Empirical Methods for Bioethics: A Primer: Volume 11

This book is dedicated to our husbands Bill Jacoby and Jacek Ghosh for their unfailing support

In recent years, concerns over how to use the results of scientific advances, changing expectations of how medical decisions are made, and questions about the implications of demographic changes have raised ethical challenges regarding allocation of resources, justice, and patient autonomy. Bioethics – no longer the singular purview of moral philosophy – is now accepted as a legitimate field in the academic health sciences and is helping to guide policy and clinical decision-making. To achieve its full potential, it must seamlessly integrate the methods of the humanities, social sciences and medical sciences.

How many textbooks or introductory articles in bioethics begin with a section on ethical theory? Of the many that do, the relevance of basic theories of utilitarianism, deontology, virtue ethics, feminist ethics, casuistry and so on, is assumed. These theories are also considered in light of the well-accepted principles of medical ethics: (1) respect for patient autonomy, (2) beneficence, (3) non-maleficence and (4) justice. Those of us trained in philosophy find these sections on theory terse summations of complex philosophical views. Physicians and nurses, and others not trained in philosophy, sometimes struggle to get their gist, and end up with an ability to make a basic analysis and formulate arguments about ethical problems from each of these perspectives, and to write and discuss the issues that arise with fellow ethicists. But how essential are these theoretical perspectives to the real work of clinical ethics consultants? It is important that we do not forget just how applied and practical that work is.

While some of us enjoy engaging in many forms of bioethical activity, including philosophical analysis and debate, clinical ethics consultation, and empirical research, only the latter matters much to the practicing physician. Practically minded, most doctors have little concern with fine moral distinctions when faced with a patient's request for assistance in dying or a pharmaceutical company's offer to attend a product “consultation” session at a first class resort in addition to an attractive fee for participation. Physicians want to know what facts might bear on ethical questions they confront, how ethical conflicts that have an impact on patient care can be understood and resolved, and whether research reveals consistently clear, helpful findings. The following discussion offers some examples of how empirical research related to bioethical issues has provided evidence and guides for physicians at both individual-patient care and policy levels, and further reviews areas that warrant continued research attention.

Content analysis is a family of systematic, rule-guided techniques used to analyze the informational contents of textual data (Mayring, 2000). It is used frequently in nursing research, and is rapidly becoming more prominent in the medical and bioethics literature. There are several types of content analysis including quantitative and qualitative methods all sharing the central feature of systematically categorizing textual data in order to make sense of it (Miles & Huberman, 1994). They differ, however, in the ways they generate categories and apply them to the data, and how they analyze the resulting data. In this chapter, we describe a type of qualitative content analysis in which categories are largely derived from the data, applied to the data through close reading, and analyzed solely qualitatively. The generation and application of categories that we describe can also be used in studies that include quantitative analysis.

Focus groups can provide a rich and meaningful context in which to explore diverse bioethics topics. They are particularly useful for describing people's experiences of and/or attitudes toward specific ethical conundrums, but can also be used to identify ethics training needs among medical professionals, evaluate ethics programs and consent processes, and stimulate patient advocacy. This chapter discusses these and other applications of focus group methodology. It examines how to ethically and practically plan and recruit for, conduct, and analyze the results of focus groups. The place of focus groups among other qualitative research methods is also discussed.

Ethnography is a qualitative, naturalistic research method derived from the anthropological tradition. Ethnography uses participant observation supplemented by other research methods to gain holistic understandings of cultural groups’ beliefs and behaviors. Ethnography contributes to bioethics by: (1) locating bioethical dilemmas in their social, political, economic, and ideological contexts; (2) explicating the beliefs and behaviors of involved individuals; (3) making tacit knowledge explicit; (4) highlighting differences between ideal norms and actual behaviors; (5) identifying previously unrecognized phenomena; and (6) generating new questions for research. More comparative and longitudinal ethnographic research can contribute to better understanding of and responses to bioethical dilemmas.

In this chapter, we present semi-structured interviewing as an adaptable method useful in bioethics research to gather data for issues of concern to researchers in the field. We discuss the theory and practice behind developing the interview guide, the logistics of managing a semi-structured interview-based research project, developing and applying a codebook, and data analysis. Throughout the chapter we use examples from empirical bioethics literature.

Surveys about ethically important topics, when successfully conducted and analyzed, can offer important contributions to bioethics and, more broadly, to health policy and clinical care. But there is a dynamic interplay between the quantitative nature of surveys and the normative theories that survey data challenge and inform. Careful attention to the development of an appropriate research question and survey design can be the difference between an important study that makes fundamental contributions and one that is perceived as irrelevant to ethical analysis, health policy, or clinical practice. This chapter presents ways to enhance the rigor and relevance of surveys in bioethics through careful planning and attentiveness in survey development, fielding, and analysis and presentation of data.

Hypothetical vignettes have been used as a research method in the social sciences for many years and are useful for examining and understanding ethical problems in clinical practice, research, and policy. This chapter provides an overview of the value of vignettes in empirical bioethics research, discusses how to develop and utilize vignettes when considering ethics-related research questions, and reviews strategies for evaluating psychometric properties. We provide examples of vignettes and how they have been used in bioethics research, and examine their relevance to advancing bioethics. The chapter concludes with the general strengths and limitations of hypothetical vignettes and how these should be considered.

Deliberative procedures can be useful when researchers need (a) an informed opinion that is difficult to obtain using other methods, (b) individual opinions that will benefit from group discussion and insight, and/or (c) group judgments because the issue at hand affects groups, communities, or citizens qua citizens. Deliberations generally gather non-professional members of the public to discuss, deliberate, and learn about a topic, often forming a policy recommendation or casting an informed vote. Researchers can collect data on these recommendations, and/or individuals’ preexisting or post hoc knowledge or opinions. This chapter presents examples of deliberative methods and how they may inform bioethical perspectives and reviews methodological issues deserving special attention.

This chapter discusses the role of intervention research in bioethical inquiry. Although many ethical questions of interest are not appropriate for intervention research, some questions can only be answered using experimental or quasi-experimental designs. The critical characteristics of intervention research are identified and strengths of this method are described. Threats to internal validity and external validity are discussed and applied to a case example in bioethical research. Several recent intervention studies that were federally funded in the area of informed consent are discussed, and recommendations for future intervention research are presented.