An Empirical Analysis of the Medical Informed Consent Doctrine: Search for a Standard of Disclosure

Informed consent and its conceptual equivalents, e.g., right-to-know, are increasingly important. The author discusses the development of the informed consent doctrine in tort cases and attempts to evaluate the consistency of its application. He concludes that it is difficult to separate that which must be disclosed from that which need not be. He also argues that much remains to be done in achieving the objectives of the informed consent doctrine

Psychosocial Risks of Storing and Using Human Tissues in Research

Dr. Merz argues that genetics technology makes it more compelling that researchers plan more carefully for the collection and disposition of information derived from subjects\u27 tissues and blood

In Support of Huber

The author takes exception to two recent reviews of GALILEO\u27S REVENGE

Review of: Carl F. Cranor, Regulating Toxic Substances

Review of: Carl F. Cranor, Regulating Toxic Substances (Oxford University Press 1993). Acknowledgments, appendices, bibliography, figures, foreword by The Honorable George E. Brown, Jr., index, notes, tables. LC 91-47046; ISBN 0-19- 507436-X. [272 pp. Cloth $45.00. 200 Madison Avenue, New York NY 10016.

Disease Genes Are Not Patentable: A Rebuttal of McGee

Dr. McGee presents a cogent argument for the patentability of the diagnosis of gene forms that are found to be associated with disease or other phenotypic manifestations. We’re convinced he’s wrong. An analogy will help explain why

What Are Gene Patents and Why Are People Worried about Them?

This article examines what it means to patent a gene. Numerous ethical concerns have been raised about the effects of such patents on clinical medical practice as well as on research and development. We describe what kinds of inventions are covered by human gene patents, give several examples and summarize the small body of empirical research performed in the US examining the effects of these patents. There is little evidence that early fears about gene patenting placing substantial restraints on research and clinical medicine have come to fruition. Nonetheless, there are areas of concern, and policy makers, physicians and the public should be alert to ensure that the net social benefits of patenting human genes are maintained

The prevalence of patent interferences in gene technology

Unlike all other countries in the world, the United States awards patents to the first to invent, not to the first to file an application for a patent. In cases where two or more inventors submit patent applications claiming the same invention, an interference may be declared. Interference is the process by which the US Patent & Trademark Office (USPTO; Washington, DC, USA) determines which of the applicants was the first to invent and diligently reduce the invention to practice. More than half of these are resolved in favor of the inventor who was the first-to-file, raising questions about whether this unique system is worth retaining. Interferences are relatively rare. For the period 1998-2002, an average of four interferences were declared for every 10,000 patent applications filed. Data we have gathered suggest that interference proceedings in gene discovery and biotechnology are much more prevalent than other areas of technology. The resulting legal fees are costing the biotechnology industry millions of dollars each year

\u27Iceland Inc.\u27?: On the ethics of commercial population genomics

A detailed analysis of the Icelandic commercial population-wide genomics database project of deCODE Genetics was performed for the purpose of providing ethics insights into public/private efforts to develop genetic databases. This analysis examines the moral differences between the general case of governmental collection of medical data for public health purposes and the centralized collection planned in Iceland. Both the process of developing the database and its design vary in significant ways from typical government data collection and analysis activities. Because of these differences, the database may serve the interests of deCODE more than it serves the interests of the public, undermining the claim that presumed consent for this data collection and its proprietary use is ethical. We believe that there is an evolving consensus that informed consent of participants must be secured for population-based genetics databases and research. The Iceland model provides an informative counterexample that holds key ethics lessons for similar ventures

All Gifts Large and Small

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated

Empirical developments in retraction

This study provides current data on key questions about retraction of scientific articles. Findings confirm that the rate of retractions remains low but is increasing. The most commonly cited reason for retraction was research error or inability to reproduce results; the rate from research misconduct is an underestimate, since some retractions necessitated by research misconduct were reported as being due to inability to reproduce. Retraction by parties other than authors is increasing, especially for research misconduct. Although retractions are on average occurring sooner after publication than in the past, citation analysis shows that they are not being recognised by subsequent users of the work. Findings suggest that editors and institutional officials are taking more responsibility for correcting the scientific record but that reasons published in the retraction notice are not always reliable. More aggressive means of notification to the scientific community appear to be necessary