What kinds of decisions can be made by research ethics committees?
The following example is fictional and driven to extremes, although based on experience from various research ethics committees.
The University of Illnesshire cooperates closely with the local health enterprise and a cluster of biotechnology companies. They have now received research funding to initiate a major research project: Molecular Mechanisms and Therapies of Shift Work Sleep Disorder. The project will study the so-called shift-work syndrome that afflicts many who work nights or irregular shift schedules: their sleep rhythms are disturbed, and they feel drowsy and tired at work. This causes them major discomfort, but may also pose a direct risk to others (such as passengers or patients). The research project will investigate the molecular causes of the syndrome and test new drugs that will keep those afflicted awake at work. Especially promising is a combination of active ingredients that have been isolated from a species of moss called upquicker moss. This moss has been used for centuries by a small group of inland fishermen in Humbledale belonging to the Kven ethnic minority, who chew it to stay awake on nightly fishing trips.
Before the research project can start, it must be approved by the Regional Committee for Medical and Health Research Ethics (REK). REK has a large caseload and normally distributes the task of being spokesperson among its members. For this project, REK has appointed Juliette Doctor, Senior Consultant, to act as spokesperson. In the meeting, she describes the various aspects of research ethics involved: hospital doctors and nurses with and without shift-work syndrome will be recruited to participate in neurological and molecular-genetics tests, later to be followed by a double-blind trial of the drug Upquixin, which is being developed. This is good research practice of international quality that may bring relief to many afflicted shift workers. The investigation has a low risk of adverse effects, and the research group has presented a good plan for follow-up. Approvals must be applied for, pursuant to the Biobanking Act, privacy legislation and regulations for drugs, but the researchers have submitted adequate declarations of all this. However, the information leaflet to be given to the participants is written in English and is also very incomplete. The spokesperson proposes that the project be approved, provided that the information leaflet be revised and assessed on the authority of REK's chair.
Is medicalisation a concern for research ethics?
Now a lay representative of REK, Justine Freek, takes the floor. She is highly sceptical of the project and summarises her view in three arguments. First she claims that the project will not help provide an understanding of and relief from what she sees as the underlying causes of shift-work syndrome: the rapid pace of work and pressure for efficiency in modern working life. She sees the sleep disturbances among the shift workers as a natural reaction to this pressure. She believes that a new drug that will keep them awake will only serve to increase this drive for efficiency and undermine the workers' rights in the long term. She refers to Ivan Illich's book Medical Nemesis, saying that this research only serves to promote the medicalisation of society. Social organisation bears the blame, but it is shifted onto individuals, she claims.
Second, she describes the project as biopiracy. Local knowledge about upquicker moss will be stolen from a local community, a vulnerable national minority in Norway at that, with no form of "benefit sharing" whatsoever. On the contrary, a patent will be applied for and the revenues will be shared by the University of Illnesshire and three biotechnology companies owned by three former professors. And third, is upquicker moss not on the red list of threatened species? Since no efforts to grow the moss in a laboratory or manufacture the active ingredients with biotechnological methods have so far succeeded, the project will depend on harvesting that may be a direct threat to the proliferation of the species, she says.
The next person to speak is the leader of REK, Magnus Rex. He thanks Juliette Doctor for her thorough presentation and Justine Freek for taking such a personal interest in the case. He states that without the commitment of laypeople, REK will lose its legitimacy. Here, however, certain clarifications seem to be called for. To be sure, upquicker moss is on the red list, but it is very unclear whether a modest collection for research purposes could pose any real threat. In addition, the researchers have been granted an exemption by the environmental authorities. Furthermore, as regards medicalisation and benefit sharing, these are political, rather than ethical issues. The Helsinki Declaration contains no reference to such issues, nor do any of the other documents on research ethics that REK normally deals with. Magnus supports Juliette's proposal for a decision, adding that he is hoping that REK may reach a consensus also on this occasion. That would benefit everybody involved, not least this important, internationally recognised research project. Justine turns red in the face, but looks down and says nothing. The decision is unanimous.
What is research ethics?
The above story is fictional. Upquicker moss, upquixin and Humbledale are all very unlikely to exist. What exists, however, is the controversy regarding what research ethics is and ought to be. In the story, Justine's arguments are rejected on the grounds that they refer to political issues rather than ethical ones. Here, the leader of REK relies not only on the key documents of medical research ethics, but also on what is common practice. He might also have referred to typical reading lists for courses in medical ethics and research ethics.
Justine, on the other hand, could have referred to other documents and practices, for example the International Treaty on Plant Genetic Resources. Not least, she could have referred to the guidelines issued by the National Committee for Research Ethics in Science and Technology (NENT), for example Articles 2 and 17–18. Here, NENT ascribes an ethical responsibility to research in terms of sustainable development and respect for traditional knowledge and its bearers. In Articles 10–11, NENT also imbues research with a more comprehensive social responsibility with regard to "ethically unacceptable consequences for health, society and the environment" without providing any specific definitions of these. Justine could have argued that medicalisation is an unacceptable consequence for health and society.
There is real disagreement on these issues. This disagreement does not pertain to whether informed consent, information leaflets and the Helsinki Declaration are important; everybody agrees with this. The disagreement is about whether the wider issues regarding the consequences of research should be considered as matters of research ethics. We can thus distinguish between a "narrow" and a "broad" meaning of research ethics. One way to draw this distinction is to say that narrow research ethics is mostly concerned with what may happen to research participants and other subjects of study during the research process itself, while broad research ethics is also concerned with what may happen when the new knowledge is applied in society and the environment. A similar distinction was introduced by the philosopher Knut-Erik Tranøy, who distinguishes between research ethics and science ethics (Tranøy 1986).
"The politics of research ethics" in the narrow sense
What kinds of decisions may REK and the other research ethics committees make? Are they permitted to enter into research ethics in the broad sense, and to what extent? One way to approach this question is to consult applicable laws and regulations and the political decisions that have been made with regard to the committees. One can read and interpret the Research Ethics Act, the Health Research Act, various guidelines and the formal mandate of the committees. We could call this politics in the narrow sense. The Norwegian encyclopaedia Store Norske Leksikon defines politics thus:
Politics, the activity that involves governance or leadership of social development. Since there are governmental bodies, alternatively similar bodies at the sub- or supranational level, that are responsible for determining the content of this governance, politics will in practice be the activity that takes place in association with governmental bodies [...] (Source: www.snl.no/politikk, accessed 15 March 2009).
Such an approach may provide some kind of answer to what research ethics in fact is in the form of committees, and their degree of freedom of action. One obtains less of an answer to the question of what research ethics ought to be. As a matter of fact, one obtains very few specific answers to the first question either. The national research ethics committees, for example, are formally free to decide for themselves what issues they want to discuss. This notwithstanding, a review of REK's role shows the difficulties involved in placing a major emphasis on such issues as medicalisation. A rejection of a research project by REK may mean that the project cannot be implemented. Would REK have sufficient real power to ride out the storm blown up by researchers and their funding institutions if the committee had decided to reject the upquixin project on the grounds that it would lead to medicalisation? Would the decision have been overruled? Would it have been able to stand up in a legal battle in which the project would have been backed by health enterprises, research councils, industrial enterprises and patients' associations? When asking such questions we are shifting focus away from the purely formal structures towards another and wider understanding of the concept of politics.
"The politics of research ethics" in the broad sense
Like "ethics", the term "politics" is used in a variety of ways, and there is legitimate disagreement regarding its meaning. Above we saw how it was defined in an official Norwegian encyclopaedia. Norwegian Wikipedia provides an interesting contrast:
Politics [...] concerns the distribution of benefits and burdens in society. Within a political system, politics is the activity that involves definition of objectives, ranking of priorities, distribution of values and selection and application of means. The concept of politics can be defined in a broad as well as a narrow sense. A broad definition implies that politics includes all social affairs that involve power, governance and authority, while a narrow definition says that politics is the activity of public decision-making and the frameworks that steer the actions of individuals and groups towards a public decision. [...] Here, the choice of a conceptual understanding announces a perspective on the conditions in question, and no choice of terms is completely neutral. (Source: http://no.wikipedia.org/wiki/Politikk, accessed 15 March 2009)
The EU report Taking the European Knowledge Society Seriously is based on a broad perspective on the politics of research ethics. The report is scorching in its criticism of the prevailing understanding of ethics related to modern technology, and not least of how this understanding is reflected in ethics committees, rules and guidelines. It refers to "the unpolitics of ethics", i.e. how a democratic deficit has arisen with regard to controversial issues linked to modern science and technology, because the authorities have delegated such questions to ethics committees and experts. The ensuing problem is that ethics committees and experts often operate within a narrow definition of research ethics. Turning back to our fictional story we could imagine a popular protest against the project, along the lines argued by Justine. However, one could also imagine the following response: "What are you making so much fuss about? Academic experts have concluded that this project is good science, and the ethics committee has approved it. Everything is OK." In other words, by directing the debate through formal channels, including REK, all the broader issues (irrespective of whether we refer to them as political or ethical) are peeled away because they fall by the wayside, cf. Nydal and Strand (2008).
The social contract of science
In this sense, the choice between research ethics in the narrow or broad sense – the Helsinki Declaration or NENT rules – is a political choice. However, this is not a simple choice between two preferences. The opponents of broad research ethics regard it as misconceived and dangerous, or even as a monstrosity. I believe that this is linked to a strong belief in science as a very particular social sector that needs very particular rules. According to this view, science must enjoy complete freedom, with the exception of restrictions in terms of access to resources (research politics in the narrow sense) and restrictions in terms of harm to research participants (research ethics in the narrow sense). If science is granted this freedom, it will effectively produce new knowledge and welfare for all, and its freedom and openness is a necessary force for an open and democratic society. This notion of the role of science in society has a long tradition in European philosophy. If the autonomy of science is tampered with, we risk falling back into the Middle Ages or Stalinism, and most certainly falling behind in the globalised, innovation-based economy. This is the traditional understanding of "the social contract of science".
The politics of research ethics is linked to philosophy of science
Much has been said and written about the social contract of science, see e.g. Nowotny et al. (2001). Here, I will only point out that the notion described in the preceding section has been largely abandoned in science and technology studies and history, philosophy and sociology of science, the research disciplines that have scientific research as their subject matter. With reference to this body of literature, it can be argued that the relationship between science and society has always been a close and complex one, with numerous forms of mutual influence. We therefore need to ask questions such as: Who benefits from a certain type of research being given encouragement and free rein? Who stands to lose from it? There is also a growing recognition that scientific and technological development has played a considerable role in many of the global problems that the world is facing. This does not mean that we should refrain from putting further effort into scientific development to solve or learn to live with these problems. The opponents of the traditional notion of the social contract of science, however, will argue that society must develop mechanisms of self-defence against the problematic and occasionally harmful consequences of new knowledge.
In extreme cases, this may mean imposing bans, such as in the case of human cloning. One could also imagine bans on knowledge, for example if someone found a simple recipe for weapons of mass destruction. Not many, however, would agree to a ban on our hypothetical Upquixin project. Thus, the question of what research ethics ought to be has a practical side to it as well. If research ethics should primarily involve approving or banning/preventing research projects, we are led towards a narrowly defined research ethics. If a broad research ethics is wanted, we need other ways to exercise it: debate, dialogue, perhaps increased interaction between researchers and citizens in various ways. Perhaps the guidelines for "broad" research ethics (such as the NENT guidelines) should be seen as a tool for dialogue, rather than as a legal code. In other words, what research ethics ought to be, remains a question of political choice and about creativity and the need for new knowledge – exactly as is the case with most other matters that have an impact on society.
This article has been translated from Norwegian by Erik Hansen, Akasie språktjenester AS