Ethical Issues in the Use of Nudges to Obtain Informed Consent for Biomedical Research

Nudge in perspective: A systematic literature review on the ethical issues with nudging

“…This domain includes discussions about using nudges to increase organ donation, stimulate healthy living (e.g., by discouraging drinking and smoking (Quigley, 2014; Ram-Tiktin, 2018; Schmidt, 2016), stimulating healthy nutrition (Bonotti, 2015; Korthals, 2015) and physical exercise), increase vaccination rates (Navin, 2017), pediatric practice (M’hamdi et al, 2017; Navin, 2017; Stanak, 2019) decrease winter deaths (Allmark and Tod, 2014), steer patient choices during important health decisions such as to operate or not (Epstein, 2017; Gorin et al, 2017), and steer people to register for pre-emptive screening of diseases (Damhus et al, 2018; Hofmann and Stanak, 2018). It also includes questions surrounding informed- and presumed consent (Whyte et al, 2012; Cohen, 2013; Gelfand, 2016; Mehlman et al, 2018) and the question whether family members of a patient could be nudged (Blumenthal-Barby and Opel, 2018; Chandler and Gruben, 2016; Sharif and Moorlock, 2018). In the second field, philosophy, the morality of nudges is discussed in abstractum, without explicitly applying them to any area of empirical research.…”

Using Behavioral Nudges to Engage Pregnant Women in a Smoking Cessation Trial: An Online Field Quasi-Experiment

“…There are few studies informing the topic in general, including one study providing a taxonomy of proposed behavioral economics interventions to improve clinical trial enrollment [5] and one discussing ethical aspects of using nudges [10]. Behavioral economics approaches have raised potential ethical concerns due to the adjustments the researchers might make to the choice architecture (i.e., changing default options; recruitment by physicians or authority figures) [9]. Since our experiment was limited to changes made to recruitment materials (Facebook Ads and RCT website interface) and it did not involve any changes in the consent procedures, it raised no ethical concerns.…”

“…The Quit Together RCT was implemented in Romania and consisted of over-the-phone motivational interviewing counselling sessions, designed to increase motivation and facilitate problem solving related to difficulties pregnant women meet in their smoking cessation attempts. The RCT protocol has been described elsewhere [9]. In brief, the enrollment process involved online promotion through paid Facebook ads and a dedicated project website with direct links to RCT forms hosted on the secured Qualtrics [14] platform.…”

“…Behavioral nudges have been defined as any "aspect of the choice architecture that alters people's behavior in a predictable way without forbidding any options or significantly changing their economic incentives" [8]. Yet, the research on this topic is limited, with most focusing on the potential ethical concerns raised by using behavioral nudges to obtain individuals' informed consent for research enrollment [9,10].…”