Bert Heinrichs

Das Wiskott-Aldrich-Syndrom (WAS), ein genetisch bedingter Immundefekt mit klinischer Manifestation im Kleinkindalter, wird voraussichtlich in näherer Zukunft erstmals versuchsweise durch eine somatische Gentherapie behandelt werden. Im vor- liegenden Beitrag werden die wichtigsten medizinisch-naturwissenschaftlichen Fakten dieses Krankheitsbildes sowie die bisherigen Erfahrungen mit somatischen Gentherapien bei anderen Immunmangelsyndromen ausführlich dargestellt. Sodann erfolgt eine ethische Analyse eines möglichen gentherapeutischen Eingriffs bei WAS-Patienten, bei der die spezifischen Aspekte des Wiskott-Aldrich-Syndroms – insbesondere die fast ausschließliche Betroffenheit von Kindern sowie die unterschiedlich aussichtsreiche Alter- nativoption einer allogenen Knochenmarktransplantation–wesentliche Aspekte der Beurteilung sind. Im Ergebnis zeigt sich, dass ein gentherapeutischer Eingriff im vorliegenden Fall nicht im Rahmen einer Forschungsstudie, d.h. als Humanexperiment, gerechtfertigt werden kann, sondern allein als individueller Heilversuch. Gleichwohl las- sen die besonderen Risiken und die Innovativität eines solchen Eingriffs es notwendig erscheinen, diesen Heilversuch – anders als andere Heilbehandlungen mit bislang unerprobten Mitteln – in streng kontrollierter Form durchzuführen. Der neuartige Gedanke eines kontrollierten individuellen Heilversuchs zeichnet sich daher für den vorliegenden Fall, und womöglich auch für vergleichbare risikoreiche Behandlungsansätze namentlich im Bereich der Gentherapie, als geeignetes Instrument der Konzeption und Beurteilung ab.

This document presents the Bonn PRINTEGER Consensus Statement: Working with Research Integrity—Guidance for research performing organisations. The aim of the statement is to complement existing instruments by focusing specifically on institutional responsibilities for strengthening integrity. It takes into account the daily challenges and organisational contexts of most researchers. The statement intends to make research integrity challenges recognisable from the work-floor perspective, providing concrete advice on organisational measures to strengthen integrity. The statement, which was concluded February 7th 2018, provides guidance on the following key issues: § 1.Providing information about research integrity § 2.Providing education, training and mentoring § 3.Strengthening a research integrity culture § 4.Facilitating open dialogue § 5.Wise incentive management § 6.Implementing quality assurance procedures § 7.Improving the work environment and work satisfaction § 8.Increasing transparency of misconduct cases § 9.Opening up research § 10.Implementing safe and effective whistle-blowing channels § 11.Protecting the alleged perpetrators § 12.Establishing a research integrity committee and appointing an ombudsperson § 13.Making explicit the applicable standards for research integrity

This document presents the Bonn PRINTEGER Consensus Statement: Working with Research Integrity—Guidance for research performing organisations. The aim of the statement is to complement existing instruments by focusing specifically on institutional responsibilities for strengthening integrity. It takes into account the daily challenges and organisational contexts of most researchers. The statement intends to make research integrity challenges recognisable from the work-floor perspective, providing concrete advice on organisational measures to strengthen integrity. The statement, which was concluded February 7th 2018, provides guidance on the following key issues: § 1. Providing information about research integrity§ 2. Providing education, training and mentoring§ 3. Strengthening a research integrity culture§ 4. Facilitating open dialogue§ 5. Wise incentive management§ 6. Implementing quality assurance procedures§ 7. Improving the work environment and work satisfaction§ 8. Increasing transparency of misconduct cases§ 9. Opening up research§ 10. Implementing safe and effective whistle-blowing channels§ 11. Protecting the alleged perpetrators§ 12. Establishing a research integrity committee and appointing an ombudsperson§ 13. Making explicit the applicable standards for research integrity

It has become evident that neuroimaging raises new normative questions that cannot be addressed adequately within the (in this regard unspecific) frameworks of existing research ethics. Questions that are especially troubling are, among others, provoked by incidental findings. Two questions are particularly intricate in view of incidental findings: (1) How can the research subject’s right not to know be guaranteed? And (2) should a diagnostic check of scans by a neuroradiologist become an obligatory part of neuroscientific research protocols? The present paper examines these question against the background of two recent recommendations. The differentiation between difference position and similarity position serves as an analytic tool to further investigate the issue and to develop a distinct proposal for answering the questions

It is important to be able to offer an account of which activities count as scientific research, given our current interest in promoting research as a means to benefit humankind and in ethically regulating it. We attempt to offer such an account, arguing that we need to consider both the procedural and functional dimensions of an activity before we can establish whether it is a genuine instance of scientific research. By placing research in a broader schema of activities, the similarities and differences between research activities and other activities become visible. It is also easier to show why some activities that do not count as research can sometimes be confused with research and why some other activities can be regarded only partially as research. Although the concept of research is important to delimit a class of activities which we might be morally obliged to promote, we observe that the class of activities which are regarded as subject to ethical regulation is not exhausted by research activities. We argue that, whether they be research or not, all the activities that are likely to affect the rights and interests of the individuals involved and impact on the rights and interests of other individuals raise ethical issues and might be in need of ethical regulation.

In this paper, I examine whether the use of artificial intelligence (AI) and automated decision-making (ADM) aggravates issues of discrimination as has been argued by several authors. For this purpose, I first take up the lively philosophical debate on discrimination and present my own definition of the concept. Equipped with this account, I subsequently review some of the recent literature on the use AI/ADM and discrimination. I explain how my account of discrimination helps to understand that the general claim in view of the aggravation of discrimination is unwarranted. Finally, I argue that the use of AI/ADM can, in fact, increase issues of discrimination, but in a different way than most critics assume: it is due to its epistemic opacity that AI/ADM threatens to undermine our moral deliberation which is essential for reaching a common understanding of what should count as discrimination. As a consequence, it turns out that algorithms may actually help to detect hidden forms of discrimination.

In this paper I propose to examine the concept of discrimination from an ethical viewpoint. In a preliminary part, I will point out which aspects of the subject matter I will focus on and which I will leave aside (II). On the basis of the Aristotelian principle “treat like cases alike”, I will continue with a very formal definition, according to which discrimination can be understood as acting in a way that implies that like cases are not treated alike. This leads to the difficult question of which cases are to be considered as “alike”, or which traits can serve as morally valid reasons for identifying cases as “unlike” (III). I will argue that this question cannot be answered independently from the specific circumstances and the normative premises referred to for describing these circumstances. My conclusion is that the concept of discrimination derives its “moral strength” solely from these normative premises. As a consequence, the use of the con- cept of discrimination can often be misleading since it falsely presupposes that there is agreement about the underlying normative premises (IV). Finally, I will illustrate the argumentation using “genetic discrimination” in connection with insurance contracts as an example (V).

The so-called Principlism of Beauchamp and Childress is one of the most prominent approaches in bioethics. It has, nevertheless, given rise to an ongoing debate on methodology in bioethics. At the bottom of this debate lies the question whether a multi-principles approach or a single-principle approach is more convincing in bioethics. In this paper I shall propose a 'third way' of bioethical reasoning that is committed neither to a multi-principles nor to a single-principle approach. In contrast, I will take up the Kantian differentiation of formal and material principles. This differentiation permits combining the strengths of multi-principles as well as of single-principle approaches.

Background: Informed consent is a legal as well as ethical prerequisite in clinical research. For dementia research, informed consent can be a problem if subjects with dementia, whose capacity for understanding and thus also decision making might be limited, are to be exam- ined. This might result in exclusion of dementia patients from research, as capacity for understanding and decision making are often equated with the ability for rational decision making. However, this valuation has been criticized at times for attaching too much impor- tance to the cognitive aspect of decision making. Methods: This qualitative study investigates the actual consent procedure of a clini- cal research study in Germany with regard to dementia patients’ subjective and objective understanding of informed consent information. Research participants were ten dementia patients, who volunteered in two clinical research studies, as well as their caregivers. Data were collected by use of semi-structured interviews. Results: It was determined that the patients’ comprehension of informed consent infor- mation was rather limited. However, a number of patients were quite aware of this. In con- trast, all caregivers claimed to have fully understood the provided information, while their objective comprehension was also incomplete. Several participants indicated that they did not attach much importance to the information given in the consent procedure and that their consent did not primarily depend on this information. Rather, participation in the research study for them seemed to be more of a problem-focused coping strategy for dealing with their diagnosis of dementia. Conclusion: For research ethics these results raise the question whether the currently prevailing emphasis on the cognitive aspect of autonomous decision making, i.e., compre- hension, may be too one-sided, and to what extent the “volitional” aspect in giving consent should be given greater consideration.

Recent advances in genomic research have led to the development of new diagnostic tools, including tests which make it possible to predict the future occurrence of monogenetic diseases (e.g. Chorea Huntington) or to determine increased susceptibilities to the future development of more complex diseases (e.g. breast cancer). The use of such tests raises a number of ethical, legal and social issues which are usually discussed in terms of rights. However, in the context of predictive genetic tests a key question arises which lies beyond the concept of rights, namely, What should we want to know about our future? In the following I shall discuss this question against the background of Kant’s Doctrine of Virtue. It will be demonstrated that the system of duties of virtue that Kant elaborates in the second part of his Metaphysics of Morals offers a theoretical framework for addressing the question of a proper scope of future knowledge as provided by genetic tests. This approach can serve as a source of moral guidance complementary to a justice perspective. It does, however, not rest on the – rather problematic – claim to be able to define what the “good life” is

Although the principle of informed consent is well established and its importance widely acknowledged, it has met with criticism for decades. Doubts have been raised for a number of different reasons. In particular, empirical data show that people regularly fail to reproduce the information provided to them. Many critics agree, therefore, that the received concept of informed consent is no more than a myth. Strategies to overcome this problem often rest on a flawed concept of informed consent. In this paper, it is suggested that informed consent is a communicative act between two persons. The challenge is to elucidate the norms and constraints for successfully performing such a communicative act. The view developed here has major consequences with regard to the standards for information disclosure as well as for the general scope of informed consent.

Unterschiedlichste Anwendungsformen künstlicher Intelligenz bestimmen schon heute den Alltag vieler Menschen – von Einsatz von KI-Systeme in Finanzgeschäften über die Vergabe von Studienplätzen bis hin zur Steuerung von Pflegerobotern, Autos und Waffensystemen. Diese vielfältigen neuen Möglichkeiten und Visionen wecken einerseits Hoffnungen auf persönlichen und gesellschaftlichen Nutzen und Fortschritt; andererseits rufen sie aber auch Bedenken, Ängste und gelegentlich auch grundsätzliche Ablehnung hervor. Angesichts dieser Ambivalenz sind ethische Analysen gefordert, die ausloten, wie ein verantwortungsvoller Umgang mit KI gestaltet werden sollte. Der Band greift viele dieser Probleme auf und unterzieht sie einer eingehenden philosophischen Analyse. Die Auseinandersetzung ist nach klassischen Teilbereichen der Philosophie gegliedert, aus deren Perspektive heraus jeweils spezielle Teilaspekte oder einzelne Anwendungsformen von KI beleuchtet werden. Das Themenspektrum reicht entsprechend von Fragen der Handlungstheorie und Philosophie des Geistes über wissenschaftstheoretische Problemstellungen bis hin zu ethischen Fragen die beispielsweise den Einsatz von KI in der Medizin und im Wirtschafts- und Arbeitsleben betreffen. In Auseinandersetzung mit aktuellen Debatten werden eigenständige Positionen entwickelt.

Case studies, both with a view to didactical and argumentative purposes, are widely used in applied ethics. However, case studies are often used without methodological considerations concerning the premises and limitations of these kind of studies as methodological tools within ethics. The present paper critically examines the recourse to – real or fictitious – case studies. Important suggestions will be taken from Kant’s philosophy. Kant himself occasionally uses case studies in his ethical writings. Yet, he also discusses the relevance as well as the limitations of case studies in ethics. Against the background of this analysis, the opinion that ethics can be taught or developed in concreto, or that ethics might eventually be resolved into compilations of case studies must be rejected.

Will brain imaging technology soon enable neuroscientists to read minds? We cannot answer this question without some understanding of the state of the art in neuroimaging. But neither can we answer this question without some understanding of the concept invoked by the term “mind reading.” This article is an attempt to develop such understanding. Our analysis proceeds in two stages. In the first stage, we provide a categorical explication of mind reading. The categorical explication articulates empirical conditions that must be satisfied if mind reading is to be achieved. In the second stage, we develop a metric for judging the proficiency of mind reading experiments. The conception of mind reading that emerges helps to reconcile folk psychological judgments about what mind reading must involve with the constraints imposed by empirical strategies for achieving it.

For a couple of years, “Aristotelian Naturalism” has been the subject of intensive debates. Among the most prominent proponents of this type of ethical theory are Philippa Foot and John McDowell. At first sight, these approaches are quite attractive for they seem to combine a number of advantages. The central thesis of the present paper is, however, that they do not succeed in developing a convincing ethical theory. To substantiate this claim, Foot’s approach will be presented in a first step. In a second step, McDowell’s critique on Foot will be out- lined. Foot’s attempt to provide an external foundation for morality takes centre stage here. In a third step, McDowell’s own version of Aristotelian Naturalism, which has an explicitly anti-foundational shape, will be delineated. Although McDowell’s critique on Foot proves to be valid, it leads him to the wrong con- clusions. He ignores that a reason-internal foundation of morality is available which resists his legitimate critique while being superior to his own anti-foun- dational theory. At the core of such an approach lies a non-reductive concept of person, which stands in clear contrast to Foot’s concept of “life form” as well as to McDowell’s concept of “second nature”.

Unter Off-Label-Use versteht man den zulassungsüberschreitenden Einsatz eines Arzneimittels außerhalb der von Zulassungsbehörden genehmigten Anwendungsgebiete. Er ist in der medizinischen Praxis weit verbreitet und fächerübergreifend zu beobachten. Der Beitrag gibt eine Einschätzung der Off-Label-Anwendung aus ethischer Sicht. Dazu wird die Off- Label-Anwendung zunächst von anderen, sachlich verwandten Anwendungsweisen abgegrenzt. Danach wird über die aktuelle Verbreitung des Off-Label- Use informiert. Sodann wird gezeigt, dass sich bekannte Problemlagen aus der Medizinethik bei der Off-Label-Anwendung in spezifischer Weise verschärfen. Schließlich wird diskutiert, wie eine ethisch akzeptable Off-Label-Anwendung von Arzneimitteln ausgestaltet werden könnte und auf welchen Ebenen sie ansetzen müsste.

In this paper, we address the question of whether AI should be used for suicide prevention on social media data. We focus on algorithms that can identify persons with suicidal ideation based on their postings on social media platforms and investigate whether private companies like Facebook are justified in using these. To find out if that is the case, we start with providing two examples for AI-based means of suicide prevention in social media. Subsequently, we frame suicide prevention as an issue of beneficence, develop two fictional cases to explore the scope of the principle of beneficence and apply the lessons learned to Facebook’s employment of AI for suicide prevention. We show that Facebook is neither acting under an obligation of beneficence nor acting meritoriously. This insight leads us to the general question of who is entitled to help. We conclude that private companies like Facebook can play an important role in suicide prevention, if they comply with specific rules which we derive from beneficence and autonomy as core principles of biomedical ethics. At the same time, public bodies have an obligation to create appropriate framework conditions for AI-based tools of suicide prevention. As an outlook we depict how cooperation between public and private institutions can make an important contribution to combating suicide and, in this way, put the principle of beneficence into practice.

In this paper, we use some elements of the philosophical theories of Wilfrid Sellars and Robert Brandom for examining the interactions between humans and machines. In particular, we adopt the concept of the space of reasons for analyzing the status of artificial intelligent agents. One could argue that AIAs, like the widely used recommendation systems, have already entered the space of reasons, since they seem to make knowledge claims that we use as premises for further claims. This, in turn, can lead to a sense of alienation because AIAs do not quite play by the rules of the space of the reason. We, therefore, ask somewhat pointedly whether aliens have entered the space of reasons. A closer look reveals that it is a misconception to consider AIAs as being in the space of reasons. In fact, they should be seen as very sophisticated tools. Since these tools affect our own acting in the space of reasons, special regulations are required for their proper use.

Position papers on artificial intelligence (AI) ethics are often framed as attempts to work out technical and regulatory strategies for attaining what is commonly called trustworthy AI. In such papers, the technical and regulatory strategies are frequently analyzed in detail, but the concept of trustworthy AI is not. As a result, it remains unclear. This paper lays out a variety of possible interpretations of the concept and concludes that none of them is appropriate. The central problem is that, by framing the ethics of AI in terms of trustworthiness, we reinforce unjustified anthropocentric assumptions that stand in the way of clear analysis. Furthermore, even if we insist on a purely epistemic interpretation of the concept, according to which trustworthiness just means measurable reliability, it turns out that the analysis will, nevertheless, suffer from a subtle form of anthropocentrism. The paper goes on to develop the concept of strange error, which serves both to sharpen the initial diagnosis of the inadequacy of trustworthy AI and to articulate the novel epistemological situation created by the use of AI. The paper concludes with a discussion of how strange error puts pressure on standard practices of assessing moral culpability, particularly in the context of medicine.

In this paper, I will suggest an unorthodox hybrid theory of ethical justification that combines, on an ontological level, a realist approach with constructivist elements. On an epistemological level, the realist part of the theory will be squared with an intuitionist account. Eventually, the suggested hybrid theory will take the form of an intuitionist ethics of persons. I will start with briefly sketching the ontological shape of the relevant concept of person whereby I will extensively draw on Kant and endorse a realist reading of his ethical theory (2.). Subsequently, I will explain why and how constructivist elements must complement the picture (3.). Then, I will focus on the epistemological shape of the theory. In particular, I will suggest an intuitionist reading of Kant’s doctrine of “the fact of reason” (4.). Next, I will briefly comment on classical intuitionism and on Bernard William’s notion of convergence in ethics (5.). Subsequently, I will compare my approach with Robert Audi’s attempt to refine a Rossian type of intuitionism (6.). Finally, I will revisit the charge of dogmatism that has traditionally been raised against intuitionism (7.).

Unter welchen Bedingungen kann es als ethisch vertretbar gelten, Menschen in biomedizinischen Experimenten als Probanden einzusetzen? Bert Heinrichs unternimmt es, die Ethik der Forschung am Menschen grundlegend und systematisch zu erschließen. Seine ethische Rahmentheorie wird im Hinblick auf drei kontrovers diskutierte Problemkomplexe ausgewertet, nämlich die Forschung mit Minderjährigen, randomisierte klinische Studien und Forschung in Entwicklungsländern. Sie soll helfen, wesentliche Orientierung bei der konkreten Problemlösung zu geben.

abstract The so‐called Principlism of Beauchamp and Childress is one of the most prominent approaches in bioethics. It has, nevertheless, given rise to an ongoing debate on methodology in bioethics. At the bottom of this debate lies the question whether a multi‐principles approach or a single‐principle approach is more convincing in bioethics. In this paper I shall propose a ‘third way’ of bioethical reasoning that is committed neither to a multi‐principles nor to a single‐principle approach. In contrast, I will take up the Kantian differentiation of formal and material principles. This differentiation permits combining the strengths of multi‐principles as well as of single‐principle approaches.

BackgroundAdvance research directives (ARD) have been suggested as a means by which to facilitate research with incapacitated subjects, in particular in the context of dementia research. However, established disclosure requirements for study participation raise an ethical problem for the application of ARDs: While regular consent procedures call for detailed information on a specific study (“token disclosure”), ARDs can typically only include generic information (“type disclosure”). The introduction of ARDs could thus establish a double standard in the sense that within the context of ARDs, type disclosure would be considered sufficient, while beyond this context, token disclosure would remain necessary.Main bodyThis paper provides an ethical analysis of ARDs, taking into account the results of numerous empirical studies that have been performed so far. It will be argued that a revised understanding of informed consent can allow for context-sensitive disclosure standards. As a consequence, ARDs that include type disclosure can be acceptable under suitable circumstances. Such an approach raises a number of objections. A thorough examination shows, however, that they are not sufficient to justify a rejection of the approach.ConclusionThe approach presented in this paper avoids introducing a double standard. It is, therefore, more suitable for the implementation of ARDs than established approaches.

Um gängigen Missverständnissen, die der Begriff „Ethikkommission“ mit sich bringt, entgegenzuwirken, schlägt der Autor Heinrichs vor, die Kommissionen stattdessen in „Patientenschutzkommissionen“ umzubenennen. Um der Hauptaufgabe des Probandenschutzes gerecht zu werden, sollten Ethikkommissionen die Aufklärungs- und Einwilligungsprozedur überprüfen, die Risiken und Belastungen der Probanden einschätzen und Gerechtigkeit im Hinblick auf Rekrutierung und Auswahl gewährleisten. Heinrichs verwirft die Lösung, Ethikkommissionen als reine Rechtsanwendungsbehörden zu verstehen, da Prozesse ethischer Bewertung unumgänglich seien.