Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model.
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ABSTRACT:
SUBMITTER: Poplazarova T
PROVIDER: S-EPMC7482740 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundEthical decision-making confidence develops from clinical expertise and is a core competency for nurse leaders. No tool exists to measure confidence levels in nurse leaders based upon an ethical decision-making framework.AimsThe objective of this research was to compare ethical decision-making among nurse leaders in the U.S. and three German-speaking countries in Europe by developing and testing a newly constructed Ethical Decision-Making Confidence (EDMC) scale.MethodsThe cross-sectional survey included 18 theory-derived questions on ethical decision-making confidence which were used to develop the scale.ParticipantsA convenience sample of nurse leaders from the U.S. and three German-speaking countries in Europe who self-identified as holding a leadership position.Ethical considerationsEthical approval was given by the IRB Board of a U.S. university. Participation in the survey implied voluntary consent.ResultsThe scale's item structure dimensionality and subscale's reliability were analyzed and compared between nurse leaders from all four countries. A principal component analysis (PCA) produced a 15-item bi-dimensional EDMC scale yielding a skill-related (9-item) and a behavior-related (6-item) confidence dimension. EDMC subscales showed good-to-excellent internal consistency. In both subscales, U.S. nurse leaders rated their mean EDMC score higher than their German-speaking counterparts in Europe.DiscussionThis exploratory study is the first of its kind to focus on nurse leaders' confidence regarding ethical decision-making in an international context. An overarching factor structure was identified, which is shared by the two samples of nurse leaders and to examine (sub)scales' psychometric properties.ConclusionThis newly developed scale is an effective tool for measuring ethical decision-making confidence in nurse leaders. The promising results of this study should be replicated to ensure validity and reliability of the EDMC scale measuring skill-related and behavior-related concepts and include nurse leaders from various cultural, social, and demographic groups.
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Project description:The ecosystem services (ES) concept has emerged and spread widely recently, to enhance the importance of preserving ecosystems through global change in order to maintain their benefits for human well-being. Numerous studies consider various dimensions of the interactions between ecosystems and land use via ES, but integrated research addressing the complete feedback loop between biodiversity, ES and land use has remained mostly theoretical. Few studies consider feedbacks from ecosystems to land use systems through ES, exploring how ES are taken into account in land management decisions. To fill this gap, we carried out a role-playing game to explore how ES cognition mediates feedbacks from environmental change on farmers' behaviors in a mountain grassland system. On a close to real landscape game board, farmers were faced with changes in ES under climatic and socio-economic scenarios and prompted to plan for the future and to take land management decisions as they deemed necessary. The outcomes of role-playing game were complemented with additional agronomic and ecological data from interviews and fieldwork. The effects of changes in ES on decision were mainly direct, i.e. not affecting knowledge and values, when they constituted situations with which farmers were accustomed. For example, a reduction of forage quantity following droughts led farmers to shift from mowing to grazing. Sometimes, ES cognitions were affected by ES changes or by external factors, leading to an indirect feedback. This happened when fertilization was stopped after farmers learned that it was inefficient in a drought context. Farmers' behaviors did not always reflect their attitudes towards ES because other factors including topographic constraints, social value of farming or farmer individual and household characteristics also influenced land-management decisions. Those results demonstrated the interest to take into account the complete feedback loop between ES and land management decisions to favor more sustainable ES management.
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Project description:Visitation restrictions in hospitals during the COVID-19 (coronavirus disease 2019) pandemic led to great psychological burden for patients, their relatives and employees. For hospitals, they represent a complex organizational challenge with respect to ethics. The present recommendations are intended to support decision-making at the meso- and microlevels.
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Project description:ImportancePhysicians endorse deprescribing of risky or unnecessary medications for older adults (aged ≥65 years) with dementia, but there is a lack of information on what influences decisions to deprescribe in this population.ObjectiveTo understand how physicians make decisions to deprescribe for older adults with moderate dementia and ethical and pragmatic concerns influencing those decisions.Design, setting, and participantsA cross-sectional national mailed survey study of a random sample of 3000 primary care physicians from the American Medical Association Physician Masterfile who care for older adults was conducted from January 15 to December 31, 2021.Main outcomes and measuresThe study randomized participants to consider 2 clinical scenarios in which a physician may decide to deprescribe a medication for older adults with moderate dementia: 1 in which the medication could cause an adverse drug event if continued and the other in which there is no evidence of benefit. Participants ranked 9 factors related to possible ethical and pragmatic concerns through best-worst scaling methods (from greatest barrier to smallest barrier to deprescribing). Conditional logit regression quantified the relative importance for each factor as a barrier to deprescribing.ResultsA total of 890 physicians (35.0%) returned surveys; 511 (57.4%) were male, and the mean (SD) years since graduation was 26.0 (11.7). Most physicians had a primary specialty in family practice (50.4% [449 of 890]) and internal medicine (43.5% [387 of 890]). A total of 689 surveys were sufficiently complete to analyze. In both clinical scenarios, the 2 greatest barriers to deprescribing were (1) the patient or family reporting symptomatic benefit from the medication (beneficence and autonomy) and (2) the medication having been prescribed by another physician (autonomy and nonmaleficence). The least influential factor was ease of paying for the medication (justice).Conclusions and relevanceFindings from this national survey study of primary care physicians suggests that understanding ethical aspects of physician decision-making can inform clinician education about medication management and deprescribing decisions for older adults with moderate dementia.
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Project description:BackgroundThe four principles of Beauchamp and Childress--autonomy, non-maleficence, beneficence and justice--have been extremely influential in the field of medical ethics, and are fundamental for understanding the current approach to ethical assessment in health care. This study tests whether these principles can be quantitatively measured on an individual level, and then subsequently if they are used in the decision making process when individuals are faced with ethical dilemmas.MethodsThe Analytic Hierarchy Process was used as a tool for the measurement of the principles. Four scenarios, which involved conflicts between the medical ethical principles, were presented to participants who then made judgments about the ethicality of the action in the scenario, and their intentions to act in the same manner if they were in the situation.ResultsIndividual preferences for these medical ethical principles can be measured using the Analytic Hierarchy Process. This technique provides a useful tool in which to highlight individual medical ethical values. On average, individuals have a significant preference for non-maleficence over the other principles, however, and perhaps counter-intuitively, this preference does not seem to relate to applied ethical judgements in specific ethical dilemmas.ConclusionsPeople state they value these medical ethical principles but they do not actually seem to use them directly in the decision making process. The reasons for this are explained through the lack of a behavioural model to account for the relevant situational factors not captured by the principles. The limitations of the principles in predicting ethical decision making are discussed.
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