‘Nudges,’ Complexity, and Private Information Factor into Informed Consent’s Evolution

maxwell mehlman

Maxwell Mehlman, Professor of Law, Case Western Reserve University

Are uses of messaging tactics termed “nudges”—intended to influence a decision without the participant’s awareness—ethically questionable? As an interdisciplinary team of researchers begins examining how specific types of messaging can subconsciously influence participation in research studies, a member of ACRP’s Professional Ethics Committee cautions that, while nudging has a place in the industry, its best use may be found at the public, rather than individual, level.

“If you can’t use nudges [like subliminal advertising] to sell [products to consumers], should you be able to use them to get people to participate in medical experiments?” is a question raised by Maxwell Mehlman, the study’s co-principal investigator and a professor of law at Case Western Reserve University.

Mehlman, who also co-directs the Law-Medicine Center, is a part of a research team recently awarded a four-year, $1.6 million grant by the National Center for Advancing Translational Sciences at the National Institutes of Health. The team plans to examine ethical and legal concerns raised by the use of nudges—an approach rooted in behavioral economics, decision making, behavioral policy, and social psychology—in obtaining informed consent from people participating in biomedical experiments.

“Nudging includes accepted public health practices such as putting calorie counts on products when it’s not required, placing salad on the menu before the entrees, and displaying graphic images on cigarette packages,” Mehlman said. “But when we think about nudging people to be subjects in medical trials, that troubles me. It certainly raises a lot of questions.”

Some of those questions, according to ACRP Professional Ethics Committee member Bridget Browder, CCRC, director of compliance and regulatory affairs with MedTrials, Inc., who is not involved in Mehlman’s study, include how nudges are categorized and applied in the real world.

“Nudging can be beneficial for clinical trials,” Browder said in reaction to a press release about the new and ongoing study, “but we will need to define the line between education and coercion. Nudging does have a place in our industry, but I would argue that its best use is in increasing public awareness of clinical trials.”

An ethical nudge, Browder explains, would be one which allows for the individual to hear information, but have a free choice on how to act on it. “Choosing to not provide any information, through nudges or other means, and let the default choice be ‘non-participation,’ will have the potential to harm medical science and the marketing of safe and effective new treatments,” she says.

Mehlman is joined in the research by co-principal investigator Kim Kaphingst at the University of Utah and other collaborators from Case Western Reserve University and Cleveland Clinic Children’s Hospital. The researchers will learn about nudging techniques used to recruit participants, including skewing the questions asked and the checklist items on informed consent forms, and how potential subjects view their use. Once the data are collected and analyzed, the team will share its findings and make policy recommendations.

“I’m curious as to what kind of nudges [they] will actually uncover,” Browder says. She adds her expectations are that the nudges identified by the team “will more likely be either obvious [informed consent practices], or even things that we don’t even realize we are doing.”

Meanwhile, with or without nudges, informed consent forms can be overwhelming for patients—they are written at a level that is too high for many of them, possibly impeding true informed consent, according to a report given at the recent International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (Abstract MA08.04).

The report by Bellinda King-Kallimanis, PhD, director of patient-focused research at the LUNGevity Foundation, and her colleagues summarized a multistep project involving patients and caregivers, trialists, regulators, and clinical trial sponsors to streamline the informed consent process. One idea for improving informed consent forms that arose from the work is to create a trifold template summarizing key points of the form that are relevant to patients, and which can be used as an addendum to the informed consent form.

Further, a proposed U.S. Food and Drug Administration rule, “Protection of Human Subjects and Institutional Review Boards,” open for public comment until November 28, involves new elements of informed consent largely tied to how patients’ private information or biospecimens may be used beyond the immediate purposes of a specific clinical trial.

Among other matters, the proposed rule, if finalized, would amend CFR parts 50 and 56 of the Code of Federal Regulations. Changes would include revisions to the content, organization, and presentation of information included in the informed consent form and process to facilitate a prospective subject’s decision about whether to participate in the research, and the addition of a new basic element of informed consent and three other new elements.

The new basic element of informed consent would require a description of how information or biospecimens may be used for future research or distributed for future research. The three other new elements would include a statement as to how private information or biospecimens collected during the research may be used for commercial profit and whether the subject will or will not share in this commercial profit, whether clinically relevant results will be disclosed to study subjects, and, for research involving biospecimens, whether the research involves whole genome sequencing.

Edited by Gary Cramer