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

Terminological confusion about sedation in palliative care: results of an international online vignette survey

Background: Terminological problems concerning sedation in palliative care and consequences for research and clinical decision making have been reported frequently. Objectives: To gather data on the application of definitions of sedation practices in palliative care to clinical cases and to analyze implications for high-quality definitions. Design: We conducted an online survey with a convenience sample of international experts involved in the development of guidelines on sedation in palliative care and members of the European Association for Palliative Care (EAPC). Participants were asked to apply four published definitions to four case vignettes. Data were analyzed using descriptive statistics. Results: A total of 32 experts and 271 EAPC members completed the survey. The definitions were applied correctly in n = 2200/4848 cases (45.4%). The mean number of correct applications of the definitions (4 points max.) was 2.2 ± 1.14 for the definition of the SedPall study group, 1.8 ± 1.03 for the EAPC definition, 1.7 ± 0.98 for the definition of the Norwegian Medical Association, and 1.6 ± 1.01 for the definition of the Japanese Society of Palliative Medicine. The rate of correct applications for the 16 vignette-definition pairs varied between 70/303 (23.1%) and 227/303 (74.9%). The content of definitions and vignettes together with free-text comments explains participants' decisions and misunderstandings. Conclusions: Definitions of sedation in palliative care are frequently incorrectly applied to clinical case scenarios under simplified conditions. This suggests that clinical communication and research might be negatively influenced by misunderstandings and inconsistent labeling or reporting of data

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

The Role of Physicians in Rationing Cancer Care. Attitudes of German Oncologists

Background: Against the background of limited resources, the rise in the cost of therapy as well as in the number of cancer patients fuels the discussion about the necessity to ration, i.e., setting limits to beneficial treatment for cost reasons. Recently, we presented the self-reported prevalence of bedside rationing among German oncologists. Here, we describe oncologists' views on cost containment strategies and their role therein. Methods: We performed an online survey including structured questions and free field sections with the members of the German Society of Hematology and Oncology. Results: In the perception of oncologists, cost considerations and negotiations are gaining in importance and consume considerable working time. This negatively affects job satisfaction in 72% of the 345 respondents. Oncologists are concerned that the quality of care will suffer from rationalization and implicit rationing. They are ambivalent as to who is best suited to decide about resource rationing: 66% support the view that limits for costly procedures should be set by a form of commission; nevertheless, 48% consider physicians as the best decision makers in these situations. Conclusion: We suggest a broad public discussion and an interdisciplinary debate among the oncology community to define and legitimize decisions on rationing by setting explicit criteria

To Remind or Not to Remind During Recruitment? An Analysis of an Online Panel in Germany

Objective: To explore the role of reminders in recruiting and maintaining participation in an online panel.Methods: 50,045 individuals from five German federal states were invited by regular mail to participate in the online study “Health-Related Beliefs and Healthcare Experiences in Germany.” Those who did not respond to the first attempt received a postal reminder. Comparisons of sociodemographic characteristics and responses were made between first-attempt respondents and those who enrolled after the second letter.Results: After the initial letter, 2,216 (4.4%, 95%CI: 4.3%–4.6%) registered for the study; after a reminder 1,130 (2.5%, 2.3%–2.6% of those reminded) enrolled. Minor sociodemographic differences were observed between the groups and the content of the responses did not differ. Second-attempt respondents were less likely to participate in subsequent questionnaires: 67.3% of first-attempt vs. 43.3% of second-attempt respondents participated in their fourth survey. Recruitment costs were 79% higher for second-attempt respondents.Conclusion: While reminders increased the number of participants, lower cost-effectiveness and higher attrition of second-attempt respondents support the use of single invitation only for studies with a similar design to ours when the overall participation is low