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The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the United States government launched a one-year deliberative process to address the continuing controversy surrounding so-called "gain-of-function" (GOF) research on respiratory pathogens with pandemic potential. The gain of function controversy began in late 2011 with the question of whether to publish the results of two experiments involving H5N1 avian influenza and continued to focus on certain research with highly pathogenic avian influenza over the next three years. The heart of the U.S. process is an evaluation of the potential risks and benefits of certain types of GOF experiments with influenza, SARS, and MERS viruses that would inform the development and adoption of a new U.S. Government policy governing the funding and conduct of GOF research. Potential Risks and Benefits of Gain-of-Function Research is the summary of a two-day public symposia on GOF research. Convened in December 2014 by the Institute of Medicine and the National Research Council, the main focus of this event was to discuss principles important for, and key considerations in, the design of risk and benefit assessments of GOF research. Participants examined the underlying scientific and technical questions that are the source of current discussion and debate over GOF research involving pathogens with pandemic potential. This report is a record of the presentations and discussion of the meeting.
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
This volume addresses the challenges associated with methodology and application of risk and resilience science and practice to address emerging threats in environmental, cyber, infrastructure and other domains. The book utilizes the collective expertise of scholars and experts in industry, government and academia in the new and emerging field of resilience in order to provide a more comprehensive and universal understanding of how resilience methodology can be applied in various disciplines and applications. This book advocates for a systems-driven view of resilience in applications ranging from cyber security to ecology to social action, and addresses resilience-based management in infrastructure, cyber, social domains and methodology and tools. Risk and Resilience has been written to open up a transparent dialog on resilience management for scientists and practitioners in all relevant academic disciplines and can be used as supplement in teaching risk assessment and management courses.
Effective risk communication is essential to the well-being of any organization and those people who depend on it. Ineffective communication can cost lives, money and reputations. Communicating Risks and Benefits: An Evidence-Based User’s Guide provides the scientific foundations for effective communications. The book authoritatively summarizes the relevant research, draws out its implications for communication design, and provides practical ways to evaluate and improve communications for any decision involving risks and benefits. Topics include the communication of quantitative information and warnings, the roles of emotion and the news media, the effects of age and literacy, and tests of how well communications meet the organization’s goals. The guide will help users in any organization, with any budget, to make the science of their communications as sound as the science that they are communicating.
From the beginning of 21st century, there has been an awareness of risk in the environment along with a growing concern for the continuing potential damage caused by hazards. In order to ensure environmental sustainability, a better understanding of natural disasters and their impacts is essential. It has been recognized that a holistic and integrated approach to environmental hazards needs to be attempted using common methodologies, such as risk analysis, which involves risk management and risk assessment. Indeed, risk management means reducing the threats posed by known hazards, whereas at the same time accepting unmanageable risks and maximizing any related benefits. The risk management framework involves evaluating the importance of a risk, either quantitatively or qualitatively. Risk assessment comprises three steps, namely risk identification (data base, event monitoring, statistical inference), risk estimation (magnitude, frequency, economic costs) and risk evaluation (cost-benefit analysis). Nevertheless, the risk management framework also includes a fourth step, risk governance, i.e. the need for a feedback of all the risk assessment undertakings. There is currently a lack of such feedback which constitutes a serious deficiency in the reduction of environmental hazards. This book emphasises methodological approaches and procedures of the three main components in the study of environmental hazards, namely forecasting - nowcasting (before), monitoring (during) and assessment (after), based on geoinformatic technologies and data and simulation through examples and case studies. These are considered within the risk management framework and, in particular, within the three components of risk assessment, namely risk identification, risk estimation and risk evaluation. This approach is a contemporary and innovative procedure and constitutes current research in the field of environmental hazards. Environmental Hazards Methodologies for Risk Assessment and Management covers hydrological hazards (floods, droughts, storms, hail, desertification), biophysical hazards (frost, heat waves, epidemics, forest fires), geological hazards (landslides, snow avalanches), tectonic hazards (earthquakes, volcanoes), and technological hazards. This book provides a text and a resource on environmental hazards for senior undergraduate students, graduate students on all courses related to environmental hazards and risk assessment and management. It is a valuable handbook for researchers and professionals of environmental science, environmental economics and management, and engineering. Editor: Nicolas R. Dalezios, University of Thessaly, Greece
Economists, decision analysts, management scientists, and others have long argued that government should take a more scientific approach to decision making. Pointing to various theories for prescribing and rational izing choices, they have maintained that social goals could be achieved more effectively and at lower costs if government decisions were routinely subjected to analysis. Now, government policy makers are putting decision science to the test. Recent government actions encourage and in some cases require government decisions to be evaluated using formally defined principles 01' rationality. Will decision science pass tbis test? The answer depends on whether analysts can quickly and successfully translate their theories into practical approaches and whether these approaches promote the solution of the complex, highly uncertain, and politically sensitive problems that are of greatest concern to government decision makers. The future of decision science, perhaps even the nation's well-being, depends on the outcome. A major difficulty for the analysts who are being called upon by government to apply decision-aiding approaches is that decision science has not yet evolved a universally accepted methodology for analyzing social decisions involving risk. Numerous approaches have been proposed, including variations of cost-benefit analysis, decision analysis, and applied social welfare theory. Each of these, however, has its limitations and deficiencies and none has a proven track record for application to govern ment decisions involving risk. Cost-benefit approaches have been exten sively applied by the government, but most applications have been for decisions that were largely risk-free.
The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.