This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.

Human population genetic research (HPGR) seeks to identify the diversity and variation of the human genome and how human group and individual genetic diversity has developed. This book asks whether developing countries are well prepared for the ethical and legal conduct of human population genetic research, with specific regard to vulnerable target group protection. The book highlights particular issues raised by genetic research on populations as a whole, such as the potential harm specific groups may suffer in genetic research, and the capacity for current frameworks of Western developed countries to provide adequate protections for these target populations. Using The People’s Republic of China as a key example, Yue Wang argues that since the target groups of HPGR are almost always from isolated and rural areas of developing countries, the ethical and legal frameworks for human subject protection need to be reconsidered in order to eliminate, or at least reduce, the vulnerability of those groups. While most discussion in this field focuses on the impact of genetic research on individuals, this book breaks new ground in exploring how the interests of target groups are also seriously implicated in genetic work. In evaluating current regulations concerning prevention of harm to vulnerable groups, the book also puts forward an alternative model for group protection in the context of human population genetic research in developing countries. The book will be of great interest to students and academics of medical law, ethics, and the implications of genetic research.

This brief, practical text covers all aspects of tactical emergency medicine—the practice of emergency medicine in the field, rather than at the hospital, during disasters, police or military conflicts, mass events, and community incidents. Key topics covered include hostage survival, insertion and extraction techniques, continuum of force, medical support, planning and triage, medical evaluation in the incident zone, care in custody, medical control of incident site, decontamination, community communication, and more. Boxed definitions, case scenarios, and treatment algorithms are included. The concluding chapter presents "real world" scenarios to run tactical teams through and lists recommended training programs and continuing education.

The Oxford Textbook of Clinical Research Ethics is the first systematic and comprehensive reference on clinical research ethics. Under the editorship of experts from the National Institutes of Health of the United States, the book offers a wide-ranging and systematic examination of all aspects of research with human beings. Considering historical triumphs of research as well as tragedies, the textbook provides a framework for analysing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the textbook examines issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent as well as focused consideration of international research ethics, conflicts of interests and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research with human beings.

AIDS researchers are investigating new vaccines that would prevent infection with HIV and reduce the spread of AIDS. Some have argued that product liability concerns have discouraged investment in HIV vaccine research and development. The purpose of this OTA background paper is to describe the current state of development of HIV vaccines, and to discuss what is known about adverse reactions that may occur. The background paper provides an overview of ethical issues that arise in the conduct of HIV vaccine trials. The report also discusses alternatives to the current product liability system to encourage the development of HIV vaccines and to fairly compensate those who are harmed as a result of adverse reactions to the vaccine. This background paper was prepared in response to a request from the Subcommittee on Health of the House Ways and Means Committee. It is eleventh in OTA's series of studies on HIV-related issues.

Nursing and Midwifery Research is an essential guide in assisting students and practitioners develop sound research skills to enhance their knowledge and practice. Written by Dean Whitehead and Caleb Ferguson, the 6th ANZ edition includes the most recent updates and developments in Australian and New Zealand nursing and midwifery practice, with a focus on evidence-based practice, along with a range of contemporary research articles and pedagogy to support specific chapter content. Using clear language and examples, the 6th edition of Nursing and Midwifery Research provides a valuable resource to assist healthcare students and practitioners in developing strong skills in research literacy and critical appraisal, as well as the confidence to successfully conduct research and apply outcomes to practice. A focus on digital communication - includes overviews and tips on navigating professional and personal electronic media Individual and group activities throughout to encourage skill development, reflection and awareness of self and others An extensive suite of scenarios - practise and apply your communication skills using realistic situations and individuals that healthcare professionals encounter in clinical practice Additional resources on Evolve eBook on VitalSource Instructor resources: Answer guides to Tutorial Triggers PowerPoint presentations Student and Instructor resources: Answer guides to An Unexpected Hurdle Answers to Learning Activities Research Articles and Questions Answer guides to Time to Reflect Glossary New co-editor, Caleb Ferguson, from Western Sydney University Fully updated Chapter 15 'Indigenous Peoples and Research' offers leading cultural insights into Indigenous approaches to research Fully updated Chapter 20 'A Research Project Journey: from Conception to Completion' fully details the process of a mixed methods project, from beginning to dissemination, that explores the topical issue of patients and carers living with bladder cancer Updated chapters throughout reflect current nursing and midwifery perspectives to provide you with the latest data and most recent examples of evidence-based practice A stronger focus on the role of social media and bibliometrics in conducting and disseminating research outcomes ensures latest best practice guidelines Real-world examples of the research process prepare you for common experiences you can expect during your own research journey and the processes that you are likely to encounter An eBook included in all print purchases

More people in communities of color are contracting, living with, and being treated for HIV/AIDS than ever before. In 2005, 71% of new AIDS cases were diagnosed in people of color. The rate of HIV infection in the African-American community alone has increased from 25% of total cases diagnosed in 1985 to 50% in 2005. Latinos similarly comprise a disproportionate segment of the AIDS epidemic: though they make up only 14% of the U.S. population, 20% of AIDS cases diagnosed in 2004 were Latino/a. Though the number of racial and ethnic minority HIV/AIDS cases continues to grow, the health care community has been unable to adequately meet the unique medical needs of these populations. African-American, Latino/Latina, and other patients of color are less likely to seek medical care, have sufficient access to the health care system, or receive the drugs they need for as long as they need them. HIV/AIDS in Minority Communities acknowledges the prevalence of HIV/AIDS within minority communities in the U.S. and strives to educate physicians about the barriers to treatment that exist for minority patients. By analyzing the main causes of treatment failure and promoting respect for individual and cultural values, this book effectively teaches readers to provide responsive, patient-centered care and devise preventive strategies for minority communities. Comprehensive chapters contributed by physicians with extensive experience dealing with HIV/AIDS in minority communities cover issues as far-reaching as: anti-retroviral therapy; dermatologic manifestations and co-morbidities of the disease in patients of color; unique risks to women and MSMs of color; participation of minority cases in HIV research; and substance abuse and mental health issues.

Alongside globalization, the sense of vulnerability among people and populations has increased. We feel vulnerable to disease as new infections spread rapidly across the globe, while disasters and climate change make health increasingly precarious. Moreover, clinical trials of new drugs often exploit vulnerable populations in developing countries that otherwise have no access to healthcare and new genetic technologies make people with disabilities vulnerable to discrimination. Therefore the concept of ‘vulnerability’ has contributed new ideas to the debates about the ethical dimensions of medicine and healthcare. This book explains and elaborates the new concept of vulnerability in today’s bioethics. Firstly, Henk ten Have argues that vulnerability cannot be fully understood within the framework of individual autonomy that dominates mainstream bioethics today: it is often not the individual person who is vulnerable, rather that his or her vulnerability is created through the social and economic conditions in which he or she lives. Contending that the language of vulnerability offers perspectives beyond the traditional autonomy model, this book offers a new approach which will enable bioethics to evolve into a global enterprise. This groundbreaking book critically analyses the concept of vulnerability as a global phenomenon. It will appeal to scholars and students of ethics, bioethics, globalization, healthcare, medical science, medical research, culture, law, and politics.

In June 1993 a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although all the remaining patients were contacted and told to stop taking their medication, six more subsequently developed severe toxicity. Five patients died, and two others were probably saved from death only by having liver transplants. In response to a request from the Secretary of the Department of Health and Human Services, the IOM committee has analyzed the FIAU clinical trials, making recommendations for additional safeguards for the conduct of future clinical trials. This evaluation included the review of documents pertaining to investigational new drug submissions, protocols and consent forms from other clinical trials, as well as information available from other clinical and preclinical experience with compounds related to FIAU and its parent drug, fiacitibine (FIAC), which is metabolized to FIAU. The committee does not seek to affix responsibility for the adverse outcome of this NIH trial, but instead focuses on whether any rules or procedures governing the clinical trials process itself need to be changed, and if so, what burdens or costs such changes might place on future clinical trials.

Clinical Trials in Older Adults is the first book to consider the methodological issues underlying the evaluation of new treatments in older people. Provides information on the methodology, monitoring and regulations for those planning to conduct a clinical trials involving older adults Contains examples of ongoing trials involving older adults, and presents the main characteristics of many recently published Depicts how the issues regarding older adults in clinical trials could be properly addressed with the appropriate study design and conduct Identifies key issues in performing clinical trials in older patients with common geriatric conditions, i.e. Alzheimer’s dementia, depression, low muscle mass, cancer