Empirical Methods in Bioethics

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The period since 1970 has seen the development and maturation of the field of bioethics into a major area of scholarly inquiry. Scholarship in bioethics has traditionally relied on the discipline of moral philosophy and has taken a normative or prescriptive stance. However, bioethics is primarily a field of practical and applied study as well as a theoretical one. As such, to be relevant and useful to the providers and consumers of healthcare, bioethics must address questions and recommend solutions in the real world. Empirically-based studies provide an understanding of public and professional attitudes, practices, and the implications and intersections of practice and policy. These studies can provide information about the level at which purported problems actually exist and can be described and quantified. Similarly, they can measure the success or failure of public policies designed to help solve bioethics problems.

Employing the qualitative and quantitative methodologies of the social sciences and public health, bioethics scholars, often in collaboration with clinicians and scientists, have shed light on important bioethics questions such as:

  • Patient and family preferences for treatment at the end of life;
  • Nature and quality of communication between patients and physicians;
  • Attitudes and understanding of informed consent by investigators and research subjects;
  • Competency and the robustness of individual's stated wishes about end of life treatment;
  • Why policy and legislative initiatives have failed to increase consent rates to organ donation;
  • Impact of new genetic information on individuals, families, and society;
  • Equity in allocation of scarce resources such as dialysis and organ transplantation;
  • Disparities in the provision of care to ethnic minorities.

Research Methods

The methods used by researchers engaged in the empirical study of bioethics range from the quantitative to the qualitative, and often combine the two to provide a richer description of phenomenon and to answer research questions. Empirical research methods of all types comprise those that can be used to describe valid and reliable inquiries into phenomenon, including human behavior. Quantitative methods are used to answer hypotheses or to provide generalizable descriptions of populations and the incidence and prevalence of behaviors and problems within a population. Traditional quantitative methods in the social sciences include controlled experiments to compare the effects of an intervention on a sample population and measurement of subject characteristics. These measurements can include characterizing attitudes, behaviors, or physical characteristics. They are distinguished by the use of measurement tools that can provide reliable and replicable descriptions, usually in the form of numeric signifiers. Examples of such measurements are the use of psychometric tools to measure cognitive traits (e.g., anxiety, coping style, depression) and attitudes (trust in the healthcare system, fatalism). Psychometric techniques can also be sued to the measurement of physical traits such as health status (using measurements like the SF–36 or activities of daily living). Most of these measurements take place within structured interviews (either interviewer-administered or self-administered) in which the responses of subjects are strictly prescribed. The phrasing of questions is regimented and the respondent is provided with what are called forced choice responses in which information is produced as standardized coded information. Aside from obtaining information directly from subjects, another major source of quantitative data is secondary sources, such as administrative databases (such as the Medicare database) and medical records. The advantages of quantitative methods are that they enable collection of data from large sample sizes in standardized ways that permit comparisons across various populations and time periods. They also allow for controlled interventions or controlled introduction of conditions to subjects. These methods have allowed the documentation of racial and gender disparities in the provision of healthcare services.

Bioethics researchers have generally used qualitative methods in the generation of hypotheses rather than in the testing of hypotheses. Deduction characterizes qualitative methods, whereas induction characterizes research using quantitative methods. Qualitative methods permit detailed, and sometimes more accurate, observation of behaviors and contribute to the understanding of underlying social and cultural characteristics associated with specific patterns of behaviors. Moreover, qualitative methods allow discovery of subjects' perspectives rather than imposing a pre-existing framework. Qualitative methods can allow researchers to access areas of investigation not amenable to quantitative research, and to explore areas that have been little researched in the past. For example, how infertile couples have experienced new reproductive technologies and how they have incorporated traditional understandings of parenthood into their conceptual models of the rights and obligations of parents.

Qualitative methods include a variety of techniques. Subject interviews that incorporate wholly or partly open-ended questions are commonly used. These allow respondents to provide answers to questions in their own words, and allow interviewers to probe or follow up on information provided by respondents. More formative interviewing, in which the interviewer uses a guide to begin discussion about the research topic but does not structure the questions that follow, can also be used. In this type of interview, the subject creates a narrative and engages in a dialogue with the interviewer that informs the researcher about the topic under investigation. A similar technique, the focus group, uses six to twelve informants gathered to discuss a particular issue. For example, a study of the social and ethical consequences of genetic testing for Huntington's Disease might gather individuals from families affected by Huntington's Disease to discuss their attitudes, preferences, and intentions about genetic testing.

Qualitative methods can also include direct observation of healthcare situations and populations. For example, studies of informed consent to clinical trials have included directly observing and audio- or video-taping the consent conversation. Conversations can be examined as narratives and themes explored, or behaviors can be coded to extract quantitative data. For example, a trained observer can use 0, 1 coding to measure whether certain behaviors (e.g., explaining that trial participation is voluntary) occur or not. Participant observation—in which the observer actually participates in and observes the daily activities of a setting of interest (for example, observing a primary care setting to understand how or when advance directives are discussed with elderly patients)—can also generate a variety of data types. Personal diaries in which individuals are asked to keep records of activities and behaviors are another technique.

Historically, social sciences researchers have strictly divided themselves into researchers using quantitative methods (i.e., psychologists) or qualitative methods (i.e., anthropologists). However, in recent years there has been a blurring of these distinctions and an increasing enthusiasm for multimethod research. Whereas qualitative research begins by acknowledging that there is a range of different ways of making sense of the world, and approaches its subject matter in a naturalistic, interpretive way, quantitative research overlays hypothesized paradigms on the research phenomena of interest and collects data that can help determine the distributions of characteristics and behaviors in populations and settings. For example, quantitative studies have established how frequently dying patients are treated with futile therapies, but have not been especially successful in explaining why.


Ultimately, scholarship in bioethics can benefit from the methodologies of both the humanities and the empirical sciences. Normative bioethics provides a framework and guideposts for suggesting how healthcare services ought to be delivered, and what the fiduciary responsibilities of clinicians to patients are. However, normative bioethics is unable to describe and explain how these play out in real life. Moreover, the value placed in the principles of bioethics and the use made of these principals by actors in healthcare settings can only be illuminated using empirical methods. In the final analysis, the best empirical research in bioethics will always be based on a sophisticated understanding of the historical, philosophical, and cultural contexts of the delivery and consumption of healthcare services. Similarly, philosophical debate can often be enriched by an awareness of empirical data.

laura a. siminoff

SEE ALSO: Anthropology and Bioethics; Medicine, Anthropology of; Medicine, Sociology of; Organ Transplants, Sociocultural Aspects of; Public Health: Methods; Public Policy and Bioethics; Research Ethics Committees; Research Methodology; Research Policy; Research, Unethical


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