Informing the Future Critical Issues in Health, Third Edition (2005) / Chapter Skim
Currently Skimming:
Guiding Biomedical and Clinical Research
Guiding Biomedical and Clinical Research
Pages 19-28
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From page 19... ...
Guidelines for Human Embryonic Stem Cell Research (2005) recommends an oversight process which should assure that hES cell research is conducted in a responsible and ethically sensitive manner, and in compliance with all regulatory requirements pertaining to biomedical research in general.
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The Best Pharmaceuticals for Children Act of 2002 charged the IOM with reviewing current regulations and research efforts and recommending desirable practices for clinical research involving children. Developing an effective and Ethical Conduct of Clinical Research Involving adequately funded system for Children (2004)
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In order to help fill gaps in information about how well current federal regulations are working in protecting children, the DHHS should develop and carry out a plan for collecting and reporting data on pediatric research and its oversight. In addition, national and local professional organizations and research institutions should voluntarily promote quality-improvement efforts in the design, review, and conduct of clinical research involving children.
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recommends Instead, it calls for a congressional process for modifications to improve funding reviewing specific proposals for change in the procedures for innovative NIH structure. interdisciplinary research that reflects strategic objectives and The second study addresses the concuts across all of the institutes tentious question of how to apportion funding and centers.
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reconciliation, amendment, and conference negotiations among NIH, HHS, OMB Executive Office House and Senate appropriation Office of of the President committees Management and Budget (OMB) House and Senate President's budget committees Congress Budget This figure illustrates the complex processes involved in NIH's budget.
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offers recommendations for improving the classification and tracking of center programs, improving the decision processes, setting criteria for establishing new centers, resolving disagree ments, and evaluating the performance of center programs more regularly and systematically. The report concludes by noting that recent changes in the nature of biomedical research have opened the possibilities for understanding complex biological systems through collaborations among multiple investigators in different fields and at different institutions and through the assembly of large scale research infrastructures and databases.
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The DoD turned to the IOM for guidance about the design of a research strategy to study prion disease. The 1985 outbreak of mad cow disease in the United Kingdom generated global awareness of a new class of neurodegenerative diseases called transmissible spongiform encephalopathies (TSEs)
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Particular attention is given to translational research, which focuses on transferring basic discoveries in the lab oratory into clinical trials and ultimately into practice. Efforts should focus on three areas: increasing knowledge of basic neurobiology and therapeutic approaches, emphasizing and coordinating translational multidisciplinary research and clinical trials, and strengthening the research infrastructure and enhancing the training of scientists and physicians working in this field.
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From page 27... ...
York Spinal Cord Injury Research Board, which requested the study.
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