Throughout the years, people from most racial, ethnic, and socioeconomic minority groups have been historically underrepresented in medical clinical trials. Although multiple attempts have been made to accommodate an increase in patient diversity, efforts for inclusion are multifactorial. The informed consent process is a key player in preventing full patient diversity
and integration. Informed consent is defined as the process through which a healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention, so long as the patient is competent. Situations that call for informed consent include medical
treatments, clinical trials, and invasive procedures, such as surgery, blood transfusions, and anesthesia, as well as the sharing of patient information via HIPAA laws. The basis of informed consent goes as far back as 1949 to the Nuremberg Code. It was created in response to patient mistreatment during World War 2, after which the Joint Commission was established in 1951 to uphold these principles. In every situation necessitating informed consent, the Joint Commission requires a description of the procedure, the risks and benefits, alternatives to the procedure, the risks and benefits to these alternatives, and an assessment of the patient’s understanding.1 These components are typically addressed through the use of informed consent forms (ICFs). However, recent research has found ICFs less useful than previously believed.
ICFs are currently recommended to be written between a 6th and 8th-grade reading level, but
most are written at an 11th or 12th-grade reading level, if not higher.1 Additionally, the recommended word count is below 1250 words or seven pages, but the average length of these documents has increased over 10-fold through the past three decades.2 Yet, even with the increased detail and length, informed consent forms have failed to improve patient 30 years.4 Only half of patients completing ICFs for
clinical trials understand placebo trials and randomization, and just over half of patients could
accurately identify at least one risk of an intervention.4
The consequences of failing to provide patients with the information needed for informed consent from patients can be dire. One Norwegian study, which investigated incidents involving elderly patients where the ability to provide valid informed consent was questionable, found that overlooking the duty of ensuring patient comprehension by a medical center led to multiple documented cases of patient coercion that went against the guidelines of the 1999 Norwegian Patient Rights Act, which requires that patients have the right to opt-out of life-sustaining treatment if they so choose.13,15 According to the Act, specific provisions on coercion exist with respect to patients with contagious diseases who pose a risk to the public and patients with psychiatric disorders or mental conditions.14
In the case of this study, formal Norwegian
requirements for the use of coercion were largely neglected, and there was little documentation to support the justification of such force.13 By not doing due diligence in obtaining patient consent, physicians and researchers may unintentionally victimize patients who do not know what they getting into, causing future contempt towards research teams, decrease adherence, and confound study results.
Understandably, one reason for the length and complexity of ICFs is that these documents include specific details that provide legal protection for both patients and healthcare providers. Fear amongst the medical and research communities that simplified ICFs may influence legal disputes or even lead to lawsuits is justified. Such concerns can be circumvented by utilizing simplified ICFs as a supplement to existing detailed and full-length ICFs. The University of California San Francisco’s IRB launched the Plain Language Informed Consent Form Project, which strives to provide research and clinical trial participants with supplemental ICFs, written in plain language and translated into all required languages to cover the needs of local participant populations.17These “companion documents” were implemented in November of 2023, and are
an ongoing addition to improve readability and accessibility.17 This is a great compromise that would improve patient comprehension on their protected rights within a given study and protect research teams from time wasted on legal proceedings due to misunderstandings around patient and provider rights. IRBs themselves recognize the legal, cultural, and communication challenges with informed consent.
A study in 2017 received feedback from 150 IRB chairs that found concerns about reading comprehension and participant understanding. Over 70% claimed their local IRB does not assess the reading level of consent forms.10 New regulations also acknowledge this need for change. The Food and Drug Administration report has concluded that IRB review is not needed for translating approved forms and electronic consent modalities can also be used when appropriate.5 These initiatives amended guidelines, coupled with the IRB’s role in advocating for
increased readability, make the process of informed consent simpler and increase accessibility.
As informed consent has to apply to an increasingly diverse population, gaps in communications are still a major concern. Along with barriers to comprehension, physicians and researchers must be aware of other challenges that may factor into gaining consent from minority communities. Many patients currently report that they occasionally view informed consent documents as legal documents instead of regarding them as a form of communication with the research team. This lack of in-person communication can further exacerbate feelings of fear and distrust from patients who come from ethnic groups with a history of mistreatment in the academic world (such as African Americans).6 In addition, even when informed consents are translated at a lower reading comprehension level, language barriers can still be an issue, leading minority participants to request additional resources.
Longitudinal research participants have expressed a desire for ongoing transparency and feedback to address complex and dynamic concerns beyond the scope of ICFs.6 These challenges call for a revised approach to informed consent to facilitate improved inclusion of minority and underrepresented populations in clinical trials and increased patient adherence to therapies. One such approach includes using multimedia methods to make the informed consent process more inclusive. Multimedia ICFs are a feasible way to convey information to the patient, as used in the Cancer Health Assessments Reaching Many (CHARM) study to streamline the process and make consent more accessible.7 Patients reported that this system presented information clearly and thoroughly, even for those with limited health literacy, and believed it could replace paper documents. They also felt more in control, as the system allowed them to proceed through. the form at their own pace. In another group, using tablets to sign ICFs encouraged participants to not feel rushed. They did not feel pressure to quickly sign the form without understanding it and even clicked on embedded hyperlinks to find out more information. It was a comfortable way to answer their questions Using pictures to explain a task made them more at ease with performing it, as they now had a better idea of what they were getting themselves into.9
Multimedia methods can overcome language barriers through translation, bridge the gap for those with lower education and poor literacy, and offer a way to read, hear, watch, and understand procedures in real time. In essence, multimedia ICFs facilitate the inclusion of more diverse patient populations and their usage has been found to increase the likelihood of patient
participation in clinical trials.
Participant diversity, in terms of literacy, geography, culture, and language, can also be improved through multimedia usage. As per FDA analysis, the participation in clinical trials by subpopulation for new molecular entities and therapeutic biologics approved in 2020 was less than 15% of Black African Americans, Asians, and Hispanics.8 Even today, the ethnic diversity among participants in clinical trials remains low.8 For trials to represent the American population, understanding the factors impeding minority participation in research studies is of paramount importance. This gap in participation can be bridged by using multimedia methods to create a culturally sensitive system tailored to the community. With differing cultures, it may be rude to ask questions to a person of authority, and patients may be hesitant to express their concerns.
Multimedia methods have been shown to address these nuances in communication among different ethnic groups.7,9,12 Language barriers can also cause many potential research participants to feel uncomfortable and confused with traditional ICFs; however, with multimedia ICFs, complex procedures or terms can be broken down into simple, easy-to-understand visual and auditory formats. The visual explanations offered by multimedia ICFs can help bridge the gap for those who struggle with reading comprehension in a new language, aiding those who might not be proficient in the primary language of the consent form to better understand what they are signing up for. A
traditionally hard-to-recruit population of Mexican immigrants reported an increase in their understanding of randomization, intention to enroll, and attitude toward participating in research after a randomized trial looking into the effectiveness of a multimedia approach.11 For patients with limited English proficiency, those who had access to video consent forms had higher comprehension scores than those who received traditional verbal consent alone12 This difference persisted when data was stratified by language, and when controlled for educational level and prior procedures performed.12
The need to reform the informed consent process through accessible, comprehensible, and culturally sensitive means is undeniable. Although legality is still a concern, supplemental ICFs can work to bridge the gap of inadequate communication, as seen in novel institutional and research initiatives. To address the IRB’s concerns about the effectiveness of these novel informed consent forms and researcher’s concerns about potential lost time invested into developing such mediums, IRBs across institutions can create documents that show clear patient education on the risks and benefits of studies, tailored to appropriate reading levels. This can be augmented by collaborations with cultural offices and medical translator services to ensure that cultural barriers are overcome as well.
Interactive multimedia elements can also be added to ICFs to allow participants to ask questions and receive immediate feedback, ensuring they fully understand the information before giving consent. Multimedia consent forms can also be designed to be accessible to individuals with disabilities, such as incorporating screen reader compatibility, sign language interpretation, and other educational aid technologies, thus allowing disabled individuals greater opportunity to participate in research. This would offer an efficient and educationalway to overcome current challenges in the clinic and hospital, where healthcare teams may be limited in both time and depth due to high patient loads and responsibilities.
Administering a multimedia consent form simultaneously as the clinical staff takes care of other duties would reduce the in-clinic time needed to properly consent patients. Multimedia informed
consent documents can be seamlessly integrated into existing healthcare workflows by embedding them into electronic health record (EHR) systems. Clinicians could initiate multimedia consent processes during patient intake or pre-procedure consultations, ensuring that these materials are reviewed before any medical intervention. This would involve a standardized protocol where patients receive multimedia content on tablets or through a patient portal, with time allocated for them to ask questions or express concerns. With correctly designed multimedia forms, there may be an added benefit of cultural flexibility, language translation, and improved patient education and adherence. Thus, multimedia and culturally competent informed consent
forms hypothetically could simultaneously improve efficiency and communication between a wide spectrum of patients and providers.9
Embracing innovative modalities like multimedia methods to streamline and enhance the readability of consent forms can improve patient comprehension and bridge linguistic, cultural, and educational gaps. To achieve this transformation, collaboration between healthcare providers, researchers, ethicists, and regulatory bodies is essential. It is time to prioritize patient-centered communication in informed consent, ensuring that every individual, regardless of background or literacy level, comprehends the risks and benefits of participating in research and medical procedures.
Shriya Veluri is a third-year dual degree MD/MPH candidate at UT Health San Antonio and the UT Health School of Public Health in Houston. Shriya completed her B.S. in Healthcare Studies at the University of Texas at Dallas, where she developed a passion for minority issues, including women’s health, refugee and immigrant care, and racial/ethnic disparities in care. She aims to find an area of intersection between her clinical interests of vascular medicine and interventional radiology as well as her public health and advocacy interests. In her free time, Shriya is an avid classical dancer and enjoys long walks and experimenting with new recipes in the kitchen.
