Claudia Wiesemann

Ethical principles and recommendations for the medical management of differences of sex development (DSD)/intersex in children and adolescents

The medical management of differences of sex development (DSD)/intersex in early childhood has been criticized by patients’ advocates as well as bioethicists from an ethical point of view. Some call for a moratorium of any feminizing or masculinizing operations before the age of consent except for medical emergencies. No exhaustive ethical guidelines have been published until now. In particular, the role of the parents as legal representatives of the child is controversial. In the article, we develop, discuss, and present ethical principles and recommendations for the medical management of intersex/DSD in children and adolescents. We specify three basic ethical principles that have to be respected and substantiate them. The article includes a critical discussion of the best interest of the child and of family privacy. The argumentation draws upon recommendations by the working group “Bioethics and Intersex” within the German Network DSD/Intersex, which are presented in detail. Unlike other recommendations with regard to intersex, these guidelines represent a comprehensive view of the perspectives of clinicians, patients, and their families.ConclusionThe working group identified three leading ethical principles that apply to DSD management: (1) to foster the well-being of the child and the future adult, (2) to uphold the rights of children and adolescents to participate in and/or self-determine decisions that affect them now or later, and (3) to respect the family and parent–child relationships. Nine recommendations for the management of DSD indicate how these ethical principles can spelled out and balanced against each other in the clinical setting.

Deciding on Gender in Children with Intersex Conditions

Biologic factors such as genetic and hormonal influences contribute to gender identity, gender role behavior, and sexual orientation in humans, but this relationship is considerably modified by psychologic, social, and cultural factors. The recognition of biologically determined conditions leading to incongruity of genetically determined sex, somatic phenotype, and gender identity has led to growing interest in gender role development and gender identity in individuals with intersex conditions. Sex assignment of children with ambiguous genitalia remains a difficult decision for the families involved and subject to controversial discussion among professionals and self-help groups. Although systematic empirical data on outcomes of functioning and health-related quality of life are sparse, anecdotal evidence from case series and individual patients about their experiences in healthcare suggests traumatic experiences in some. This article reviews the earlier ‘optimal gender policy’ as well as the more recent ‘full consent policy’ and reviews published data on both surgical and psychosocial outcomes. The professional debate on deciding on sex assignment in children with intersex conditions is embedded in a much wider public discourse on gender as a social construction. Given that the empirical basis of our knowledge of the causes, treatment options, long-term outcomes, and patient preferences is insufficient, we suggest preliminary recommendations based on clinical experience, study of the literature, and interviews with affected individuals.

Non-therapeutic research with minors: how do chairpersons of German research ethics committees decide?

Objectives: Clinical trials in humans in Germany—as in many other countries—must be approved by local research ethics committees (RECs). 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 (in parts) 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.

Lehrziele "Medizinethik im Medizinstudium"

Die verbesserte Integration medizinethischer Lehrziele ist seit langer Zeit ein Desiderat in der rztlichen Ausbildung [4, 5, 9]. Am 26. April 2002 hat der Bundesrat die von der Bundesgesundheitsministerin nach langj hrigen Beratungen vorgelegte Reform der rztlichen Approbationsordnung beschlossen. Diese gilt bereits f r Studierende, die zum Wintersemester 2003/04 ihre Ausbildung beginnen. Die neuen Regelungen zielen generell auf eine Verbesserung der praktischen Ausbildung, auf die Vernetzung vorklinischen und klinischen Wissens, auf f cher bergreifenden und fallbezogenen Unterricht sowie auch auf die st rkere Vermittlung sozialer Kompetenz [1]. Zugleich wurden Pr fungswesen und Struktur des Studiums ge ndert [2]: Nach einem Studium von zwei Jahren wird eine Staatspr fung abgelegt; nach vier weiteren Jahren folgt zum Studienabschluss eine zweite Staatspr fung (jeweils schriftlich und m ndlich). F r die Zulassung zum Praktischen Jahr (11./12. Semester) sind benotete Leistungsnachweise erforderlich. Die „Vermittlung der geistigen, historischen und ethischen Grundlagen rztlichen Verhaltens“ geh rt zum Kernbereich des Medizinstudiums (§ 1, 1 AppO; [1], S. 2405). Der neu eingef hrte Querschnittsbereich „Geschichte, Theorie, Ethik der Medizin“ ist einer von zw lf Querschnittsbereichen, in denen ein benoteter Leistungsnachweis obligatorisch erbracht werden muss. Dar ber hinaus kann Medizinethik als Wahlfach im ersten und prinzipiell auch im zweiten Abschnitt angeboten werden. Außerdem ist eine Integration medizinethischer Inhalte in andere vorklinische oder klinische Unterrichtsveranstaltungen denkbar, etwa im Rahmen des Praktikums zur Einf hrung in die klinische Medizin oder in f cherspezifischen Lehrveranstaltungen. Angesichts dieser Entwicklung erging im Mai letzten Jahres von der Abteilung Ethik und Geschichte der Medizin der Universit t G ttingen eine Einladung an Dozent(inn)en, die in Deutschland Medizinethik f r Medizinstudierende lehren, sich im Rahmen eines Arbeitskreises an der Erarbeitung gemeinsamer Lehrziele zu beteiligen. berdies wurden alle Mitglieder der Akademie f r Ethik in der Medizin ber die geplanten Arbeitstreffen informiert; die Teilnahme stand allen Interessierten offen. Das erste Treffen im Juli 2002 fand mit ber 20 Expert(inn)en aus ganz Deutschland regen Zuspruch und bestand, wie auch die nachfolgenden beiden Treffen, aus einer mehrst ndigen Arbeitssitzung mit intensiver Diskussion. Wie von den Veranstaltern betont wurde, war das Ziel nicht, einen umfassenden Themenkatalog der Medizinethik zu schaffen; die Fragestellung war vielmehr dezidiert auf die Entwicklung von Lehrzielen in der Ausbildung von Medizinstudierenden beschr nkt. Dabei nahm der Arbeits-

The significance of prognosis for a theory of medical practice

A typical problem of modern medicine results from the gap between scientific knowledge and its application in individual cases. Whereas scientific knowledge is generalized and impersonal information, medical practice takes place under conditions which are singular, individual and irreversible. The paper examines whether prognosis is able to bridge this gap or “hiatus theoreticus.” It is shown that diagnosis of a single case always relies on prognostic considerations. The individual prognosis (as distinguished from the nosologic prognosis of a certain disease) enables doctors to apply scientific knowledge and practice according to the actual situation, the history and personal preferences of the patient. Prognosis – not diagnosis – therefore legitimizes medical interference. A methodology of individual prognosis as the basis for a theory of practice is discussed.

Ethical Guidelines for the Clinical Management of Intersex

The clinical management of intersex has undergone a significant change in values. Whereas in former times, benevolent medical paternalism was the rule, today, the patient’s right to respect for dignity and self-determination is given priority. This paper discusses ethical considerations shaping the modern therapeutic management of intersex conditions that do not entail acute health risks. It concludes with basic ethical guidelines for clinical practice.

Is there a right not to know one's sex? The ethics of ‘gender verification’ in women's sports competition

The paper discusses the current medical practice of ‘gender verification’ in sports from an ethical point of view. It takes the recent public discussion about 800 m runner Caster Semenya as a starting point. At the World Championships in Athletics 2009 in Berlin, Germany, Semenya was challenged by competitors as being a so called ‘sex impostor’. A medical examination to verify her sex ensued. The author analyses whether athletes like Semenya could claim a right not to know that is generally acknowledged in human genetics and enforced by international and national genetic privacy laws. The relevance of this right for genetic diagnosis in sports is discussed. To this end, the interests of the athlete concerned and of third parties are balanced according to the expected benefits and harms.Harm is documented in a number of cases and includes unjustified disqualification, severe sex and gender identity crisis, demeaning reactions, social isolation, depression and suicide. Benefits are dubious as most cases of intersex are considered irrelevant for sports competition. It has to be concluded that the benefits to be gained from ‘gender verification’ in sports via genetic testing do not outweigh the grave individual disadvantages. The current practice of athletic associations to largely ignore the right of competitors not to know does not comply with prevailing ethical provisions on the protection of sensitive personal data. Therefore, genetic ‘gender verification’ in sports should be abolished.

Understanding collective agency in bioethics

Bioethicists tend to focus on the individual as the relevant moral subject. Yet, in highly complex and socially differentiated healthcare systems a number of social groups, each committed to a common cause, are involved in medical decisions and sometimes even try to influence bioethical discourses according to their own agenda. We argue that the significance of these collective actors is unjustifiably neglected in bioethics. The growing influence of collective actors in the fields of biopolitics and bioethics leads us to pursue the question as to how collective moral claims can be characterized and justified. We pay particular attention to elaborating the circumstances under which collective actors can claim ‘collective agency.’ Specifically, we develop four normative-practical criteria for collective agency in order to determine the conditions that must be given to reasonably speak of ‘collective autonomy’. For this purpose, we analyze patient organizations and families, which represent two quite different kinds of groups and can both be conceived as collective actors of high relevance for bioethical practice. Finally, we discuss some practical implications and explain why the existence of a shared practice of trust is of immediate normative relevance in this respect.

Gender in medical ethics: re-examining the conceptual basis of empirical research.

Conducting empirical research on gender in medical ethics is a challenge from a theoretical as well as a practical point of view. It still has to be clarified how gender aspects can be integrated without sustaining gender stereotypes. The developmental psychologist Carol Gilligan was among the first to question ethics from a gendered point of view. The notion of care introduced by her challenged conventional developmental psychology as well as moral philosophy. Gilligan was criticised, however, because her concept of ‘two different voices’ may reinforce gender stereotypes. Moreover, although Gilligan stressed relatedness, this is not reflected in her own empirical approach, which still focuses on individual moral reflection. Concepts from social psychology can help overcome both problems. Social categories like gender shape moral identity and moral decisions. If morality is understood as being lived through actions of persons in social relationships, gender becomes a helpful category of moral analysis. Our findings will provide a conceptual basis for the question how empirical research in medical ethics can successfully embrace a gendered perspective.

Junge oder Mädchen

ZusammenfassungWir diskutieren ethische Probleme der medizinischen Behandlung intersexueller Kinder. Gefragt wird nach dem Stellenwert von Elternwünschen nach eindeutiger Geschlechtszuweisung sowie nach den Konfliktfeldern, die zum einen zwischen konkurrierenden Wunschvorstellungen der Eltern und der behandelnden Ärzte, zum andern zwischen Kindeswohl und Kinderrechten entstehen können. Gegenwärtig wird Neugeborenen mit anatomisch uneindeutigem Genital trotz unsicherer Prognose über die Behandlungsergebnisse oft noch ein Geschlecht zugewiesen und operativ erstellt. Dieses Vorgehen ist von verschiedenen Seiten ethisch heftig kritisiert worden. Kipnis u. Diamond forderten 1998 im „Journal of Clinical Ethics“ ein Moratorium für alle nicht vital indizierten geschlechtskorrigierenden Eingriffe. Diese Forderung orientiert sich am Interesse des zukünftigen Erwachsenen, betont dessen prospektive Autonomie und klammert den Elternwunsch aus. Dieses „Modell des antizipierten Konsenses“ kann jedoch mit Bezug auf Neugeborene und Kleinkinder bedeutsame Aspekte des Eltern-Kind-Verhältnisses nicht angemessen erfassen. Im Aufsatz werden Argumente angeführt, die es aus Sicht einer Ethik der Elternschaft rechtfertigen, ethische Entscheidungen auf der Basis eines beziehungsorientierten Modells zu treffen. In unserem Modell fallen Elternwünsche ethisch ins Gewicht.AbstractDefinition of the problem:Ethical guidelines for the treatment of newborns with disorders of sex development have come under critical discussion. Former patients urgently demand a reassessment of surgical genital corrections, arguing that modern societies are more willing to tolerate sexual ambiguity and that clear-cut gender differences are becoming less and less important.Arguments:The growing children’s rights movement has stressed the fact that children are not just objects of their parents and society’s expectations. The limits of parental decision making in case of sexual ambiguity are an object of ongoing controversies. We discuss the relative authority of parents’ wishes in the determination of the newborn child’s sex.Conclusion:We reject a purely autonomy based approach. Our arguments are based on a relational ethics of parenthood.