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The Regulatory environment for science.

The Regulatory environment for science.
Author: United States. Congress. Office of Technology Assessment
Publisher: DIANE Publishing
Total Pages: 139
Release: 1986
Genre:
ISBN: 1428923136

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Science and the Regulatory Environment

Science and the Regulatory Environment
Author: United States. Congress. House. Committee on Science and Technology. Task Force on Science Policy
Publisher:
Total Pages: 182
Release: 1986
Genre: Science
ISBN:

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Biotechnology Research in an Age of Terrorism

Biotechnology Research in an Age of Terrorism
Author: National Research Council
Publisher: National Academies Press
Total Pages: 164
Release: 2004-03-02
Genre: Technology & Engineering
ISBN: 0309089778

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In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.


Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 118
Release: 2012-04-04
Genre: Medical
ISBN: 0309222176

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The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.


Institutions and Incentives in Regulatory Science

Institutions and Incentives in Regulatory Science
Author: Jason Scott Johnston
Publisher: Lexington Books
Total Pages: 235
Release: 2012
Genre: Law
ISBN: 0739169467

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Institutions and Incentives in Regulatory Science explores fundamental problems with regulatory science in the environmental and natural resource law field. Each chapter covers a variety of natural resource and regulatory areas, ranging from climate change to endangered species protection and traditional health-based environmental regulation. Regulatory laws and institutions themselves strongly influence the direction of scientific research by creating a system of rewards and penalties for science. As a consequence, regulatory laws or institutions that are designed naively end up incentivizing scientists to generate and then publish only those results that further the substantive regulatory goals preferred by the scientists. By relying so heavily on science to dictate policy, regulatory laws and institutions encourage scientists to use their assessment of the state of the science to further their own preferred scientific and regulatory policy agendas. Additionally, many environmental and natural resource regulatory agencies have been instructed by legislatures to rely heavily upon science in their rulemaking. In areas of rapidly evolving science, regulatory agencies are inevitably looking for scientific consensus prematurely, before the scientific process has worked through competing hypotheses and evidence. The contributors in this volume address how institutions for regulatory science should be designed in light of the inevitable misfit between the political or legal demand for regulatory action and the actual state of evolving scientific knowledge.