Elsevier

Social Science & Medicine

Volume 65, Issue 11, December 2007, Pages 2223-2234
Social Science & Medicine

Informed consent, anticipatory regulation and ethnographic practice

https://doi.org/10.1016/j.socscimed.2007.08.008Get rights and content

Abstract

In this paper we examine the application of informed consent to ethnographic research in health care settings. We do not quarrel with either the principle of informed consent or its translation into the requirement that research should only be carried out with consenting participants. However, we do challenge the identification of informed consent with the particular set of bureaucratic practices of ethical review which currently operate in Canada, the US and elsewhere. We argue that these anticipatory regulatory regimes threaten the significant contribution of ethnographic research to the creation of more efficient, more effective, more equitable and more humane health care systems. Informed consent in ethnographic research is neither achievable nor demonstrable in the terms set by anticipatory regulatory regimes that take clinical research or biomedical experimentation as their paradigm cases. This is because of differences in the practices of ethnographic and biomedical research which we discuss. These include the extended periods of time ethnographers spend in the research setting, the emergent nature of ethnographic research focus and design, the nature and positioning of risk in ethnographic research, the power relationships between researchers and participants, and the public and semi-public nature of the settings normally studied. Anticipatory regulatory regimes are inimical to ethnographic research and risk undermining the contribution of systematic inquiry to understanding whether institutions do what they claim to do, fairly and civilly and with an appropriate mobilisation of resources. We do not suggest that we should simply ignore ethics or leave matters to the individual consciences of researchers. Rather, we need to develop and strengthen professional models of regulation which emphasise education, training and mutual accountability. We conclude the paper with a number of suggestions about how such professional models might be implemented.

Introduction

This paper discusses the impact of the concept of informed consent, adopted in ethical review by most anticipatory regulatory regimes, on qualitative research in sociology, with particular reference to ethnography. Drawing upon our own experiences of such research over the last 35 years, we consider the relevance of these regimes to the ethical dilemmas which, in practice, confront ethnographers. We also consider the threat of such bureaucratic regulation to ethnography's contribution to improving the efficiency, effectiveness, equity and humanity of health services.

Ethnography typically involves researchers spending extended periods of time (sometimes a year or longer) in one or more settings (for example, a hospital ward, a general practice surgery, a laboratory or an out-patient clinic) observing what goes on, talking to members of the setting, collecting documents and, on occasion, interviewing. The researcher's objective is to recover the ‘situated rationality of action’—the ways in which, in context, people's actions make sense, even when they seem, to others outside the situation, to be inappropriate or counter-productive.

Studies of this kind have a long and distinguished history in sociological research on health and health care. Classic examples include Goffman (1961) on mental hospitals, Glaser and Strauss (1965) on death and dying, Becker, Geer, Hughes, and Strauss (1961) on the professional socialisation of medical students and Davis (1963) on the experiences of polio victims and their families. More recently ethnographies of hospital wards (Allen, 1997), responses to medical error (Bosk, 1979), paediatric clinics (Strong, 1979), genetic counselling in a children's hospital (Bosk, 1992), care in private nursing homes (Diamond, 1992), paediatric intensive care (Anspach, 1992), emergency rooms (Timmermans, 1999), the construction of disease (Mol, 2002) and medical examiners (Timmermans, 2006) have all made important contributions to our understanding of health care organization.

Ethnographies have a key role to play in creating a more efficient, more effective, more equitable and more humane health care system, particularly in illuminating the organizational and interactional processes through which health care is delivered. They offer important information, to policy makers and practitioners, about factors that compromise or promote high-quality care, particularly the ways in which well-intentioned actions may have unanticipated negative consequences.

The elaborate, bureaucratised, systems of ethical review currently operating in the US, Canada, UK and elsewhere threaten the survival of ethnographic research with little gain in protecting research participants. These anticipatory regulatory regimes were developed for governance of clinical and biomedical research, primarily in response to abusive experimentation in Nazi Germany revealed in the Nuremberg Trials (Annas & Grodin, 1992; Hazelgrove, 2002; Lifton, 1986; Schmidt, 2004; Weindling, 2004). The subsequent uncovering of highly questionable clinical and biomedical research practices between the 1920s and 1950s, in both the US and the UK, strengthened the case for the regulatory regimes that began to develop from the mid-1960s (Beecher (1959), Beecher (1966); Hazelgrove, 2002; Jones, 1981; Papworth, 1967; Rothman, 1993). However, these regimes are ill-suited to assessing ethnographic study proposals (Murphy & Dingwall, 2003). This is neither because ethnographic research is free from ethical challenges, nor because such challenges are unusually difficult or intransigent. It is, rather, because anticipatory regulatory regimes are based on assumptions derived from the model of clinical trials or biomedical experimentation, with prior specification of hypotheses, design, instruments and implementation in protocols that are finalised before the study begins. In principle, this model is readily transferable to survey research, where it is possible to specify, in advance, exactly what a study will involve. This is not true of ethnographic research. In the rest of this paper, we explore the ways in which ethnographic research in sociology departs from the assumptions underlying these regimes before concluding by considering the implications for designing appropriate regulation.

We should, though, first be clear that we have no quarrel with the notion that research participation should be free from coercion. The concept of informed consent is deeply embedded in liberal individualist assumptions about the virtue of autonomy and the priority of individual over community rights (D’Agostino, 1998; Wolpe, 1998). However, respect for persons, as operationalised through the practice of informed consent, is only one of the three principles articulated in The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) which underpins the subsequent development of Institutional Review Boards (US), Research Ethics Boards (Canada) and Ethics Committees (UK). The other principles, of justice and beneficence, are equally relevant and may, in some instances, compete with the principle of autonomy (Wolpe, 1998). Nevertheless, our critique in this paper is neither of the principle of autonomy, nor of its operationalisation in the requirement that research should only be carried out with consenting participants. Our challenge is to the identification of the principle with a particular set of bureaucratic practices more suited to biomedical experimentation.

Ethnographers do not universally share our commitment to openness in research. Some reject the principle of informed consent altogether, defending covert methods and deliberately misleading people about their research purposes (Douglas, 1976). Others defend deceit in terms of the value of the research findings. For example, Diamond argues that the value of his exposé of the exploitation of nursing assistants and the erosion of patient autonomy, privacy and dignity in three Chicago nursing homes justifies any wrong done to unwitting participants in his ‘undercover’ research study (Diamond, 1992). If his employers had found out that he was doing research, he would have been dismissed and unable to complete the study. Given the choice between abandoning his research and misleading staff and patients, he chose the latter. The compromise of autonomy was, in his view, outweighed by the beneficence of the findings for residents and workers.

Diamond is, however, in the minority among contemporary ethnographers. Most, including ourselves, interpret the principle of respect for persons as requiring us to conduct research as overtly as possible consistent with avoiding distress or disruption to the settings we study. While deception may be ‘shaded in many different ways’ (Haggerty, 2004) and, in research as in everyday life, the boundary between truth and deceit is often blurred, we are wary of the argument that the ends justify the means. Such judgements often depend too heavily on individual researchers’ estimation of the value of ends in which they have a heavy personal investment. We also believe that the difficulties of obtaining valid data using overt methods in even very challenging settings can be exaggerated. There are numerous examples of ethnographers being granted access to highly sensitive settings including the UK night-time economy (Monaghan, 2004), the British Civil Service (Heclo & Wildavsky, 1974), the Mafia (Ianni & Ianni, 1972), professional ‘fences’ Klockars (1974), professional criminals (Polsky, 1971) and drug barons (Adler, 1985) (see also the discussions in Lee-Treweek and Linkogle (2000)). Moreover, covert ethnographers may underestimate harm caused to those they study, if and when they discover they have been misled about the researcher's real interest (Bulmer, 1980). Subjects of covert research may be harmed as well as wronged.

Our argument is not that informed consent is trivial or irrelevant. It is, rather, that informed consent in ethnography is neither achievable nor demonstrable in the terms set by anticipatory regulatory regimes that take clinical research or biomedical experimentation as their paradigm cases. This is because of fundamental differences in the practices of ethnographic and experimental research that we now examine.

Section snippets

Extended periods of involvement in research settings

In ethnography, researchers spend extended periods of time, often a year or more, in their research setting. The practice of obtaining prior informed consent was developed in relation to the discrete episodic interventions typical of clinical trials or biomedical experimentation. Such interventions lend themselves to the legalistic, contractual approach embodied in obtaining signed consent from research subjects prior to the start of research. In ethnography, consent is more likely to be

Emergent research focus and design

Since Nuremberg, there has been general agreement between ethicists, regulators and scientists that research participation must not only be voluntary but also based on adequate knowledge and understanding of the nature, duration, purpose, methods and potential hazards of the study. This has, in practice, been translated into the requirement that the research participant give written consent, at the outset, based on a clear specification of the research. Clearly, it is not straightforward to

Nature, degree and positioning of risk in ethnographic research

Giving potential participants ‘information on all known foreseeable risks’ (Corrigan, 2003) is central to the operationalisation of informed consent. The application of this principle to ethnographic research is more complex than in biomedical experimentation, where it is normally possible to specify and quantify risks in advance with reasonable precision. While ethnographic research is not risk-free, for either hosts or researchers (Lee-Treweek & Linkogle, 2000; Punch, 1994; Renzetti & Lee,

Power in researcher/participant relationships

Regulatory practices around biomedical research were born out of concerns about the possible exploitation of power differentials between researcher and researched. To a large extent, the resulting regulations model the researcher–researched relationship on that believed to prevail between doctors and patients. The research participant is taken to be passive, vulnerable and in need of protection and the researcher is understood to be powerful and capable of exploiting dependent patients. Written

Public versus private settings

A further uncertainty concerns the application of the requirement for informed consent to public as opposed to private settings. Some ethnographies are conducted in settings which are open to the public and where there is no expectation that presence or participation requires prior negotiation. Such settings are typically highly complex and mobile and this makes obtaining written, or even oral, informed consent from all who pass through impractical. Sometimes strict application of the

Discussion

Anticipatory regulatory regimes that transfer models of consent from clinical or biomedical research to ethnography are highly problematic. Approaches currently adopted in the UK and other developed countries are erecting insuperable barriers to ethnographic work or creating such disincentives that scholars are choosing not to do it. This presents us with a stark choice—a choice that hinges upon whether or not we believe that ethnography has anything to offer to the creation of a better

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