Tobacco control implications of the first European product liability suit.
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OBJECTIVE: To examine tobacco control implication of the first European product liability suit in Finland. METHODS: Systematic search of internal tobacco industry documents available on the internet and at the British American Tobacco Guildford Depository. RESULTS: Despite legal loss, the litigation contributed to subsequent tobacco control legislation in Finland. The proceedings revealed that the industry had concealed the health hazards of its products and, despite indisputable evidence, continued to deny them. The positions taken by the industry rocked its reliability as a social actor and thus weakened its chances of influencing tobacco policy. Despite fierce opposition from the tobacco industry, tobacco products were included in the product liability legislation, tobacco was entered on the Finnish list of carcinogens, and an extensive Tobacco Act was passed in Parliament. CONCLUSIONS: Tobacco litigation might not stand alone as a tool for public health policymaking but it may well stimulate national debate over the role of smoking in society and influence the policy agenda. (+info)
The limits of competing interest disclosures.
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OBJECTIVE: To assess the effectiveness of conflict of interest disclosure policies by comparing a competing interests disclosure statement that met the requirements established by the journal in a 2003 article on health effects of secondhand smoke based on the American Cancer Society CPS-I dataset with internal tobacco industry documents describing financial ties between the tobacco industry and authors of the study. DESIGN: Descriptive analysis of internal tobacco industry documents retrieved from the Legacy Tobacco Documents Library, University of California, San Francisco. RESULTS: Meeting the requirements for financial disclosure established by the journal did not provide the reader with a full picture of the tobacco industry's involvement with the study authors. The tobacco industry documents reveal that the authors had long standing financial and other working relationships with the tobacco industry. CONCLUSION: These findings are another example of how simply requiring authors to disclose financial ties with the tobacco industry may not be adequate to give readers (and reviewers) a full picture of the author's relationship with the tobacco industry. The documents also reveal that the industry funds research to enhance its credibility and endeavours to work with respected scientists to advance its goals. These findings question the adequacy of current journal policies regarding competing interest disclosures and the acceptability of tobacco industry funding for academic research. (+info)
Resident and faculty perceptions of conflict of interest in medical education.
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OBJECTIVE: To determine resident and faculty perceptions of the pharmaceutical industry's influence on medical education. DESIGN, SETTING, AND PARTICIPANTS: Anonymous survey of categorical residents and faculty in the department of medicine at a large, Midwestern, urban, independent academic medical center. MAIN RESULTS: Eighty-one residents (69.2%) and 196 faculty (75.7%) responded to the survey. Residents believed that a significantly higher percentage of primary care and subspecialist faculty receives industry income or gifts compared to faculty respondents. Many faculty, and to a significantly greater degree residents, indicated that income or gifts influence the teaching of both internal attending physicians and visiting faculty in a variety of educational settings. The majority of residents (61.7%) and faculty (62.2%) believed that annual income or gifts less than $10,000 could influence an attending physician's teaching. Most residents (65.4%) and faculty (74%) preferred that lecturers report all financial relationships with industry regardless of which relationships the lecturer believes are relevant. CONCLUSIONS: Most internal medicine residents and their faculty perceive that industry influences teaching in different educational settings, and want teachers to disclose all of their financial relationships with industry. This information may guide further development of policies and curricula addressing industry relationships within graduate medical education. (+info)
Public Health Service policies on research misconduct. Final rule.
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This final rule removes 42 CFR part 50, subpart A, "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science," and replaces it with a new, more comprehensive part 93, "Public Health Service Policies on Research Misconduct." The proposed part 93 was published for public comment on April 16, 2004. The final rule reflects both substantive and non-substantive amendments in response to public comments and to correct errors and improve clarity, but the general approach of the NPRM is retained. The purpose of the final rule is to implement legislative and policy changes applicable to research misconduct that occurred over the last several years, including the common Federal policies and procedures on research misconduct issued by the Office of Science and Technology Policy on December 6, 2000. (+info)
IRBs, conflict and liability: will we see IRBs in court? Or is it when?
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The entire human research infrastructure is under intense and increasing financial pressure. These pressures may have been responsible for several errors in judgment by those responsible for managing human research and protecting human subjects. The result of these errors has been some terrible accidents, some of which have cost the lives of human research volunteers. This, in turn, is producing both increased liability risk for those who manage the various aspects of human research and increasing scrutiny as to the capability of the human research protection structure as currently constituted. It is the author's contention that the current structure is fully capable of offering sufficient protection for participants in human research-if Institutional Review Board (IRB) staff and members are given sufficient resources and perform their tasks with sufficient responsibility. The status quo alternative is that IRBs and their members will find themselves at great risk of becoming defendants in lawsuits seeking compensation for damages resulting from human experimentation gone awry. (+info)
Legal liabilities in research: early lessons from North America.
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The legal risks associated with health research involving human subjects have been highlighted recently by a number of lawsuits launched against those involved in conducting and evaluating the research. Some of these cases have been fully addressed by the legal system, resulting in judgments that provide some guidance. The vast majority of cases have either settled before going to trial, or have not yet been addressed by the courts, leaving us to wonder what might have been and what guidance future cases may bring. What is striking about the lawsuits that have been commenced is the broad range of individuals/institutions that are named as defendants and the broad range of allegations that are made. The research community should take this early experience as a warning and should reflect carefully on practices where research involving human subjects is concerned. (+info)
At issue: A model for academic/industry collaboration.
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Relationships between academia and industry are increasingly intimate and commercial. While opportunities are created for each partner, there are also important conflict of interest issues. Particularly challenging is ensuring that universities maintain their traditional role in public science while partnering with a commercial entity with a tradition of proprietary science. We describe a collaboration where the interests and values of each partner were articulated in advance and conflict of interest issues were resolved before legal and business arrangements were established in a contract. We discuss the principles involved and the resolutions achieved in the hope that it may provide a useful model for addressing academic/industry scientific collaborations. (+info)
Workshop proceedings: managing conflict of interest in science. A little consensus and a lot of controversy.
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There is no doubt that participants in the Conflict of Interest (COI) Workshop at the Society of Toxicology (SOT) 2005 Annual Meeting (New Orleans, 6-10 March 2005) engaged in a vigorous and useful exchange of diverse ideas and viewpoints. While there was consensus on the value and interest of this Workshop, there was less consensus and more controversy over many of the issues discussed during the Workshop, which included the distinction between bias and conflict, the success or failure of policies of disclosure, whether waivers should or should not be granted to conflicted individuals in order to seat a "balanced" committee with appropriate expertise, whether conflicted individuals retain the ability to recognize their own conflict, and more. The discussion left no doubt, however, that conflict of interest will remain an important and controversial issue in the scientific community for some time to come. (+info)