Bert Heinrichs

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.

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

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.

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.

As a negative protective right, freedom of science is – within the limits marked by other fundamental liberty rights – widely accepted. This also applies, pars pro toto, to the field of medical research. It is far less clear, however, whether a positive claim to medical research can be justified as well. Research of this kind could be articu- lated by potential beneficiaries of its applications as a welfare right. If one bases pub- lic obligations on the concept of fostering individual liberties and, in addition, bears in mind the existential importance of effective therapies especially for severe dis- eases, the presumption of such a claim may not be unfounded. Yet, if such a claim can be justified its proper addressee still needs to be identified. Against the back- ground of frequent criticism directed against pharmaceutical companies, asserting that they disregard certain patient groups or types of diseases in their research activ- ities in a morally irresponsible way, the attempt to clarify this issue gains immediate practical relevance.

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

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.

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

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.