Changing patient preferences toward better trial recruitment: an ethical analysis

Abstract

While randomized controlled trials are essential to health research, many of these trials fail to recruit enough participants. Approaching recruitment through the lens of behavioral science can help trialists to understand influences on the decision to participate and use them to increase recruitment. Although this approach is promising, the use of behavioral influences during recruitment is in tension with the ethical principle of respect for persons, as at least some of these influences could be used to manipulate potential participants. In this paper, we examine this tension by discussing two types of behavioral influences: one example involves physician recommendations, and the other involves framing of information to exploit cognitive biases. We argue that despite the apparent tension with ethical principles, influencing trial participants through behavior change strategies can be ethically acceptable. However, we argue that trialists have a positive obligation to analyze their recruitment strategies for behavioral influences and disclose these upfront to the research ethics committee. But we also acknowledge that since neither trialists nor ethics committees are presently well equipped to perform these analyses, additional resources and guidance are needed. We close by outlining a path toward the development of such guidance.

A response to Al et al. Trials 2023;24:233

“…In their recent paper, Al and colleagues [ 1 ] argue that, at least with nonvulnerable subjects, manipulation of the methods of recruitment using well-known techniques in order to increase enrollment can be ethically acceptable. They do add that researchers attempting to use such methods should study their practices (perhaps to ensure they do not rise to the level of coercing or unduly influencing potential subjects), and disclose their methods and purpose to relevant ethics committees.…”

Response to Merz

“…Firstly, he argues that our argument rests on the incorrect assumption that consenting to research participation is the right choice for potential participants. Secondly, Merz objects to our proposal of using a daily life standard of behavioral influences, which states that “behavioral influence strategies could be considered prima facie autonomy-respecting if it is comparable to other uncontroversial behavioral influence strategies to which an individual is routinely exposed in their daily life [ 2 ].” Merz argues that this will devolve research ethics into “an ‘ethics’ of the marketplace” with advertisements based on the tools of propaganda [ 1 ].…”

“…To be clear though, “we believe additional resources and guidance are needed. We have proposed [...] a few components of this guidance, but recognize that much more work is needed [ 2 ].”…”

“…We posit that regret is an important marker of an enrollment decision that was not the right one for the participant . Trialists should attend carefully to recruitment and other aspects of the conduct of the trial to “ensure (as much as possible) that their research participants do not regret their decision to enroll [ 2 ].”…”