Methods for ethical assessment

Introduction

The Norwegian system of research ethics committees is based on a line of thought from discourse ethics (Habermas 1989; Apel and Kettner 1992), which postulates that ethical assessments are best made in a community. This community should be relatively broadly composed in order to reflect a diversity of social viewpoints and values, and the committees therefore include laypeople in addition to researchers from various disciplines. Furthermore, ethicists and possibly also representatives of other stakeholders and organisations may be included, depending on the mandate and function of each committee. When undertaking ethical assessments in such a community, the aim is to achieve an adequate testing of the various arguments and viewpoints that are put forward, and thus achieve a quality assurance of the assessment.

Guidelines and other principle-based ethics

In the work of the committees, ethical guidelines are important. Medical research ethics committees often base their work on the Helsinki Declaration of the World Medical Association. In Norway, The Committee for Social Sciences and Humanities (NESH) and the Committee for Natural Sciences and Technology (NENT) have developed their own guidelines. The guidelines set the direction for the committees’ work, and are explicitly referred to in the justification of judgements. Ethical guidelines can be viewed as a form of principle-based ethics, even though principle-based ethics tend to be associated with a specific approach within biomedical ethics (Beauchamp and Childress 1979, 2013). Beauchamp and Childress identify four principles that they see as essential in biomedical ethics:

• the principle of beneficence
• the principle of non-maleficence
• the principle of autonomy
• the principle of justice

These four principles can be further specified with regard to specific cases, and they often need to be balanced against each other. Beauchamp and Childress’ theory elaborates how such a balancing of principles should be undertaken. The guidelines referred to above also include requirements for balancing, especially with regard to the requirement that the objective of research “outweighs the risks and burdens that the research imposes on the participants” (Section 18 of the Helsinki Declaration). This balancing is one of the committees’ most important tasks.

Casuistry

In their work, the committees often implicitly use a casuist method. Casuistry has its origin in antiquity and was widely used during the Medieval period. Jonsen and Toulmin (1988) revived this method, which involves a systematic procedure to compare ethical cases. In a new case, one decides what the correct ethical assessment is (for example the correct application of principles or guidelines) by comparing with paradigmatic cases in which one can be relatively certain that a correct assessment was made. Thereby, one achieves consistency and predictability in the ethical assessments that are made.

Participatory methods

In addition to the methods that are routinely applied in the committees’ work, other methods are occasionally used to undertake ethical assessments. This will often be relevant for cases that are not of a routine character, but have wider social implications. In particular, this will apply to technological development that provides new opportunities for influencing nature and people, but also involves new risks and uncertainties. Such cases may arise in the work of the committees for medicine, natural sciences and social sciences/humanities, for example with regard to biotechnology and genetic engineering, nanotechnology, information technology etc. The issues involved are often of a highly complex and interdisciplinary nature, and they may have an impact on individuals, groups and society as a whole in ways which are not transparent. In some cases, it is therefore deemed necessary to include a wider range of experts, stakeholders or laypeople in such assessments, which are made with the aid of so-called participatory methods.

Consensus conferences

Consensus conferences are an important participatory method for technology assessment. Genetically modified foods were discussed at consensus conferences held by the Norwegian Biotechnology Advisory Board, the Norwegian Board of Technology and the National Committees for Research Ethics in 1996 and 2001 (see Kaiser and Skavlid 2001). A consensus conference is an event where non-experts assess a given topic. The participants at a consensus conference represent a cross-section of the population and should ideally arrive at the same assessment that the general population would have made if they had been given the same opportunity to become informed about the matter at hand. The participating laypeople should have no special interests linked to the topic being discussed. At the first stage of the process, the lay participants are presented with information on the topic, and they decide for themselves what kind of knowledge they believe will be needed most for making a judgement, and the corresponding kind of experts who should be invited. At the second stage, they deliberate the matter until they arrive at a recommendation. A variant of the consensus conference is consensus cells; smaller focus groups consisting of laypeople (Kaiser et al. 2006).

Ethical matrix

The ethical matrix process is another participatory method in frequent use. The ethical matrix is a method developed by Ben Mepham in the early 1990s, which has been used for assessing a number of different technologies. The Norwegian Committees for Research Ethics have used the method for ethical assessment of fishery technology (see Kaiser and Forsberg 2001), strategies for radiation protection (see Oughton, Forsberg et al. 2004) and genetically modified rapeseed (see Forsberg 2007). The ethical matrix model is a variant of principle-based ethics, but unlike the method described by Beauchamp and Childress, it systematises the fundamental principles in a matrix that also includes categories of relevant stakeholders (an ethical matrix for development of fishery technology is shown in Figure 1 below).

Figure 1: Ethical matrix for assessment of fishery technology (Kaiser and Forsberg 2001)

This matrix is used as a basis for discussions of ethically relevant concerns and consequences of a specific technology or research trajectory. When this ethical assessment is undertaken in a process that involves representatives of stakeholders  may be referred to as a value workshop. An ethical matrix can also be used in processes involving laypeople (see e.g. Kaiser, Millar et al. 2007). The ethical matrix has also been used by researchers for assessment of the researchers’ responsibility with regard to the ethical implications of their work (ref. Jensen, Forsberg, et al. 2011).

Other dialogical methods

Other dialogical methods are also used ‒ either researcher-based or expert-based. Researchers can discuss ethical aspects of their work in expert-based consensus conferences (Kaiser and Forsberg 2002) or in ethical delphi processes (Millar, Thorstensen et al. 2007). Here the researchers discuss ethical problems either in the form of a conference (consensus conference) or anonymously by letter/email (ethical delphi). Such methods are also used outside the field of ethics. These methods are well suited to obtaining a deeper understanding of scientific agreement and disagreement concerning the factual base of an issue and to making provisions for letting the experts take a stand on relevant value-based issues.

Choice of methodology

Ethical methods – or ethical tools, as they are often called (see Beekman, de Bakker, et al. 2006) – must be applied consciously in light of the demands of the issue at hand. The objective, participation and design must be well-considered, not least in light of the fact that some of the methods, the larger participatory processes in particular, are highly resource-intensive. The choice of method in general and design in particular may also influence the ethical assessment itself. Ideally, ethical issues should be deliberated with the aid of a variety of methods, and it is essential that they are accompanied by a discussion of how quality assurance of the methods can be undertaken and how they can be developed further as the need arises.

Ethics and the ethicists

Some of the methods also have the effect of diminishing the ethicists’ control over the ethical assessments. This may be regarded as compromising the philosophical quality of the reflections. However, at times it may be necessary to anchor the ethical discussion among those experiencing the ethical dilemmas and challenges, i.e. among different groups of researchers, stakeholders or in the society in general. This may be equal in importance to theoretical stringency. Conceptual contributions from philosophers and theologians are often essential to elucidate certain aspects of contentious issues, but the discussions of values must not be “outsourced” to ethics experts. Today’s committee system functions exactly on these premises: that researchers, laypeople and ethics experts can discuss value issues as a group.

This article has been translated from Norwegian by Erik Hansen, Akasie språktjenester AS.

Literature

REFER TO
Beauchamp, T. & J. Childress (2001): Principles of Biomedical Ethics. Oxford and New York: Oxford University Press

FURTHER READING
Ruyter, Knut (red.): Forskningsetikk. Beskyttelse av enkeltpersoner og samfunn. Oslo: Gyldendal Norsk Forlag 2003