Mission: Impossible? On Empirical-Normative Collaboration in Ethical Reasoning

Schleidgen, Sebastian; Jungert, Michael; Bauer, Robert H.

doi:10.1007/s10677-009-9170-x

Cited by 8 publications

(2 citation statements)

References 13 publications

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“…In our attempt to explore the role of RECs, although the aim would be to be value-neutral, the questions in and of themselves that were asked of the respondents and the responses have some underlying normative assumptions. Therefore, it would be disingenuous and almost impossible to ignore that there is a relationship between facts and values (Borry et al, 2004(Borry et al, , 2013Schleidgen et al, 2010). Molewijk et al suggest that empirical ethics addresses this relationship by integrating moral theory and empirical data.…”

Section: An Empirical Normative Approach To a Study On Recsmentioning

confidence: 99%

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

Cox

Solbakk

Bernabe

2021

Current Medical Research and Opinion

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BackgroundFor approximately six decades, Research Ethics Committees (RECs), also known as Institutional Review Boards (IRBs), have played an integral part in the identification of ethical issues before the commencement of clinical research globally. The importance and relevance of the REC/IRB prospective review are widely acknowledged, admired, and critiqued. In many jurisdictions, legislative and policy frameworks are in place to prevent clinical research from taking place without prior review and approval by a REC/IRB. It is, therefore, reasonable to assume that research with a favorable opinion of a REC/IRB is ethically sound and scientifically appropriate. There is evidence, however, that researchers may deviate from the approved protocols. Many of these deviations are ethically relevant yet remain unaddressed. These unaddressed deviations form the basis for this interrogative thesis into the post-approval role of RECs/IRBs. It employs the sociological frame of role theory to illuminate concepts such as role expectations, identity, and behavior concerning REC/IRBs in the post-approval oversight of clinical trials. MethodsQualitative research methods were employed to explore the main objectives. The research approach includes hermeneutic content analysis combined with thematic analysis to guide data extraction, reading, interpretation, and reporting. The primary data sources were regional and international normative documents related to clinical research and REC/IRBs in Europe and the USA and US Academic health center IRBs' web page content. Stakeholder engagement included REC representatives in Europe using the European Network for Research Ethics Committee (EUREC) member list. ResultsThe general post-approval role expectations of REC/IRBs are 1) to review significant protocol amendments and issue opinions or approval on these amendments, 2) to receive notification of safety and adverse events reports, and 3) to receive notification of the end of a trial and a final report. There is disagreement between regions on whether RECs ought to conduct continuing reviews. Within the EU and allied countries, continuing review is considered a form of active monitoring delegated to the regulatory authorities. Contrariwise, the law mandates continuing review within the USA, which is also distinguished from active monitoring. There are challenges with the use of and interpretation of clinical trial nomenclature. The authority of US IRBs to suspend and terminate trials is not commonplace in the EU. Conclusion/RecommendationsThe overarching role expectation of REC/IRBs after the approval of clinical trial protocols is to protect research participants. This may be achieved through post-approval activities such as continuing review, active monitoring, ethics support and education to researchers, and the issuance of an opinion on the final reports at the end of clinical trials. There may be hesitancy in European countries to conduct active follow-up of approved trials due to a lack of supporting legislation/policy, types of org...

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Section: An Empirical Normative Approach To a Study On Recsmentioning

confidence: 99%

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

Cox

Solbakk

Bernabe

2021

Current Medical Research and Opinion

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“…While a number of marketing ethics studies adopt either of the above approaches, Schleidgen et al (2010) suggest a collaboration between normative and positive approaches, known as a symbiotic approach (Weaver and Trevino, 1994). The symbiotic approach allows both previous approaches to interact, a positive approach collects and evaluates factual phenomenon and the normative approach provides principles to evaluate the phenomenon.…”

Section: Marketing Ethics Approachesmentioning

confidence: 99%

Public evaluation of the ethics of tobacco marketing in Indonesia: symbiotic ethical approach

Tjandra

Aroean

Prabandari

2020

QMR

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Purpose This study aims to explore the public evaluation of the ethics of marketing tobacco in Indonesia through the theoretical lens of normative ethics. Design/methodology/approach The present study adopted a symbiotic ethical approach, which combined normative and positive ethical approaches. The data was collected in Yogyakarta, Indonesia, from 6 focus groups and 30 photo-elicitation interviews with a total of 71 participants. Findings Five main themes have been identified as follows: product-related, authority-related, economic-related, vulnerable-party-related and firm-behaviour-related themes. The findings reveal a profound picture of the hopes, arguments and dilemmas surrounding the five main themes, which highlight the issues of harmfulness, lenient regulation, economic reliance, vulnerability and aggressiveness. Research limitations/implications The thematic analysis has identified six main themes, namely, the economic contribution of the tobacco industry, the harmful nature of tobacco products, tobacco marketing targeting vulnerable groups, covering the danger of smoking, intention and integrity of tobacco marketers and infringement of the law and social norms. Adopting the theoretical lens of utilitarianism, deontology, contractarianism and virtue ethics, the analysis illustrates that most participants believed that tobacco marketing practices in Indonesia are unethical. Social implications The findings of the study were disseminated in a public engagement event to stakeholders in Yogyakarta. The findings influenced the development of no-smoking area monitoring instruments and the introduction of “free from tobacco advertisement in the no-smoking area” policy in Sleman Regency, Yogyakarta. Originality/value Indonesia, with its lenient regulatory environment, provides a unique setting for investigating public evaluation of the ethics of tobacco marketing. This is one of the first studies that investigates public evaluation of tobacco marketing ethics in Indonesia through the theoretical lens of utilitarianism, deontology, virtue ethics and contractarianism.

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A fallacious jar? The peculiar relation between descriptive premises and normative conclusions in neuroethics

Wagner

Northoff

2015

Theor Med Bioeth

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Ethical questions have traditionally been approached through conceptual analysis. Inspired by the rapid advance of modern brain imaging techniques, however, some ethical questions appear in a new light. For example, hotly debated trolley dilemmas have recently been studied by psychologists and neuroscientists alike, arguing that their findings can support or debunk moral intuitions that underlie those dilemmas. Resulting from the wedding of philosophy and neuroscience, neuroethics has emerged as a novel interdisciplinary field that aims at drawing conclusive relationships between neuroscientific observations and normative ethics. A major goal of neuroethics is to derive normative ethical conclusions from the investigation of neural and psychological mechanisms underlying ethical theories, as well as moral judgments and intuitions. The focus of this article is to shed light on the structure and functioning of neuroethical arguments of this sort, and to reveal particular methodological challenges that lie concealed therein. We discuss the methodological problem of how one can--or, as the case may be, cannot--validly infer normative conclusions from neuroscientific observations. Moreover, we raise the issue of how preexisting normative ethical convictions threaten to invalidate the interpretation of neuroscientific data, and thus arrive at question-begging conclusions. Nonetheless, this is not to deny that current neuroethics rightly presumes that moral considerations about actual human lives demand empirically substantiated answers. Therefore, in conclusion, we offer some preliminary reflections on how the discussed methodological challenges can be met.

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Mission: Impossible? On Empirical-Normative Collaboration in Ethical Reasoning

Cited by 8 publications

References 13 publications

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

Public evaluation of the ethics of tobacco marketing in Indonesia: symbiotic ethical approach

A fallacious jar? The peculiar relation between descriptive premises and normative conclusions in neuroethics

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