The National Children's Study Research Plan


Book Description

The National Children's Study (NCS) is planned to be the largest long-term study of environmental and genetic effects on children's health ever conducted in the United States. It proposes to examine the effects of environmental influences on the health and development of approximately 100,000 children across the United States, following them from before birth until age 21. By archiving all of the data collected, the NCS is intended to provide a valuable resource for analyses conducted many years into the future. This book evaluates the research plan for the NCS, by assessing the scientific rigor of the study and the extent to which it is being carried out with methods, measures, and collection of data and specimens to maximize the scientific yield of the study. The book concludes that if the NCS is conducted as proposed, the database derived from the study should be valuable for investigating hypotheses described in the research plan as well as additional hypotheses that will evolve. Nevertheless, there are important weaknesses and shortcomings in the research plan that diminish the study's expected value below what it might be.







Principles and Practice of Clinical Research


Book Description

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government







Beyond the HIPAA Privacy Rule


Book Description

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.




Examining the Health Disparities Research Plan of the National Institutes of Health


Book Description

In the United States, health among racial and ethnic minorities, as well as poor people, is significantly worse than the overall U.S. population. Health disparities are reflected by indices such as excess mortality and morbidity and shorter life expectancy. Examining the Health Disparities Research Plan of the National Institutes of Health is an assessment of the National Institutes of Health (NIH) Strategic Research Plan and Budget to Reduce and Ultimately Eliminate Health Disparities. It focuses on practical solutions to remedy the state of the current health disparity crisis. The NIH has played the leading role in conducting extensive research on minority health and health disparities for more than two decades. Although additional research is critical to facilitating a better understanding of the overarching social, economic, educational, and environmental factors that predispose groups to specific diseases and conditions, there is also a great need to translate the existing and new information into best care practices. This means increasing communication with affected populations and their communities. Examining the Health Disparities Research Plan of the National Institutes of Health presents solutions to improving the health disparities nationwide and evaluates the NIH strategy plan designed to actively correct and combat the ongoing health disparities dilemma.




Responsible Conduct of Research


Book Description

Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.




The Health of Lesbian, Gay, Bisexual, and Transgender People


Book Description

At a time when lesbian, gay, bisexual, and transgender individuals-often referred to under the umbrella acronym LGBT-are becoming more visible in society and more socially acknowledged, clinicians and researchers are faced with incomplete information about their health status. While LGBT populations often are combined as a single entity for research and advocacy purposes, each is a distinct population group with its own specific health needs. Furthermore, the experiences of LGBT individuals are not uniform and are shaped by factors of race, ethnicity, socioeconomic status, geographical location, and age, any of which can have an effect on health-related concerns and needs. The Health of Lesbian, Gay, Bisexual, and Transgender People assesses the state of science on the health status of LGBT populations, identifies research gaps and opportunities, and outlines a research agenda for the National Institute of Health. The report examines the health status of these populations in three life stages: childhood and adolescence, early/middle adulthood, and later adulthood. At each life stage, the committee studied mental health, physical health, risks and protective factors, health services, and contextual influences. To advance understanding of the health needs of all LGBT individuals, the report finds that researchers need more data about the demographics of these populations, improved methods for collecting and analyzing data, and an increased participation of sexual and gender minorities in research. The Health of Lesbian, Gay, Bisexual, and Transgender People is a valuable resource for policymakers, federal agencies including the National Institute of Health (NIH), LGBT advocacy groups, clinicians, and service providers.




Implementation Research in Health


Book Description

Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.




Designing Clinical Research


Book Description

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.