Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent.

Pragmatic clinical trials of standard-of-care interventions compare the relative merits of medical treatments already in use. Traditional research informed consent processes pose significant obstacles to these trials, raising the question of whether they may be conducted with alteration or waiver of informed consent. However, to even be eligible, such a trial in the United States must have no more than minimal research risk. We argue that standard-of-care pragmatic clinical trials can be designed to ensure that they are minimal research risk if the random assignment of an intervention in a pragmatic clinical trial can accommodate individualized, clinically motivated decision-making for each participant. Such a design will ensure that the patient-participants are not exposed to any risks beyond the clinical risks of the interventions, and thus, the trial will have minimal research risk. We explain the logic of this view by comparing three scenarios of standard-of-care pragmatic clinical trials: one with informed consent, one without informed consent, and one recently proposed design called Decision Architecture Randomization Trial. We then conclude by briefly showing that our proposal suggests a natural way to determine when to use an alteration versus a waiver of informed consent.

When medical assistance in dying is not a last resort option: survey of the Canadian public.

OBJECTIVES: What are the Canadian public's understanding of and views toward medical assistance in dying (MAID) in persons refusing recommended treatment or lacking access to standard treatment or resources? DESIGN/SETTING: An online survey assessed knowledge of and support for Canadian MAID law, and views about four specific scenarios in a two (medical or psychiatric) by two (treatment refusal or lack of access) design. PARTICIPANTS: A quota sample (N=2140) matched to the 2021 Canadian census by age, gender, income, education and province. MAIN OUTCOMES: Participants' level of support for MAID in general and in the four specific scenarios. RESULTS: Only 12.1% correctly answered ≥4 of 5 knowledge questions about the MAID law; only 19.2% knew terminal illness is not required and 20.2% knew treatment refusal is compatible with eligibility. 73.3% of participants expressed support for the MAID law in general, matching a nationally representative poll that used the same question. 40.4% of respondents supported MAID for mental illnesses. Support for MAID in the scenarios depicting refusal or lack of access to treatment ranged from 23.2% (lack of access in medical condition) to 32.0% (treatment refusal in medical illness). Older age, more education, higher income, lower religious attendance or being white was associated with greater support for MAID in general but was either negatively associated or not associated with support for MAID in the four refusal or lack of access scenarios. CONCLUSIONS: Most Canadians support the current MAID law but appear unaware that MAID cases they do not support are compatible with that law. The lower support for MAID in the four scenarios cuts across sociodemographics. The gap between current policy and public opinion warrants further study. For jurisdictions debating MAID, opinion surveys may need to go beyond assessing general attitudes, and target knowledge and views regarding implications of legalisation.

Questioning our presumptions about the presumption of capacity.

All contemporary frameworks of mental capacity stipulate that we must begin from the presumption that an adult has capacity. This presumption is crucial, as it manifests respect for autonomy and guards against prejudice and paternalism on the part of the evaluator.Given its ubiquity, we might presume that we all understand the presumption's meaning and application in the same way. Evidence demonstrates that this is not the case and that this has led to harm in vulnerable persons. There is thus strong reason to question our presumptions about the presumption of capacity.We distinguish between two main ways of understanding and applying the presumption of capacity, and advocate for the one that we argue mitigates risk of harm. Our proposed interpretation offers many advantages in that it is consonant with actual practice of capacity evaluations, precludes confused and abusive avoidance of needed evaluations, and preserves the respect for autonomy motivating the presumption in the first place.