The benefits and threats of research partnerships with industry

During the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. It is estimated that between 1980 and 2003 the overall research and development expenditure by US pharmaceutical companies increased from $2 billion to $33 billion [1]. The sources of funding for biomedical research have also shifted significantly towards industry. By 2002, 70% of funding for clinical trials came from industry [2]. The involvement of industry partners in research has undoubted benefits. Drug development is extraordinarily expensive, and government and other non-commercial sources of research funding have generally not been able to or willing to underwrite the enormous sums necessary to develop and test the medications and devices that have made remarkable improvements in the lives of so many. But partnership with industrial sponsors of research also carries potential threats both to human subject protection and to research integrity. Because such research may result in financial or other rewards for researchers and institutions, commercially sponsored research may taint individual or institutional judgment concerning important aspects of the conduct of research. To the extent that researchers have a financial interest in the success of the research, such as an equity interest in the sponsor, or if the researcher has come to rely upon the sponsor for research funding or for personal income, the researcher has financial interests that substantially align with those of the sponsor; that is, for a successful project with adequate recruitment and positive results. In an increasingly entrepreneurial environment, researchers and and/or institutions may own shares, options, or other interests in biotechnology companies formed for the purpose of exploiting research findings. Such interests may cause the investigator, perhaps unwittingly, to recruit subjects inappropriately, to downplay risks or exaggerate benefits, to cut corners on inclusion/exclusion criteria, or to under-report adverse events. Institutions that have come to rely on industry-sponsored research for overhead payments and other amounts that support the broader research enterprise may fail to provide adequate oversight to ensure appropriate research practices. While the existence of a financial or non-financial conflict does not itself show improper behavior, maintaining public trust in the integrity of scientific investigation and the protection of human subjects requires that conflicts be carefully managed. Particular precautions are necessary in critical care to ensure that appropriate research standards are met. For research in the intensive care unit there is frequently limited time available to secure consent, …