Toward More Inclusive, Accessible Clinical Trial Consent Forms

Toward More Inclusive, Accessible Clinical Trial Consent Forms

Patient Advocacy
Oct 15, 2021
James J. Incollingo
Ivy Elkins

It is a trend many years in the making, but the time is ripe to fix the increasing problems with clinical trial consent documentation. The word count and complexity of mandated information in informed consent forms have been multiplying, but their value remains dubious. In 2016, Danish researchers studying consent forms found that “a considerable share of research participants do not read or understand the information they are given, or do not base their decisions on trial participation on the information [provided].”1

The incomprehensibility of many of these documents is bad; but worse is that it may skew study participation toward people skilled in reading lengthy, dense, and technical text—that is, those who are older, wealthier, and more educated. Scientifically, this is untenable, but a combination of research findings and pressure from patients and advocates is beginning a move toward reform.

Ivy Elkins has been sharing her perspective with researchers, clinicians, and other healthcare providers since she was diagnosed with lung cancer in 2013. As a patient advocate, she has reviewed informed-consent documents for pharmaceutical companies and research teams to ensure they are comprehensible to a broad range of patients.

She also takes part in the yearly ASCO/AACR Methods in Clinical Cancer Research Workshop on the essentials of effective clinical trial design for all oncology subspecialties, helping to fine-tune the process. In this role, Ms. Elkins has helped many young researchers learn how to write informed-consent documents. “It’s an essential need because they’ll be doing it for the rest of their careers, and it affects the whole healthcare process,” she said. 

Jill Feldman, also a patient advocate affected by lung cancer, agrees: “Having lay people and patient advocates involved in creating consent forms is fundamental to getting it right. People make these life-or-death decisions at a time when anxiety and stress can cloud their ability to think critically. Clear, patient-friendly documentation and a thoughtful discussion with a trained research-team member are crucial.”

Short and simple are important, but they are in perpetual tension with the requirement to fully inform each trial participant. “By law, certain information must be included in these documents, but elements of style like clarity and brevity are too often overlooked,” said Elkins. She added, “These factors are likely reducing the number of potential participants, as well as their ethnic, socioeconomic, and educational diversity, but we don’t have data to prove this definitively.”

Some concurring data came from Turkey in 2020. A study comparing informed-consent forms for national and international clinical trials found poor readability across the board and recommended that researchers receive “easy-to-read informed consent form writing training.”2

In June of this year, Mayo Clinic researchers published a study seeking to determine whether the number of words in a consent form could affect patient attitudes about enrolling. A total of 240 volunteers who had cancer were given either a 2,000- or a 6,000-word form to read, then polled on their opinions. Unsurprisingly, the shorter form took less time to read, and it also resulted in 84% of the 2,000-word group expressing a willingness to join the study. In contrast, only 73% of participants in the 6,000-word cohort agreed. The conclusion was that more research is needed into the “efficiency and efficacy of shorter consent forms for cancer clinical trial enrollment.”3 On the basis of her anecdotal experience, Ms. Elkins agrees. 

“Often when informed consents are written,” she said in a recent interview, “the researchers have little control over the details, because most institutions follow a template; many of these [forms] are dense and complex due to the information they must include, and they can run up to 30 pages long.” 

New patients, especially, are unlikely to be familiar with the relevant lexicon of medical terminology, some of which is outdated and potentially hurtful. Ms. Feldman noted that even a simple but carelessly applied word such as “subject” can feel diminishing in a treatment or trial situation: “We are people, not subjects, so ’participant’ is OK, although ’volunteer’ is better.”

For volunteers with additional challenges such as dyslexia or ADHD, the documents’ actual layout can present readability issues. “To help these people,” Ms. Feldman suggests, “add images or use analogies that we all understand, and be specific with numerical information—some people have difficulty processing numbers, fractions, and percentages.” In the same vein, she advises printing bold-faced questions in headings to attract curious eyes. 

Ms. Elkins suggests attaching a simply written, one- or two-page summary document along with a patient’s calendar of events, “so patients can easily determine when and where they need to be for trial-related treatments, as well as a breakdown of any costs they have to bear versus those that insurance will cover or those that are free with trial participation.” That information must be accessible up front, she said, along with contact numbers and email addresses patients can use to get their questions answered.

Another quick reform, according to Ms. Feldman, is to eliminate in-person requirements when filling out consent forms: “This can be a barrier for people who must travel, take off work, or find transportation or childcare. The U.S. Food and Drug Administration (FDA) allows consent forms to be secured remotely via digital e-consents, but many large academic centers and institutional review boards still require patients to enter this information in person. This should change.”

A 2017 University of Pretoria study recommended thinking of “informed consent as a process rather than consent being merely focused on written information.” Much like Ms. Elkins and Ms. Feldman, the researchers agreed that “participant-specific engagement”—that is, individual conversations—“should guide whether family and friends, videos, pictures, additional reading material, and FAQ sheets would be of assistance in improving understanding.”4

Ultimately, the best way to check the excesses of clinical trial consent forms may be to empower a review board to evaluate and approve them before use. With an eye toward maximizing health literacy and comprehension at about the eighth-grade level, such an entity could continually standardize and improve the language that is used.

“Despite the FDA’s and other authorities’ requirements for disclosure,” Ms. Elkins said, “we need shorter, easily comprehensible forms, and new federal legislation may be necessary. We also need a helpful, effective way for patients to get standard trial information without confusing terminology and eligibility criteria.”

In the end, for Ms. Elkins, the equation is simple: “Every clinical trial participant is an individual, just as every patient is. We need a system with the flexibility and compassion to serve all types of people in the places where they are. Only then will we get the true cross-section of humanity that will generate the most robust, reliable, and useful research findings.”

References
  • 1. Wadmann S. Clinical Trial Informed Consent Information for Participants Can Be Improved. Article in Danish. Ugeskr Laeger. 2016;178(32):V03160192.
  • 2. Gungor B, Aylin M, Asena A, et al. Evaluation of Legal Legislation Compliance and Readability of Clinical Trial Informed Consent Forms. Ther Innov Regul Sci. 2020;54(2):468-475.
  • 3. Almodallal Y, Duong Q, Satele D, et al. Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms. JCO Oncol Pract. 2021. [Epub ahead of print].
  • 4. Somers R, Van Staden C, Steffens F. Views of Clinical Trial Participants on the Readability and Their Understanding of Informed Consent Documents. AJOB Empir Bioeth. 2017;8(4):277-284.

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About the Authors

James J. Incollingo

Contributing Writer