Research participants’ perceptions and views on consent for biobank research

$\bf Background:$ Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. $\bf Methods:$ Review question: Which empirical data are available on research participants’ perceptions and views regarding information and elicitation of consent for biobank research? Search of articles published till March 1st 2014 in Pubmed. Review of abstracts and potentially relevant full text articles by two authors independently. As categories for content analysis we defined (i) understanding or recall of information, (ii) preferences regarding information or consent, and (iii) research participants’ concerns. $\bf Results:$ The search in Pubmed yielded 337 abstracts of which 10 articles were included in this study. Approaches to information and consent varied considerably across the selected studies. The majority of research participants opted for some version of limited consent when being informed about such possibility. Among the factors influencing the type of preferred consent were information about sponsoring of biobank research by pharmaceutical industry and participants’ trade-off between privacy and perceived utility. Studies investigating research participants’ understanding and recall regarding the consent procedure indicated considerable lack of both aspects. Research participants’ perceptions of benefits and harms differ across those studies. $\bf Conclusion:$ The knowledge, perceptions and views of research participants who have undergone a consent procedure within the context of biobank research raise several questions on the issue of how to inform and elicit consent in an ethically acceptable way. In our empirical-ethical analysis we develop suggestions on how the practice of eliciting consent in the biobank context should be improved

Assisted suicide and the discrimination argument

According to the "discrimination argument", it would be discriminatory and hence impermissible to categorically exclude people with mental illness (PMI) from access to assisted suicide (AS) if AS is accessible to people with somatic illnesses. In objection to this, it could be argued that excluding PMI is not discriminatory, but rather based on their inability to meet certain eligibility criteria for AS. Which criteria are deemed necessary depends on the approach taken to justifying AS. In this article, we describe two distinct ethical approaches to justifying AS and the eligibility criteria they entail and examine whether PMI can fulfill these criteria. A widespread "joint" approach based on beneficence and autonomy assumes that AS is justified when it alleviates the severe and irremediable suffering of a person who autonomously requests AS. An alternative, exclusively autonomy-based approach assumes that providing AS is justified when a person's request is autonomous, regardless of whether AS is in her best interests. The latter approach underlies an important judgment of the German Federal Constitutional Court from 2020. We argue that PMI can in principle fulfill both beneficence- and autonomy-based eligibility criteria for AS, and that a blanket exclusion of all PMI from AS is thus discriminatory on either approach. However, depending on which approach is taken, there are differences regarding the subgroups of PMI that would be eligible for AS. Whether the exclusion of specific PMI is discriminatory therefore depends on how we understand and justify AS

Treatment recommendations within the leeway of clinical guidelines

$\textbf {Background:}$ Recommending the optimal treatment for an individual patient requires a well-balanced consideration of various medical, social and ethical factors. The interplay of these factors, interpretation of the patient’s situation and understanding of the existing clinical guidelines can lead to divergent therapy recommendations, depending on the attending physician. Gaining a better understanding of the individual process of medical decision-making and the differences occurring will support the delivery of optimal individualized care within the clinical setting. $\textbf {Methods:}$ A case vignette of a 64-year-old patient with locally advanced pancreatic adenocarcinoma was discussed with oncologists in 14 qualitative, semi-structured interviews at two academic institutions. Relevant factors that emerged were ranked by the participants using the Q card sorting method. Qualitative data analysis and descriptive statistics were performed. $\textbf {Results:}$ Oncologists recommend different therapeutic approaches within the leeway of the relevant clinical guidelines. One group of participants endorses a rather aggressive and potentially curative approach with a combination chemotherapy following the FOLFIRINOX protocol to provide the patient with the best chances of resectability. The second group suggests a milder chemotherapy approach with gemcitabine, highlighting the palliative approach and the patient’s quality of life. Clinical guidelines are generally seen as an important point of reference, but are complicated to apply in highly individual cases. $\textbf {Conclusion:}$ The physician’s individual assessment of factors, such as biological age, general condition or prognosis, plays a decisive role in treatment recommendations, particularly in those cases which are not fully covered by guidelines. Judgment and discretion remain crucial in clinical decision-making and cannot and should not be fully ruled out by evidence-based guidelines. Therefore, a more comprehensive reflection on the interaction between evidence-based medicine and the physician’s estimation of each individual case is desirable. Knowledge of existing barriers can enhance the implementation of guidelines, for example, through medical education

The normative background of empirical-ethical research

$\bf Background:$ Empirical-ethical research constitutes a relatively new field which integrates socio-empirical research and normative analysis. As direct inferences from descriptive data to normative conclusions are problematic, an ethical framework is needed to determine the relevance of the empirical data for normative argument. While issues of normative-empirical collaboration and questions of empirical methodology have been widely discussed in the literature, the normative methodology of empirical-ethical research has seldom been addressed. Based on our own research experience, we discuss one aspect of this normative methodology, namely the selection of an ethical theory serving as a background for empirical-ethical research. $\bf Discussion:$ Whereas criteria for a good ethical theory in philosophical ethics are usually related to inherent aspects, such as the theory’s clarity or coherence, additional points have to be considered in the field of empirical-ethical research. Three of these additional criteria will be discussed in the article: (a) the adequacy of the ethical theory for the issue at stake, (b) the theory’s suitability for the purposes and design of the empirical-ethical research project, and (c) the interrelation between the ethical theory selected and the theoretical backgrounds of the socio-empirical research. Using the example of our own study on the development of interventions which support clinical decision-making in oncology, we will show how the selection of an ethical theory as a normative background for empirical-ethical research can proceed. We will also discuss the limitations of the procedures chosen in our project. $\bf Summary:$ The article stresses that a systematic and reasoned approach towards theory selection in empirical-ethical research should be given priority rather than an accidental or implicit way of choosing the normative framework for one’s own research. It furthermore shows that the overall design of an empirical-ethical study is a multi-faceted endeavor which has to balance between theoretical and pragmatic considerations

Interaktives Lernen

Das Gebot des "Social Distancing" während der COVID-19-Pandemie hat eine Revision der bisherigen Lehr-Lern-Settings an Universitäten erforderlich gemacht. Als positiven Nebeneffekt hat die begegnungsarme Kommunikation einen Innovationsschub in puncto digitale Lehre ausgelöst und diente vielen Dozierenden als Anlass, neue Formate zu erproben. Vor diesem Hintergrund hat das Institut für Medizinische Ethik und Geschichte der Medizin der Medizinischen Fakultät der Ruhr-Universität Bochum ein neues Lehrkonzept für den Pflicht-Querschnittsbereich Geschichte, Theorie, Ethik der Medizin (GTE) im Studium der Humanmedizin entwickelt.$^{1}$ Im Folgenden geben wir einen Einblick in die Erwartungen des Teams, die Herausforderungen, die sich bei der Umsetzung gestellt haben, und die Resonanz der Studierenden. $^{1}$Unser Institut ist für die GTE-Lehre an den Medizinischen Fakultäten der Ruhr-Universität Bochum und der Universität Duisburg-Essen verantwortlich. Der neue GTE-Kurs wurde für die Lehre an der Medizinischen Fakultät der Universität Duisburg-Essen entwickelt und dort im Sommersemester 2021 erstmals eingesetzt

Limiting treatment and shortening of life

$\textbf {Background:}$ Limiting treatment forms part of practice in many fields of medicine. There is a scarcity of robust data from Germany. Therefore, in this paper, we report results of a survey among German physicians with a focus on frequencies, aspects of decision making and determinants of limiting treatment with expected or intended shortening of life. $\textbf {Methods:}$ Postal survey among a random sample of physicians working in the area of five German state chambersof physicians using a modified version of the questionnaire of the EURELD Consortium. Information requested referred to the patients who died most recently within the last 12 months. Logistic regression was performed to analyse associations between characteristics of physicians and patients regarding limitation of treatment with expected or intended shortening of life. $\textbf {Results:}$ As reported elsewhere, 734 physicians responded (response rate 36.9%) and of these, 174 (43.2%) reported a withholding and 144 (35.7%) a withdrawal of treatment. Eighty one physicians estimated that there was at least some shortening of life as a consequence. In 25.9% of these cases hastening death had been discussed with the patient at the time or immediately prior to this action. Types of treatment most frequently limited was artificial nutrition ($\it n$ = 35). Bivariate analysis indicates that limitation of treatment with possible or intended shortening of life for patients aged > 75 years is performed significantly more often ($\it p$ = 0.007, OR 1.848). There was significantly less limitation of treatment in patients who died from cancer compared to patients with other causes of death ($\it p$ = 0.01, OR 0.486). There was no significant statistical association with physicians’ religion, palliative care qualification or frequencies of limiting treatment. $\textbf {Conclusions:}$ In comparison to recent research from other European countries, limitation of treatment with expected or intended shortening of life is frequently performed amongst the investigated sample. The role of clinical and non-medical aspects possibly relevant for physicians’ decision about withholding or withdrawal of treatment with possible or intended shortening of life and reasons for non-involvement of patients should be explored in more detail by means of mixed method and interdisciplinary empirical-ethical analysis

Das Verständnis von Wohl im Betreuungsrecht

Mit der 2023 in Kraft tretenden Reform des Betreuungsrechts wird der Begriff "Wohl" aus dem Gesetz gestrichen. Hierdurch soll stärker hervorgehoben werden, dass sich der Betreuer an den subjektiven Wünschen des Betreuten statt an einem objektiven Wohlverständnis orientieren soll. In diesem Beitrag wird ermittelt, welches Verständnis von Wohl das reformierte Betreuungsrecht in Abgleich zu gängigen medizinethisch-philosophischen Auffassungen des Wohls implizit enthält. Indem untersucht wird, in welchem Verhältnis das betreuungsrechtliche und das medizinethische bzw. philosophische Verständnis von Wohl zueinanderstehen, soll die interdisziplinäre Verständigung zwischen Recht und Ethik gefördert werden. In der Begründung zur Reform wird betont, dass dem Betreuungsrecht weiterhin ein subjektives Verständnis von Wohl zugrunde liege. Dieses Verständnis deckt sich jedoch nicht mit philosophischen subjektiven Theorien des Wohlergehens, nach denen nur das zum Wohl einer Person beiträgt, was diese sich wünscht. Das Betreuungsrecht nimmt hingegen an, dass die Befolgung bestimmter Wünsche zu objektiven Schädigungen der Person führen und damit ihr Wohl beeinträchtigen kann. Negative Konsequenzen für das objektive Wohl eines Betreuten sind betreuungsrechtlich insofern relevant, als dass sie eine Grenze für die Befolgung aktueller Wünsche aufzeigen, die auf einem natürlichen Willen basieren und nicht Ausdruck von Selbstbestimmung sind. Dies ähnelt einer hybriden Konzeption des Wohls aus medizinethisch-philosophischer Sicht, nach der grundsätzlich angenommen wird, dass die Befolgung der Wünsche einer Person zu ihrem Wohl beiträgt, während aber auch gewisse objektive Kriterien als relevant für ihr Wohl angesehen werden.$\textit {Definition of the problem}$ The reform of German guardianship law coming into force in 2023 will remove the term "well-being" from the law. This is intended to emphasise that the legal guardian should be guided by the subjective wishes of the person rather than by an objective understanding of well-being. This article analyses the understanding of well-being underlying the reformed guardianship law in comparison to common conceptions of well-being in philosophy and medical ethics, aiming to promote interdisciplinary understanding between ethics and law. $\it Arguments$ The justification for the reform emphasises that the law is based on a subjective understanding of well-being. However, this understanding does not correspond to philosophical subjective theories of well-being, according to which only things that a person desires can contribute to her well-being. In contrast, the guardianship law assumes that the fulfilment of certain wishes can lead to objective harm to the person and thus impair her well-being. Negative consequences for the objective well-being of a person are only relevant insofar as they indicate a limit to following current wishes that are based on a natural will and are not an expression of self-determination. $\it Conclusion$ While the term "well-being" is removed from reformed guardianship law, the law implicitly contains an understanding of well-being comparable to a hybrid conception of well-being from a medical ethics perspective. According to this conception, fulfilment of a person's wishes generally contributes to her well-being, although certain objective criteria are also taken into consideration

Ward atmosphere and patient satisfaction in psychiatric hospitals with different ward settings and door policies

$\textbf {Background:}$ Open-door policies in psychiatry are discussed as a means to improve the treatment of involuntarily committed patients in various aspects. Current research on open-door policies focuses mainly on objective effects, such as the number of coercive interventions or serious incidents. The aim of the present study was to investigate more subjective perceptions of different psychiatric inpatient settings with different door policies by analyzing ward atmosphere and patient satisfaction. $\textbf {Methods:}$ Quantitative data on the ward atmosphere using the Essen Climate Evaluation Scale (EssenCES) and on patient satisfaction (ZUF-8) were obtained from involuntarily committed patients ($\it n$ = 81) in three psychiatric hospitals with different ward settings and door policies (open, facultative locked, locked). Furthermore, qualitative interviews with each of 15 patients, nurses, and psychiatrists were conducted in one psychiatric hospital with a facultative locked ward comparing treatment in an open vs. a locked setting. $\textbf {Results:}$ Involuntarily committed patients rated the EssenCES’ subscale "Experienced Safety" higher in an open setting compared with a facultative locked and a locked setting. The subscale "Therapeutic Hold" was rated higher in an open setting than a locked setting. Regarding the safety experienced from a mental health professionals’ perspective, the qualitative interviews further revealed advantages and disadvantages of door locking in specific situations, such as short-term de-escalation vs. increased tension. Patient satisfaction did not differ between the hospitals but correlated weakly with the EssenCES’ subscale "Therapeutic Hold". $\textbf {Conclusion:}$ Important aspects of the ward atmosphere seem to be improved in an open vs. a locked setting, whereas patient satisfaction does not seem to be influenced by the door status in the specific population of patients under involuntary commitment. The ward atmosphere turned out to be more sensitive to differences between psychiatric inpatient settings with different door policies. It can contribute to a broader assessment by including subjective perceptions by those who are affected directly by involuntary commitments. Regarding patient satisfaction under involuntary commitment, further research is needed to clarify both the relevance of the concept and its appropriate measurement