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• W2023890154 abstract "The reasons for concern about misconduct in medical research are easy to discern. False or unsupported claims by scientists can lead to inappropriate or harmful treatments; unnecessary additional research that wastes the time of other scientists and diverts the resources of the community; and undermining of the confidence of the broader community in science and medicine generally. Despite universal agreement about the need for scientific integrity, however, uncertainty exists about the scope and implications of misconduct in medical research and what, if anything, needs to be done about it. To understand the dimensions of the problem it is helpful to reflect on the nature of the social institution of science and the pressures to which individual scientists are exposed. Science is a complex collection of practices, the primary purpose of which is to produce and extend certified knowledge. This takes the form of properly confirmed statements about empirical regularities and is carried out by a community of individuals whose patterns of behaviour and forms of communication are highly structured and regulated. Because the products of science have a major impact on the larger community, the latter maintains a deep interest in the conduct of scientists and their achievements. In order to guarantee the reliability of ­scientific knowledge and to facilitate new discoveries, scientists are required to observe certain norms. These norms − which may be considered to constitute the ‘ethos’ of science − include a reliance on formalized, impersonal validation processes; a commitment to open sharing of results; a separation of the pursuit of personal interest from actual scientific production; and an agreement to subject all claims, no matter what their source, to rigorous and thorough scrutiny. It may even be argued that these behavioural norms − sometimes referred to, respectively, as ‘universalism’, ‘communism’, ‘disinteredness’ and ‘organized scepticism’− define the practice of science itself.1 In return for strict observance by scientists of these rules of conduct, the community places its trust in the products of scientific endeavour and provides substantial resources to support it. However, no social institution runs completely smoothly and deviant behaviour in some form − behaviour that is discrepant with respect to established norms − always arises. Sometimes this can be productive and can lead to daring new insights or the development of new techniques. In other cases it can be destructive or, at least, can threaten the stability and continuity of the underlying practices that sustain the culture. The bulk of deviant behaviour in science is of the latter type, and is therefore regarded both by scientists and the wider community as ‘misconduct’, with perpetrators being subjected to severe sanctions. Deviant behaviour is rarely completely unintelligible or irrational. On the contrary, it is usually generated by tensions within the culture from which it arises. In the case of science, the pathogenic stimulus is the system of rewards whereby individuals are judged according to formal criteria (such as publication rates) and receive benefits, in proportion to their accomplishments, in the form of enhanced status and prestige and career advancement (although progressive commercialization has also provided increasing opportunities to benefit in more material ways). An excessive concern with achieving such rewards can lead to behaviours that contradict the underlying, defining ethos of science, ranging from tendentious or selective reporting of data to outright fabrication, fraud and plagiarism. It is remarkable that, given the pressures to which individuals are subject in academic life, the reported incidence of such transgressions historically has been low, and remains low.2, 3 How important is misconduct in medical research today? What needs to be done about it? The article by Breen poses these questions in a helpful way and sets out the arguments in favour of possible responses.4 With respect to the first question, the facts remain in dispute. The exact incidence of scientific transgressions is unknown, as is their impact on society and medicine. Indeed, arguably, medical researchers today observe higher ethical standards than previously. The development throughout the world of the ethic committee system has provided clear guidelines with respect to research conduct and an important educative function for research and the larger community. There is not even agreement about how to define misconduct. Although a variety of approaches has been proposed,5-7 there is ongoing concern that an excessively narrow view of what constitutes proper conduct may compromise scientific freedom and limit the scope for radical new departures in either techniques or ideas. Indeed, it has often been pointed out that science (as it is actually practised) does not always conform to the high ideals it poses for itself, with scientists often arguing vigorously in support of attractive theories and the reputations of well-known investigators clearly influencing decisions about publication.8 In his own definition of misconduct Dr Breen includes acceptance of ‘agreements with sponsors not to publish or to forgo editorial control of the research data’.4 Many would agree that such practices − and indeed the many other devices that are commonly used to control the outcomes of experiments, such as the judicious choice of study design, subjects, dosages, and statistical methods9-11− offend the ethos of science. However, there are also many − most notably in the pharmaceutical industry, which controls the vast bulk of clinical trials − for whom control of data is a necessary fact of commercial life. The relationships between academic researchers and the pharmaceutical and biotechnology industries have become increasingly complex in recent years.12 This is partly because the imperatives they subserve may differ profoundly. The discrepancy between the ethos of science and that of the capitalist economy is an effect of the larger culture, to which an effective resolution has yet to be found. The question of what to do about misconduct in medical research is even more contentious. Histor­ically, the scientific community has been encouraged to regulate itself. Although it is universally acknowledged that education and training are essential, there is disagreement about who should be responsible for surveillance and for punishment of transgressions. A range of models has developed in recent times, extending from a strictly decentralized system (such as in Australia) to one in which standards are set centrally but decision-making power is devolved to local institutions (as in the United States) to a centralized policing apparatus (as in the Scandinavian countries). Breen discusses these models and suggests an additional one, which provides a role for medical boards. Although he leaves the argument open, it would seem that, recently, pressure from a number of sources has been mounting for a movement towards more centralized models.13 There are several reasons why great caution must be exercised before self-regulation and decentralized approaches to the surveillance and control of s­cientific conduct are abandoned. First, allegations of misconduct often refer to detailed technical questions about the collection and interpretation of data that can be evaluated only by individuals with an intimate knowledge of the actual research involved (i.e. the use of particular equipment, experimental conditions, analysis of raw data). It is unlikely that a centralized committee could command the necessary expertise to engage in such an intricate process. Second, much research today is conducted collabor­atively across different centres (often located in different countries) and allegations of misconduct frequently arise in the setting of submissions to international journals. In such cases, no single body is likely to have access to the primary evidence that would allow a judgement to be made; rather, close co-operation between many institutions is needed. Third, health-related research today encompasses a wide range of approaches, including: (i) qualitative and quantitative method­ologies, (ii) epidemiological and basic science techniques and (iii) clinical trials. After years of effort, substantial progress has been made towards the development of common ethical standards for the conduct of human subject research of all kinds;14 an achievement which would be significantly undermined by a shift to a single, medically based regulatory system. However, more important than all this, the institution of a centralized regulatory apparatus runs counter to the nature of science itself and the ethos the system it is supposed to be upholding. One of the greatest strengths of contemporary science is its democratic character − even if it is realized imperfectly − and its relative independence from the social institutions of power. As the history of science demonstrates, scientific creativity flourishes best in settings of openness and freedom. Non-democratic, authoritarian solutions − despite their laudable aim of protecting society from the consequences of erroneous data − are likely to compromise this basic feature of science. Further, from an ethical point of view, centralization is also counterproductive because the mechanical observance of a rule is incompatible with moral decision-making, whereas democratic processes enhance individual responsibility and empower both individuals and communities. In conclusion, the problem of misconduct in medical research is a complex one which needs to be understood in the context of both the history and social structure of science. Research is needed to define more precisely its incidence and significance with respect to society as a whole, and the impact of different models of regulation. New strategies may need to be developed to respond to new tendencies in the organization of research, such as the proliferation of international collaborations and the increasing preponderance of private research over academic research. For the moment, caution should be exercised to avoid compromising the decentralized nature of science with a centralized punitive system. Openness, transparency and democracy are still the best insurance policies." @default.
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• W2023890154 title "Misconduct in medical research: ethics and democracy" @default.
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