Individual and institutional conflict of interest: policy review by research universities in the United States

This paper is a discussion of efforts to manage real and potential conflicts of interest in university research in the United States. The focus is on the report by an Association of American Universities (AAU) task force that addresses both individual and institutional conflict of interest issues. 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.     

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.     

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.     

Future directions in engineering ethics research: microethics, macroethics and the role of professional societies

Three frames of reference for engineering ethics are discussed—individual, professional and social—which can be further broken down into “microethics” concerned with individuals and the internal relations of the engineering profession and “macroethics” referring to the collective social responsibility of the engineering profession and to societal decisions about technology. Few attempts have been made at integrating microethical and macroethical approaches to engineering ethics. The approach suggested here is to focus on the role of professional engineering societies in linking individual and professional ethics and in linking professional and social ethics. A research program is outlined using ethics support as an example of the former, and the issuance of position statements on product liability as an example of the latter. An earlier version of this paper was presented at the International Symposium on Technology and Society 2000 (ISTAS 2000), Rome, Italy, 7 September 2000. Joseph R. Herkert directs a dual-degree program in engineering and humanities/social sciences and is editor of Social, Ethical, and Policy Implications of Engineering (Wiley/IEEE Press).     

Sex Biases in Subject Selection: A Survey of Articles Published in American Medical Journals

This study discusses the results of a survey of 1,800 articles published in American medical journals from 1985--1996. The study finds 9% of these articles reported research that uses only male subjects to examine medical conditions that affect both sexes; the ratio of research on female to male conditions among these articles was greater than 5:1; but 76.5% of the articles reported research that includes both male and female subjects. The study also discusses evidence that sex biases against women (and men) are decreasing. This study also offers some possible psychological, institutional, medical, and economic explanations of the sex biases in medical research published in American journals, and discusses some policy implications of sex biases in medical research. The study concludes by urging others to conduct more empirical research on sex biases in medical research.