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Understanding research ethics committees
ОглавлениеHaving explored the theoretical, historical and contextual dimensions of ethical decision-making, we can now turn in more detail to research ethics and the governance structures that have been developed to support, review and implement ethical approaches to research.
Research ethics has developed as a subset of wider ethical discourses that help us determine what are considered to be the ‘right’ and ‘wrong’ ways of doing things. They are based on values and beliefs that are held in high esteem and are aspirational to a society, a culture, groups and individuals. Most researchers and those thinking about undertaking research are aware of the societal expectation that research must be undertaken in an ethical way, and an important part of the research process is seeking approval from a research ethics committee. Many researchers, however, experience this process as yet another ‘hoop’ to jump through or even an obstacle to be overcome in their research programme.
Institutions such as universities, health services, government bodies and non-government agencies auspice and mandate research ethics committees to oversee the ethical integrity of research studies for which they are responsible. These committees usually operate within overarching national or state-based legislation and policy frameworks that adhere to and accept universally accepted codes for the ethical conduct of research. As previously discussed, they emerged in the 1960s in most countries in the developed world following international developments on the ethical conduct of research. Their main objectives are to review, approve and monitor research projects and investigations to ensure the integrity of the research and the welfare, safety and rights of those participating in it. They have powers to reject, sanction and terminate research activities that do not meet ethical standards.
These bodies are known by various names in different countries: some of the more common names are ‘institutional review boards’ (USA), ‘research ethics boards’ (Canada), ‘research ethics committees’ (UK), ‘human subject ethics committees’ and ‘human research ethics committees’ (Australia).
Research ethics committees usually have representatives from a broad cross-section of constituencies including biomedical sciences, physical sciences, humanities and social sciences, theological and consumer backgrounds. Research activity must be expressed in lay language and be able to be understood and assessed by members of the community as well as technical experts from the field who will determine its scientific and academic merit. Committees review research proposals in detail, and research can only proceed once their approval is obtained. When a study is completed, researchers wishing to publish their research in refereed journals or books are required to provide details of the ethics committee review and approval to editors.
With the emergence of these committees, predominantly in the mid-1960s, the criteria for review of research proposals was exclusively located within a scientifically orientated positivist research paradigm. The nature of reality was fixed, single and tangible. Research quality was measured by the adherence to methodology that measured elements, and quantified and proved causal relationships between identified variables located in a research hypothesis. Research studies could be trusted if they clearly demonstrated internal and external validity, reliability and objectivity. The researcher was independent of the research subjects. Research was done ‘on’ and ‘to’ subjects. Data and analysis were formulaic and context-free. The research was considered to be objective and value-free. Conclusions and results could be generalized and knowledge creation was linear, supporting one singular notion of truth and reality.
More recently, research ethics committees aim to ensure that relationships between researchers and those involved in the research process recognize and address implicit and explicit ethical relationships that may lead to the researchers and participants being unequal members of the research inquiry. This is particularly the case for groups that may be vulnerable to exploitation. In the case of research with Aboriginal, Indigenous and First Nation peoples, a further application may be required. In countries with Indigenous peoples, research governing bodies have developed specific guidelines for researching with them – for example, in New Zealand, the Ma¯ori Health Committee of the Health Research Council of New Zealand (2008); in Australia, the National Health and Medical Research Council National Statement Guidelines on research with Aboriginal and Torres Strait Islander Peoples, and the Guidelines for Ethical Research in Indigenous Studies (Australian Institute of Aboriginal and Torres Strait Islander Studies, 2012); and in Canada, a tri-council statement of the Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada (2010). These guidelines have been developed with and by Indigenous and non-Indigenous members, but are still considered by many Indigenous leaders as conforming to a white, Western, post-colonial paradigm (Bessarab and Ng’andu, 2010; Bessarab, 2013).
Although the governance structures of research authorities vary across countries, governments, universities, agencies and so on, there are some common elements of ethics applications that can be linked back to the ethical stance or approach that primarily informs them. In Table 3.1 we have identified some of these common elements with reference to the principles-based approach discussed in the earlier part of this chapter. Drilling down into each section, the four principles are clearly evident in the intention of each section.
Finally, ethics applications usually include questions about particular relationships between researchers and participants that may be considered unequal, and often list specific groups. Some relationships that may fall into this category are:
Teachers and students
Employers and employees
Children
Those in dependent relationships with government authorities, such as wards of the state and those under guardianship or care orders
Prisoners
Refugees and asylum seekers
Members of the armed services
Those with mental health issues
Those with intellectual or developmental issues
Patients and health care providers
Aboriginal and Indigenous peoples
The intention of these questions is to clearly recognize that unequal relationships can exist between the researcher and those being researched. Research applicants who tick any of these categories on the application form need to satisfy the ethics reviewers that their research does not exploit or disempower these participants. The moral basis of such questions, their intention and possible outcomes are discussed later in the chapter.
In a few final words on ethics committees, we need to acknowledge the current reality for many such committees and the researchers who interact with them. The demands on institutional research ethics committees to review increasing numbers of research ethics applications each year, combined with the growing complexities of contemporary research approaches, have led to many of those involved in the process considering the possibilities of alternative methods of assessment and review. Whilst the established approaches have merit in the achievement of the ethical imperatives of these committees, without discretion they can at times be seen as prescriptive and counter-productive in terms of the spirit and intention of new research initiatives and more ‘political’ orthodoxies. Rather than considering the ethical merits of the study, there are, on occasion, elements of risk management and political pragmatism that may influence the levels of approval for some types of research. To many researchers the process of obtaining research ethics approval seems more a bureaucratic process than one about ethics. Conversely, for those who are members of research ethics committees, often reviewing underdeveloped and ill-thought-out applications, the process is a continual reminder of the need to uphold ethical principles and practices that are often poorly understood by researchers.
Table 3.1 Principles-based approach underpinning research ethics applicati