Using Nudges to Recruit Human Subjects in Clinical & Translational Research

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Project Summary/Abstract To obtain grants and successfully conduct biomedical research with human subjects, researchers must recruit and retain sufficient numbers of participants. Literature on ethical concerns with coercion and undue influence abounds, but there is little consideration of whether it is ethical to employ behavioral economics techniques called “nudges” that can encourage participation, such as screening surveys that predispose participants to consent, structured choice architecture in consent forms, certain forms of community engagement to generate group support for participation, and certain positive personal behaviors by recruiters. In addition, little prior empirical research has examined what recruitment nudges are actually being used in recruitment into human subjects research and their effects. This project addresses to what extent recruitment nudges are being used in recruitment into clinical trials, whether they impact participation, the views of human subjects about their use, and whether their use is ethical in research studies with varying ratios of risk to human subjects. To address these issues, this interdisciplinary investigator team of translational scientists, bioethicists, and legal scholars at Case Western Reserve University and the University of Utah will first identify use of different types of recruitment nudges in clinical trials with varying ratios of risk (minimal risk vs. more than minimal risk) and benefit (direct benefit vs. no direct benefit) to human subjects. Aim 1 will characterize use of recruitment nudges in clinical trials with varying risk/benefit ratios by conducting interviews and a survey with clinical trials recruiter. Aim 2 will examine the effects of a set of nudges on recruitment into a minimal risk interview study for healthy adult volunteers and views of participants on the use of nudges for themselves and others. Aim 3 will utilize the empirical data generated in Aims 1 and 2 to identify the normative, legal and ethical considerations for different recruitment techniques used in clinical trials and propose policy and practice recommendations.