A researcher places a 20-page form full of “legalese” in front of a potential study participant, gives a brief explanation, and hands over a pen.
“The average research subject doesn’t even read the form. It makes a sham of informed consent, which is a real shame,” says Tim Lahey, MD, MMSc, chair of the clinical ethics committee at Dartmouth-Hitchcock Medical Center in Lebanon, NH.
Long sentences, large paragraphs, technical language, and multisyllabic words all contribute to reading and comprehension difficulties, found a recent study.1
“Forms prone to these problems include those involving areas of high-tech clinical research, such as artificial intelligence and deep learning, robotics, genetics, artificial organs, and imaging,” says Katrina A. Bramstedt, PhD, senior ethics officer at Philips Research Eindhoven and adjunct professor at Bond University School of Medicine in Queensland, Australia.
People may feel that reading the entire form will waste the researcher’s time, and perhaps even jeopardize their opportunity for study participation. “They might feel uncomfortable admitting they do not understand the content of the form, and be embarrassed to ask questions,” adds Bramstedt. Research ethics committees can play an important role in educating research teams to produce consent forms that use lay language and facilitate the informed consent process, she says.
Kavita Shah Arora, MD, MBE, assistant professor of reproductive biology and bioethics at Case Western Reserve University in Cleveland, has seen one informed consent form, in particular, that is difficult to understand: the federally mandated Title XIX sterilization consent form. This is required to be signed by all patients on Medicaid or Medicare prior to receiving a sterilization procedure. “When evaluated for readability and comprehension, this form has scored poorly,” says Arora.
After signing the form, some patients are still unaware that sterilization is permanent, or that nonpermanent contraceptive options as effective as sterilization are available. “Revised versions of the forms that have been tested in research settings that are shorter and easier to read have led to additional understanding about the nature of sterilization,” says Arora.
Ann Munro Heesters, director of bioethics at University Health Network in Toronto, Canada, says the length of forms is only part of the problem: The words used, and the order they’re in, also are problematic. “Consent forms typically address questions that no one would ever ask,” she explains. “They fail to clarify exactly what is being offered, and why a participant should consider the offer being made to them.”
‘Great Vulnerability’
In research encounters, participants are like “strangers in a strange land,” says Heesters. “They are in a position of great vulnerability. The customs are different. The language is foreign.” Some are suffering and in great need of care.
Participants may fail to understand the very nature of research: That it tries to answer unanswered questions. “Enrollment in a clinical trial may make them worse off, because we simply don’t know which treatments or interventions will be better for people like them,” explains Heesters.
There are important tradeoffs to be weighed: Improvement in one set of symptoms may come at the cost of an increase in others. Trial participation also may involve significant time.
“Participants often conflate research and clinical care,” adds Heesters. Based on the assumption that the researcher’s job is to act in participants’ best interests, people overlook the fact that research participation has the potential to make conditions worse.
Including all the required information in a succinct way is quite a challenge, says Heesters, “especially when study designs are complex, potential side effects are many, and multiple procedures and data points are involved.”
Out-of-the-box Ideas
If a form is incomprehensible to participants, “the consent they provide can no longer be considered ‘informed.’ At that point, the informed consent process is actually obfuscating its own purpose,” says Tamar Krishnamurti, PhD, assistant research professor of engineering and public policy at Carnegie Mellon University in Pittsburgh.
Shortening consent documents makes no significant difference to how well potential research participants understand a clinical trial, found a recent study.2 “If documents are too long or dense, there is a risk that people may skim them or fail to read them at all,” says Krishnamurti. This could result in someone unwittingly taking a risk that they would otherwise find unacceptable. There also is a risk to scientific integrity. “Enrolling uninformed participants may increase their likelihood of dropping out of research studies, causing unnecessary attrition problems,” says Krishnamurti.
Lahey says the traditional approach to informed consent undermines the ability to obtain real informed consent. “We need to come up with pithier, non-legalistic ways of connecting potential research subjects to the information they need to make informed decisions,” says Lahey. “This will require creative, out-of-the-box thinking.” The following are suggested approaches:
• Add short, one-page summaries to overly legalistic forms.
“In time, these one-pagers should replace the legal malarkey of these longer forms,” says Lahey.
• Use a “teach back” process.
Simply put, the researcher explains the study to a potential participant, who then explains it to the researcher. “That way, it is clear, not what from the subject signed or what words were said near them by the researcher, but actually what we care about: what the subject understood,” says Lahey.
• Ask patients what information they think they need to make a decision.
Krishnamurti and a colleague developed a methodology for creating a shorter, patient-centered informed consent document.3
Researchers gave potential study participants a lengthy consent form, and asked them to extract only the information pertinent to their decision-making. “We then created a shorter form that met normative standards for good clinical practice, but did not contain information that wasn’t relevant to participants’ informed decision-making,” says Krishnamurti.
The findings: Providing concise informed consent content, systematically developed from patients’ self-reported information needs, may be more effective at informing participants than the traditional consent approach. There was no detriment to comprehension, risk assessment, or enrollment.
“Even potential participants with high levels of technical understanding and reading comprehension levels will benefit from easy-to-read forms,” notes Krishnamurti.
• Include pictures, videos, or online pop-up windows defining unfamiliar terms.
“One form used pictorial representations that were more meaningful to patients with aphasia than printed words,” recalls Heesters.
As an institutional review board chair, Heesters acknowledges that board members occasionally can be taken off-guard by unusual consent strategies. “These unconventional approaches, however, may be precisely what we should endorse if we are to better meet the needs of our participants,” says Heesters.
Regardless of what type of form is utilized, enough time is needed for meaningful discussions. “Participants should be able to focus on the aspects of the trial that concern them most,” says Heesters. “And research coordinators should have the time to assess the understanding of those they enroll.”
REFERENCES
- Villafranca A, Kereliuk S, Hamlin C, et al. The appropriateness of language found in research consent form templates: A computational linguistic analysis. PLoS ONE 2017; 12(2):e0169143.
- Grady C, Touloumi G, Walker AS, et al. A randomized trial comparing concise and standard consent forms in the START trial. PLoS ONE, 2017; 12(4): e0172607.
- Krishnamurti T, Argo N. A patient-centered approach to informed consent: Results from a survey and randomized trial. Medical Decision Making 2016; 36(6):726-740.
SOURCES
- Kavita Shah Arora, MD, MBE, Assistant Professor of Reproductive Biology and Bioethics, Case Western Reserve University, Cleveland. Phone: (216) 778-4444. Fax: (216) 778-8642. Email: [email protected].
- Katrina A. Bramstedt, PhD, Senior Ethics Officer, Philips Research Eindhoven/Adjunct Professor, Bond University School of Medicine, Queensland, Australia. E-mail: [email protected].
- Ann Munro Heesters, Director of Bioethics, University Health Network, Toronto, Ontario. Phone: (416) 340-4800 ext. 8607. Email: [email protected].
- Tamar Krishnamurti, PhD, Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh. Email: [email protected].
- Tim Lahey, MD, MMSc, Chair, Clinical Ethics Committee, Dartmouth-Hitchcock Medical Center, Lebanon, NH. Phone: (603) 650-6063. Fax: (603) 650-6110. Email: [email protected].
Long sentences, large paragraphs, technical language, and multisyllabic words all contribute to reading and comprehension difficulties for informed consent forms, found a recent study.
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