Christian Lenk

Spätestens mit Inkrafttreten des Gendiagnostikgesetzes wird in Recht, Ethik und Genetik verstärkt diskutiert, wie das dort dem Grunde nach anerkannte "Recht auf Nichtwissen" in den jeweiligen konkreten Anwendungskontexten rechtspraktisch operationalisiert werden kann. Vor diesem Hintergrund etablierte sich eine vom BMBF geförderte Göttinger Projektgruppe, die sich aus renommierten Vertretern der Fachdisziplinen Ethik, Humangenetik, Genetischer Psychiatrie und Recht zusammensetzte. Ihr Ziel war es, unter besonderem Fokus auf die aktuellen bzw. absehbaren technologischen Entwicklungen der modernen Gensequenzierung den zentralen Wertekonflikt im Spannungsfeld von "Autonomie" und "ärztlicher Fürsorge" interdisziplinär und systematisch unter anderem auf Grundlage einer begleitenden Fragebogenstudie zu analysieren. Dieser Band bündelt die wesentlichen Erkenntnisse der einzelnen Forschungsdisziplinen; zudem beziehen weitere namhafte Experten zu den Ergebnissen und aktuellen Entwicklungen vertiefend Stellung.

The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called ‘no-property rule’ is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles

Risks and burdens in the study participation, as well as an adequate risk-benefit balance, are key concepts for the evaluation of clinical studies by research ethics committees. An adequate assessment and continuous monitoring to ensure compliance of risks and burdens in clinical trials have long been described as a central task in research ethics. However, there is currently no uniform and solid theoretical approach to risk assessment by RECs. Regulatory standards of research ethics such as the Declaration of Helsinki provide only minimal guidance on how risk decisions are considered. Due to discrepancies in the existing literature and guidance documents, adequate risk assessment by RECs remains to be elusive. In this article, we address current definitions of risk and present our own concept of aggregate risk definition. Moreover, we highlight the concept of benefit, the standard of reasonableness with respect to ethics literature and different approaches of risk-benefit assessment. In order to present a comprehensive theoretical approach of risk assessment by RECs, further understanding of the definitions of risk may improve adequate decision-making tasks by RECs. To improve the process of risk assessment by RECs, a dynamic framework will be illustrated, showing step-by-step risk assessment functions. This approach may be a promising tool to ensure adequacy in risk assessment by RECs.

ZusammenfassungJeder extrahierte Zahn ist primär Eigentum des betreffenden Patienten und unterliegt dessen autonomiebasiertem Selbstbestimmungsrecht. Diesem weitgehend unstrittigen Sachverhalt steht die praktische Notwendigkeit gegenüber, extrahierte Zähne für Forschung und Lehre bereitzustellen. So ist z. B. die Erprobung neuer Wurzelfüllmaterialien und -techniken ohne den Einsatz extrahierter Zähne ebenso wenig denkbar wie eine zahnbezogene praktische Ausbildung angehender Zahnärzte im Rahmen des universitären Studiums. In jüngster Zeit wurde vermehrt Kritik an der konventionellen Praxis der Rekrutierung und Nutzung extrahierter Zähne geübt. Vor diesem Hintergrund widmet sich der vorliegende Beitrag der Frage nach den ethischen und rechtlichen Voraussetzungen für die Verwendung extrahierter Zähne in Lehre und Forschung. Damit verbunden sind die Fragen nach 1) der Indikationsstellung zur Extraktion, 2) dem Umgang mit Kommerzialisierungsgefahren und äußerem Druck, 3) dem geeigneten Zeitpunkt der Aufklärung, 4) der Reichweite der Aufklärungspflicht und 5) Art und Umfang der Dokumentation. Der Beitrag fußt auf einer ethisch-rechtlichen Analyse der vorgenannten Problemkreise unter Berücksichtigung der einschlägigen rechtlichen Bestimmungen und der verfügbaren Fachliteratur und führt zu dem Ergebnis, dass die Rekrutierung und Nutzung extrahierter Zähne unter bestimmten, klar definierten Rahmenbedingungen ethisch und rechtlich zulässig ist.

Objectives: Clinical trials in humans in Germany—as in many other countries—must be approved by local research ethics committees . The current study has been designed to document and evaluate decisions of chairpersons of RECs in the problematic field of non-therapeutic research with minors. The authors’ purpose was to examine whether non-therapeutic research was acceptable for chairpersons at all, and whether there was certainty on how to decide in research trials involving more than minimal risk.Design: In a questionnaire, REC chairpersons had to evaluate five different scenarios with non-therapeutic research. The scenarios described realistic potential research projects with minors, involving increasing levels of risk for the research participants. The chairpersons had to decide whether the respective projects should be approved.Methods: A total of 49 German REC chairpersons were sent questionnaires; 29 questionnaires were returned. The main measurements were approval or rejection of research scenarios.Results: Chairpersons of German RECs generally tend to accept non-therapeutic research with minors if the apparent risk for the participating children is low. If the risk is clearly higher than “minimal”, the chairpersons’ decisions differ widely.Conclusion: The fact that there seem to be different attitudes of chairpersons to non-therapeutic research with minors is problematic from an ethical point of view. It suggests a general uncertainty about the standards of protection for minor research participants in Germany. Therefore, further ethical and legal regulation of non-therapeutic research with minors in Germany seems necessary

Nanomedicine plays a prominent role among emerging technologies. The spectrum of potential applications is as broad as it is promising. It includes the use of nanoparticles and nanodevices for diagnostics, targeted drug delivery in the human body, the production of new therapeutic materials as well as nanorobots or nanoprotheses. Funding agencies are investing large sums in the development of this area, among them the European Commission, which has launched a large network for life-sciences related nanotechnology. At the same time government agencies as well as the private sector are putting forward reports of working groups that have looked into the promises and risks of these developments. This paper will begin with an introduction to the central ethical themes as identified by selected reports from Europe and beyond. In a next step, it will analyse the most frequently invoked ethical concerns–risk assessment and management, the issues of human identity and enhancement, possible implications for civil liberties (e.g. nanodevices that might be used for covert surveillance), and concerns about equity and fair access. Although it seems that the main ethical issues are not unique to nanotechnologies, the conclusion will argue against shrugging them off as non-specific items that have been considered before in the context of other biomedical technologies, such as gene therapy or xenotransplantation. Rather, the paper will call on ethicists to help foster a rational, fair and participatory discourse on the different potential applications of nanotechnologies in medicine, which can form the basis for informed and responsible societal and political decisions

Genetic predispositions often concern not only individual persons, but also other family members. Advances in the development of genetic tests lead to a growing number of genetic diagnoses in medical practice and to an increasing importance of genetic counseling. In the present article, a number of ethical foundations and preconditions for this issue are discussed. Four different models for the handling of genetic information are presented and analyzed including a discussion of practical implications. The different models’ ranges of content reach from a strictly autonomous position over self-governed arrangements in the practice of genetic counseling up to the involvement of official bodies and committees. The different models show a number of elements which seem to be very useful for the handling of genetic data in families from an ethical perspective. In contrast, the limitations of the standard medical attempt regarding confidentiality and personal autonomy in the context of genetic information in the family are described. Finally, recommendations for further ethical research and the development of genetic counseling in families are given.

Doping in sport counts as a typical example of unfair behaviour and a good illustration of ethical problems produced by enhancement activities. However, there are some authors who argue that enhancement in sport is not intrinsically problematic but only so in those circumstances that make it dangerous for athletes or unfair to competitors, or which give rise to suspicion in the viewing public. In contrast to this, the author of the present article shows that enhancement activities are contradictory to basic requirements and preconditions of sports competitions. These preconditions are, firstly, a basic equality of opportunities for all competitors and, secondly, a clear causal connection between a specific performance and an individual athlete, in the sense of authorship of that performance. It cannot be excluded that there could exist future sports competitions without these qualities, but this would clearly be a fundamentally different kind of sport from nowadays. Therefore, the normative background of the current concept of sports competitions, as such, limits the use of enhancement practices to a rather low level