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Background: Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards., Methods: From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions' agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials., Results: Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions--from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50])--demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items., Conclusions: Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed., (Copyright 2002 Massachusetts Medical Society)

This review of recently published pharmaceutical industry-sponsored comparative psychotropic drug trials aims to classify apparent design and reporting modifications that favor the sponsor's product. The modifications have been grouped into 13 discrete categories, and representative examples of each are presented. Strong circumstantial evidence suggests that marketing goals led to these adjustments. The consequences of marketing influences on comparative psychopharmacology trials are discussed in terms of conflicts of interest, the integrity of the scientific literature, and costs to consumers, as well as their impact on physician practice.

In the past few years, US federal agencies governing research with human subjects and institutional review boards have taken a higher-profile path than ever before, both at home and internationally. This trend carries profound significance for US-based institutions and has implications also for the rest of the world. What does this critical moment of heightened federal scrutiny mean for the workings of US institutional review boards? We examined board activity across 3 dimensions: time, place, and consciousness. We conclude that although institutions in all areas of biomedical and social science research are adapting their practices, the field of public health is especially well positioned to adapt to, and succeed in, new efforts to ensure protection of human research subjects.

The debate on the ethics of international clinical research involving collaboration with developing countries has achieved a high profile in recent years. Informed consent and universal standards have been most intensively debated. Exploitation and lack of adequate attention to justice in the distribution of risks/harm and benefits to individuals and communities have to a lesser extent been addressed. The global context in which these debates are taking place, and some of the less obvious implications for research ethics and for health are discussed here to broaden understanding of the complexity of the debate. A wider role is proposed for research ethics committees, one that includes an educational component and some responsibility for audit. It is proposed that new ways of thinking are needed about the role of research ethics in promoting moral progress in the research endeavour and improving global health.

Background: The development and use of an operations manual has the potential to improve the capacity of nurse scientists to address the complex, multifaceted issues associated with conducting research in today's healthcare environment. An operations manual facilitates communication, standardizes training and evaluation, and enhances the development and standard implementation of clear policies, processes, and protocols. A 10-year review of methodology articles in relevant nursing journals revealed no attention to this topic., Objectives: This article will discuss how an operations manual can improve the conduct of research methods and outcomes for both small-scale and large-scale research studies. It also describes the purpose and components of a prototype operations manual for use in quantitative research., Conclusion: The operations manual increases reliability and reproducibility of the research while improving the management of study processes. It can prevent costly and untimely delays or errors in the conduct of research.

Background: Previous studies limited to specific drugs or journal types have shown an association between the source of funding of research and the published results., Objective: The aim of the present study was to determine the association between source of support of research and published outcomes of randomized controlled drug trials in general interest medical journals., Methods: Randomized controlled drug trials (n = 314) published in five general interest medical journals over a 2-year period were reviewed. Study outcome was classified as positive or negative. Support was classified as pharmaceutical industry or non-industry. Association between source of support and outcome was tested with the chi-squared statistic., Results: Positive findings were found in 77% of studies, negative findings in 20% and an uncertain outcome in 3%. Support from commercial sources was found in 68% of trials. Negative findings were found in 13% of industry-supported studies and in 35% of non-industry-supported studies (chi-squared = 18.36, P < 0.0001, odds ratio = 3.54, 95% confidence interval 1.90-6.62)., Conclusions: An association was found between the source of study support and the published outcome. Though the reason for this association cannot be determined from the data collected, future studies may clarify the importance of this finding for readers concerned with the relationship of funding bodies to the publication of research outcomes.

There is an urgent need for robust empirical data to guide the assessment and treatment of patients near the end of life. Because they are important providers of end-of-life care in this country, hospices have an important role to play in facilitating this research. However, hospices may also face considerable ethical challenges in doing so. This task force statement begins by discussing the importance of hospices' potential contributions to research. Next, we describe ways in which characteristics of hospice patients, and hospices' structure, create ethical challenges that may limit these contributions. We conclude by proposing ways in which hospices and national professional organizations can begin to overcome some of these challenges.

Increasing attention is being directed to measuring and monitoring the use of health-related R&D funding, partly to justify this expenditure and partly to ensure that R&D effort is directed to achieving the paybacks desired by funders. These paybacks include contributing to knowledge, contributing to R&D capacity, political benefits, benefits to the health service and to patients, and more general economic benefits. This paper addresses the issues that must be considered when designing a routine performance management system for health R&D. Conventional methods of routine performance management are often rendered inappropriate in this context by the intangible and unpredictable outcomes of research, which are heterogeneous across projects and programmes and which can be hard to attribute to particular R&D support. Instead, to be effective in this context, a routine system must combine quantitative and qualitative indicators, utilising information from a number of different sources. The system must achieve acceptable levels (defined by the funder) on each of the following criteria: it must measure those dimensions of payback that are valued by the funder; it must be decision-relevant; it must be consistent with truthful compliance; it must minimise perverse incentives; and it must have acceptable net costs. It is vitally important that the system itself generates a positive payback. We illustrate these issues by outlining a system that might be used to monitor the payback from government-funded R&D.

As industry sponsorship of pharmacoeconomic studies has increased, concerns have been raised about potential biases, owing to the conflicts of interest that this sponsorship creates. A review of the literature indicates that there are some causes for concern, given the fact that most pharmacoeconomic studies report positive findings for the sponsor's drug. However, a more detailed analysis suggests that, although the methodologic quality of some published studies may be poor, the main reason for positive results is that companies only sponsor economic studies where a positive outcome is likely. Therefore, it is concluded that the best way of dealing with perceptions of sponsorship bias is not increased rhetoric, but rather increased public funding for economic evaluation of medicines, thereby creating a true mixed economy for research funding in this field.

Investigator's and institutions' financial conflicts of interest in clinical research raise serious questions about the objectivity of such research, the safety of human subjects, and the threat to public trust in the integrity of clinical research. Yet the author makes clear that a conflict of interest is a state of affairs, not a behavior, and therefore not automatically a manifestation of improper actions. Indeed, conflicts of interest are quite common in complex settings such as those of academic medicine, and usually pose no problem, both because of the safeguards already in place and the integrity of most researchers. But it is clear that both non-financial conflicts of interest (e.g., career advancement, peer recognition, garnering grants and publications) and financial ones are double-edged: they can motivate individuals to do their best work but also can compromise judgment and undermine objectivity. In particular, conflicts of interest involving money, especially money from external sources, warrant special, targeted safeguards. And whether or not such conflicts of interest have actually created significant problems, academic medicine risks great peril if its leaders fail to respond to the growing perception that such problems exist. To foster public trust, the public needs to be better educated about how, with proper safeguards, limited financial incentives in the conduct of clinical research can benefit everyone. In addition, safeguards against the downsides of such financial incentives must be visibly strengthened. The author offers eight suggestions for what academic medicine's leaders might do in this regard (comply with existing full-disclosure requirements; establish principles governing institutional conflicts of interest; etc.). He closes by reiterating that the pursuit of clinical research depends entirely on the ability and willingness of the research community to merit public trust.