Informed consent forms can be overwhelming for patients—they are written at a level that is too high for many patients, possibly impeding true informed consent, according to a report given by King-Kallimanis et al at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (Abstract MA08.04).
The purpose of the informed consent form is to outline risks and benefits of an interventional clinical trial to a patient. But most informed consent form are written using scientific jargon, are long, and include extraneous information not pertinent to the patient (eg, legalities of trial participation), according to Bellinda King-Kallimanis, PhD, Director of Patient-Focused Research at the LUNGevity Foundation.
Project Steps and Findings
Dr. King-Kallimanis and her colleagues conducted a multistep project involving patients and caregivers, trialists, regulators, and clinical trial sponsors to streamline the informed consent process. After a thorough analysis of their findings, some key challenges emerged, along with ideas for improving informed consent forms. One possible strategy that patients supported would be to create a trifold template summarizing key points of the form that are relevant to patients, which can be used as an addendum to the informed consent form.
The first step included an audit of 20 informed consent forms guided by U.S. Department of Health and Human Services regulations for the protection of human participants in research. The second step included focus groups and in-depth interviews with nine patients living with lung cancer to learn what information was critical when considering participation in a clinical trial using a hypothetical informed consent form to guide the conversation.
The 20 informed consent forms reviewed were from phase I, II, and III clinical trials covering predominantly non–small cell lung cancer; 60% were global trials. Most of the legally required code of federal regulation topics were covered. However, forms were long, ranging between 15 and 34 pages, with an average length of 21 pages. Readability varied by section, but the average reading level across sections was 10th grade, whereas the average U.S. reading level is 8th grade.
The second step of the study was the qualitative research component in which participants were presented with a hypothetical informed consent form. Participants generally noted feeling “overwhelmed” by the hypothetical form; it was noted that “a lot of information was good” but that important information for deciding whether to participate was often too hard to find. When asked the intent of the forms, one participant noted it was “to cover their butts”. The idea of an addendum that provides a summary with reference to page numbers in the informed consent form for more details was well received by participants. The next phase of this work is to develop a trifold addendum and test it with patients and caregivers.
“While informed consent forms place greatest emphasis on trial procedures and risks, variations in informed consent form architecture and readability make it difficult for patients to make an informed decision to participate in a clinical trial,” Dr. King-Kallimanis reported. “Our study implications extend beyond lung cancer, highlighting key areas for improvements to the informed consent forms and providing a clear roadmap for developing a patient-centric addendum for informed consent forms in all cancer clinical trials.”
