Challenges in the informed consent process: identifying design strategies that enhance communication in adult clinical trials.

The informed consent process in research is an ongoing exchange of information between the research team and the study participants throughout the course of a trial. The goals of informed consent are to provide participants with relevant and understandable information and to promote autonomy in participation and decision-making. Informed consent goals are imperfectly realized because of increasing complexity of consent forms, lack of adequate supplemental educational information, and inadequacies in communication methods needed to target the learning needs of diverse adult audiences. A review of the literature identified innovative communication methods applied to the informed consent process, such as study booklets, study glossaries, audiovisual presentations, and electronic information. For each of these methods, attention to basic design principles, including the selection of appropriate prose and graphics in an easy-to-read layout, may assist study participants in understanding how to better interpret the informed consent forms.

Key Words: design of informed consent materials, informed consent process, communication during informed consent.

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Research professionals use informed consent in clinical trials as the information highway to explain study procedures, risks, benefits, and participant rights to study volunteers. Over the past 50 years, the increased complexity in clinical trial design and new federal regulations have required research professionals to communicate a large amount of information to study participants during the informed consent process. Federal regulations assign legal responsibility to the clinical investigator for ensuring documentation of the participant's informed consent prior to study involvement. However, the entire research team has the ethical responsibility to ensure that the participant understands and freely consents to participate in the study. Therefore, the informed consent process extends beyond the signing of a consent form and involves "a dynamic and continuing exchange of information between the research team and the participant throughout the research experience." (1)

Scope of the problem

Historically, the concept of informed consent emerged in the late 1940s and early 1950s in response to investigator and participant concerns regarding patients' involvement in experimental procedures without prior knowledge. (2) Since then, federal regulations outlined in 21 CFR 50 and 45 CFR 46 govern the scope of information exchanged during informed consent. (3,4) Over the past 50 years, the informed consent document has evolved into a complex legal document, and with this evolution, its effectiveness as a communication tool for prospective study participants has been debated.

In 1996, the National Institutes of Health (NIH) realized the need for new informed consent procedures and issued a request for research on methods to improve communication during the informed consent process. The NIH noted several areas needing improvement, including communication methods to increase participant comprehension and autonomy in decision-making, methods to simplify the informed consent process, and ways to provide study-specific information to diverse populations. (5) Providing supplemental materials for the active information seeker also was encouraged.

Designing the informed consent message

Innovative communication strategies may help researchers achieve the goals of informed consent by promoting understanding among study participants. When communication is effective, participants receive clear, pertinent information that responds to their needs and are able to make decisions freely. (6)

Graphic designers contribute to effective communication by combining both verbal and visual fluency as tools to concisely package a specific message. (7) Graphic design, in the broadest definition, specializes in the arrangement of parts, details, form, and color used to convey a message to a target audience. It is the intermediary between the message originator and its audience, and it aims to accelerate learning and help more people understand a given message. (8) (See Visual design in the informed consent process on page 172.)

This paper will identify the challenges to communicating clinical trial information to adult audiences and identify design strategies used to enhance communication during the informed consent process.

Understanding audience needs

The learning needs of adult patients and the informed consent process do not always align. Lengthy informed consent documents are challenging and often introduce new and unfamiliar information.

Reading levels vary considerably; approximately 1 in 5 adult Americans has serious literacy problems. (9) Functional competency levels or grade level assignments are used to describe literacy skills of individuals. Adults who can read at a fifth grade level or higher level are considered literate to varying degrees, and those reading below the fifth grade level are classified as functionally illiterate. (9) Approximately one-third of Americans have marginal reading skills, reported somewhere in the sixth to ninth grade reading level. Marginal readers and functionally illiterate readers comprise one-half of the adult population and are referred to as "poor readers" …