Obstacles to researching the researchers: A case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials

<p>Abstract</p> <p>Background</p> <p>Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.</p> <p>In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons.</p> <p>In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions.</p> <p>Discussion and conclusion</p> <p>Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research.</p> <p>Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential benefit of this research in the broader research community, and those who sit on ethics committees, is perhaps needed. In addition, changes to the ethical review process which involve separation between those who review proposals to undertake methodological research using ethics applications, and those with responsibility for reviewing ethics applications for trials, should be considered. Finally, we contend that the research community could benefit from quality improvement approaches used in allied sectors.</p

Impact of approaches in improving male partner involvement in the prevention of mother-to-child transmission (PMTCT) of HIV on the uptake of PMTCT services in sub-Saharan Africa: a protocol of a systematic review and meta-analysis

Introduction: Several studies have reported approaches used in improving the delivery of prevention of mother-to-child transmission (PMTCT) of HIV services through the involvement of male partners, but evidence from a systematic review is limited. We aim at determining the impact of male partner involvement on PMTCT in sub-Saharan Africa. Methods and analysis: This will be a systematic review of published literature. Interventional and observational studies on male involvement in PMTCT carried out in sub-Saharan Africa will be included irrespective of the year and language of publication. OVID Medline, Embase, PschINFO, and Cochrane database of controlled trials will be searched. After manual searching of articles, authors shall be contacted for further information. 2 authors (NFT and CJ) will independently screen potential articles for eligibility using defined inclusion and exclusion criteria. Critical Appraisal Skills Programme (CASP) tools, Jadad scale and the STROBE checklist will be used for critical appraisal, and the 2 authors will independently assess the quality of articles. Authors will independently extract data from studies using a pre-established data collection form, and any discrepancies will be sorted by a third author (TRK). Outcomes will be analysed using STATA V.12.0. The random effect model will be used to produce forest plots. The heterogeneity χ2 statistics and I2 will be used to assess for heterogeneity. Publication bias will be assessed using funnel plots. This protocol is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines. Ethics and dissemination: No ethical approval since included studies will be published studies that had already obtained ethical approvals. The findings will guide HIV programmes on the best approaches towards involving male partners in PMTCT with a view to improving PMTCT services in sub-Saharan Africa

Theoretical and practical approach to information ethics based on Roman Ingarden's phenomenology of values

Etyka informacyjna, jako dynamicznie rozwijany w ostatnich latach nurt w filozofii informacji oraz dziedzina praktyczna etyki, związana z moralnością człowieka w otoczeniu informacyjnym, poszerza nieustannie granice swoich zainteresowań. Rodzi to niebezpieczeństwo odejścia od podstawowych dla etyki kwestii moralnych w stronę innych, pozaetycznych aspektów życia i działalności samego człowieka oraz jego artefaktów. Każda próba uporządkowania tego pola wydaje się zatem pożądana i taki też jest główny cel realizowany w tej pracy. W artykule przywołano myśl filozoficzną i etyczną wybitnego polskiego fenomenologa XX w. Romana Ingardena, proponując adaptację jego teorii wartości moralnych i koncepcji struktury etyki do etyki informacyjnej. W efekcie przeprowadzonej analizy i krytyki literatury przedmiotu w wariancie heurystycznym: (1) opracowano trzypoziomowy model dla etyki informacyjnej, który daje metaetyczne spojrzenie na etykę informacyjną w ujęciach: teoretycznym, normatywnym i stosowanym (praktycznym), (2) ugruntowano teorię etyki informacyjnej w teorii wartości R. Ingardena i doprecyzowano pod względem znaczeń podstawowe dla etyki informacyjnej kategorie etyczne: wartość moralna, podmiot moralny, odpowiedzialność moralna, (3) zaproponowano fenomenologiczny paradygmat badań w etyce informacyjnej.Information ethics, as a dynamically developing trend in philosophy of information and a practical field of ethics related to human morality in the information environment, constantly expands the boundaries of its interests. This poses a risk of departing from moral issues that are fundamental for ethics towards other, non-ethical aspects of the life and activities of both man himself and his artifacts. Therefore, any attempt to organize this field seems desirable, and so is the main objective of this paper. The article refers to the philosophical and ethical thought of the outstanding Polish phenomenologist of the 20th century, Roman Ingarden, and proposes to apply his theory of moral values and his concept of the structure of ethics to information ethics. Critical review of the literature on the subject in the heuristic variant has led to the following outcomes: (1) a three-tier model for information ethics has been developed, providing a meta-ethical view of information ethics in theoretical, normative and applied (practical) aspects, (2) the theory of information ethics was grounded in the Ingarden’s theory of values, with clear definitions specified for ethical categories that are fundamental to information ethics: moral value, moral subject, and moral responsibility, (3) a phenomenological paradigm for research in information ethics has been proposed

From punishment to universalism

Many philosophers have claimed that the folk endorse moral universalism. Some have taken the folk view to support moral universalism; others have taken the folk view to reflect a deep confusion. And while some empirical evidence supports the claim that the folk endorse moral universalism, this work has uncovered intra-domain differences in folk judgments of moral universalism. In light of all this, our question is: why do the folk endorse moral universalism? Our hypothesis is that folk judgments of moral universalism are generated in part by a desire to punish. We present evidence supporting this across three studies. On the basis of this, we argue for a debunking explanation of folk judgments of moral universalism. Our results not only further our understanding of the psychological processes underpinning folk judgments of moral universalism. They also bear on philosophical discussions of folk meta-ethics

Mobile learning: a meta-ethical taxonomy

In this paper I discuss some of the ethical issues relating to the use of mobile technologies in education. I argue that the frames of reference used by educators and technologists fail to capture the nature, scope and impact of ethical issues in mobile learning. A taxonomy of ethical issues based on dominant positions in meta-ethical moral theory is proposed. Using categories from the Mobile Technologies in Lifelong Learning (MOTILL) project, I show how this taxonomy can be applied in such a way as to facilitate understanding of ethical issues in mobile learning

The Dark Side of Morality: Group Polarization and Moral Epistemology

This article argues that philosophers and laypeople commonly conceptualize moral truths or justified moral beliefs as discoverable through intuition, argument, or some other purely cognitive or affective process. It then contends that three empirically well-supported theories all predict that this ‘Discovery Model’ of morality plays a substantial role in causing social polarization. The same three theories are then used to argue that an alternative ‘Negotiation Model’ of morality—according to which moral truths are not discovered but instead created by actively negotiating compromises—promises to reduce polarization by fostering a progressive willingness to ‘work across the aisle’ to settle moral issues cooperatively. This article then examines potential methods for normatively evaluating polarization, arguing there are prima facie reasons to favor the Negotiation Model over the Discovery Model based on their hypothesized effects on polarization. Finally, I outline avenues for further empirical and philosophical research

Are Moral Judgements Adaptations? Three Reasons Why It Is so Difficult to Tell

An increasing number of scholars argue that moral judgements are adaptations, i.e., that they have been shaped by natural selection. Is this hypothesis true? In this paper I shall not attempt to answer this important question. Rather, I pursue the more modest aim of pointing out three difficulties that anybody who sets out to determine the adaptedness of moral judgments should be aware of (though some so far have not been aware of). First, the hypothesis that moral judgements are adaptations has been advocated in various different specificities and scopes, and on various different levels. Second, the three kinds of evidence that have most often been appealed to by discussants of this hypothesis require additional arguments. And third, there is significant reasonable disagreement about what moral judgements essentially are

Meta-epistemic defeat

An account of meta-epistemic defeaters—distinct from traditional (first-order) epistemic defeaters—is motivated and defended, drawing from case studies involving epistemic error-theory (e.g., Olson 2011, Reasons for belief; cf., Streumer 2012, J Philos 110:1–25) and epistemic relativism (e.g., MacFarlane 2005, Oxford Stud Epistemol 1:197–233; 2011; 2014, Assessment sensitivity: Relative truth and its applications). Mechanisms of traditional epistemic defeat and meta-epistemic defeat are compared and contrasted, and some new puzzles are introduced

The ethics of distress: Toward a framework for determining the ethical acceptability of distressing health promotion advertising

© 2014 International Union of Psychological Science. Distressing health promotion advertising involves the elicitation of negative emotion to increase the likelihood that health messages will stimulate audience members to adopt healthier behaviors. Irrespective of its effectiveness, distressing advertising risks harming audience members who do not consent to the intervention and are unable to withdraw from it. Further, the use of these approaches may increase the potential for unfairness or stigmatization toward those targeted, or be considered unacceptable by some sections of the public. We acknowledge and discuss these concerns, but, using the public health ethics literature as a guide, argue that distressing advertising can be ethically defensible if conditions of effectiveness, proportionality necessity, least infringement, and public accountability are satisfied. We do not take a broad view as to whether distressing advertising is ethical or unethical, because we see the evidence for both the effectiveness of distressing approaches and their potential to generate iatrogenic effects to be inconclusive. However, we believe it possible to use the current evidence base to make informed estimates of the likely consequences of specific message presentations. Messages can be pre-tested and monitored to identify and deal with potential problems. We discuss how advertisers can approach the problems of deciding on the appropriate intensity of ethical review, and evaluating prospective distressing advertising campaigns against the conditions outlined

Pervasion of what? : techno–human ecologies and their ubiquitous spirits.

Are the robots coming? Is the singularity near? Will we be dominated by technology? The usual response to ethical issues raised by pervasive and ubiquitous technologies assumes a philosophical anthropology centered on existential autonomy and agency, a dualistic ontology separating humans from technology and the natural from the artificial, and a post-monotheistic dualist and creational spirituality. This paper explores an alternative, less modern vision of the 'technological' future based on different assumptions: a 'deep relational' view of human being and self, an ecological view of human–technology relations, and 'ubiquitous' spirituality. Moving beyond an ethics of fear and control, it is argued that technology is part of a lived and active whole that is at the same time human, technological, social, and spiritual. Influenced by ecological and Eastern thinking, it is concluded that an ethics of technology understood as a relational ethics of life asks us to adapt and grow within this multi-faced ecology, which is currently - but not necessarily - pervaded by hyper-individualist modernity and its ego-boosting technologies of the self. This growth is only possible by relating to, and learning from, other cultures and from their specific way of pervading and being pervaded