Investigators,industry, and the heuristic device: Ethics,patent law,and clinical innovation

There has been much discussion about the prevalence of scientific misconduct. Investigational drug trials and cancer clinical trials have been audited systematically in recent years. Review of the results of these audits indicates that misconduct is not uncommon: serious deficiencies have been identified in 11% of audits of drug trials by the United States Food and Drug Administration. The trend has been toward fewer of the most serious problems in the most recent years of the audit program, suggesting that it is having a deterrent effect. Still, many problems remain. A series of possible strategies for addressing them are critically assessed. The experience of this program of fers a model approach to evaluating potential misconduct in science against which programs in other agencies and other areas of science should be measured.     

Liability risk in the pharmaceutical industry: Tort law in the US and UK

This paper examines the extent to which product liability risk contributes to the high costs of pharmaceuticals in the United States relative to prices in the United Kingdom. Research on pharmaceutical prices rarely accounts for the impact of liability risk, and none that we are aware of compares the United States and United Kingdom. Drawing on a dataset of 77 brand name drugs sold in both the U.S. and the U.K., we analyze relative manufacturers’ factory prices in each nation. We utilize several proxies for liability risk including drug litigation history, the percentage of plaintiff wins, and controlled substance classification. Importantly, under U.S. law there are no caps on the amount that can be awarded to a plaintiff claiming economic losses in the U.S. However, payouts in the U.K. are limited. Accounting for market differences and regulatory environments, we find liability risk can account for a portion of the price differential that exists between the U.S. and U.K., warranting further investigation.     

Research ethics and clinical trials: Fostering collaboration with research participants

Accountability in research is a concept that applies to researchers and study participants alike. Human subjects play an active part in the success or failure of a clinical trial by virtue of their understanding of a study's goals expectations of personal gain, and adherence to study design. Trials must be designed to address patient concerns, offer an improved consent process, and move beyond our narrow conception of “patient rights.”; Problems with protocol adherence may be reduced by conceptualizing clinical research as an endeavor with mutual accountability within a relational ethic.     

Axiomatizing bounded rationality: the priority heuristic

This paper presents an axiomatic framework for the priority heuristic, a model of bounded rationality in Selten’s (in: Gigerenzer and Selten (eds.) Bounded rationality: the adaptive toolbox, 2001) spirit of using empirical evidence on heuristics. The priority heuristic predicts actual human choices between risky gambles well. It implies violations of expected utility theory such as common consequence effects, common ratio effects, the fourfold pattern of risk taking and the reflection effect. We present an axiomatization of a parameterized version of the heuristic which generalizes the heuristic in order to account for individual differences and inconsistencies. The axiomatization uses semiorders (Luce, Econometrica 24:178–191, 1956), which have an intransitive indifference part and a transitive strict preference component. The axiomatization suggests new testable predictions of the priority heuristic and makes it easier for theorists to study the relation between heuristics and other axiomatic theories such as cumulative prospect theory.     

自然法:法律与道德之间

自然法是对与错的终极标准,是制度正当与否的试金石,是保守与革命的最终理据.它兼有法律和道德的双重特征,还肩负着在两者之间做出基本区分的使命.在人类漫长的思想进程特别是欧洲思想近三个世纪理性化建构中,自然法是人们探究法律适当的道德基础,又是小心避免法律受道德污染的有力工具.它为法律和道德之间的那个交叉点提供了一个名称.     

The time frame problem: the law, social construction, and the sciences

Among our official noblest virtues are truth and justice. In the sciences, officially, truth overrides every other virtue. In the law, officially, justice likewise overrides. That is neither to deny that justice should be tempered by mercy, nor that truth should be qualified by wisdom. Any discussion of law and the sciences is potentially high philosophy, the meeting ground of truth and justice. But there are also more practical concerns. How should scientific information and advice be used in the law courts? There is now a rather staid but thoroughly solid assessment of the current state of play in the United States Federal Court systems, Foster and Huber’s(1997) Judging Science: Scientific Knowledge and the Federal Courts. Far more challenging to the philosopher, the scientist and the student of jurisprudence is Sheila Jasanoff’s(1995) Science at the Bar because she enters current debates as a professed social constructionist, with a distinguished career of investigating science and public policy (Jasanoff and Jasanoff).     

Person-oriented research ethics: integrating relational and everyday ethics in research

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a “person-oriented research ethics” approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.     

Statistics,ethics, and research: An agenda for education and reform

This essay argues that the research community needs to pay more attention to the appropriate use of statistical methods in discussions of research ethics, and proposes some strategies for enhancing discussions of the ethical uses of statistics within investigational, educational, and organizational settings. The essay supports its position by 1) explaining why statistics plays such a key role in research integrity, 2) describing how some common misuses of statistics in research violate ethical standards pertaining to honesty and error avoidance, and 3) reviewing evidence which suggests that the misuse of statistics is more prevalent (and perhaps more significant) than research misconduct (narrowly defined as “fabrication, falsification, or plagiarism").     

Large firms,legitimation and industry identity: The growth of the North Carolina wine industry

This paper examines the recent rapid growth of wineries in North Carolina and the role that a few large wineries have played in establishing efficiency parameters for small wineries. Specifically, we argue capital intensive wineries have subsidized institutional changes and promoted operational procedures that have improved quality and reputation of the embryonic industry. In establishing efficiency mandates they have helped incipient industry identity and also provided an important benchmark for industry newcomers, thus facilitating further entrepreneurial growth.     

Exploring the ethics of treatments for depression: The ethics of care perspective

This article explores the ethics of current treatments for depression through the lenses of social work values and ethics. As a vehicle for analysis, the approach associated with ethics of care will be utilized. Particular attention is paid to ethical dilemmas in the treatment of depression under the auspices of managed care companies. A case example is presented to help social workers understand these dilemmas in the context of practice. Adopting an ethics of care perspective would mandate that social workers become more politically active, and work toward integrating direct and indirect practice approaches in treating people who suffer from depression and similar problems.     

Trade, education, and innovation: Prospects for the U.S. economy

This paper examines international trade issues as vital indicators of the economic prospects of the United States and other developed economies. In particular, it challenges misuses of the doctrine of mutual gains from trade and instead argues that comparative advantage does not guarantee increases in benefits to both trading partners—especially when one partner seeks to distort the market mechanism in its favor. In the face of such mercantilist or protectionist practices, efforts to advance innovation, without retaining manufacturing jobs, will not ensure continued prosperity, as the number of jobs entailed in the invention process is small compared with the number of jobs associated with manufacturing an innovative product for mass consumption. These matters call for the urgent rethinking of trade policy by the United States and other developed nations, if they are to balance their imports and exports and ensure continued economic growth.