Animal spare parts? A Canadian public consultation on xenotransplantation

Xenotransplantation, or the use of animal cells, tissues and organs for humans, has been promoted as an important solution to the worldwide shortage of organs. While scientific studies continue to be done to address problems of rejection and the possibility of animal-to-human virus transfer, socio-ethical and legal questions have also been raised around informed consent, life-long monitoring, animal welfare and animal rights, and appropriate regulatory practices. Many calls have also been made to consult publics before policy decisions are made. This paper describes the Canadian public consultation process on xenotransplantation carried out by the Canadian Public Health Association in an arm’s length process from Health Canada, the ministry overseeing government health policy and regulation. Focusing on six citizen fora conducted around the country patterned after the citizen jury deliberative approach, the paper describes the citizen panelists’ recommendations to hold off on proceeding with clinical trials and the rationales behind this recommendation. The consultation process is discussed in the context of constructive technology assessment, a framework which argues for broader input into earlier stages of technology innovation, particularly at the technology design stage. This study was supported by a grant to the first author from the Social Sciences and Humanities Research Council in Canada.     

Conflict of interest: the importance of potential

The UK Medical Research Council (MRC) takes the issue of conflict of interest very seriously. The overall aim is to preserve a climate in which personal and organisational innovation can flourish while ensuring that potential conflicts are disclosed and identified and conflicts are either avoided or managed with integrity. The approach needs to encompass the MRC’s various responsibilities and the levels at which conflicts might arise: MRC staff (scientists and administrators); the governing Council; research Boards and committees; external peer-reviewers; and applicants for funding. To achieve its goals, the MRC has issued practical guidance on various aspects of conflict of interest. For the future, the MRC has identified the continuing commercialisation of science and the increasing involvement of lay people in scientific decision-making as special challenges in this area. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

From case management to prevention of scientific dishonesty in Denmark

In 1992, The Danish Medical Research Council established a national committee on scientific dishonesty with the twofold task of handling cases of scientific misconduct and taking preventive initiatives. Scientific dishonesty was proven in only five cases, but in another nine cases lesser degrees of deviations from good scientific practice were found. The experiences from a total of 24 treated cases indicated that three key areas were at the basis of most of the accusations and the deviations from good practice: uncertainty about 1) authorship, about 2) rights and duties to use scientific data and about 3) agreements at the initiation of joint studies. As a consequence guidelines on good practice have been issued on these key subjects. An earlier version of this paper was presented at a symposium, Scientific Misconduct. An International Perspective, organised by The Medical University of Warsaw, 16 November, 1998.     

Evolving research misconduct policies and their significance for physical scientists

Scientific misconduct includes the fabrication, falsification, and plagiarism (FFP) of concepts, data or ideas; some institutions in the United States have expanded this concept to include “other serious deviations (OSD) from accepted research practice.” It is the absence of this OSD clause that distinguishes scientific misconduct policies of the past from the “research misconduct” policies that should be the basis of future federal policy in this area. This paper introduces a standard for judging whether an action should be considered research misconduct as distinguished from scientific misconduct: by this standard, research misconduct must involve activities unique to the practice of science and must have the potential to negatively affect the scientific record. Although the number of cases of scientific misconduct is uncertain (only the NIH and the NSF keep formal records), the costs are high in terms of the integrity of the scientific record, diversions from research to investigate allegations, ruined careers of those eventually exonerated, and erosion of public confidence in science. Existing scientific misconduct policies vary from institution to institution and from government agency to government agency; some have highly developed guidelines that include OSD, others have no guidelines at all. One result has been that the federal False Claims Act has been used to pursue allegations of scientific misconduct. As a consequence, such allegations have been adjudicated in federal courts, rather than judged by scientific peers. The federal government is now establishing a first-ever research misconduct policy that would apply to all research funded by the federal government regardless of which agency funded the research or whether the research was carried out in a government, industrial or university laboratory. Physical scientists, who up to now have only infrequently been the subject of scientific misconduct allegations, must nonetheless become active in the debate over research misconduct policies and how they are implemented since they will now be explicitly covered by this new federal wide policy. Disclaimer: The authors are grateful for the support for conduct of this research provided by the United States Department of Energy (DOE). The views expressed in this paper are solely those of the authors and were formed and expressed without reference to positions taken by DOE or the Pacific Northwest National Laboratory (PNNL). The views of the authors are not intended either to reflect or imply positions of DOE or PNNL.     

Toward a Comprehensive Strategy for Effective Practitioner–Scientist Partnerships and Larger-Scale Community Health and Well-Being

This article articulates joint priorities for the fields of prevention science and community psychology. These priorities are intended to address issues raised by the frequent observation of natural tensions between community practitioners and scientists. The first priority is to expand the knowledge base on practitioner–scientist partnerships, particularly on factors associated with positive outcomes within communities. To further articulate this priority, the paper first discusses the rapid growth in community-based partnerships and the emergent research on them. Next described is an illustrative research project on a partnership model that links state university extension and public school delivery systems. The article then turns to the second, related priority of future capacity-building for diffusion of effective partnership-based interventions to achieve larger-scale health and well-being across communities. It outlines two salient tasks: clarification of a conceptual framework and the formulation of a comprehensive capacity-building strategy for diffusion. The comprehensive strategy would require careful attention to the expansion of networks of effective partnerships, partnership-based research agendas, and requisite policy-making.     

The immoral gene: Does it really exist?

Over the last years several European patents were opposed for protecting technology violating the morality requirement under Article 53(a) EPC. Attempts have been made by the Appeal Boards of the European Patent Office (EPO), as well as by amendments introduced into the Implementing Regulations of the European Patent Convention (EPC), to address this sensitive patentability requirement more precisely. The most recent hot topic coming up in this context is the patentability of stem cells. It is to be expected that this discussion will still go on in the field of biotechnological inventions for the next several years. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

Ethics and patentability in biotechnology

The systems of patent rights in force in Europe today, both at the level of national law and on the regional level, contain general clauses prohibiting the patenting of inventions whose publication and exploitation would be contrary to “ordre public” or morality. Recent years have brought frequent discussion about limiting the possibility of patent protection for biotechnological inventions for ethical reasons. This is undoubtedly a result of the dynamic development in this field in the last several years. Human genome sequencing, the first successful cloning of mammals, and the progress in human stem cell research present humanity with many new questions of an ethical nature. Directive 98/44 of the European Parliament and of the Council of July 6, 1998, on the Legal Protection of Biotechnological Inventions created a new basis for patent protection in this field of technology. Based on the European experience to now, however, it must be said that patent law is not the right place to legislate the consequences of the morality of an invention. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

评中国思想家对道德与法律之关系的探索

儒家礼法合一论的真义是对“善法”的追求 ,对“恶法”的否定。因为善法体现了儒家的道德精神 ,反映了一种人道主义的价值取向 ,而恶法则是反人道的。墨家强调“法不仁不可以为法” ,其真实的意思是不道德的法律不是真正的法律 ,与儒家的礼法合一论有相似之处。法家主张“法虽不善犹善于无法” ,从而否定了法律的道德基础和价值根据。今天 ,我们在立法中贯彻道德的法律化取向需要谨慎从事 :一是注意把那些体现时代精神、合乎社会潮流的道德予以法律化 ,不能把落伍于时代的道德法律化 ;二是切忌把过高的道德义务转化为法律义务。必须认识到 ,应该法律化的道德只是“底线道德” ,而高层次的道德是不宜法律化的 ,否则就是强人所难。     

Ethical issues at the university-industry interface: A way forward?

This paper forms an introduction to this issue, the contents of which arose directly or indirectly from a conference in May 2001 on Corruption of scientific integrity? — The commercialisation of academic science. The introduction, in recent decades, of business culture and values into universities and research institutions is incompatible with the openness which scientific and all academic pursuit traditionally require. It has given rise to a web of problems over intellectual property and conflict of interest which has even led to corporate sponsors’ suppressing unfavourable results of clinical trials, to the detriment of patients’ health. Although there are those who see the norms of science developing to recognise the importance of instrumental science aiming at specific goals and of knowledge judged by its value in a context of application, none justifies the covert manipulation of results by vested interest.Public awareness of these problems is growing and creating a climate of opinion where they may be addressed. We suggest a way forward by the introduction of nationally and internationally-accepted guidelines for industrial collaboration which contain proper protections of the core purposes of universities and of the independence of their research. Some codes suggested for this purpose are discussed. We note that some universities are moving to adopt such codes of conduct, but argue the need for strong support from the government through its funding bodies.     

Responsible engineering: the importance of character and imagination

Engineering Ethics literature tends to emphasize wrongdoing, its avoidance, or its prevention. It also tends to focus on identifiable events, especially those that involve unfortunate, sometimes disastrous consequences. This paper shifts attention to the positive in engineering practice; and, as a result, the need for addressing questions of character and imagination becomes apparent.