Counterfactual Consent and the Use of Deception in Research

Wilson, Alan T.

doi:10.1111/bioe.12142

Cited by 10 publications

(10 citation statements)

References 3 publications

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“…This may allow for subgroup analysis to explore the effect of the timing of the intervention (early or later in a professional's career). As knowledge of the hypothesis being studied is likely to bias the results, concealing the research hypothesis or deceiving the participants about the precise purpose of the study may be permissible and may counterbalance the lack of direct blinding …”

Section: Discussionmentioning

confidence: 99%

The role of ergonomic saddle seats and magnification loupes in the prevention of musculoskeletal disorders. A systematic review

Plessas

Delgado

2018

Int J Dental Hygiene

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Based on a limited number of studies, the use of ergonomic saddle seats and dental loupes leads to improved working postures. The use of loupes appears to relieve shoulder, arm and hand pain. However, their effect on neck pain is scarce. None of the studies reported on the effect of the saddle seats on musculoskeletal pain. Future well-powered prospective longitudinal studies are deemed necessary to confirm the conclusions of this review.

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Section: Discussionmentioning

confidence: 99%

The role of ergonomic saddle seats and magnification loupes in the prevention of musculoskeletal disorders. A systematic review

Plessas

Delgado

2018

Int J Dental Hygiene

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“…Counterfactual consent is delivered when two conditions are satisfied: 1) the participant is not ignorant of any fact that would cause them to withhold their consent if they were aware of it, and 2) they voluntarily consent. 15 Deception about study goals does not violate autonomy but deception about the existence of the study does. We proposed that participants would give consent for a study examining the quality and safety of their home pain management.…”

Section: Study Design and Populationmentioning

confidence: 99%

A prospective observational study of pediatric opioid prescribing at postoperative discharge: how much is actually used?

Caldeira-Kulbakas

Stratton

Roy

et al. 2020

Can J Anesth/J Can Anesth

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Purpose Research describing opioid misuse in children after surgery currently describes single specialties, short follow-up, and heterogeneous data not conducive to comparative discussion. Our primary objective was to quantify opioids prescribed to pediatric surgical patients on discharge from hospital. Secondary objectives were quantifying opioids remaining unused at four-week followup, and family attitudes to safe storage and disposal. Methods We conducted a prospective observational study under counterfactual consent with telephone follow-up at four weeks of children who had undergone a surgical procedure and filled an opioid prescription at The Hospital for Sick Children, Toronto, ON, Canada. Exclusion criteria included opioid use within the previous six months, history of chronic pain, or discharge to a rehabilitation facility. Pre-and post-discharge prescribing, dispensing, and consumption data were collected prospectively in addition to parental reports of home opioid use. Opioiddosing was converted to oral morphine milligram equivalents (MME). Results There were 8,672 MMEs prescribed to 110 patients. Twenty-one patients were lost to follow-up, accounting for 1,416 MME. Of the remaining 7,256 MME, 67% went unused. At follow-up, 78% of unused opioid remained in the home. Most opioids were stored in an easily accessible location in the home. Conclusion These findings confirm overprescribing of opioids to pediatric surgical patients. Families tend not to return opioids that exceed post-discharge analgesic requirements at home and many of the reported disposal methods are unsafe. We recommend future studies focus on optimizing opioid prescriptions to meet, but not excessively surpass, home pain management requirements, and to encourage safe opioid disposal/return methods. Trial registration www.clinicaltrials.gov (NCT03562013); registered 7 June, 2018. Re ´sumeÓbjectif La recherche s'inte ´ressant a `la mauvaise utilisation des opioı ¨des apre `s une chirurgie chez des enfants de ´crit actuellement des spe ´cialite ´s uniques, un suivi de courte dure ´e et des donne ´es he ´te ´roge `nes ne permettant pas de de ´boucher sur un de ´bat comparatif. Notre objectif principal e ´tait de quantifier les opioı ¨des prescrits a `des patients chirurgicaux pe ´diatriques au moment de leur conge ´de l'ho ˆpital. Les objectifs secondaires e ´taient de quantifier les opioı ¨des inutilise ´s restant apre `s quatre

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“…whether valid justifications are considered to perform such studies and whether such studies are also accompanied by debriefing sessions’ (Focus Group Member #6). In keeping with dominant trends in the scholarly literature (Benham, 2008b; Boynton et al, 2013; Miller et al, 2008; Wilson, 2015), one of the discussants also suggested what makes deceptive or covert research exceptional and ethically acceptable in certain circumstances: ‘. .…”

Section: Resultsmentioning

confidence: 94%

Enhancing ethics review of social and behavioral research: developing a review template in Ethiopia

Wassie

Gebre-Mariam²,

Tarekegne

et al. 2019

Research Ethics

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Background: Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory capacities, in terms of ethical review processes, are also generally weak. The ethical assessment of social and behavioral research is relatively neglected compared to the review of biomedical and clinical studies, which led us to develop an ethics review assessment tool for use in the review of social and behavioral research in Ethiopia, which could potentially be of value in low- and middle-income settings. Methods: Initially, we did a comprehensive literature review on principles, guidelines, and practices of research ethics, on social and behavioral studies, from which we extracted query terms to explore the opinions of selected key informants and focus groups in Ethiopia. The discussants and informants were selected using a convenience sampling method to evaluate an ethics review template, which integrated issues that commonly arise in social and behavioral studies. Finally, we directly solicited opinions from the discussants about the desirability, feasibility, acceptability, and relevance of the ethics review assessment tool and used the resulting data to refine our initial draft. Results and conclusion: Although the same basic ethics principles govern all research studies, social and behavioral research have some disciplinary particularities that may require reviewers to exercise a different orientation of ethical attention in some cases. Using a qualitative approach, we developed a review assessment tool that could potentially be useful to raise awareness, focus attention, and strengthen the review of social and behavioral studies by ethics review committees, particularly in settings without a long-standing tradition of reviewing such research. This process also exposed some areas where further capacity building and discussion of ethical issues may be necessary among stakeholders in the review of social and behavioral research.

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Counterfactual Consent and the Use of Deception in Research

Abstract: ABSTRACT

Cited by 10 publications

References 3 publications

The role of ergonomic saddle seats and magnification loupes in the prevention of musculoskeletal disorders. A systematic review

The role of ergonomic saddle seats and magnification loupes in the prevention of musculoskeletal disorders. A systematic review

A prospective observational study of pediatric opioid prescribing at postoperative discharge: how much is actually used?

Enhancing ethics review of social and behavioral research: developing a review template in Ethiopia

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