Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. Nevertheless, (...) the proposed declaration contains persistent flaws... (shrink)

El problema de la transición de los participantes desde una investigación hacia la atención de la salud apropiada es un problema global. La publicación de una nueva versión de la Declaración de Helsinki es una excelente oportunidad para repensar este problema. Según mi interpretación, la Declaración de Helsinki 2013 introduce dos tipos diferentes de obligaciones posinvestigación, a saber, (1) obligaciones de acceso a atención de la salud y (2) obligaciones de acceso a información. Los beneficiarios pretendidos de estas (...) obligaciones son los participantes individuales de estudios de investigación. Y la Declaración identifica a los patrocinadores, investigadores y gobiernos de los países anfitriones como los principales agentes responsables de cumplir con las obligaciones posinvestigación. Para justificar esta interpretación de los tipos, agentes y beneficiarios de las obligaciones posinvestigación, presento primero una clasificación tentativa de las obligaciones posinvestigación. Luego hago una breve reconstrucción conceptual de las formulaciones de las obligaciones posinvestigación en las versiones anteriores de la Declaración y reviso las principales críticas. Finalmente presento un análisis crítico de la nueva formulación de las obligaciones posinvestigación basándome en la discusión de las secciones anteriores. [ABSTRACT] The problem of transitioning research participants when the study is concluded to the appropriate health care is a global problem. The publication of a new version of the Declaration of Helsinki and its public discussion is a great opportunity to rethink this problem. According to my interpretation, the Declaration of Helsinki 2013 identifies two different types of post-trial obligations, namely, (1) obligations of access to health care and (2) the obligations of access to information. The intended beneficiaries of these obligations are individual participants of research studies. And the Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of the types, agents and beneficiaries of post-trial obligations, I first introduce a tentative classification of post-trial obligations. Then I make a brief conceptual reconstruction of formulations of post-trial obligations in earlier versions of the Declaration and revise the main critiques. Finally I advance a critical analysis of the new formulation of post-trial obligations based on the discussion in the previous sections. (shrink)

The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, (...) specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

In September 2020, Helsinki and Amsterdam announced the launch of their open AI registers—the first cities in the world to offer such a service. The AI registers describe what, where, and how AI applications are being used in the two municipalities; how algorithms were assessed for potential bias or risks; and how humans use the AI services. Examining issues of security and transparency, this paper discusses the potential for implementing AI in an urban public service setting and how this (...) might be harnessed to improve services and citizens’ experiences. -/- . (shrink)

El objetivo del presente trabajo es analizar la nueva formulación del principio de acceso posinvestigación en la más reciente (2008) revisión de la Declaración de Helsinki. Se identifican los artículos relevantes de la Declaración y se presentan dos interpretaciones posibles del principio de acceso posinvestigación: una interpretación robusta y otra permisiva, inspiradas cada una por modelos de justicia distintos. Luego, se hace una evaluación crítica de dichas interpretaciones y se intenta avanzar argumentos en contra de la interpretación permisiva. [The (...) objective of this study is to critically analyze the new formulation of the principle of post-trial access in the most recent (2008) revision of the Helsinki Declaration. The relevant articles of the declaration are identified and two possible interpretations of the principle of post-trial access are set out; one robust and one permissive, inspired by different models of distributive justice. A critical evaluation of both interpretations is presented and arguments against the permissive one advanced.]. (shrink)

En el año 2000 se publica la quinta revisión de la Declaración de Helsinki con el objetivo de responder a nuevos problemas éticos producidos en la última década por las investigaciones biomédicas realizadas en países en desarrollo. Una de las innovaciones más importantes que presenta la Declaración es la formulación del principio ético de acceso post investigación obligatorio para los participantes. En el presente trabajo, comienzo con la exposición del estado del consenso internacional sobre el carácter obligatorio del acceso (...) post investigación, de acuerdo con las guías y documentos de países desarrollados y en desarrollo. Luego, reconstruyo la justificación ética del principio de acceso post investigación y discuto algunos argumentos que se han presentado en su contra. De esta forma, defiendo la idea de que el acceso post investigación a las intervenciones probadas efectivas debe ser obligatorio siempre que los participantes se beneficien de las mismas y no tengan un acceso alternativo a ellas. (shrink)

Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do otherwise is essentially viewed as violation of the human research subject’s legal and moral rights. However, with the recent philosophical concerns about responsible robotics, the limits and ambiguities of research-subjects ethical codes (...) become apparent on the matter of constructing automata that maximally resemble human beings (as defined hereunder). In this case, the automata themselves, as products of research and development, are in the very process of their construction subjects of research and development. However, such research faces a paradox: The subjects cannot give their informed consent to this research for their own development, although their consent would be needed for the research. According to ethical codes, this research would be unethical. The article then explores whether the background concepts giving rise to this paradox could be reframed in order to allow such research to proceed ethically. (shrink)

USKALI MÄKI (Helsinki, 1951) is a philosopher of science and a social scientist, and one of the forerunners of the strong wave of research on the philosophy and methodology of economics that has been expanding during the last three decades. His research interests and academic contributions cover many topics in the philosophy of economics, such as realism and realisticness, idealisation, scientific modelling, causation, explanation, rhetoric, the sociology and economics of economics, and the foundations of new institutional and Austrian economics. (...) He is a coeditor of The handbook of economic methodology (1998); Economics and methodology: crossing boundaries (1998); Rationality, institutions and economic methodology (1993). And the editor of two compilations of essays that have become highly influential to the shaping of the field: The economic world view: studies in the ontology of economics (2001), and Fact and fiction in economics: realism, models, and social construction (2002). (shrink)

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of (...) the REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role. (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)

The COVID-19 pandemic has demonstrated how different (even conflicting) interventions on nature can be scientifically justified: interventions can be deemed "effective" only in relation to specific target variables - in relation to variables the values of which we seek to control. Choosing the "right" target variables, in turn, depends on our values and pragmatic aims. This essay is based on a presentation given at the symposium "Multidisciplinary Perspectives on the COVID-19 Pandemic", organised at the Helsinki Collegium for Advanced Studies (...) on 16 June 2020. (shrink)

The present volume collects presented at a symposium on The History of Logic held in Helsinki in June 11–13, 2000 hosted by the University of Helsinki, Finland. They bear on issues in the history of logic and foundations of mathematics and are contributions by some of the most renown scholars in the field.

The National Library of Finland and the Von Wright and Wittgenstein Archives at the University of Helsinki keep the collected correspondence of Georg Henrik von Wright, Wittgenstein’s friend and successor at Cambridge and one of the three literary executors of Wittgenstein’s Nachlass. Among von Wright’s correspondence partners, Elizabeth Anscombe and Rush Rhees are of special interest to Wittgenstein scholars as the two other trustees of the Wittgenstein papers. Thus, von Wright’s collections held in Finland promise to shed light on (...) the context of decades of editorial work that made Wittgenstein’s later philosophy available to all interested readers. In this text, we present the letters which von Wright received from Anscombe and Rhees during the first nine months after Wittgenstein’s death. This correspondence provides a vivid picture of the literary executors as persons and of their developing relationships. The presented letters are beautiful examples of what the correspondence as a whole has to offer; it depicts – besides facts of editing – the story of three philosophers, whose conversing voices unfold the human aspects of inheriting Wittgenstein’s Nachlass. Their story does not only deal with editing the papers of an eminent philosopher, but with the attempt to do justice to the man they knew, to his philosophy and to his wishes for publication. (shrink)

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department (...) of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

For smart cities, data-driven innovation promises societal benefits and increased well-being for residents and visitors. At the same time, the deployment of data-driven innovation poses significant ethical challenges. Although cities and other public-sector actors have increasingly adopted ethical principles, employing them in practice remains challenging. In this commentary, we use a virtue-based approach that bridges the gap between abstract principles and the daily work of practitioners who engage in and with data-driven innovation processes. Inspired by Aristotle, we describe practices of (...) data-driven innovation in a smart city applying the concepts of virtue and phronêsis, meaning good judgment of and sensitivity to ethical issues. We use a dialogic case-study approach to study two cases of data-driven innovation in the city of Helsinki. We then describe as an illustration of how our approach can help bridge the gap between concrete practices of data-driven innovation and high-level principles. Overall, we advance a theoretically grounded, virtue-based approach, which is practice oriented and linked to the daily work of data scientists and other practitioners of data-driven innovation. Further, this approach helps understand the need for and importance of individual application of phronêsis, which is particularly important in public-sector organizations that can experience gaps between principle and practice. This importance is further intensified in cases of data-driven innovation in which, by definition, novel and unknown contexts are explored. (shrink)

Placebo-trials on HIV-infected pregnant women in developing countries like Thailand and Uganda have provoked recent controversy. Such experiments aim to find a treatment that will cut the rate of vertical transmission more efficiently than existing treatments like zidovudine. This scenario is first stated as generally as possible, before three ethical principles found in the Belmont Report, itself a sharpening of the Helsinki Declaration, are stated. These three principles are the Principle of Utility, the Principle of Autonomy and the Principle (...) of Justice. These are taken as voices of moral imperative. But although each has intuitive appeal, it can be shown that there are possible scenarios in which they give conflicting prescriptions. To achieve consistency, one must be subordinate to the others. The voice of utility is taken as subordinate to those of justice and autonomy and it is shown that given plausible assumptions about the level of poverty and education in the developing country targeted, the experiment is ruled morally wrong in the name of both justice and autonomy. Moreover, it is argued that no justification can be found for the inclusion of a placebo group, when strictly defined. By contrast, a ‘no- treatment’ control arm might be justified, but only when the demands of autonomy are satisfied, demands that are more stringent than they might appear. A utilitarian defence of the experiment is examined, namely that the would-be participants are in a no-loss situation, and it is shown that this defence is seriously flawed. Finally, it is concluded that there is no justification for amending the Declaration of Helsinki. (shrink)

Having scandalous unethical research practices in the mid and late 20th century, study protocols of biomedical research reviewed by the Ethics Committee (EC) has become the accepted international standard. The Declaration of Helsinki uniformly requires that all biomedical research involving human participants, including research on identifiable human material or data, should be approved by the EC. Today, concerns over the quality of the EC functions worldwide. There are research globally in this regard but no data are available from Bangladesh. (...) Hence, we conducted a questionnaire based pilot study on knowledge and attitude of EC members on bioethics and structure & function of EC in Bangladesh. (shrink)

In my ethnographic research on death and dying in contemporary Finland, I explore how Finns facing end of life due to a long-term illness or other terminal condition seek to orient themselves and make meaning with cultural tools such as imagery, language, and metaphysical thinking. My primary research material is based on extensive fieldwork at Terhokoti Hospice and in the cancer clinic of Helsinki University Hospital, where I have had numerous conversations with terminally ill patients. This paper seeks to (...) explore the way in which metaphysical aesthetics is assuming the role that religious thinking has traditionally played. When the role of institutional religion is diminishing, it becomes important to understand how emotional and spiritual resolution can be arrived at by means of aesthetics. (shrink)

Translation from Spanish to English of ANMAT’s procedure for import of post-trial access provisions. This is a regulatory mechanisim to comply with post-trial provisions requirement in Declaration of Helsinki, paragraph 34. The translation it is based on a selection of the text of ANMAT’s Provision 12792/2016. -/- .

Book review of Jean-Paul Sartre, George Orwell, and István Bibó: _Antisemitismin kirous: kolme kriittistä esseetä_. Translated by Anssi Halmesvirta and Tuomas Laine-Frigren. Helsinki: Gaudeamus, 2023.

Book review of Esa Kirkkopelto, Logomimesis: tutkielma esiintyvästä ruumiista (Helsinki: Tutkijaliitto, 2020).

Book review of Jean-Luc Nancy, Singulaarinen pluraalinen oleminen [Être singulier pluriel], translated into Finnish by Viljami Hukka and Anna Nurminen (Helsinki: Tutkijaliitto, 2021).

Book review of Quentin Meillassoux, Äärellisyyden jälkeen: tutkielma kontingenssin välttämättömyydestä [Après la finitude: essai sur la nécessité de la contingence], translated into Finnish by Ari Korhonen (Helsinki: Gaudeamus, 2017).

Book review of Martin Heidegger, Perusteen periaate [Der Satz vom Grund], translated into Finnish by Miika Luoto (Helsinki: Teos, 2018).

As presented in the early work, 'Revolution in Poetic Language,' Julia Kristeva’s 'subject-in-process' can be interpreted as a semiotic alternative to older conceptions of the philosophical subject.This discussion of Kristeva’s early work will attempt to demonstrate that new interpretations of Fregean logic and Freudian psychoanalysis radically displace the traditional subject. This act of displacement allows Kristeva to employ Hegelian dialectics to introduce a “textual” conception of meaning of experience. As a consequence, the Kristevan semiotexte offers a basis for both understanding (...) and misunderstanding in which language mediates between semiotic meaning and cultural practices. The conclusion of the paper maintains that Kristeva's unique formulation of the semiotexte re-defines human subjectivity in relation to the existing world. (shrink)

One of the most fundamental questions in the philosophy of mathematics concerns the relation between truth and formal proof. The position according to which the two concepts are the same is called deflationism, and the opposing viewpoint substantialism. In an important result of mathematical logic, Kurt Gödel proved in his first incompleteness theorem that all consistent formal systems containing arithmetic include sentences that can neither be proved nor disproved within that system. However, such undecidable Gödel sentences can be established to (...) be true once we expand the formal system with Alfred Tarski s semantical theory of truth, as shown by Stewart Shapiro and Jeffrey Ketland in their semantical arguments for the substantiality of truth. According to them, in Gödel sentences we have an explicit case of true but unprovable sentences, and hence deflationism is refuted. -/- Against that, Neil Tennant has shown that instead of Tarskian truth we can expand the formal system with a soundness principle, according to which all provable sentences are assertable, and the assertability of Gödel sentences follows. This way, the relevant question is not whether we can establish the truth of Gödel sentences, but whether Tarskian truth is a more plausible expansion than a soundness principle. In this work I will argue that this problem is best approached once we think of mathematics as the full human phenomenon, and not just consisting of formal systems. When pre-formal mathematical thinking is included in our account, we see that Tarskian truth is in fact not an expansion at all. I claim that what proof is to formal mathematics, truth is to pre-formal thinking, and the Tarskian account of semantical truth mirrors this relation accurately. -/- However, the introduction of pre-formal mathematics is vulnerable to the deflationist counterargument that while existing in practice, pre-formal thinking could still be philosophically superfluous if it does not refer to anything objective. Against this, I argue that all truly deflationist philosophical theories lead to arbitrariness of mathematics. In all other philosophical accounts of mathematics there is room for a reference of the pre-formal mathematics, and the expansion of Tarkian truth can be made naturally. Hence, if we reject the arbitrariness of mathematics, I argue in this work, we must accept the substantiality of truth. Related subjects such as neo-Fregeanism will also be covered, and shown not to change the need for Tarskian truth. -/- The only remaining route for the deflationist is to change the underlying logic so that our formal languages can include their own truth predicates, which Tarski showed to be impossible for classical first-order languages. With such logics we would have no need to expand the formal systems, and the above argument would fail. From the alternative approaches, in this work I focus mostly on the Independence Friendly (IF) logic of Jaakko Hintikka and Gabriel Sandu. Hintikka has claimed that an IF language can include its own adequate truth predicate. I argue that while this is indeed the case, we cannot recognize the truth predicate as such within the same IF language, and the need for Tarskian truth remains. In addition to IF logic, also second-order logic and Saul Kripke s approach using Kleenean logic will be shown to fail in a similar fashion. (shrink)

"Complexity" is a catchword of certain extremely popular and rapidly developing interdisciplinary new sciences, often called accordingly the sciences of complexity. It is often closely associated with another notably popular but ambiguous word, "information"; information, in turn, may be justly called the central new concept in the whole 20th century science. Moreover, the notion of information is regularly coupled with a key concept of thermodynamics, viz. entropy. And like this was not enough it is quite usual to add one more (...) at present extraordinarily popular notion, namely chaos, and wed it with the abovementioned concepts. It is my aim in this paper to critically analyse this conceptual mess from a logical and philosophical point of view concentrating on the concepts of complexity and information and the question concerning the true relation between them. (shrink)