Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries

BACKGROUND: The synthesis of published research in systematic reviews is essential when providing evidence to inform clinical and health policy decision-making. However, the validity of systematic reviews is threatened if journal publications represent a biased selection of all studies that have been conducted (dissemination bias). To investigate the extent of dissemination bias we conducted a systematic review that determined the proportion of studies published as peer-reviewed journal articles and investigated factors associated with full publication in cohorts of studies (i) approved by research ethics committees (RECs) or (ii) included in trial registries. METHODS AND FINDINGS: Four bibliographic databases were searched for methodological research projects (MRPs) without limitations for publication year, language or study location. The searches were supplemented by handsearching the references of included MRPs. We estimated the proportion of studies published using prediction intervals (PI) and a random effects meta-analysis. Pooled odds ratios (OR) were used to express associations between study characteristics and journal publication. Seventeen MRPs (23 publications) evaluated cohorts of studies approved by RECs; the proportion of published studies had a PI between 22% and 72% and the weighted pooled proportion when combining estimates would be 46.2% (95% CI 40.2%-52.4%, I2 = 94.4%). Twenty-two MRPs (22 publications) evaluated cohorts of studies included in trial registries; the PI of the proportion published ranged from 13% to 90% and the weighted pooled proportion would be 54.2% (95% CI 42.0%-65.9%, I2 = 98.9%). REC-approved studies with statistically significant results (compared with those without statistically significant results) were more likely to be published (pooled OR 2.8; 95% CI 2.2-3.5). Phase-III trials were also more likely to be published than phase II trials (pooled OR 2.0; 95% CI 1.6-2.5). The probability of publication within two years after study completion ranged from 7% to 30%. CONCLUSIONS: A substantial part of the studies approved by RECs or included in trial registries remains unpublished. Due to the large heterogeneity a prediction of the publication probability for a future study is very uncertain. Non-publication of research is not a random process, e.g., it is associated with the direction of study findings. Our findings suggest that the dissemination of research findings is biased.

Éthique et transfusion sanguine [Ethics and blood transfusion.]

Le don de sang représente un acte solidaire. Il est le plus souvent bénévole et, selon les pays et les circonstances, non rémunéré. Les éléments de la réflexion éthique sont, entre autres, l'augmentation des besoins, les critères d'exclusion de plus en plus nombreux, l'exigence sécuritaire et les modifications des structures de nos sociétés. Compte tenu de cela, les acteurs de la chaîne transfusionnelle doivent s'interroger sur certains paramètres : la valeur du don, le sens du bénévolat, l'opportunité de rémunérer l'acte de livrer une partie de soi, non plus comme un don et comme une expression d'altruisme et de solidarité, mais comme une prestation commerciale définie par des règles économiques. Blood donation is an act of solidarity. Most often, this act is done on a volunteer basis and, depending on countries and circumstances, is not remunerated. The increase in need, the always-greater number of deferral criteria, the safety issues and the changes in the structures of our societies are among the many subjects for ethical debates. Taking these into account, the actors of the transfusion must analyze certain parameters: the value of a donation, the meaning of volunteering, the appropriateness of remunerating the act of giving a part of one's self, no longer as a donation or an expression of altruism and solidarity, but as a commercial act regimented by economic laws.

The Original Risk: Over-Theologizing Ethics and Under-Theologizing Sin

The project of articulating a theological ethics on the basis of liturgical anthropology is bound to fail if the necessary consequence is that one has to quit the forum of critical modern rationality. The risk of Engelhardt's approach is to limit rationality to a narrow vision of reason. Sin is not to be understood as the negation of human holiness, but as the negation of divine holiness. The only way to renew theological ethics is to understand sin as the anthropological and ethical expression of the biblical message of the justification by faith only. Sin is therefore a secondary category, which can only by interpreted in light of the positive manifestation of liberation, justification, and grace. The central issue of Christian ethics is not ritual purity or morality, but experience, confession and recognition of our own injustice in our dealing with God and men.

Ethical issues of human genetic databases : a challenge to classical health research ethics?

[Contents] - Introduction - Selected existing genetic database : distinctive features, ethical problems and the public debate - The ethical debate : principles, values and interests : the ethical foundations of guidelines - Selected issues of consensus and of controversy - Ethical issues of human genetic databases and the future This book compares the new area of biobanking with the tradition of ethically accepted classical research and highlights the distinctive features of existing databases and guidelines

Cohort study of trials submitted to ethics committee identified discrepant reporting of outcomes in publications.

OBJECTIVES: To identify factors associated with discrepant outcome reporting in randomized drug trials. STUDY DESIGN AND SETTING: Cohort study of protocols submitted to a Swiss ethics committee 1988-1998: 227 protocols and amendments were compared with 333 matching articles published during 1990-2008. Discrepant reporting was defined as addition, omission, or reclassification of outcomes. RESULTS: Overall, 870 of 2,966 unique outcomes were reported discrepantly (29.3%). Among protocol-defined primary outcomes, 6.9% were not reported (19 of 274), whereas 10.4% of reported outcomes (30 of 288) were not defined in the protocol. Corresponding percentages for secondary outcomes were 19.0% (284 of 1,495) and 14.1% (334 of 2,375). Discrepant reporting was more likely if P values were <0.05 compared with P ≥ 0.05 [adjusted odds ratio (aOR): 1.38; 95% confidence interval (CI): 1.07, 1.78], more likely for efficacy compared with harm outcomes (aOR: 2.99; 95% CI: 2.08, 4.30) and more likely for composite than for single outcomes (aOR: 1.48; 95% CI: 1.00, 2.20). Cardiology (aOR: 2.34; 95% CI: 1.44, 3.79) and infectious diseases (aOR: 1.77; 95% CI: 1.01, 3.13) had more discrepancies compared with all specialties combined. CONCLUSION: Discrepant reporting was associated with statistical significance of results, type of outcome, and specialty area. Trial protocols should be made freely available, and the publications should describe and justify any changes made to protocol-defined outcomes.

Peut-on accepter les progrès en sciences biomèdicales sans progrès en éthique ? [Can we take for granted medical progress without progress in ethics ?].

Since the mid 20th century progress in biomedical science has been punctuated by the emergence of bioethics which has fashioned the moral framework of its application to both research and clinical practice. Can we, however, consider the advent of bioethics as a form of progress marking the advances made in biomedical science with an adequate ethical stamp? The argument put forward in this chapter is based on the observation that, far from being a mark of progess, the development of bioethics runs the risk of favouring, like modern science, a dissolution of the links that unite ethics and medicine, and so of depriving the latter of the humanist dimensions that underlie the responsibilities that fall to it. Faced with this possible pitfall, this contribution proposes to envisage as a figure of moral progress, consubstantial with the development of biomedical science, an ethical approach conceived as a means of social intervention which takes the first steps towards an ethics of responsibility integrating the bioethical perspective within a hermeneutic and deliberative approach. By the yardstick of a prudential approach, it would pay particular attention to the diverse sources of normativity in medical acts. It is suggested that this ethical approach is a source of progress insofar as it constitutes an indispensable attitude of watchfulness, which biomedical science can lean on as it advances, with a view to ensuring that the fundamental link uniting ethics and medicine is maintained.

Kitcher's Revolutionary Reasoning Inversion in Ethics

This paper examines three specific issues raised by The Ethical Project. First, I discuss the varieties of altruism and spell out the differences between the definitions proposed by Kitcher and the ways altruism is usually conceived in biology, philosophy, psychology, and economics literature. Second, with the example of Kitcher's account, I take a critical look at evolutionary stories of the emergence of human ethical practices. Third, I point to the revolutionary implications of the Darwinian methodology when it is thoughtfully applied to ethics.