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Incorporating ethics and welfare into randomized experiments.

ABSTRACT: Randomized controlled trials (RCTs) enroll hundreds of millions of subjects and involve many human lives. To improve subjects' welfare, I propose a design of RCTs that I call Experiment-as-Market (EXAM). EXAM produces a welfare-maximizing allocation of treatment-assignment probabilities, is almost incentive-compatible for preference elicitation, and unbiasedly estimates any causal effect estimable with standard RCTs. I quantify these properties by applying EXAM to a water-cleaning experiment in Kenya. In this empirical setting, compared to standard RCTs, EXAM improves subjects' predicted well-being while reaching similar treatment-effect estimates with similar precision.

SUBMITTER: Narita Y

PROVIDER: S-EPMC7817215 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Incorporating ethics and welfare into randomized experiments.

Narita Yusuke Y

Proceedings of the National Academy of Sciences of the United States of America 20210101 1

Randomized controlled trials (RCTs) enroll hundreds of millions of subjects and involve many human lives. To improve subjects' welfare, I propose a design of RCTs that I call Experiment-as-Market (EXAM). EXAM produces a welfare-maximizing allocation of treatment-assignment probabilities, is almost incentive-compatible for preference elicitation, and unbiasedly estimates any causal effect estimable with standard RCTs. I quantify these properties by applying EXAM to a water-cleaning experiment in ...[more]

PMID: 33443151

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Project description:Farm animal welfare is a major concern for society and food production. To more accurately evaluate animal farming in general and to avoid exposing farm animals to poor welfare situations, it is necessary to understand not only their behavioral but also their cognitive needs and capacities. Thus, general knowledge of how farm animals perceive and interact with their environment is of major importance for a range of stakeholders, from citizens to politicians to cognitive ethologists to philosophers. This review aims to outline the current state of farm animal cognition research and focuses on ungulate livestock species, such as cattle, horses, pigs and small ruminants, and reflects upon a defined set of cognitive capacities (physical cognition: categorization, numerical ability, object permanence, reasoning, tool use; social cognition: individual discrimination and recognition, communication with humans, social learning, attribution of attention, prosociality, fairness). We identify a lack of information on certain aspects of physico-cognitive capacities in most farm animal species, such as numerosity discrimination and object permanence. This leads to further questions on how livestock comprehend their physical environment and understand causal relationships. Increasing our knowledge in this area will facilitate efforts to adjust husbandry systems and enrichment items to meet the needs and preferences of farm animals. Research in the socio-cognitive domain indicates that ungulate livestock possess sophisticated mental capacities, such as the discrimination between, and recognition of, conspecifics as well as human handlers using multiple modalities. Livestock also react to very subtle behavioral cues of conspecifics and humans. These socio-cognitive capacities can impact human-animal interactions during management practices and introduce ethical considerations on how to treat livestock in general. We emphasize the importance of gaining a better understanding of how livestock species interact with their physical and social environments, as this information can improve housing and management conditions and can be used to evaluate the use and treatment of animals during production.

Project description:ImportanceIncentivizing research participation is controversial and variably regulated because of uncertainty regarding whether financial incentives serve as undue inducements by diminishing peoples' sensitivity to research risks or unjust inducements by preferentially increasing enrollment among underserved individuals.ObjectiveTo determine whether incentives improve enrollment in real randomized clinical trials (RCTs) or serve as undue or unjust inducements.Design, setting, and participantsTwo RCTs of incentives that were embedded in 2 parent RCTs, 1 comparing smoking cessation interventions (conducted at smoking cessation clinics in 2 health systems) and 1 evaluating an ambulation intervention (conducted across wards of the Hospital of the University of Pennsylvania) included all persons eligible for the parent trials who did not have prior knowledge of the incentives trials. Recruitment occurred from September 2017 to August 2019 for the smoking trial and January 2018 through May 2019 for the ambulation trial; data were analyzed from January 2020 to July 2020.InterventionsPatients were randomly assigned to incentives of $0, $200, or $500 for participating in the smoking cessation trial and $0, $100, or $300 for the ambulation trial.Main outcomes and measuresThe primary outcome of each incentive trial was the proportion of people assigned to each recruitment strategy that consented to participate. Each trial was powered to test the hypotheses that incentives served neither as undue inducements (based on the interaction between incentive size and perceived research risk, as measured using a 10-point scale, on the primary outcome), nor unjust inducements (based on the interaction between incentive size and participants' self-reported income). Noninferiority methods were used to test whether the data were compatible with these 2 effects of incentives and superiority methods to compare the primary and other secondary outcomes.ResultsThere were a total of 654 participants (327 women [50.0%]; mean [SD] age, 50.6 [12.1] years; 394 Black/African American [60.2%], 214 White [32.7%], and 24 multiracial individuals [3.7%]) in the smoking trial, and 642 participants (364 women [56.7%]; mean [SD] age, 46.7 [15.6] years; 224 Black/African American [34.9%], 335 White [52.2%], and 5 multiracial individuals [0.8%]) in the ambulation trial. Incentives significantly increased consent rates among those in the smoking trial in 47 of 216 (21.8%), 78 of 217 (35.9%), and 104 of 221 (47.1%) in the $0, $200, and $500 groups, respectively (adjusted odds ratio [aOR] for each increase in incentive, 1.70; 95% CI, 1.34-2.17; P < .001). Incentives did not increase consent among those in the ambulation trial: 98 of 216 (45.4%), 102 of 212 (48.1%), and 92 of 214 (43.0%) in the $0, $100, and $300 groups, respectively (aOR, 0.88; 95% CI, 0.64-1.22; P = .45). In neither trial was there evidence of undue or unjust inducement (upper confidence limits of ORs for undue inducement, 1.15 and 0.99; P < .001 showing noninferiority; upper confidence limits of ORs for unjust inducement, 1.21 and 1.26; P = .01 and P < .001, respectively). There were no significant effects of incentive size on the secondary outcomes in either trial, including time spent reviewing the risk sections of consent forms, perceived research risks, trial understanding, perceived coercion, or therapeutic misconceptions.Conclusions and relevanceIn these 2 randomized clinical trials, financial incentives increased trial enrollment in 1 of 2 trials and did not produce undue or unjust inducement or other unintended consequences in either trial.Trial registrationClinicalTrials.gov Identifier: NCT02697799.

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Incorporating ethics and welfare into randomized experiments.

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Incorporating ethics and welfare into randomized experiments.

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