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American Speech 75.2 (2000) 149-168
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Semantic and Pragmatic Variability in Medical Research Terms:
Implications for Obtaining Meaningful Informed Consent
Ronald R. Butters, Jeremy Sugarman and Lyla Kaplan
It is a fundamental requirement of scientific research using human subjects that the investigators obtain the INFORMED CONSENT of those subjects. That is, prior to taking part in any project, subjects must receive and understand relevant information as to the goals of the research, the nature of the procedures to be followed, and the risks and potential benefits to the participants. However, what constitutes "relevant information" can be a complex question, and researchers are therefore generally required to submit informed-consent materials to review boards for approval. Some of the historical, ethical, and legal aspects of INFORMED CONSENT are summarized in appendix A.
Linguists know well that the presentation of "relevant information" to people does not guarantee that subjects will fully "receive" it or that it will be properly "understood." The very language that medical researchers use in advertising their projects and in obtaining informed consent can be as important and influential as the information itself in affecting the willingness of medical patients to serve as subjects in medical research (Advisory Committee on Human Radiation Experiments [ACHRE] 1995, 748). Obviously, to prevent misunderstanding, sentence structure must be straightforward and free from ambiguity; medical jargon must be explained--if it is necessary to use it at all. Most perplexing, however, is ordinary-language word choice: the lexicon used during disclosure of informed-consent information must avoid connotations that could unduly and unreasonably influence potential subjects, and researchers must be particularly aware of [End Page 149] how language interacts with context in the pragmatics of the informed-consent disclosure situation. Moreover, it is not always the case that scientists in general--and medical scientists in particular--understand important terms used during disclosure in the same way that ordinary citizens do. Often in medical research, physicians are also faced with a potential conflict between their roles as healers and their roles as scientific investigators (Kass et al. 1996). While frank disclosure about the investigative nature of research is critical, researchers obviously do not want to unduly frighten people from participating in research. They also hold a great degree of their patients' trust and, as a result, "should be sensitive to the extraordinary power of their remarks" (27).
Certainly linguists--especially linguists who study the meanings of words in contemporary American English--have much to offer in preventing problems of communication in the informed-consent process. To this end, the authors of this paper--a medical-school professor who specializes in medical ethics, an experimental psychologist with a strong interest in qualitative research, and a linguist--have joined together to isolate some of the potential linguistic challenges. Our methods involve two familiar modes of linguistic inquiry (in addition to the authors' own intuitions as native speakers of American English): (1) the analysis of the dictionary entries for a number of important terms, entries which themselves are the result of empirically grounded inductive study of printed sources, and (2) linguistic research based on data collected in structured interviews in which actual research subjects defined and discussed informed-consent terminology in light of their previous participation experiences.
Among the most important terms used in any informed-consent disclosure are those that name the enterprise itself, its methods, and the potential benefits to participants. In general, words that researchers use to label medical research projects using human subjects have variously included study, research, trial, experiment, and investigation, often preceded by the descriptors medical or clinical. Our study focuses on the following BASIC TERMS: clinical investigation, clinical study, clinical trial, medical experiment, medical research, and medical study. Subjects in the structured interviews were asked explicitly to define four of these INDEX TERMS: clinical investigation, clinical trial, medical experiment, and medical study. The other two were added as a result of our judgment of their importance on the basis of an analysis of the structured interviews.
Both the dictionary definitions...