Bioethical research has tended to focus on theoretical discussion of the principles on which the analysis of ethical issues in biomedicine should be based. But this discussion often seems remote from biomedical practice where researchers and physicians confront ethical problems. On the other hand, published empirical research on the ethical reasoning of health care professionals offer only descriptions of how physicians and nurses actually reason ethically. The question remains whether these descriptions have any normative implications for nurses and physicians? In (...) this article, we illustrate an approach that integrates empirical research into the formulation of normative ethical principles using the moral-philosophical method of Wide Reflective Equilibrium (WRE). The research method discussed in this article was developed in connection with the project ‘Bioethics in Theory and Practice’. The purpose of this project is to investigate ethical reasoning in biomedical practice in Denmark empirically. In this article, we take the research method as our point of departure, but we exclusively discuss the theoretical framework of the method, not its empirical results. We argue that the descriptive phenomenological hermeneutical method developed by Lindseth and Norberg (2004) and Pedersen (1999) can be combined with the theory of WRE to arrive at a decision procedure and thus a foundation for the formulation of normative ethical principles. This could provide health care professionals and biomedical researchers with normative principles about how to analyse, reason and act in ethically difficult situations in their practice. We also show how to use existing bioethical principles as inspiration for interpreting the empirical findings of qualitative studies. This may help researchers design their own empirical studies in the field of ethics. (shrink)

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

Background: Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and increasing (...) the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making. Methods/DesignDyads (n = 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments. DiscussionThis study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system. Trial RegistrationISRCTN89993391. (shrink)

BackgroundThe methodology of medical ethics during the last few decades has shifted from a predominant use of normative-philosophical analyses to an increasing involvement of empirical methods. The articles which have been published in the course of this so-called 'empirical turn' can be divided into conceptual accounts of empirical-normative collaboration and studies which use socio-empirical methods to investigate ethically relevant issues in concrete social contexts.DiscussionA considered reference to normative research questions can be expected from good quality empirical research in medical ethics. (...) However, a significant proportion of empirical studies currently published in medical ethics lacks such linkage between the empirical research and the normative analysis. In the first part of this paper, we will outline two typical shortcomings of empirical studies in medical ethics with regard to a link between normative questions and empirical data: (1) The complete lack of normative analysis, and (2) cryptonormativity and a missing account with regard to the relationship between 'is' and 'ought' statements. Subsequently, two selected concepts of empirical-normative collaboration will be presented and how these concepts may contribute to improve the linkage between normative and empirical aspects of empirical research in medical ethics will be demonstrated. Based on our analysis, as well as our own practical experience with empirical research in medical ethics, we conclude with a sketch of concrete suggestions for the conduct of empirical research in medical ethics.SummaryHigh quality empirical research in medical ethics is in need of a considered reference to normative analysis. In this paper, we demonstrate how conceptual approaches of empirical-normative collaboration can enhance empirical research in medical ethics with regard to the link between empirical research and normative analysis. (shrink)

Autonomy has been hailed as the foremost principle of bioethics, and yet patients’ decisions and research subjects’ voluntary participation are being subjected to frequent restrictions. It has been argued that patient care is best served by a limited form of paternalism because the doctor is better qualified to take critical decisions than the patient, who is distracted by illness. The revival of paternalism is unwarranted on two grounds: firstly, because prejudging that the sick are not fully autonomous is a biased (...) and unsubstantial view; secondly, because the technical knowledge of healthcare professionals does not include the ethical qualifications and prerogative to decide for others.Clinical research settings are even more prone to erode subjects’ autonomy than clinical settings because of the tendency and temptation to resort to such practices as shading the truth when consent to participation is sought, or waiving consent altogether when research is done in emergency settings.Instead of supporting such dubious practices with unconvincing arguments, it would seem to be the task of bioethics to insist on reinforcing autonomy. (shrink)

Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the (...) circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals? perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research. (shrink)

Like any discipline, bioethics is a developing field of academic inquiry; and recent trends in scholarship have been towards more engagement with empirical research. This ‘empirical turn’ has provoked extensive debate over how such ‘descriptive’ research carried out in the social sciences contributes to the distinctively normative aspect of bioethics. This paper will address this issue by developing a practical research methodology for the inclusion of data from social science studies into ethical deliberation. This methodology will be based on a (...) naturalistic conception of ethical theory that sees practice as informing theory just as theory informs practice – the two are symbiotically related. From this engagement with practice, the ways that such theories need to be extended and developed can be determined. This is a practical methodology for integrating theory and practice that can be used in empirical studies, one that uses ethical theory both to explore the data and to draw normative conclusions. (shrink)

In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research (...) with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected. (shrink)

The paucity of research data to guide current paediatric practice has led to children being termed therapeutic orphans. This difficulty is especially pertinent to research in emergency situations, such as acute resuscitation or critical care, where accepted ethical standards for overall research, have historically created practical difficulties for researchers. The welcome establishment of organisations to support UK paediatric research is helping to ensure safer and more effective medications for children, however as the balance between protection and access at the heart (...) of the paediatric research ethical debate shifts to ever increasing access for researchers to children, it remains crucial to ensure the protection for these vulnerable participants. The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if standards are to be improved by human subjects research in such areas. Proxy, deferred and retrospective consent have all been advocated as solutions to this difficulty and this paper explores the ethical justification for these approaches and their utility in safeguarding children and families in emergency situations when traditional informed consent, as currently defined, cannot be obtained in the necessary time frame to enable research. (shrink)

Voluntariness of consent to research has not been sufficiently explored through empirical research. The aims of this study were to develop a more comprehensive approach to assessing voluntariness and to generate preliminary data on the extent and correlates of limitations on voluntariness. We developed a questionnaire to evaluate subjects’ reported motivations and constraints on voluntariness. 88 subjects in five different areas of clinical research—substance abuse, cancer, HIV, interventional cardiology, and depression—were assessed. Subjects reported a variety of motivations for participation. Offers (...) of financial incentives were common but not influential, pressures from others were rare, and no threats were reported. However, certain financial incentives and—paradoxically—altruistic motivations led some subjects to feel more constrained. Consistent with previous studies, no one pattern of motivation was common to all research subjects. There was little evidence of constrained voluntariness, but some suggestion of areas of concern. Voluntariness appears to be susceptible to systematic empirical investigation. (shrink)