a review of empirical data and ethical analysis

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. 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. 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. 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

Intentional sedation as a means to ease suffering: a systematically constructed terminology for sedation in palliative care

BACKGROUND: Terminology concerning sedation in palliative care is heterogeneous, vague, and difficult to apply with negative impact on the reliability of quantitative data, practice, and ethical discourse. DESIGN: To clarify the concept, we systematically developed definitions of core terms in an interdisciplinary research group comprising palliative care, ethics, law, and philosophy, integrating feedback from external experts. RESULTS: We define terms stepwise, separating matters of terminology (What is the practice?) from matters of good practice (How to use it?). We start with an operational definition of “reduced level of consciousness” (score < 0 on the Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL), followed by defining “sedating,” “sedation,” and “intentional sedation” as the result or process of sedating a patient as a means of achieving a previously defined treatment goal and the terms “light,” “deep,” “temporary,” and “sedation until death.” CONCLUSION: The terminology facilitates the precise phrasing of aims, indications, and rules for good practice. Empirical research on acceptance and feasibility is needed

Information and participation in decision-making about treatments: A qualitative study of the perceptions and preferences of patients with rheumatoid arthritis

ABSTRACT Objectives: To elicit the perceptions and preferences of patients with rheumatoid arthritis regarding information and participation in treatment decision-making

Research participants’ perceptions and views on consent for biobank research: a review of empirical data and ethical analysis

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. 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. 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. 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

Setting standards for empirical bioethics research:A response to Carter and Cribb

Abstract This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics

Limiting treatment and shortening of life: data from a cross-sectional survey in Germany on frequencies, determinants and patients' involvement

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. Methods: Postal survey among a random sample of physicians working in the area of five German state chambers of 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. 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 (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 (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 (p = 0.01, OR 0.486). There was no significant statistical association with physicians' religion, palliative care qualification or frequencies of limiting treatment. 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

Möglichkeiten und Grenzen von Ethikberatung im Rahmen der COVID-19-Pandemie

&lt;jats:title&gt;Zusammenfassung&lt;/jats:title&gt;&lt;jats:p&gt;Wie ist der Freiwillige Verzicht auf Essen und Trinken und eine medizinische Begleitung dabei ethisch zu bewerten? Die ethische Bewertung des Freiwilligen Verzichts auf Essen und Trinken stellt Patienten und Angehörige, aber auch begleitende Ärzte und Pflegende vor erhebliche Schwierigkeiten. Basierend auf Ergebnissen eigener qualitativer Interviews mit Personen nach dem FVET ihrer Angehörigen legt dieser Artikel die bestehende Unklarheit und inhärente ethische Ambivalenz des Begriffs FVET frei, stellt aber in der Unterscheidung von FVET-Fällen – mit bzw. ohne terminale Erkrankung – einen Weg zur Lösung der Frage nach der ethischen Bewertung des „Sterbefastens“ und seiner medizinischen Begleitung vor: Ethisch wird der Freiwillige Verzicht auf Essen und Trinken und seine medizinische Begleitung erst in der Analyse von Situation und Intention der Handelnden beurteilbar. Ausgehend vom Konzept eines frei gewollten Verzichts auf Essen und Trinken bei einsichts- und einwilligungsfähigen Personen mit dem Bewusstsein, damit ihr Leben zu verkürzen oder zu beenden, wird mit der Philosophie Thomas von Aquins argumentiert, dass eine ethische Bewertung die Begleitumstände und beabsichtigten Ziele miteinschließen muss, ebenso wie die Auswirkungen auf Angehörige und die Implikationen von und für ein Behandlungsteam.&lt;/jats:p&gt