The article focuses on the issue of access to experimental therapy under the Convention for the Protection of Human Rights and Fundamental Freedoms, and more specifically in the case law of the European Court of Human Rights. To date, this issue has been the subject of three cases decided by the Court. In none of these cases the Court has recognized a right to experimental therapy. The article has two main research objectives. The first is to reconstruct the arguments for (...) the validity of the right to experimental therapy provided by the applicants in the cases considered by the Court. The second objective is to assess these arguments, as well as their criticism that might be found in Court’s decisions. (shrink)

The following text is a voice in the discussion around normative problems of innovative therapies. It refers to problems related to the amendment to the Polish Act on the Professions of Physician and Dentist, particularly to therapeutic experiment category, also discussed in this issue in the article by Maria Gutowska-Ibbs: “Off-label - practical consequences of unclear legislation.”.

The following text is a voice in the discussion around normative problems of innovative therapies. It particularly refers to problems related to the concept of risk and the principle of its minimization, also discussed in this issue in the article by Wojciech Załuski "On the Limits of Medical Experiment from the Perspective of Rational Choice Theory.”.

Artykuł dotyczy instytucji pozarejestracyjnego stosowania produktów leczniczych oraz problemów w rozgraniczeniu sytuacji, w których taka forma leczenia ma charakter terapii innowacyjnej od normalnej praktyki leczniczej. Poruszona została kwestia istotnego ryzyka kwalifikacji rutynowej terapii przy użyciu produktów leczniczych jako eksperymentu medycznego oraz relacja pomiędzy pojęciem aktualnej wiedzy medycznej a Charakterystyką Produktu Leczniczego. Omówione zostały trudności w ustaleniu, czy proponowany sposób leczenia jest metodą nową lub częściowo wypróbowaną oraz przedstawiono postulat zwiększenia aktywności lekarskich towarzystw naukowych w tym zakresie. Przedstawiono implikacje kwalifikacji leczenia (...) off-label jako eksperymentu leczniczego w zakresie konieczności uzyskania opinii komisji bioetycznej oraz zawarcia ubezpieczenia odpowiedzialności cywilnej podmiotu przeprowadzającego eksperyment medyczny oraz ich wpływ na bezpieczeństwo pacjenta, bezpieczeństwo prawne lekarza oraz dostępność do świadczeń medycznych. (shrink)

The following text is a voice in the discussion around normative problems of innovative therapies. It particularly refers to the problem of the relationship between therapeutic experiment and the research purpose of a physician's action, also discussed in this issue in the article by Rafał Kubiak "A few comments on the background of the article »Off label - practical consequences of unclear legislation«.”.

Polish medical law does not explicitly regulate the possibility of off-label use of medicines. Such procedures therefore raise doubts in medical practice, where medicines are often prescribed beyond the Characteristic of Medicinal Product. This phenomenon particularly affects the treatment of children, as there is a lack of registered medicines in this age group, but they are registered for use in adults. Since such treatment goes beyond the scope of registration, a dilemma arises as to whether it is permissible and, if (...) so, under what conditions and whether sanctions are imposed on the medical professional using the off-label medicine. These issues are addressed in an article by Dr Maria Gutowska-Ibbs, entitled 'Off label - practical consequences of unclear legislation". The present study complements these considerations and is in part an ad vocem statement. The article attempts to differentiate between the use of off-label medicines and medical experiments, following the criterion of the purpose for which a given medical action is performed. The limits of admissibility of such actions under criminal law are also discussed in more detail. Off-label treatment is considered through the prism of the required precautionary rules, compliance with which is the antithesis of inadvertence. It is assumed that if the drug was administered in accordance with current medical knowledge and the treatment is adequate to the patient's condition, there is no violation of these rules, which excludes the imputation of inadvertence. An extensive section of the study is devoted to the issue of the patient's consent to treatment outside the indications. Above all, it emphasises the need to explain in detail to the patient the circumstances of prescribing such a drug and, on this basis, to obtain informed consent. It also stresses the importance of the written form of consent, which can have a significant evidentiary impact in potential litigation. (shrink)

Przedmiotem opracowania jest omówienie dopuszczalności udzielania i finansowania terapii spoza katalogu świadczeń gwarantowanych w niemieckim ubezpieczeniu zdrowotnym. Punktem wyjścia jest analiza tzw. uchwały mikołajkowej niemieckiego federalnego trybunału konstytucyjnego (BverfG) oraz konkretyzujących zawarte w niej wytyczne wyroków federalnego sądu socjalnego (BSG). Następnie na tym tle przedstawiona zostanie kodyfikująca je regulacja § 2 ust. 1a księgi piątej niemieckiego kodeksu socjalnego (SGB V), statuująca – na zasadzie wyjątku – prawo ubezpieczonych do świadczeń opieki zdrowotnej nie objętych systemową gwarancją.

Artykuł przedstawia rozważania oparte na regulacji prawa unijnego oraz polskiego dotyczące wytwarzania oraz stosowania produktów leczniczych terapii zaawansowanej – wyjątków szpitalnych. Autorka omawia unijne źródło regulacji ATMP-HE, jej funkcję oraz cel wprowadzenia do prawa unijnego, a następnie relację tej regulacji do polskiego uregulowania dotyczącego eksperymentu leczniczego. W ocenie autorki na gruncie obowiązującego stanu prawnego nie jest zasadne stanowisko, zgodnie z którym produkt leczniczy terapii zaawansowanej – wyjątek szpitalny jest na tyle legalnie odrębnym pojęciem, a wręcz instytucją prawną, że nie stosuje (...) się do niego regulacji krajowej. Jest to bowiem stanowisko nie tylko niespójne z regulacją unijną oraz krajową, ale również skutkujące przerzuceniem ciężaru ryzyka zastosowania tego produktu bez jakiejkolwiek kontroli oraz odpowiedzialności na pacjenta. Autorka wyraziła stanowisko, zgodnie z którym de lege lata zastosowanie produktu leczniczego terapii zaawansowanej – wyjątku szpitalnego należy kwalifikować jako eksperyment leczniczy, do którego stosuje się także granice dopuszczalności jego przeprowadzenia. Autorka przedstawia skutki uznania zastosowania ATMP-HE za eksperyment leczniczy oraz skutki przyjęcia stanowiska odmiennego. Ponadto w artykule zawarte zostały rozważania na temat niezasadności utożsamiania stosowania ATMP-HE z off-label use oraz compassionate use. Autorka sformułowała również postulaty de lege ferenda. (shrink)

Polskie przepisy prawne formułujące warunki dopuszczalności eksperymentu medycznego, a więc ipso facto wyznaczające jego granice, można różnorako interpretować, zwłaszcza w tym zakresie, w jakim określają wymagany dla przeprowadzenia eksperymentu bilans związanych z nim możliwych korzyści i szkód. W artykułach prawniczych komentujących te przepisy w zasadzie jednak brak prób systematycznego i (na tyle, na ile pozwala na to sam przedmiot analizy) ścisłego wyróżnienia tych interpretacji w języku tzw. teorii racjonalnego wyboru (rational choice theory), teorii szczególnie przydatnej w tym kontekście z uwagi (...) na jej rozbudowany aparat pojęciowy pozwalający badać różnorakie konfiguracje relacji między costs i benefits. Artykuł próbuje wypełnić tę lukę: wyróżnione w nim zostały różne interpretacje przepisów prawnych określających warunki dopuszczalności eksperymentu medycznego; interpretacje te zostały również poddane ocenie. (shrink)

This article presents the ethical implications for social science research emerging from our study on interpersonal communication after a laryngectomy. By tracing the evolution of our approach through specific research experiences and participant feedback, we provide empirical support for a flexible, multidimensional, and relational understanding of key ethical concepts, such as vulnerability and the researcher-participant relationship. Our approach has shifted from institutionally imposed rigid categorizations and somewhat stereotypical treatment of both the research group and the researcher-participant relationship to an emphasis (...) on building relationships founded on mutual care and rapport. We argue that this revised perspective fosters ethical collaboration that is beneficial and secure for all parties involved, and we offer practical examples of its implementation in research practice. (shrink)

Doing research in a globalized context – regardless of the discipline – requires language decisions at different stages of the research process. Many of these language decisions have ethical implications. Existing literature and ethical guidance tend to focus on ethical concerns that arise in communication with participants who use a language different from the main research language. As this article shows, language decisions with potential ethical implications can occur in many additional ways. Two questions guided this work: how do language (...) decisions and research ethics intersect at different stages of the research process, and what potential harm is related to language decisions and how can such concerns be mitigated? Relevant literature – combined with practical research experiences – show that language decisions can potentially result in harm at the conception stage of research projects, when working with participants, during data analysis, interpretation, and dissemination, as well as when managing a research project. Thus, the article highlights that the role of language-related ethical dilemmas is not only organizational (e.g., ensuring participants can understand what the research is about), but also social (e.g., developing trust and relationships in research teams) as well as ideological (e.g., awareness of power structures and diverse worldviews). In order to support researchers in globalized contexts, this article offers a reflective framework that complements regulatory guidance issued by ethical bodies and facilitates a deeper awareness of ethical implications related to language decisions in a multilingual world. (shrink)

To do minor activist research is to create and make use of critical neologistic vocabularies hopefully balancing the ascetic impoverishment of direction and syntax in majority vocabularies when conceptualized as universals. To do minor activist research is therefore to unsettle received discourses, narratives, and material social practices of power to develop means of resistance in new and different registers. To do minor activist research is to train the imagination for a collaboratively accomplished re/presentation of data through creating points of encounters, (...) thus engendering an affirmative perspectivist’s ethos. Re/presenting data as a space in which one’s own thinking is challenged, hence providing a perspective of the storying practices across participants and across different disciplinary, ideological, or personal boundaries within the researcher’s and the researched specific positioning. This requires getting everyone to participate in the “analysis” of data, and then getting everyone “inside” the text: situating data-inquiries in immanence. It therefore demands a liberation from old scripts, and challenges how everyone is transformed into text, with perspectivism being simultaneously means and objective for avoiding the reproduction of both old scripts and ethics. Our goal is to enhance (self)reflexivity regarding knowledge production and research methodologies, to influence actual research practices through fostering a more inclusive, open, and collaborative approach to research that transcends traditional boundaries and embraces the fluid and hybrid nature of knowledge production. Ultimately, turning the concept of ethics through minoring into a thinking hub and pedagogy for change. The first and theoretical section is on how to ethically represent data in a new-empiricist and post qualitative environment. We call it data-philosophy. Our ontological approach brings its own concepts, which reflect the perspectives from which we argue. In the three next sections, we follow up by looking more closely into these ideas in re/presenting empirical qualitative research to invite hybrid and fluid configurations. Here, activist research refers to bringing actors into our thinking about the data, to accentuate the collaborative, open to thinking differently through staying close to the data. We then bring it all together in a section on the rebirth of language, to open for what we refer to as a storying personifying, thereby storying data together as a process of becoming, of mutuality and affect as a source of agency. We argue that this creates a theory of science and ethics in data analysis, and in re/presenting data, which are closely entangled. (shrink)

The importance of ethics in social research has increased in recent years, something reflected, among other things, in the progressive codification and institutionalization of research ethics and the growing literature on this topic. We argue that despite increasing ethical regulation and ethical reflection in social research, ethical challenges also arise, i.e., difficult situations connected with selecting ethically appropriate behavior. The aim of this special issue is to invite social researchers to reflect upon and discuss ethical challenges in contemporary social research. (...) The contributions in this issue concern vulnerability (one critically analyzing it, and another adapting the vulnerability concept to conducting research with people after a laryngectomy), the researcher and participant relationship, research ethics in multilingual world, and the ethicality of data representation where language plays a particular role in creating a form of activist research. (shrink)

This paper examines the concept of vulnerability in the context of social research ethics. An ambiguity is noted in use of this term: it may refer to an incapacity to provide informed consent to participate in a research project, or it may imply heightened susceptibility to the risk of harm. It is pointed out that vulnerability is a matter of degree, and that there are different sources and types of harm, which must be taken into account in any judgment about (...) whether additional precautions are required to protect particular categories of research participants. Furthermore, such judgments must be sensitive to the particular context in which research is taking place. This is one of several considerations that raise questions about the desirability of the sort of pre-emptive ethical regulation that has become institutionalized in many countries over the past few decades, a form that is more appropriate to medical rather than to social research. However, this is not to deny that a concern with the vulnerability of research participants is necessary on the part of social researchers. Furthermore, it must be recognized that researchers themselves may be vulnerable to harm in the research process. Finally, some discussion is provided of the way in which a concern with vulnerability can conflict with other considerations that researchers need to take into account in doing their work. The key point is that vulnerability is a complex and controversial concept, and it requires careful handling in thinking about social research ethics. (shrink)

In this paper, we offer a defense of non-punitive measures as morally justified responses to crime within a framework of society as a fair system of cooperation among free and equal individuals. Our argument proceeds in three steps. First, we elaborate on the premises of our argument: we situate criminal acts within a model of society as a fair system of cooperation, identify the types of unfair disadvantages crimes bring about, and consider the social aim of the criminal justice system. (...) Next, we reject the claim defended by fair-play retributivists that fairness considerations make punishment a necessary response to criminal acts. In the last step, we demonstrate that it is rather non-punitive responses to crime that are warranted under the principle of fairness and, as such, are morally justified. We conclude the paper by rejecting two possible objections to our defense: the “responsibility gap” and the “victims’ claim to justice” objections. (shrink)

It has been argued that a retributivist criminal justice system treats offenders with a respect lacking in alternative criminal justice systems; retributivism presumably recognizes that offenders are fellow members of the moral community who can be held responsible for their actions. One version of the respect argument builds on P.F. Strawson’s moral responsibility theory. According to Strawson, we may take either a participant or objective attitude toward other people. The former is the default attitude when interacting with other adults, whereas (...) the latter is fit for children and the mentally disabled or ill, whom we merely try to manage and handle as best we can. The participant attitude also involves holding people responsible when they do wrong. Supposedly, a retributivist criminal justice system functions as a natural continuation of our everyday, participant, and responsibility-holding practices, unlike alternative systems that adopt an objective attitude toward offenders. I argue that this is wrong. The participant attitude requires reciprocity and, usually, some level of equality too. Even an idealized retributivist system has little room for this, not to mention the flawed versions of this system we see in reality. (shrink)

This article compares the quarantine model of criminal justice advocated by Derk Pereboom and Gregg Caruso with the corrections model of criminal justice advocated by Michael Corrado. Both of these theories are grounded on the presumption that persons lack desert-grounding free will. It is argued that on this presumption there is no reason to believe that Michael Corrado’s corrections model is any better than the quarantine model.

A growing number of theorists have launched an epistemic challenge against retributive punishment. This challenge involves the core claim that it is wrong (intentionally) to inflict serious harm on someone unless the moral argument for doing so has been established to a high standard of credibility. Proponents of this challenge typically argue that retributivism fails to meet the required epistemic standard, because retributivism relies on a contentious conception of free will, about whose existence we cannot be sufficiently certain. However, the (...) scope of the epistemic challenge should not be limited to doubts about free will or retributivism. In this article, I argue that the epistemic challenge should be expanded beyond the original focus on justifications of punishment. By “expanding the epistemic challenge” I mean demanding that other purported justifications for serious (intentional) harm be held to a high standard of credibility. To provide a focus for the argument, I will concentrate on the “Public Health Quarantine Model” defended by Gregg Caruso, but my arguments have wider implications beyond this model. A growing number of “abolitionist” theorists believe that punishment is wrong in principle. If retributive punishment, or punishment in general, were abandoned, we would need to ask, “how else should we respond to crime?”. My arguments suggest that all such abolitionists will have to face the same epistemic standard as penal theorists if they wish to replace punishment with the intentional imposition of non-punitive severe coercive measures. (shrink)

Denialism concerning free will and moral responsibility combines, in its minimal form, the rejection of libertarian free will and the rejection of compatibilism. I will address the more ambitiously “happy” or “optimistic” version of denialism, which also claims that we are better off without belief in free will and moral responsibility, and ought to try to radically reform our moral, social and personal lives without such beliefs. I argue that such denialism involves, for various reasons, a dangerous gamble, which it (...) would be morally irresponsible to follow. I conclude by reflecting upon the implications. (shrink)

This paper discusses a non-state justice system (Sistema Comunitario de Seguridad, Justicia y Reeducación, hereafter: SCSJR) applied by some of the Afromexican and Indigenous communities of the Guerrero state in Mexico as an example of a maximalist restorative justice system. Restorative justice is presented here as an alternative to criminal justice. While it responds to similar moral concerns as retributive justifications do, it offers more adequate mechanisms of dealing with certain crimes and aims to reduce coerciveness of justice when dealing (...) with lawbreaking. Restorative justice is also an approach that should be perceived as more legitimate when handling cases where the state lacks the moral standing to prosecute offenders. The SCSJR is used as an example to demonstrate the possibility of a justice system based on restorative principles to be effective in handling the entirety of lawbreaking in a community. In the case of the SCSJR this approach to justice has been proved to be effective even in the wake of high levels of criminal activity in the region. This paper discusses the SCSJR’s institutions and attitude toward lawbreaking and argues that they demonstrate an example of a justice system based on restorative justice. (shrink)

I defend a deontological social contract justification of punishment for philosophers who deny free will and moral responsibility (FW/MR). Even if nobody has FW/MR, a criminal justice system is fair to the people it targets if we would consent to it in a version of original position deliberation where we assumed that we would be targeted by the justice system when the veil is raised. Even if we assumed we would be convicted of a crime, we would consent to the (...) imprisonment of violent criminals if prison conditions were better than the state of nature but deterring enough to prevent the state of nature. (shrink)

Punishment involves the intentional infliction of harm and suffering. Both of the most prominent families of justifications of punishment – retributivism and consequentialism – face several moral concerns that are hard to overcome. Moreover, the effectiveness of current criminal punishment methods in ensuring society’s safety is seriously undermined by empirical research. Thus, it appears to be a moral imperative for a modern and humane society to seek alternative means of administering justice. The special issue of Diametros “The Abolition of Punishment: (...) Is a Non-Punitive Criminal Justice System Ethically Justified?” was brought into life precisely to give the authors a platform for such progressive inquiries. And it is now safe to say that this platform has been put to excellent use, since Valerij Zisman, Alexander Stachurski, Giorgia Brucato, Perica Jovchevski, Sofia M. I. Jeppsson, Stephen G. Morris, Benjamin Vilhauer, John Lemos, Saul Smilansky, Elizabeth Shaw, Mirko Farina, Andrea Lavazza and Sergei Levin have presented such thought-provoking texts that they are bound to set the stage for debate in the years to come. This article is an introduction to this special issue and to the authors’ papers. (shrink)