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The International Space Station human life sciences experiment implementation process

The selection, definition, and development phases of a Life Sciences flight research experiment has been consistent throughout the past decade. The implementation process, however, has changed significantly within the past two years. This change is driven primarily by the shift from highly integrated, dedicated research missions on platforms with well defined processes to self contained experiments with stand alone operations on platforms which are being concurrently designed. For experiments manifested on the International Space Station (ISS) and/or on short duration missions, the more modular, streamlined, and independent the individual experiment is, the more likely it is to be successfully implemented before the ISS assembly is completed. During the assembly phase of the ISS, science operations are lower in priority than the construction of the station. After the station has been completed, it is expected that more resources will be available to perform research. The complexity of implementing investigations increases with the logistics needed to perform the experiment. Examples of logistics issues include- hardware unique to the experiment; large up and down mass and volume needs; access to crew and hardware during the ascent or descent phases; maintenance of hardware and supplies with a limited shelf life,- baseline data collection schedules with lengthy sessions or sessions close to the launch or landing; onboard stowage availability, particularly cold stowage; and extensive training where highly proficient skills must be maintained. As the ISS processes become better defined, experiment implementation will meet new challenges due to distributed management, on-orbit resource sharing, and adjustments to crew availability pre- and post-increment. c 2001. Elsevier Science Ltd. All rights reserved.

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A national survey of policies on disclosure of conflicts of interest in biomedical research

BACKGROUND: Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. METHODS: We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. RESULTS: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent)--5 medical schools and 10 other research institutions--reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. CONCLUSIONS: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity.

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