Download or read book Clinical Research Involving Pregnant Women written by Françoise Baylis and published by Springer. This book was released on 2017-01-02 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses ‘how’ to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in clinical research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials.
Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
Download or read book Clinical Pharmacology During Pregnancy written by Donald Mattison and published by Academic Press. This book was released on 2012-12-05 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Pharmacology During Pregnancy is written for clinicians, physicians, midwives, nurses, pharmacists and other medical professionals directly involved in the care of women during pregnancy. This book focuses on the impact of pregnancy on drug disposition and also includes coverage of treatments for diseases of specific body systems, as well as essential content on dosing and efficacy. Written in a clear and practical manner, this reference provides easily accessible information and clinical guidance on how best to treat women with medications during pregnancy.
Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Safety and Quality of Abortion Care in the United States written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-05-24 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: Abortion is a legal medical procedure that has been provided to millions of American women. Since the Institute of Medicine first reviewed the health implications of national legalized abortion in 1975, there has been a plethora of related scientific research, including well-designed randomized clinical trials, systematic reviews, and epidemiological studies examining abortion care. This research has focused on examining the relative safety of abortion methods and the appropriateness of methods for different clinical circumstances. With this growing body of research, earlier abortion methods have been refined, discontinued, and new approaches have been developed. The Safety and Quality of Abortion Care in the United States offers a comprehensive review of the current state of the science related to the provision of safe, high-quality abortion services in the United States. This report considers 8 research questions and presents conclusions, including gaps in research.
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Research on the Fetus Appendix written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1975 with total page 876 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Turnaway Study written by Diana Greene Foster and published by Simon and Schuster. This book was released on 2021-06 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Now with a new afterword by the author"--Back cover.
Download or read book The Making of the Unborn Patient written by Monica J. Casper and published by Rutgers University Press. This book was released on 1998 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is now possible for physicians to recognize that a pregnant woman's fetus is facing life-threatening problems, perform surgery on the fetus, and if it survives, return it to the woman's uterus to finish gestation. Although fetal surgery has existed in various forms for three decades, it is only just beginning to capture the public's imagination. These still largely experimental procedures raise all types of medical, political and ethical questions. The Making of the Unborn Patient examines two important and connected events of the second half of the 20th century: the emergence of fetal surgery as a new medical specialty and the debut of the unborn patient.
Download or read book WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience written by World Health Organization and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Within the continuum of reproductive health care, antenatal care provides a platform for important health-care functions, including health promotion, screening and diagnosis, and disease prevention. It has been established that, by implementing timely and appropriate evidence-based practices, antenatal care can save lives. Endorsed by the United Nations Secretary-General, this is a comprehensive WHO guideline on routine antenatal care for pregnant women and adolescent girls. It aims to complement existing WHO guidelines on the management of specific pregnancy-related complications. The guidance captures the complex nature of the antenatal care issues surrounding healthcare practices and delivery, and prioritizes person-centered health and well-being --- not only the prevention of death and morbidity --- in accordance with a human rights-based approach.
Download or read book Research on Women s Health written by and published by . This book was released on 1997 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Weighing the Future written by Natali Valdez and published by Univ of California Press. This book was released on 2021-12-14 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: Epigenetics, the study of heritable changes in gene expression, has been heralded as one of the most promising new fields of scientific inquiry. Current large-scale studies selectively draw on epigenetics to connect behavioral choices made by pregnant people, such as diet and exercise, to health risks for future generations. As the first ethnography of its kind, Weighing the Future examines the sociopolitical implications of ongoing pregnancy trials in the United States and the United Kingdom, illuminating how processes of scientific knowledge production are linked to capitalism, surveillance, and environmental reproduction. Natali Valdez argues that a focus on individual behavior rather than social environments ignores the vital impacts of systemic racism. The environments we imagine to shape our genes, bodies, and future health are intimately tied to race, gender, and structures of inequality. This groundbreaking book makes the case that science, and how we translate it, is a reproductive project that requires feminist vigilance. Instead of fixating on a future at risk, this book brings attention to the present at stake.
Download or read book Pregnancy and the Pharmaceutical Industry written by Kristine E. Shields and published by Academic Press. This book was released on 2019-06-17 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pregnancy and the Pharmaceutical Industry: The Movement Toward Evidence-based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials with pregnant women. There is currently a lack of data on the safety and effectiveness of medications used during pregnancy as it is impossible to extrapolate that information from drug studies on men and non-pregnant women. As a majority of pregnant women confront a medical condition during their pregnancy, from simple pain, to ongoing or new medical issues, this book quantifies the current absence of pregnant women in drug studies and identifies ethical issues, barriers, litigation fears and opportunities. Those in the pharmaceutical industry, IRB members who approve or deny drug study plans, doctors, nurses and midwives working in obstetrics or involved in conducting studies at their institutions will find this book an essential resource. Explores the medical, ethical, scientific and legal rationales behind the inclusion of pregnant women in drug studies Describes how pharma and biotech companies can safely implement the new FDA guidance and begin to include pregnant women in drug testing Shares views from pharmaceutical industry insiders about company risks, reluctance to implement guidance, and the ultimate need to include pregnant women in studies
Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies. Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation. The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.
Download or read book Birth Settings in America written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-05-01 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: The delivery of high quality and equitable care for both mothers and newborns is complex and requires efforts across many sectors. The United States spends more on childbirth than any other country in the world, yet outcomes are worse than other high-resource countries, and even worse for Black and Native American women. There are a variety of factors that influence childbirth, including social determinants such as income, educational levels, access to care, financing, transportation, structural racism and geographic variability in birth settings. It is important to reevaluate the United States' approach to maternal and newborn care through the lens of these factors across multiple disciplines. Birth Settings in America: Outcomes, Quality, Access, and Choice reviews and evaluates maternal and newborn care in the United States, the epidemiology of social and clinical risks in pregnancy and childbirth, birth settings research, and access to and choice of birth settings.
