Informed consent is a crucial aspect of medical research, as it ensures that patients are fully aware of the risks and benefits of participating in a study before consent. The International Council of Harmonization (ICH) has established clear principles for informed consent, including the disclosure of adequate information, the patient’s understanding of that information, and the voluntary nature of their consent.
However, obtaining informed consent can be challenging when it comes to acute myocardial infarction (AMI) research, which often involves critically ill patients who require urgent therapy. Many patients in this category have been found to need more understanding of the information provided in written consent forms, preferring instead to rely on oral explanations. Despite this, verbal permission has yet to be formally examined compared to written consent forms, and previous studies have relied on subjective measures of patient comprehension.
According to BMC Medical Ethics, the role of clinical trials in developing and refining treatment guidelines for Acute Myocardial Infarction (AMI) is essential. However, the emergency nature of AMI as a disease poses extra challenges to obtaining ideal informed consent from patients. To address this issue, a recent study, PAC-VC, has utilized a questionnaire that objectively compares patients’ perspectives and comprehension of verbal assent to written consent.
The study results indicate that patients’ understanding of verbal assent is comparable to written consent, with an adequate understanding of most core components of the consent information. These include the purpose of consent, autonomy, benefits, alternative treatments, the choice to refuse participation, and confidentiality.
However, when attention to detail was required, participants showed partial to inadequate understanding, particularly in understanding alternative treatments, randomization, and side effects. This can be attributed to the complexity of these components, which require abstract thinking and complex processing that may not be possible for severely ill patients in the acute phase of the disease.
Interestingly, patients in the verbal arm of the study showed an adequate understanding of treatment side effects, which may argue that verbal information is easier to understand and emphasize the importance of this information delivery tool. Additionally, most patients in the study needed to read the provided written information. They reported that they believed making their final participation decision was optional. Instead, patients preferred a summary of verbal information and turned to oral explanations as a substitute.
Delay in treatment of AMI increases the rate of adverse outcomes and risk of death. Hence, the consent process required for AMI trials might pressure potential participants and influence patients’ willingness to consent. Most patients in the written consent arm felt pressured during the consent process, while this was less observed in the verbal assent arm. This can be interpreted as reading needs more time and exceptional attention to analyzing the facts in a written format; on the other hand, patients may find oral information and explanations an easier substitute to process the data and make a quicker decision without feeling pressured.
Based on these findings, the study advocates for more utilization of verbal consent to enroll patients in research that involves vulnerable, sick patients, such as those with AMI. However, such consent and information provision methods can have their own challenges. Administration of such information in a verbal form needs exceptional recruiters’ training to ensure consistency and quality in information delivery. Safeguards can be added throughout the recruitment process to ensure patients’ understanding.
