When the Common Rule was revised in 2017, it included a requirement that every federally funded study have a “concise and focused” key information section at the start of the informed consent form.1 “The purpose of that was to encapsulate what a potential research subject might want to know, as an easy-to-read blurb,” says Luke Gelinas, PhD, senior IRB chair director at Advarra.
Regulators did not specify what information was required to be included or what information might be important to include for participant decision-making. Therefore, when the requirement became effective, there was some uncertainty in the research community regarding what the key information sections should contain. “That uncertainty continues to persist,” says Gelinas.
Since then, another regulatory requirement was added, requiring researchers to post informed consent forms for federally funded trials on ClinicalTrials.gov.2 “We now have this really wonderful resource of publicly available consent forms for potential research, which we’ve never had before,” says Gelinas.
Gelinas and colleagues conducted a study to find out what researchers were including in the key information sections.3 “Our ultimate goal is to give some recommendations or guidance for how we might improve the sections. We did come away thinking that there is some work to be done, and that key information sections could be made better,” he says.
The researchers analyzed the key information sections of 76 informed consent forms. The readability grade level was not noticeably different from the rest of the informed consent forms. “The biggest concern right now is that they are not super readable,” says Gelinas.
Most of the key information sections included section headers and lists. Few used other visual elements, such as tables, graphs, or bullet points. “We found very little of that,” says Gelinas. Most of the key information sections were just straight text and were not visually interesting.
“Part of the problem is that health literacy principles haven’t seeped into research yet. On the whole, researchers are used to the status quo of writing in prose,” says Gelinas.
On average, the key information sections were 10% of the length of the complete informed consent document. Some researchers wonder if all of the information included in the key information section also has to be listed in the main consent form. “It’s important to be comprehensive. But you have to be careful, because we end up with 40-page consent forms that no one wants to read,” says Gelinas.
Over time, informed consent forms for cancer clinical trials have become increasingly lengthy and complex. “It is not unusual for these documents to exceed 25 pages and to feature technical language,” says David Gerber, MD, associate director of clinical research in the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern Medical Center.
As a result, some of the forms fail to provide prospective study participants with adequate information to allow for a truly informed decision. Forms that are overly long and are written at an advanced reading grade can inhibit people’s understanding of relevant information.
Gerber and colleagues sought to understand patients’ experiences with cancer clinical trial informed consent forms. The researchers assessed readability of 20 informed consent forms.4 “Most clinical trial informed consent forms were quite lengthy and written at a reading level well beyond the U.S. adult average of eighth grade,” says Gerber. The mean length of the forms was 21 pages. The forms were written at an average reading level of 10th grade.
The researchers also conducted focus groups with nine people who had lung cancer about what information was most important in a hypothetical informed consent form. “We sought their preferences for which information might be included in an abbreviated one- or two-page informed consent summary that could be provided as an addendum to the full form,” says Gerber. Patients wanted information on risks and benefits, which is routinely found in informed consent forms. In addition, patients expressed interest in information on trial eligibility criteria. “This unexpected recommendation might reflect the delay and disappointment associated with not qualifying for a trial, an outcome that occurs with increasing frequency as eligibility criteria become more stringent over time,” suggests Gerber.
For researchers, it is important to recognize that informed consent is a not just a form. “It is a process, including detailed discussions between patients, treating clinicians, and study staff,” says Gerber.
Providing a brief summary to patients considering participation in a clinical trial, alone, will not meet regulatory requirements. “Therefore, one must consider how an additional document can improve, rather than further complicate, the consent process,” says Gerber. The goal of readability of informed consent forms and other patient-facing documents is fraught with challenges. “Medical care is inherently complex and vastly different from other aspects of patients’ lives,” notes Gerber.
For researchers to achieve reading level targets, most medical terms must be avoided. Yet healthcare providers are likely to use those same terms verbally throughout a patient’s care. “Readability may penalize any efforts to educate the reader by introducing terminology that could ultimately serve them throughout the patient journey,” Gerber observes.
- LeCompte LL, Young SJ. Revised Common Rule changes to the consent process and consent form. Ochsner J 2020;20:62-75.
- 45 CFR 46.116[h] (2023)
- Gelinas L, Morrell W, Tse T, et al. Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov. J Clin Transl Sci 2023;7:e185.
- King-Kallimanis BL, Ferris A, Dropkin L, et al. Initial steps in creating a patient-centric addendum to clinical trial informed consent forms. JTO Clin Res Rep 2023;4:100575.
