on its role in research. Though these two settings are distinct, they share many parallels particularly around ensuring patient understanding and autonomy.
Obtaining informed consent is a procedure deeply rooted in communication and is used to uphold patient autonomy – a key pillar of ethical clinical research. Patient autonomy means that every individual has the right to make informed and voluntary decisions about their own health without any external influence. It is not enough for a doctor or researcher to simply say, “here is what we are going to do.” Informed consent is about putting the authority back with patients to decide whether the procedure should be done at all and making sure they have the tools needed to understand the depth of their decision.
While informed consent promises a lot, it often falls short in many areas. Many consent forms are designed to protect the institution rather than empower the patient. As well, research participants may not completely understand what they have consented to. A systematic review of 103 studies found that almost half of participants failed to understand a key aspect of what they consented to (e.g., voluntary nature of consent, risks, alternatives). Complex medical and legal terminology may contribute to the gaps in comprehension. In 2024, an analysis of 798 federally funded U.S. trials concluded that the average consent form read at a Grade 12 level, whereas the average reading level of adults in the United States is at Grade 8. The authors observed a “persistent and widespread pattern” of consent forms being written with “prohibitive complexity for the majority of United States adults,” highlighting a key opportunity to reduce this gap.
Another deeper issue is the potential power imbalance resulting from the hierarchy between researchers and participants. In many trials, especially those conducted in acute care settings, participants can feel pressured to consent. This can hinder their freedom to ask questions or refuse certain aspects of their consent, thereby diminishing autonomy.
Empathy, the ability to understand the feelings of a patient without experiencing it themselves, is a crucial aspect to address in this imbalance. Researchers possess highly specialized knowledge that can influence life-altering decisions. Without empathetic communication, consent can be unintentionally treated as a formality, leading to patients feeling like passive recipients rather than active participants in the research process.
Studies have shown that patients have higher satisfaction with their care when providers are empathetic. This includes small but meaningful gestures such as being culturally sensitive; sitting at the patient’s eye level; having attentive body language; saying phrases like “I understand this is difficult;” and asking the patient to repeat what they have just heard so gaps in communication can be resolved. This ensures both the researcher and the patient understand each other. Being empathetic creates a clear pathway to forming trust that can increase research participation. Incorporating these practices helps ensure that, just like in medical care, the “human” element of care is part of the foundation, and not a luxury.
In priority populations, being culturally sensitive is especially important. These communities may include racial and ethnic minorities, women, Indigenous peoples, non-English speakers, people with cognitive disabilities and other groups who have typically been left out of research.
Health equity research suggests that implementing clinical empathy in the informed consent process is essential to “rebuild decades of medical mistrust among marginalized groups” and avoid repeating past injustices in research settings. Validating previous experiences can combat these disparities by counteracting implicit biases and building trust in consent-related discussions. Disadvantaged groups have historically faced exclusion, exploitation and inadequate disclosure in research compared to others, which may represent an empathy gap. This term refers to the disconnect in which researchers struggle to understand the lived experiences of participants. When researchers fail to consider these differences during consent conversations, it can negatively affect outcomes by leading to misunderstandings, coercion or even participant disengagement. On the other hand, researchers who make a conscious decision to understand a patient’s medical, social and cultural history can help facilitate more equitable consenting.
Culturally competent communication is another critical component.
Culturally competent communication is another critical component. If an institution simply hands a non-English-speaking patient a long consent form in English, or if a clinician ignores a culture’s norms, the patient’s trust and care will suffer. To address this, many institutions provide professional medical interpreters and liaisons, but the issue goes beyond this. It is important to acknowledge the sociocultural factors that affect the way people interpret meaning in different languages. Exhibiting cultural humility by recognising that other perspectives can differ from one’s own can diminish the power dynamic that threatens informed consent. Policies and regulations are put in place in Canada to include diverse perspectives of our communities. An example is the Canadian Institute of Health Research’s Tri-council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) 2022.
The challenges of achieving truly informed consent are magnified in the Intensive Care Unit (ICU)). Due to their life-threatening illness or condition, many patients lack the ability to make their own decisions. One ICU study identified that 59 per cent of participants could not provide their own consent and required a family member to make decisions for them. Of those who did provide their own consent, several did not recognize their signature on the form immediately after signing, demonstrating that patients’ ability to remember and understand the decision may be hindered by their medical condition.
When patients cannot consent, the responsibility will fall to their substitute decision-maker (SDM), often a family member. This has its own challenges as SDMs are dealing with emotional and psychological struggles of a loved one suddenly being in the ICU and are “not always receptive to the idea of research or emotionally equipped to reflect rationally.” SDMs may provide consent out of hope, rather than true understanding. Conversely, some SDMs may be too distressed to acknowledge any potential benefits of research and deny consent.
To look at the issue simply, what works for a middle-aged, English-speaking adult who received a postsecondary education may not work for an elderly immigrant with limited literacy. This is especially true in critical-care environments where the “one-size-fits-all” approach is likely to fall short.
Clinicians have begun to realize this and are developing tools to assist patients engaging in discussions for research consent across various clinical settings.
The most common method is the teach-back method – a closed-loop communication technique in which the participant giving consent is asked to confirm their understanding by repeating key information back to the researcher. Using a framing statement such as, “I want to make sure I explained this correctly,” puts the responsibility on the researcher to explain details clearly, rather than the patient’s ability to understand.
Digital informed consent, or eConsent, is the use of a multimedia, online platform to create a more dynamic and patient-friendly way to deliver information. Endorsed by the Federal Drug Agency, eConsent incorporates quizzes, animations and videos to ensure understanding. It allows patients to take control of their learning and make an informed decision. As well as improving understanding, audio narration of text in different languages can help address literacy issues. A randomized control trial using a Virtual Multimedia Interactive Informed Consent (VIC) consisting of video clips, animations and presentations reported higher satisfaction with the VIC consent process, as well as ease of use and confidence in completing it independently.
Finally, aids such as infographics can be used to supplement chunks of text with pictures and diagrams to make it more understandable, and to help mitigate the hurdle of literacy barriers. Studies have shown that even in groups with similar age, gender and education levels, communication aids – specifically visual aids – had the strongest influence on comprehension and quadrupled the odds of patients answering a question regarding the procedure correctly. In critical care or complex trial settings, infographics can also address issues such as stress and information overload.
Collaborative design, or co-design, is a process that actively brings patients, community partners, and other relevant stakeholders into the conversation to prevent consenting from being an isolated process. When patients see that researchers want their input, it creates a more equitable partnership where they feel respected and have increased trust in their care providers, as well as the work being done. Co-design also clarifies intentions and addresses hesitations that certain communities or equity-deserving groups may have.
Moving forward, making informed consent truly informed – rooted in both equity and accessibility – needs to be a priority, not just an ideal. This means consistently weaving patients’ voices into every part of the process, whether in acute or critical care, clinical research or everyday medical care. By centering empathy, inclusion and shared decision-making at the forefront, informed consent can be transformed into a meaningful act of respect that recognizes every patient’s right to make decisions based on true understanding.
