Conflict of Interest in Medical Research, Education, and Practice
Conflict of Interest in Medical Research, Education, and Practice

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-09-16

Total Pages: 436

ISBN-13: 0309145449

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Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Biomedical Research in the Drugs Field
Biomedical Research in the Drugs Field

Author: Richard Muscat

Publisher: Council of Europe

Published: 2006-01-01

Total Pages: 114

ISBN-13: 9287160171

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Why is it that certain people use drugs in the first place and then why do some become dependent following repeated use while others do not? What are the possible implications of the current state of affairs of research from a biomedical or more aptly put, a Neuroscience perspective, including an ethical point of view? These are questions the author attempts to answer as the biomedical or neuroscience research in the drug field is a fast moving area with ethical implications that have arisen as a result of the conduct of such research.

Advancing the Nation's Health Needs
Advancing the Nation's Health Needs

Author: National Research Council

Publisher: National Academies Press

Published: 2005-08-13

Total Pages: 187

ISBN-13: 0309094275

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This report is the twelfth assessment of the National Institutes of Health National Research Service Awards program. The research training needs of the country in basic biomedical, clinical, and behavioral and social sciences are considered. Also included are the training needs of oral health, nursing, and health services research. The report has been broadly constructed to take into account the rapidly evolving national and international health care needs. The past and present are analyzed, and predictions with regard to future needs are presented.

Evidence-Based Medicine and the Changing Nature of Health Care
Evidence-Based Medicine and the Changing Nature of Health Care

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2008-09-06

Total Pages: 202

ISBN-13: 0309113695

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Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access
The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-01-27

Total Pages: 103

ISBN-13: 0309498511

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To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Beyond the HIPAA Privacy Rule
Beyond the HIPAA Privacy Rule

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-03-24

Total Pages: 334

ISBN-13: 0309124999

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In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

The Minipig in Biomedical Research
The Minipig in Biomedical Research

Author: Peter A. McAnulty

Publisher: CRC Press

Published: 2011-12-19

Total Pages: 713

ISBN-13: 1439811180

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The Minipig in Biomedical Research is a comprehensive resource for research scientists on the potential and use of the minipig in basic and applied biomedical research, and the development of drugs and chemicals. Written by acknowledged experts in the field, and drawing on the authors’ global contacts and experience with regulatory authorities and the pharmaceutical and other industries, this accessible manual ranges widely over the biological, scientific, and practical uses of the minipig in the laboratory. Its coverage extends from the minipig’s origins, anatomy, genetics, immunology, and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. Regulatory aspects of its use are considered. The reader will find an extensive amount of theoretical and practical information in the pharmacology; ADME and toxicology chapters which will help scientists and managers when deciding which species to use in basic research; drug discovery and pharmacology; and toxicology studies of chemicals, biotechnology products and devices. The book discusses regulatory uses of minipigs in the evaluation of human and veterinary pharmaceuticals, medical devices, and other classes of xenobiotics. It describes features of normal health, normal laboratory values, and common diseases. It also carefully elucidates ethical and legal considerations in their supply, housing, and transport. The result is an all-inclusive and up to date manual about the experimental uses of the minipig that describes ‘How to’ and ‘Why’ and ’What to expect in the normal’, combining enthusiasm and experience with critical assessment of its values and potential problems.

Testing Treatments
Testing Treatments

Author: Imogen Evans

Publisher: Pinter & Martin Publishers

Published: 2011

Total Pages: 187

ISBN-13: 1905177488

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This work provides a thought-provoking account of how medical treatments can be tested with unbiased or 'fair' trials and explains how patients can work with doctors to achieve this vital goal. It spans the gamut of therapy from mastectomy to thalidomide and explores a vast range of case studies.

Pathways of Addiction
Pathways of Addiction

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1996-11-01

Total Pages: 330

ISBN-13: 0309055334

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Drug abuse persists as one of the most costly and contentious problems on the nation's agenda. Pathways of Addiction meets the need for a clear and thoughtful national research agenda that will yield the greatest benefit from today's limited resources. The committee makes its recommendations within the public health framework and incorporates diverse fields of inquiry and a range of policy positions. It examines both the demand and supply aspects of drug abuse. Pathways of Addiction offers a fact-filled, highly readable examination of drug abuse issues in the United States, describing findings and outlining research needs in the areas of behavioral and neurobiological foundations of drug abuse. The book covers the epidemiology and etiology of drug abuse and discusses several of its most troubling health and social consequences, including HIV, violence, and harm to children. Pathways of Addiction looks at the efficacy of different prevention interventions and the many advances that have been made in treatment research in the past 20 years. The book also examines drug treatment in the criminal justice setting and the effectiveness of drug treatment under managed care. The committee advocates systematic study of the laws by which the nation attempts to control drug use and identifies the research questions most germane to public policy. Pathways of Addiction provides a strategic outline for wise investment of the nation's research resources in drug abuse. This comprehensive and accessible volume will have widespread relevanceâ€"to policymakers, researchers, research administrators, foundation decisionmakers, healthcare professionals, faculty and students, and concerned individuals.