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

Abstract

In their recent paper, Al and colleagues (Trials 2023;24:233) argue that manipulation of the methods of recruitment using well-known techniques in order to increase enrollment can be ethically acceptable. This brief response challenges that notion as an affront to voluntariness and a devolution of the ethics of human subjects research to the “ethics” of the marketplace.

A 2023 nationwide study on adjustment disorder among first year MBBS students in India

“…Medical education requires a faster, continuous, and self-directed learning pace compared to intermediate schooling, where students must reflect on their progress, identify knowledge and skill gaps, and actively seek information to address them, amplifying stress and anxiety during the commencement of medical training if they feel unprepared [8]. Enrolling in medical college can be a significant stressor, leading to various emotional and psychological challenges, as indicated by a study stating that about 50% of newly enrolled university students experience academic adjustment problems, which are significantly associated with Adjustment Disorder (AjD) [9]. A study conducted in South India revealed that 48% of medical students had low resilience to stress, and 52% displayed low coping abilities [10].…”

Response to Merz

“…Jon Merz raises two objections to our article on the ethics of behavioral influences in trial recruitment [ 1 ]. Firstly, he argues that our argument rests on the incorrect assumption that consenting to research participation is the right choice for potential participants.…”

“…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 ].…”

“…We believe that Merz’s criticisms are based on a misunderstanding of our article as defending the “manipulation of the methods of recruitment” [ 1 ]. Our paper is a call for urgently needed guidance on how techniques that can be used to influence behavior should — and should not — be used, not a defense of “manipulative methods.” The use of behavioral influences is already widespread in clinical trials, as trialists seek to recruit participants in sufficient numbers.…”

“…Far from assuming that “research participation is the correct normative choice for potential subjects and that researchers (and ethics review boards) are therefore justified in purposefully using psychological manipulation to influence potential subjects’ decisions” [ 1 ], we argue that it is the quality of trial participation that matters. To improve on the quality of trial participation, we recommend that trialists who use behavioral influences should collect data on the experience of participants.…”