Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent.

Application of either the harm principle or the best interest standard to medical decision making conflicts with some types of pediatric research that pose elevated risk without the reasonable prob...

The aim of this article is to present a critical overview of Jacques Derrida’s objections to the theories of phenomenological experience. I present and analyze Derrida’s principal arguments which show that the primordial character of such experiences is only apparent. I also try to sketch a possible line of defense and to undermine some of the interpretational presuppositions introduced by the author of La voix et le phénomène.

A child’s objection, refusal and dissent regarding participation in non-beneficial biomedical research must be respected, even when the parents or legal representatives have given their permission. There is, however, no consensus on the definition and criteria of a meaningful and valid child’s objection. The aim of this article is to clarify this issue. In the first part we describe the problems of a child’s assent in research. In the second part we distinguish and analyze two models of a child’s objection (...) to research: the capacity-based model and the distress-based model. In the last part we present arguments for a broader and unified understanding of a child’s objection within regulations and practices. This will strengthen children’s rights and facilitate the entire process of assessment of research protocols. (shrink)

When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical Practice, these irregularities (...) occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (shrink)

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union and South-East European countries that are not members of the European Union. The most common ethical (...) issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trials were the least common ethical policies. Three aspects were significantly more common in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region and (2) harsh criticism of the present version of the Directive. The proposed regulation could simplify the rules for conducting clinical trials and also rebuild the entire system of clinical trial assessment. However, it (...) seems that we probably have already lost our chance regarding the consistency and quality of functioning of research ethics committees in the EU. (shrink)

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, (...) talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups. (shrink)

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society (...) and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects. (shrink)

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of the European Union.The (...) most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trialswere the least common ethical policies. Three aspects were significantly morecommon in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation.On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences amongbiomedical journals’ ethical policies calls for further research and active measuresto harmonize policies across journals. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are (...) relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs. (shrink)

Epidemiological studies usually do not pose high risk to participants. At the same time they provide valuable knowledge and improve public and individual health. In many countries, studies involving human subjects are subject to ethics review. Research shows that the process of obtaining ethical approval from institutional research boards or research ethics committees is sometimes costly, time-consuming and seriously delays important research projects. In this article we consider arguments against and in favor of ethics review of epidemiological studies. On the (...) one hand, it seems that minimal risk epidemiological studies should not be a subject to ethics review, since any delay of an important study has its death toll and health costs. In this perspective, the calculus of costs and benefits supports rejecting the whole existing approach. Nevertheless, we argue that institutional research boards or ethics research committees protect research participants from wrongs and up till now are the best tools of social and political control over the research enterprise. (shrink)

Occasional reports in the literature suggest that biological samples collected and stored for scientific research are sometimes accessed and used for a variety of forensic purposes. However, donors are almost never informed about this possibility. In this paper we argue that the possibility of forensic access may constitute a relevant consideration at least to some potential research subjects in deciding whether to participate in research. We make the suggestion that if some type of forensic access to research collections is likely (...) to be perceived by the subjects as a reason against donating their biological materials, there are good ethical reasons to make this type of access impossible or at least severely restricted. We also provide an ethical argument for the claim that, if a total ban on this type of forensic access cannot be achieved, potential research subjects should be informed about the extent to which this type of forensic access is possible. (shrink)

Novel precision oncology trial designs, such as basket and umbrella trials, are designed to test new anticancer agents in more effective and affordable ways. However, they present some ethical concerns referred to scientific validity, risk-benefit balance and informed consent. Our aim is to discuss these issues in basket and umbrella trials, giving examples of two ongoing cancer trials: NCI-MATCH (National Cancer Institute – Molecular Analysis for Therapy Choice) and Lung-MAP (Lung Cancer Master Protocol) study. We discuss three ethical requirements for (...) clinical trials which may be challenged in basket and umbrella trial designs. Firstly, we consider scientific validity. Thanks to the new trial designs, patients with rare malignancies have the opportunity to be enrolled and benefit from the trial, but due to insufficient accrual, the trial may generate clinically insignificant findings. Inadequate sample size in study arms and the use of surrogate endpoints may result in a drug approval without confirmed efficacy. Moreover, complexity, limited quality and availability of tumor samples may not only introduce bias and result in unreliable and unrepresentative findings, but also can potentially harm patients and assign them to an inappropriate therapy arm. Secondly, we refer to benefits and risks. Novel clinical trials can gain important knowledge on the variety of tumors, which can be used in future trials to develop effective therapies. However, they offer limited direct benefits to patients. All potential participants must wait about 2 weeks for the results of the genetic screening, which may be stressful and produce anxiety. The enrollment of patients whose tumors harbor multiple mutations in treatments matching a single mutation may be controversial. As to informed consent – the third requirement we discuss, the excessive use of phrases like “personalized medicine”, “tailored therapy” or “precision oncology” might be misleading and cause personal convictions that the study protocol is designed to fulfill the individual health-related needs of participants. We suggest that further approaches should be implemented to enhance scientific validity, reduce misunderstandings and risks, thus maximizing the benefits to society and to trial participants. (shrink)

Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify treatment or prevention during the COVID-19 pandemic. However, despite the considerable number of repurposed drugs that were evaluated, only some of them were labeled for new indications. In this article, we present the case of amantadine, a drug commonly used in neurology that attracted new attention during the COVID-19 outbreak. This example illustrates some of the ethical challenges associated with (...) the launch of clinical trials to evaluate already approved drugs. In our discussion, we follow the ethics framework for prioritization of COVID-19 clinical trials proposed by Michelle N Meyer and colleagues (2021). We focus on four criteria: social value, scientific validity, feasibility, and consolidation/collaboration. We claim that launching amantadine trials was ethically justified. Although the scientific value was anticipated to be low, unusually, the social value was expected to be high. This was because of significant social interest in the drug. In our view, this strongly supports the need for evidence to justify why the drug should not be prescribed or privately accessed by interested parties. Otherwise, a lack of evidence-based argument could enhance its uncontrolled use. With this paper, we join the discussion on the lessons learned from the pandemic. Our findings will help to improve future efforts to decide on the launch of clinical trials on approved drugs when dealing with the widespread off-label use of the drug. (shrink)

Conducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method. We performed a systematic qualitative review of disaster research ethics guidelines to (...) collect and compare existing regulations. Guidelines were identified by a three-tiered search strategy: 1) searching databases, 2) an Internet search, and 3) a search of the references in the included documents from the first two searches. We used the constant comparative method for analysis of included guidelines. Fourteen full text guidelines were included for analysis. The included guidelines covered the period 2000-2014. Qualitative analysis of the included guidelines revealed two core themes: vulnerability and research ethics committee review. Within each of the two core themes, various categories and subcategories were identified. Some concepts and terms identified in analyzed guidelines are used in an inconsistent manner and applied in different contexts. Conceptual clarity is needed in this area as well as empirical evidence to support the statements and requirements included in analyzed guidelines. (shrink)

By significantly diminishing the role intentions play in communication, in Imagination and Convention Lepore and Stone attempt to overthrow the Gricean paradigm which prevails in the philosophy of language. The approach they propose is attractive to theorists of legal interpretations for many reasons. Primary among these is that the more general dispute in the philosophy of language between Griceans and non-Griceans mirrors the dispute between intentionalists and non-intentionalists in legal interpretation. The ideas proposed in Imagination and Convention naturally support the (...) non-intentionalist camp, which makes them unique in the contemporary philosophy of language.In this paper I argue that despite an almost universal acceptance for the Gricean paradigm in legal interpretation, a strong, externalist approach to language, one in which interpretation is based on conventions, not intentions, better reflects the nature of legal language. The latter functions in societies as a written, public discourse to which many individuals contribute; the number of contributions renders the identification of individual intentions impossible, making it badly suited to a Gricean, intention-based analysis. Lepore and Stone’s discourse-based, non-Gricean alternative provides a better tool for the theorist of legal interpretation to analyse legal language. In what follows, I first present an overview of the disputes in legal interpretation that may be affected by Imagination and Convention. In the second section, I analyze several of Lepore and Stone’s theses and apply them to issues in legal interpretation, paying particular attention to their concept of “direct intentionalism.” In the last section, I outline some proposals for finishing the anti-Gricean revolution, which involves Ruth Millikan’s idea of conventions as lineages. (shrink)

The thesis of the paper holds that some future developments of argumentation theory may be inspired by the rich logico-methodological legacy of the Lvov–Warsaw School (LWS), the Polish research movement that was most active from 1895 to 1939. As a selection of ideas of the LWS which exploit both formal and pragmatic aspects of the force of argument, we present: Ajdukiewicz’s account of reasoning and inference, Bocheński’s analyses of superstitions or dogmas, and Frydman’s constructive approach to legal interpretation. This paper (...) does not aim at exhaustive elaboration of any of these topics or their usefulness in current discussions within argumentation theory. Rather, we intend to indicate chosen directions of a potentially fruitful research program for the emerging Polish School of Argumentation which would consist in application of methods and conceptions elaborated by the LWS to selected open problems of contemporary research on argumentation. (shrink)

Since 1989, clinical ethics consultation in form of hospital ethics committees was established in most of the transition countries of Central and Eastern Europe. Up to now, the similarities and differences between HECs in Central and Eastern Europe and their counterparts in the U.S. and Western Europe have not been determined. Through search in literature databases, we have identified studies that document the implementation of clinical ethics consultation in Central and Eastern Europe. These studies have been analyzed under the following (...) aspects: mode of establishment of HECs, character of consultation they provide, and their composition. The results show that HECs in the transition countries of Central and Eastern Europe differ from their western-European or U.S. counterparts with regard to these three aspects. HECs were established because of centrally imposed legal regulations. Little initiatives in this area were taken by medical professionals interested in resolving emerging ethical issues. HECs in the transition countries concentrate mostly on review of research protocols or resolution of administrative conflicts in healthcare institutions. Moreover, integration of non-professional third parties in the workings of HECs is often neglected. We argue that these differences can be attributed to the historical background and the role of medicine in these countries under the communist regime. Political and organizational structures of healthcare as well as education of healthcare staff during this period influenced current functioning of clinical ethics consultation in the transition countries. (shrink)

In this paper, I argue that computationalism is a progressive research tradition. Its metaphysical assumptions are that nervous systems are computational, and that information processing is necessary for cognition to occur. First, the primary reasons why information processing should explain cognition are reviewed. Then I argue that early formulations of these reasons are outdated. However, by relying on the mechanistic account of physical computation, they can be recast in a compelling way. Next, I contrast two computational models of working memory (...) to show how modeling has progressed over the years. The methodological assumptions of new modeling work are best understood in the mechanistic framework, which is evidenced by the way in which models are empirically validated. Moreover, the methodological and theoretical progress in computational neuroscience vindicates the new mechanistic approach to explanation, which, at the same time, justifies the best practices of computational modeling. Overall, computational modeling is deservedly successful in cognitive science. Its successes are related to deep conceptual connections between cognition and computation. Computationalism is not only here to stay, it becomes stronger every year. (shrink)

The aim of this paper is to propose foundations for a formal model of representation and numerical evaluation of a possibly broad class of arguments, including those that occur in natural discourse. Since one of the most characteristic features of everyday argumentation is the occurrence of convergent reasoning, special attention should be paid to the operation ⊕, which allows us to calculate the logical force of convergent arguments with an accuracy not offered by other approaches.

This paper addresses the following question: Can one and the same utterance token, in one unique speech situation, intentionally and conventionally perform a plurality of illocutionary acts? While some of the recent literature has considered such a possibility Perspectives on pragmatics and philosophy. Springer, Cham, pp 227–244, 2013; Johnson in Synthese 196:1151–1165, 2019), I build a case for it by drawing attention to common conversational complexities unrecognized in speech acts analysis. Traditional speech act theory treats communication as: a dyadic exchange (...) between a Speaker and a Hearer who trade illocutionary acts endowed with one and only one primary force. I first challenge assumption by discussing two contexts where plural illocutionary forces are performed in dyadic discussions: dilemmatic deliberations and strategic ambiguity. Further, I challenge assumption by analyzing poly-adic discussions, where a speaker can target various participants with different illocutionary acts performed via the same utterance. Together, these analyses defend illocutionary pluralism as a significant but overlooked fact about communication. I conclude by showing how some phenomena recently analyzed in speech act theory—back-door speech acts New work on speech acts. Oxford University Press, Oxford, pp 144–164, 2018) and dog-whistles New work on speech acts. Oxford University Press, Oxford, pp 360–383, 2018)—implicitly presuppose illocutionary pluralism without recognizing it. (shrink)

In this paper, we argue that several recent ‘wide’ perspectives on cognition (embodied, embedded, extended, enactive, and distributed) are only partially relevant to the study of cognition. While these wide accounts override traditional methodological individualism, the study of cognition has already progressed beyond these proposed perspectives towards building integrated explanations of the mechanisms involved, including not only internal submechanisms but also interactions with others, groups, cognitive artifacts, and their environment. The claim is substantiated with reference to recent developments in the (...) study of “mindreading” and debates on emotions. We claim that the current practice in cognitive (neuro)science has undergone, in effect, a silent mechanistic revolution, and has turned from initial binary oppositions and abstract proposals towards the integration of wide perspectives with the rest of the cognitive (neuro)sciences. (shrink)

In the book, I argue that the mind can be explained computationally because it is itself computational—whether it engages in mental arithmetic, parses natural language, or processes the auditory signals that allow us to experience music. All these capacities arise from complex information-processing operations of the mind. By analyzing the state of the art in cognitive science, I develop an account of computational explanation used to explain the capacities in question.

In most accounts of realization of computational processes by physical mechanisms, it is presupposed that there is one-to-one correspondence between the causally active states of the physical process and the states of the computation. Yet such proposals either stipulate that only one model of computation is implemented, or they do not reflect upon the variety of models that could be implemented physically. -/- In this paper, I claim that mechanistic accounts of computation should allow for a broad variation of models (...) of computation. In particular, some non-standard models should not be excluded a priori. The relationship between mathematical models of computation and mechanistically adequate models is studied in more detail. (shrink)

This chapter argues that the extended mind approach to cognition can be distinguished from its alternatives, such as embedded cognition and distributed cognition, not only in terms of metaphysics, but also in terms of epistemology. In other words, it cannot be understood in terms of a mere verbal redefinition of cognitive processing. This is because the extended mind approach differs in its theoretical virtues compared to competing approaches to cognition. The extended mind approach is thus evaluated in terms of its (...) theoretical virtues, both essential to empirical adequacy and those that are ideal desiderata for scientific theories. While the extended mind approach may have similar internal consistency and empirical adequacy compared to other approaches, it may be more problematic in terms of its generality and simplicity as well as unificatory properties due to the cognitive bloat and the motley crew objections. (shrink)

Our new journal Philosophies is devoted to the search for a synthesis of philosophical and scientific inquiry. It promotes philosophical work derived from the experience of diverse scientific disciplines. [...].

The author wishes to add the following correction to his paper published in Philosophies [1]:The repeated fragment from lines 13–18 and part of 19 on page 69 should be deleted [...].

The author wishes to add the following correction to his paper published in Philosophies [1]:The repeated fragment from lines 13–18 and part of 19 on page 69 should be deleted [...].

The paper offers a critical analysis of the research program for formalizing informal logic proposed by Douglas Walton and Thomas Gordon. Since their proposal is based on employing the Carneades Argumentation System, this paper aims at answering two questions: what are main benefits of applying CAS as means for formalizing informal logic, and what are possible extensions of Walton and Gordon’s research program and modifications in employing CAS?

Problem rozważany w tym artykule dotyczy relacji między zdroworozsądkowym a filozoficznym poznaniem atrybutów Boga. Na przykładzie wszechmocy, wszechwiedzy i wszechobecności Boga dochodzi się do wniosku, że w oparciu o bezpośrednio daną rzeczywistość i przy zastosowaniu tylko poznania zdroworozsądkowego człowiek nie doświadcza tego rodzaju własności w świecie, lecz przypisuje je Bogu. Natomiast sam z siebie nie potrafi ich uzasadnić. Kwestią uzasadnienia problemów, powstających na gruncie poznania potocznego, zajmuje się m.in. filozofia. Dlatego przyjmuje się, że filozofia koryguje i uzupełnia poznanie przednaukowe. Jednakże (...) dla samego orientowania się i uznania wspomnianych przymiotów Boga poznanie zdroworozsądkowe jest wystarczające. --------------- Zgłoszono: 16/01/2021. Zrecenzowano: 09/03/2021. Zaakceptowano do publikacji: 11/05/2021. (shrink)

Most dialectical models view argumentation as a process of critically testing a standpoint. Further, they assume that what we critically test can be analytically reduced to individual and bi-polar standpoints. I argue that these two assumptions lead to the dominant view of dialectics as a bi-partisan argumentative discussion in which the yes-side argues against the doubter or the no-side. I scrutinise this binary orientation in understanding argumentation by drawing on the main tenets of normative pragmatic and pragma-dialectical theories of argumentation. (...) I develop my argument by showing how argumentative practice challenges these assumptions. I then lay out theoretical reasons for this challenge. This paves the way for an enhanced conceptualisation of dialectical models and their standards of rationality in terms of multi-party discussions, or argumentative polylogues. (shrink)

The discussion around dignity in nursing philosophy has been underway for many years. The literature still lacks philosophical arguments that would justify the thesis that all people have dignity. Scholars who defend dignity as an intrinsic value most often refer to Kant. However, Kant does not seem to be the most suitable candidate to defend the thesis that all human beings possess dignity. In this paper, I attempt to show that Aristotle's and Aquinas's views can help justify this thesis. To (...) this end, I distinguish between actual dignity, potential dignity, and existential dignity. I state that all human beings have existential dignity or potential dignity. (shrink)

In this paper, I argue that even if the Hard Problem of Content, as identified by Hutto and Myin, is important, it was already solved in natu- ralized semantics, and satisfactory solutions to the problem do not rely merely on the notion of information as covariance. I point out that Hutto and Myin have double standards for linguistic and mental representation, which leads to a peculiar inconsistency. Were they to apply the same standards to basic and linguistic minds, they would (...) either have to embrace representationalism or turn to semantic nihilism, which is, as I argue, an unstable and unattractive position. Hence, I conclude, their book does not offer an alternative to representation- alism. At the same time, it reminds us that representational talk in cognitive science cannot be taken for granted and that information is different from men- tal representation. Although this claim is not new, Hutto and Myin defend it forcefully and elegantly. (shrink)

The development of new methods in the field of prenatal testing leads to an expansion of information that needs to be provided to expectant mothers. The aim of this research is to explore opinions and attitudes of gynecologists in Germany, Poland and Russia towards access to prenatal testing and diagnostics in these countries. Semi-structured interviews were conducted with n = 18 gynecologists in Germany, Poland and Russia. The interviews were analyzed using the methods of content analysis and thematic analysis. Visible (...) in all three countries is a connection of prenatal medicine with the politically and socially contentious issue of pregnancy termination. Respondents in Poland and Russia concentrated on the topic of inadequate resources. Quality of information for expectant mothers is an important point in all three countries. Only in Germany was the issue of language barriers in communication raised. With regard to non-invasive prenatal testing (NIPT) respondents in Germany focused on the ethical issues of routinization of testing; in Poland and Russia they concentrated on fair access to NIPT. Challenges in all three countries arise from structural factors such as imprecise and prohibitive regulations, lack of resources or organization of healthcare services. These should be addressed on a political and medico-ethical level. (shrink)

ABSTRACT This paper gives a survey of known results related to computational devices recognising monadic generalised quantifiers infinite models. Some of these results are simple reinterpretations of descriptive-feasible correspondence theorems from finite-model theory. Additionally a new result characterizing monadic quantifiers recognized by push down automata is proven.

The claim defended in the paper is that the mechanistic account of explanation can easily embrace idealization in big-scale brain simulations, and that only causally relevant detail should be present in explanatory models. The claim is illustrated with two methodologically different models: Blue Brain, used for particular simulations of the cortical column in hybrid models, and Eliasmith’s SPAUN model that is both biologically realistic and able to explain eight different tasks. By drawing on the mechanistic theory of computational explanation, I (...) argue that large-scale simulations require that the explanandum phenomenon is identified; otherwise, the explanatory value of such explanations is difficult to establish, and testing the model empirically by comparing its behavior with the explanandum remains practically impossible. The completeness of the explanation, and hence of the explanatory value of the explanatory model, is to be assessed vis-à-vis the explanandum phenomenon, which is not to be conflated with raw observational data and may be idealized. I argue that idealizations, which include building models of a single phenomenon displayed by multi-functional mechanisms, lumping together multiple factors in a single causal variable, simplifying the causal structure of the mechanisms, and multi-model integration, are indispensable for complex systems such as brains; otherwise, the model may be as complex as the explanandum phenomenon, which would make it prone to so-called Bonini paradox. I conclude by enumerating dimensions of empirical validation of explanatory models according to new mechanism, which are given in a form of a “checklist” for a modeler. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)