Pain research and children and adolescents with severe intellectual disability: ethical challenges and imperatives.

Children with severe intellectual disabilities encounter inequities in pain-related care, yet little pain research involves this population. A considerable issue with pain research in this population is its ethical complexity. This Viewpoint delineates the ethical challenges of pain research involving children (aged 2-12 years) and adolescents (aged 13-21 years) with severe intellectual disabilities. There are two main issues. First, some of the standard methods for assessing pain and pain sensitivity are not suitable for individuals with severe intellectual disability, who are often non-verbal and unable to understand or follow instructions. Second, children and adolescents with severe intellectual disability cannot provide informed consent or assent to participate in pain research, and their dissent is not always recognised. The existing ethical guidelines for pain research by the International Association for the Study of Pain provide helpful, but general, guidance. This Viewpoint supplements these guidelines and uses a well established framework for assessing the ethics of clinical research to highlight points relevant to designing, doing, reviewing, and evaluating research involving children and adolescents with severe intellectual disability, focusing on issues that are unaddressed in existing guidance.

Nudges and hard choices.

Nudges are small changes in the presentation of options that make a predictable impact on people's decisions. Proponents of nudges often claim that they are justified as paternalistic interventions that respect autonomy: they lead people to make better choices, while still letting them choose for themselves. However, existing work on nudges ignores the possibility of "hard choices": cases where a person prefers one option in some respects, and another in other respects, but has no all-things-considered preference between the two. In this paper, I argue that many significant medical decisions are hard choices that provide patients with an opportunity to exercise a distinctive sort of "formative autonomy" by settling their preferences and committing themselves to weigh their values in a particular way. Since nudges risk infringing formative autonomy by depriving patients of this opportunity, their use in medical contexts should be sensitive to this risk.

When Not to Ask: A Defense of Choice-Masking Nudges in Medical Research.

In this article, we examine the legality and ethics of a controversial but widespread practice in clinical research: choice-masking nudges. A choice-masking nudge (CMN) exists when a research team explicitly obscures a meaningful choice from participants by presenting a default decision as the standard way forward. Even though an easy-to-use opt-out mechanism is available for participants who independently express concerns with the standard default, the fact that a default has been pre-selected is not made obvious to research participants. To opt out of the nudge, a participant must overtly request non-standard treatment. We argue that use of such nudges in medical research can be justified by their individual, collective, and social benefits, provided that they respect autonomy and satisfy our four further acceptability conditions. The structure of this Article is as follows. In Part II, we describe three controversial cases of CMNs in medical research. In Part III, we provide background on nudging and explain how our proposed CMNs fit into the existing literature on nudging and libertarian paternalism. In Part IV, we explain how the reasonable person standard as employed by United States research regulations can be used to support CMNs. In Part IV, we anticipate some of the strongest objections to CMNs by explaining how CMNs are compatible with a wide range of plausible accounts of autonomy. Finally, in Part VI, we discuss four additional core considerations an acceptable CMN must meet: legitimate policy goals; benefits outweighing harms; burdens distributed fairly; and absence of ethically superior feasible alternatives. We also analyze the three existing controversies explored in Part II and show how each would benefit from the conceptual clarity offered by our analytic framework. Medical research is complicated and can be difficult for participants to understand; thoughtfully designed CMNs can play an important role in gently guiding large numbers of research participants toward decision outcomes that really are best for them and their communities.