Concern about the commercialization of research is rising, notably in testing new drugs. The problem involves oversimplified, polarizing assumptions about research and development (R&D) and intellectual property (IP). To address this problem this paper sets forth a more complex three phase RT&D process, involving Scientific Research (R), Technological Innovation (T), and Commercial Product Development (D) or the RT&D process. Scientific research and innovation testing involve costly intellectual work and do not produce free goods, but rather require IP regulation. RT&D processes (...) involve an unrecognized IP shift from a common IP right in public goods like information and knowledge to private IP in products and other hard assets. The question then is, what kind of IP right: private or common? Since scientific research and innovation testing require openness about adverse findings, and wide, low cost diffusion of results, they require a common, inclusive IP right. Common IP is appropriate to both sharing knowledge goods and recovering the cost of production. Research is furthermore compatible with commercialization and support by other social interests. On the other hand it is incompatible with the exclusionary private IP rights that permit restrictive publication or total suppression of information. Private IP rather than commercialization conflicts with the openness requirements of scientific research and innovation testing. Commercial funding, however, is in principle compatible with research and testing, especially when regulated by a common IP right. This reflects a pragmatic view of the fundamental interconnections of knowledge and other social interests. (shrink)

Formalizing shared ethical standards is an activity of scientific societies designed to achieve a collective goal of promoting ethical conduct. A scientist who is faced with the choice of becoming a “whistleblower” by exposing misconduct does so in the context of these ethical standards. Examination of ethics policies of scientific societies which are members of the Council of Scientific Society Presidents (CSSP) shows a breadth of purpose and scope in these policies. Among the CSSP member societies, some ethics policies chiefly (...) present the ethical culture of the community in an educational context and do not have enforcement procedures. Other policies are more comprehensive and include standards for certification, procedures for addressing ethical issues, and established sanctions. Of the 36 member societies of CSSP that have developed a code or adopted a code of another professional society, 18 specifically identified a responsibility to expose ethical misconduct, demonstrating an acknowledgment of the possible critical role of the whistleblower in addressing ethical issues. Scientific societies may revise their ethics codes based upon experience gained in addressing cases of ethical misconduct. In most cases, the action of a whistleblower is the initial step in addressing an ethics violation; the whistleblower may either be in the position of an observer or a victim, such as in the case of someone who discovers that his or her own work has been plagiarized. The ethics committee of a scientific society is one of several possible outlets through which the whistleblower can voice a complaint or concern. Ethical violations can include falsification, fabrication, plagiarism and other authorship disputes, conflict of interest and other serious violations. Commonly, some of these violations may involve publication in the scientific literature. Thus addressing ethical issues may be intertwined with a scientific society’s role in the dissemination of new scientific results. For a journal published by a scientific society, the editor can refer at some point to the ethics committee of the society. Whereas, in the case of a journal published by a commercial publisher, the editor may be without direct support of the associated scientific community in handling the case. The association of a journal with a scientific society may thus direct a whistleblower towards addressing the issue within the scientific community rather than involving the press or talking to colleagues who may gossip. A formal procedure for handling ethics cases may also discourage false accusers. Another advantage of handling complaints through ethics committees is that decisions to contact home institutions or funding agencies can be made by the ethics committee and are not the responsibility of the whistleblower or the editor of the journal. The general assessment is that the establishment of ethics policies, especially policies covering publication in society journals, will promote a culture supportive of whistleblowers and discouraging to false accusers. (shrink)

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. (shrink)