Many people say that it is the intellect which makes a great scientist. They are wrong: it is character."-Albert Einstein Integrity in Scientific Research attempts to define and describe those elements that encourage individuals involved with scientific research to act with integrity. Recognizing the inconsistency of human behavior, it stresses the important role that research institutions play in providing an integrity-rich environment, citing the need for institutions to provide staff with training and education, policies and procedures, and tools and support systems. It identifies practices that characterize integrity in such areas as peer review and research on human subjects and weighs the strengths and limitations of self-evaluation efforts by these institutions. In addition, it details an approach to promoting integrity during the education of researchers, including how to develop an effective curriculum. Providing a framework for research and educational institutions, this important book will be essential for anyone concerned about ethics in the scientific community.
Genomic applications are being integrated into a broad range of clinical and research activities at health care systems across the United States. This trend can be attributed to a variety of factors, including the declining cost of genome sequencing and the potential for improving health outcomes and cutting the costs of care. The goals of these genomics-based programs may be to identify individuals with clinically actionable variants as a way of preventing disease, providing diagnoses for patients with rare diseases, and advancing research on genetic contributions to health and disease. Of particular interest are genomics- based screening programs, which will, in this publication, be clinical screening programs that examine genes or variants in unselected populations in order to identify individuals who are at an increased risk for a particular health concern (e.g., diseases, adverse drug outcomes) and who might benefit from clinical interventions. On November 1, 2017, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop to explore the challenges and opportunities associated with integrating genomics-based screening programs into health care systems. This workshop was developed as a way to explore the challenges and opportunities associated with integrating genomics-based programs in health care systems in the areas of evidence collection, sustainability, data sharing, infrastructure, and equity of access. This publication summarizes the presentations and discussions from the workshop.
This document is one of two evidence-based cornerstones of the World Health Organization's (WHO) new initiative to develop and implement evidence-based guidelines for family planning. The first cornerstone, the Medical eligibility criteria for contraceptive use (third edition) published in 2004, provides guidance for who can use contraceptive methods safely. This document, the Selected practice recommendations for contraceptive use (second edition), provides guidance for how to use contraceptive methods safely and effectively once they are deemed to be medically appropriate. The recommendations contained in this document are the product of a process that culminated in an expert Working Group meeting held at the World Health Organization, Geneva, 13-16 April 2004.
Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events.
In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.
Aspen Publishers' Health Law and Compliance Center has teamed up with the Health Care Compliance Association to produce this comprehensive, practical manual. from explanations of the major legislation, to risk assessments for each of the major practice areas, to hiring and training a compliance officer, the Health Care Compliance Professional's Manual will help you implement an effective compliance program in your health care facility.Also learn about audits, reporting mechanisms, discipline, documentation, joint venture and subcontractor relationships, ethics, baseline assessments and legal risks. Finally, a selection of real-life forms and policies will get you started in creating your own facility's documentation.
This report sets out the recommendations of an international group of experts relating to developments in the quality assurance of medicines and specifications for drug substances and dosage forms. It contains guidelines of direct relevance to the UN Prequalification Programme for Priority Essential Medicines and for quality control laboratories, including procedures governing the assessment of pharmaceutical products for procurement by UN agencies and for assessing the acceptability of quality control laboratories. It also includes discussion regarding several monographs for inclusion in the International Pharmacopoeia, relating to antiretrovirals, including fixed-dose combinations, TB medicines and antimalarial and paediatric medicines.
Although epilepsy is one of the nation's most common neurological disorders, public understanding of it is limited. Many people do not know the causes of epilepsy or what they should do if they see someone having a seizure. Epilepsy is a complex spectrum of disorders that affects an estimated 2.2 million Americans in a variety of ways, and is characterized by unpredictable seizures that differ in type, cause, and severity. Yet living with epilepsy is about much more than just seizures; the disorder is often defined in practical terms, such as challenges in school, uncertainties about social situations and employment, limitations on driving, and questions about independent living. The Institute of Medicine was asked to examine the public health dimensions of the epilepsies, focusing on public health surveillance and data collection; population and public health research; health policy, health care, and human services; and education for people with the disorder and their families, health care providers, and the public. In Epilepsy Across the Spectrum, the IOM makes recommendations ranging from the expansion of collaborative epilepsy surveillance efforts, to the coordination of public awareness efforts, to the engagement of people with epilepsy and their families in education, dissemination, and advocacy for improved care and services. Taking action across multiple dimensions will improve the lives of people with epilepsy and their families. The realistic, feasible, and action-oriented recommendations in this report can help enable short- and long-term improvements for people with epilepsy. For all epilepsy organizations and advocates, local, state, and federal agencies, researchers, health care professionals, people with epilepsy, as well as the public, Epilepsy Across the Spectrum is an essential resource.
The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results. According to Methodological Challenges in Biomedical HIV Prevention Trials, the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions.
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