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




Women and Health Research


Book Description

In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.




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.




Conflict of Interest in Medical Research, Education, and Practice


Book Description

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.




Health Research


Book Description

Health and development. Funding research. Research priorities in developing countries, in industrialized countries and international centers. International research promotion. An agenda for action. Summary of specific-recommendations







Research Methods for Public Health


Book Description

Research Methods for Public Health offers an in-depth introduction to the theories, concepts, approaches and practices, relevant to research methods in a public health setting. Informed by a socio-ecological model of public health, the book uses real world research examples and contemporary social, political and environmental themes of public health that reflect UK and international contexts. The book provides a straightforward approach to developing a research project and applying methods in practical and realistic ways, using an innovative, integrative approach that combines methodologies. The authors have moved away from traditional approaches to research methods, and include chapters on primary quantitative, qualitative and mixed methods research, evidence synthesis approaches, critical appraisal, research governance and ethics, and dissemination. Essential reading for postgraduate students, researchers and public health practitioners, or individuals preparing for the UK Faculty of Public Health Part A examination.




Who Will Keep the Public Healthy?


Book Description

Bioterrorism, drug-resistant disease, transmission of disease by global travel . . . there's no shortage of challenges facing America's public health officials. Men and women preparing to enter the field require state-of-the-art training to meet these increasing threats to the public health. But are the programs they rely on provide the high caliber professional training they require? Who Will Keep the Public Healthy? provides an overview of the past, present, and future of public health education, assessing its readiness to provide the training and education needed to prepare men and women to face 21st century challenges. Advocating an ecological approach to public health, the Institute of Medicine examines the role of public health schools and degree-granting programs, medical schools, nursing schools, and government agencies, as well as other institutions that foster public health education and leadership. Specific recommendations address the content of public health education, qualifications for faculty, availability of supervised practice, opportunities for cross-disciplinary research and education, cooperation with government agencies, and government funding for education. Eight areas of critical importance to public health education in the 21st century are examined in depth: informatics, genomics, communication, cultural competence, community-based participatory research, global health, policy and law, and public health ethics. The book also includes a discussion of the policy implications of its ecological framework.




The Future of Public Health


Book Description

"The Nation has lost sight of its public health goals and has allowed the system of public health to fall into 'disarray'," from The Future of Public Health. This startling book contains proposals for ensuring that public health service programs are efficient and effective enough to deal not only with the topics of today, but also with those of tomorrow. In addition, the authors make recommendations for core functions in public health assessment, policy development, and service assurances, and identify the level of government--federal, state, and local--at which these functions would best be handled.




Introduction to Health Research Methods


Book Description

A step-by-step guide to conducting research in medicine, public health, and other health sciences, this clear, practical, and straightforward text demystifies the research process and empowers students (and other new investigators) to conduct their own original research projects.